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1. Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

Author

David H. Johnson, Roy S. Herbst, Corey J. Langer, Louis Fehrenbacher, William Novotny, Eric Holmgren, Jacques Gaudreault, John Nemunaitis, David M. Jablons, Fairooz F. Kabbinavar, Russell F. DeVore, and Lisa A. Damico

Subjects
Male, medicine.medical_specialty, Cancer Research, Lung Neoplasms, Bevacizumab, Paclitaxel, Urology, Antibodies, Monoclonal, Humanized, Carboplatin, chemistry.chemical_compound, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Carcinoma, Motesanib, Humans, Lung cancer, Proportional Hazards Models, Dose-Response Relationship, Drug, business.industry, Area under the curve, Antibodies, Monoclonal, medicine.disease, Survival Analysis, Surgery, chemistry, Oncology, Female, business, medicine.drug, Necitumumab
Abstract

Purpose To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer. Patients and Methods In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m2) every 3 weeks or carboplatin and paclitaxel alone (n = 32). Primary efficacy end points were time to disease progression and best confirmed response rate. On disease progression, patients in the control arm had the option to receive single-agent bevacizumab 15 mg/kg every 3 weeks. Results Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels. Conclusion Bevacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer. Patients with nonsquamous cell histology appear to be a subpopulation with improved outcome and acceptable safety risks.

Published
2023

2. Postoperative Chemotherapy Use and Outcomes From ADAURA: Osimertinib as Adjuvant Therapy for Resected EGFR-Mutated NSCLC

Author

Konstantin Laktionov, Chong-Jen Yu, Kye Young Lee, Frances A. Shepherd, Roy S. Herbst, Filippo de Marinis, Yi-Long Wu, Zhijie Wang, Jonathan W. Goldman, Charuwan Akewanlop, Christian Grohé, Terufumi Kato, Thomas John, Huu Vinh Vu, Margarita Majem, Laura Bonanno, Ajlan Atasoy, Masahiro Tsuboi, Lingmin Zeng, Sang-We Kim, Shun Lu, and Manuel Domine

Subjects
Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, Randomization, EGFR, medicine.medical_treatment, Population, Disease, NSCLC, Placebo, EGFR-TKI, Carcinoma, Non-Small-Cell Lung, Internal medicine, Adjuvant therapy, Humans, Medicine, Osimertinib, Stage (cooking), education, Acrylamides, education.field_of_study, Aniline Compounds, business.industry, Adjuvant chemotherapy, ErbB Receptors, Chemotherapy, Adjuvant, Mutation, business, Adjuvant
Abstract

Introduction: Adjuvant chemotherapy is recommended in patients with resected stages II to IIIA (and select IB) NSCLC; however, recurrence rates are high. In the phase 3 ADAURA study (NCT02511106), osimertinib was found to have a clinically meaningful improvement in disease-free survival (DFS) in patients with resected stages IB to IIIA EGFR-mutated (EGFRm) NSCLC. Here, we report prespecified and exploratory analyses of adjuvant chemotherapy use and outcomes from ADAURA. Methods: Patients with resected stages IB to IIIA EGFRm NSCLC were randomized 1:1 to receive osimertinib or placebo for 3 years. Adjuvant chemotherapy before randomization was not mandatory, per physician and patient choice. DFS in the overall population (IB-IIIA), with and without adjuvant chemotherapy, was a prespecified analysis. Exploratory analyses included the following: adjuvant chemotherapy use by patient age, disease stage, and geographic location; DFS by adjuvant chemotherapy use and disease stage. Results: Overall, 410 of 682 patients (60%) received adjuvant chemotherapy (osimertinib, n = 203; placebo, n = 207) for a median duration of 4.0 cycles. Adjuvant chemotherapy use was more frequent in patients: aged less than 70 years (338 of 509; 66%) versus more than or equal to 70 years (72 of 173; 42%); with stages II to IIIA (352 of 466; 76%) versus stage IB (57 of 216; 26%); and enrolled in Asia (268 of 414; 65%) versus outside of Asia (142 of 268; 53%). A DFS benefit favoring osimertinib versus placebo was observed in patients with (DFS hazard ratio = 0.16, 95% confidence interval: 0.10-0.26) and without adjuvant chemotherapy (hazard ratio = 0.23, 95% confidence interval: 0.13-0.40), regardless of disease stage. Conclusions: These findings support adjuvant osimertinib as an effective treatment for patients with stages IB to IIIA EGFRm NSCLC after resection, with or without previous adjuvant chemotherapy. (C) 2021 International Association for the Study of Lung Cancer. Published by Elsevier Inc.

Published
2022

3. Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN)

Author

Karen Kelly, Kate Watabayashi, Vassiliki A. Papadimitrakopoulou, Monica Yee, Meghna S. Trivedi, Dawn L. Hershman, Scott D. Ramsey, David R. Gandara, Judy Johnson, Roy S. Herbst, Deborah M Delaney, Parth D. Shah, Donald L. Patrick, Paul Litwin, Joshua A. Roth, Katherine D. Crew, Joseph M. Unger, Mary W. Redman, and Stacy W. Gray

Subjects
Male, Oncology, medicine.medical_specialty, Lung Neoplasms, Sociodemographic Factors, MEDLINE, Pilot Projects, ORIGINAL CONTRIBUTIONS, 03 medical and health sciences, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, 030212 general & internal medicine, Protocol (science), Motivation, Oncology (nursing), business.industry, Health Policy, Genomics, Clinical trial, 030220 oncology & carcinogenesis, Biomarker (medicine), Female, business, Biomarkers
Abstract

PURPOSE: Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to participants. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung Cancer Master Protocol (Lung-MAP). METHODS: Eligible participants with previously treated advanced non–small-cell lung cancer were recruited from patients enrolled in Lung-MAP. Participants completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent. The survey assessed understanding about the benefits and risks of Lung-MAP participation and knowledge of the potential uses of somatic testing results returned. Descriptive statistics and odds ratios for associations between demographic factors and correct responses to survey items were assessed. RESULTS: From August 1, 2017, to June 30, 2019, we recruited 207 participants with a median age of 67, 57.3% male, and 94.2% White. Most participants “strongly/somewhat agreed” with statements that they “received enough information to understand” Lung-MAP benefits (82.6%) and risks (69.5%). In items asking about potential uses of Lung-MAP genomic results, 87.0% correctly indicated that the results help to select cancer treatment, but < 20% correctly indicated that the results are not used to confirm cancer diagnosis, would not reveal risk of developing diseases besides cancer, and would not indicate if family members had increased cancer risk. There were no associations between sociodemographic factors and proportions providing correct responses. CONCLUSION: In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study despite most indicating that they had enough information to understand benefits and risks.

Published
2021

4. Multiparameter diagnostic sensor measurements in heart failure patients presenting with SARS‐CoV‐2 infection

Author

Viktoria A. Averina, Roy S Gardner, Qi An, Rezwan Ahmed, Adrian F. Hernandez, John P. Boehmer, Robert Capodilupo, and Craig Stolen

Subjects
medicine.medical_specialty, Respiratory rate, Heart failure, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, COVID‐19, Original Research Articles, Internal medicine, Heart rate, medicine, Humans, Diseases of the circulatory (Cardiovascular) system, Decompensation, Original Research Article, 030212 general & internal medicine, Retrospective Studies, SARS-CoV-2, business.industry, ICD, COVID-19, medicine.disease, SARS‐Cov‐2, respiratory tract diseases, Hospitalization, Pneumonia, Ambulatory monitoring, Heart sounds, RC666-701, Rapid shallow breathing index, Breathing, Cardiology, CRT, sense organs, Cardiology and Cardiovascular Medicine, business
Abstract

Aims Implantable device‐based sensor measurements including heart sounds, markers of ventilation, and thoracic impedance have been shown to predict heart failure (HF) hospitalizations. We sought to assess how these parameters changed prior to COVID‐19 (Cov‐19) and how these compared with those presenting with decompensated HF or pneumonia. Methods and results This retrospective analysis explores patterns of changes in daily measurements by implantable sensors in 10 patients with Cov‐19 and compares these findings with those observed prior to HF (n = 88) and pneumonia (n = 12) hospitalizations from the MultiSENSE, PREEMPT‐HF, and MANAGE‐HF trials. The earliest sensor changes prior to Cov‐19 were observed in respiratory rate (6 days) and temperature (5 days). There was a three‐fold to four‐fold greater increase in respiratory rate, rapid shallow breathing index, and night heart rate compared with those presenting with HF or pneumonia. Furthermore, activity levels fell more in those presenting with Cov‐19, a change that was often sustained for some time. In contrast, there were no significant changes in 1st or 3rd heart sound (S1 and S3) amplitude in those presenting with Cov‐19 or pneumonia compared with the known changes that occur in HF decompensation. Conclusions Multi‐sensor device diagnostics may provide early detection of Cov‐19, distinguishable from worsening HF by an extreme and fast rise in respiratory rate along with no changes in S3.

Published
2021

5. Predicting symptomatic mesenteric mass in small intestinal neuroendocrine tumors using radiomics

Author

Stefan Klein, Roy S. Dwarkasing, Gaston J H Franssen, Johannes Hofland, Anela Blazevic, Wiro J. Niessen, Richard A Feelders, Tessa Brabander, Martijn P. A. Starmans, Renza A. H. van Gils, Wouter W. de Herder, Internal Medicine, Radiology & Nuclear Medicine, Surgery, and Medical Informatics

Subjects
Cancer Research, medicine.medical_specialty, business.industry, Mesenteric mass, Endocrinology, Diabetes and Metabolism, Neuroendocrine tumors, medicine.disease, Asymptomatic, Clinical Practice, Neuroendocrine Tumors, Endocrinology, medicine.anatomical_structure, Oncology, Radiomics, SDG 3 - Good Health and Well-being, Humans, Medicine, Tumor board, Radiology, medicine.symptom, business, Mesentery, Clinical evaluation, Retrospective Studies
Abstract

Metastatic mesenteric masses of small intestinal neuroendocrine tumors (SI-NETs) are known to often cause intestinal complications. The aim of this study was to identify patients at risk to develop these complications based on routinely acquired CT scans using a standardized set of clinical criteria and radiomics. Retrospectively, CT scans of SI-NET patients with a mesenteric mass were included and systematically evaluated by five clinicians. For the radiomics approach, 1128 features were extracted from segmentations of the mesenteric mass and mesentery, after which radiomics models were created using a combination of machine learning approaches. The performances were compared to a multidisciplinary tumor board (MTB). The dataset included 68 patients (32 asymptomatic, 36 symptomatic). The clinicians had AUCs between 0.62 and 0.85 and showed poor agreement. The best radiomics model had a mean AUC of 0.77. The MTB had a sensitivity of 0.64 and specificity of 0.68. We conclude that systematic clinical evaluation of SI-NETs to predict intestinal complications had a similar performance than an expert MTB, but poor inter-observer agreement. Radiomics showed a similar performance and is objective, and thus is a promising tool to correctly identify these patients. However, further validation is needed before the transition to clinical practice.

Published
2021

6. Communication and Interaction With Semiautonomous Ground Vehicles by Force Control Steering

Author

Tim Smith, Frank Flemisch, Qinggang Meng, Timothy Gordon, Miguel Martinez-Garcia, Roy S. Kalawsky, and Publica

Subjects
Computer science, business.industry, Control (management), Stability (learning theory), 020206 networking & telecommunications, 02 engineering and technology, Steering wheel, Ground vehicles, H670 Robotics and Cybernetics, Transfer function, Automation, Computer Science Applications, H330 Automotive Engineering, Human-Computer Interaction, Control and Systems Engineering, Control theory, Steering system, 0202 electrical engineering, electronic engineering, information engineering, Torque, 020201 artificial intelligence & image processing, Electrical and Electronic Engineering, business, Software, H660 Control Systems, Information Systems
Abstract

While full automation of road vehicles remains a future goal, shared-control and semi-autonomous driving – involving transitions of control between the human and the machine – are more feasible objectives in the near term. These alternative driving modes will benefit from new research towards novel steering control devices, more suitable where the machine intelligence controls only partially the vehicle. In this paper it is proposed that when the human shares the control of a vehicle with an autonomous or semi-autonomous system, a force control or non-displacement steering wheel (i.e., a steering wheel which does not rotate but detects the applied torque by the human driver) can be advantageous under certain schemes: tight rein or loose rein modes according to the Hmetaphor. We support this proposition with the first experiments, to the best of our knowledge, in which human participants drove in a simulated road scene with a force control steering wheel. The experiments exhibited that humans can adapt promptly to force control steering and are able to control the vehicle smoothly. Different transfer functions are tested, which translate the applied torque at the force control steering wheel to the steering angle at the wheels of the vehicle; it is shown that fractional order transfer functions increment steering stability and control accuracy when using a force control device. Transition of control experiments are also performed with both, a conventional and a force control steering wheel. This prototypical steering system can be realized via steer-by-wire controls, which are already incorporated in commercially available vehicles.

Published
2021

7. Toward personalized treatment approaches for non-small-cell lung cancer

Author

Meina Wang, Roy S. Herbst, and Chris Boshoff

Subjects
medicine.medical_specialty, Combination therapy, business.industry, medicine.medical_treatment, Personalized treatment, General Medicine, Immunotherapy, medicine.disease, Precision medicine, General Biochemistry, Genetics and Molecular Biology, respiratory tract diseases, Clinical research, medicine, DECIPHER, Non small cell, Lung cancer, Intensive care medicine, business
Abstract

Worldwide, lung cancer is the most common cause of cancer-related deaths. Molecular targeted therapies and immunotherapies for non-small-cell lung cancer (NSCLC) have improved outcomes markedly over the past two decades. However, the vast majority of advanced NSCLCs become resistant to current treatments and eventually progress. In this Perspective, we discuss some of the recent breakthrough therapies developed for NSCLC, focusing on immunotherapies and targeted therapies. We highlight our current understanding of mechanisms of resistance and the importance of incorporating genomic analyses into clinical studies to decipher these further. We underscore the future role of neoadjuvant and maintenance combination therapy approaches to potentially cure early disease. A major challenge to successful development of rational combination therapies will be the application of robust predictive biomarkers for clear-cut patient stratification, and we provide our views on clinical research areas that could influence how NSCLC will be managed over the coming decade.

Published
2021

8. Pharmacological secondary prevention of MI

Author

Simon Beggs and Roy S Gardner

Subjects
Secondary prevention, medicine.medical_specialty, business.industry, Medicine, Pharmacology (medical), Pharmacology (nursing), business, Intensive care medicine
Published
2021

9. Targeted therapies for resectable lung adenocarcinoma: ADAURA opens for thoracic oncologic surgeons

Author

Masahiro Tsuboi, Roy S. Herbst, Yi-Long Wu, and David R. Jones

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, Adenocarcinoma of Lung, Antineoplastic Agents, medicine, Humans, Osimertinib, Molecular Targeted Therapy, Pneumonectomy, Randomized Controlled Trials as Topic, Acrylamides, Aniline Compounds, Lung, business.industry, Gene Expression Profiling, Prognosis, medicine.disease, ErbB Receptors, medicine.anatomical_structure, Chemotherapy, Adjuvant, Mutation, Adenocarcinoma, Surgery, Radiology, Cardiology and Cardiovascular Medicine, business
Published
2021

10. Selecting the optimal immunotherapy regimen in driver-negative metastatic NSCLC

Author

Michael J. Grant, Sarah B. Goldberg, and Roy S. Herbst

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Chemotherapy, business.industry, medicine.medical_treatment, MEDLINE, Immunotherapy, medicine.disease, Optimal management, Clinical trial, 03 medical and health sciences, Regimen, 030104 developmental biology, 0302 clinical medicine, Cancer immunotherapy, 030220 oncology & carcinogenesis, Internal medicine, medicine, business, Lung cancer
Abstract

The treatment landscape of driver-negative non-small-cell lung cancer (NSCLC) is rapidly evolving. Immune-checkpoint inhibitors, specifically those targeting PD-1 or PD-L1, have demonstrated durable efficacy in a subset of patients with NSCLC, and these agents have become the cornerstone of first-line therapy. Approved immunotherapeutic strategies for treatment-naive patients now include monotherapy, immunotherapy-exclusive regimens or chemotherapy–immunotherapy combinations. Decision making in this space is complex given the absence of head-to-head prospective comparisons, although a thorough analysis of long-term efficacy and safety data from pivotal clinical trials can provide insight into the optimal management of each subset of patients. Indeed, histological subtype and the extent of tumour cell PD-L1 expression are paramount to regimen selection, although other clinicopathological factors and patient preferences might also be relevant in certain scenarios. Finally, several emerging biomarkers and novel therapeutic strategies are currently under investigation, and these might further refine the current treatment paradigm. In this Review, we discuss the current treatment landscape and detail our approach to first-line immunotherapy regimen selection for patients with advanced-stage, driver-negative NSCLC. Immune-checkpoint inhibitors (ICIs) are now standard-of-care therapies for patients with advanced-stage non-small-cell lung cancer (NSCLC) without a targetable driver alteration. Various ICIs or combination regimens have been approved in this setting, relative to chemotherapy, although no prospective data are available comparing the various ICI-based approaches. Here, the authors provide guidance on selecting the optimal ICI-based therapy and highlight several future research directions that will probably further improve the outcomes of patients with advanced-stage NSCLC.

Published
2021

11. Predicting Camera Color Quality

Author

Roy S. Berns

Subjects
Color quality, business.industry, Computer science, General Engineering, Computer vision, Artificial intelligence, business
Published
2021

12. Real‐world outcomes in cardiac resynchronization therapy patients: design and baseline demographics of the SMART‐ Registry

Author

Sara Veraghtert, Daniel Gras, George Mark, Roy S Gardner, Antonio D'Onofrio, Ignacio García-Bolao, and Yan Hu

Subjects
medicine.medical_specialty, Registry, lcsh:Diseases of the circulatory (Cardiovascular) system, New York Heart Association Class, medicine.medical_treatment, Population, Study Designs, Cardiac resynchronization therapy, Heart failure, 030204 cardiovascular system & hematology, Cardiac Resynchronization Therapy, 03 medical and health sciences, 0302 clinical medicine, Quality of life, medicine, Clinical endpoint, Humans, 030212 general & internal medicine, Prospective Studies, Registries, education, Response rate (survey), education.field_of_study, Study Design, business.industry, Left ventricular systolic dysfunction, medicine.disease, Prognosis, Europe, lcsh:RC666-701, Emergency medicine, Quality of Life, CRT, Observational study, Cardiology and Cardiovascular Medicine, business
Abstract

Aims The SMART (Strategic MAnagement to optimize response to cardiac Resynchronization Therapy) Registry was designed to assess real‐world outcomes for patients receiving a cardiac resynchronization therapy defibrillator (CRT‐D) and to better understand which programming and optimization techniques are used and how effective they are. Methods and results The SMART Registry is a global, multicentre, prospective, observational, post‐market CRT‐D registry with a planned enrolment of 2000 subjects from a maximum of 200 sites in Europe, North America, and Asia‐Pacific region. Each subject will be followed up for a minimum of 12 months. The primary endpoint of CRT response rate at 12 months is defined by a clinical composite score of all‐cause mortality, heart failure events, New York Heart Association Class, and quality of life as assessed by a patient global assessment instrument. A subgroup composed of the first 103 consecutive European subjects implanted with an NG4 device will have left ventricular multisite pacing feature enabled at any time during the initial 12 months of follow‐up. The primary endpoint for this sub‐analysis will be the NG4 PG‐related complication‐free rate at 36 months. Conclusions The SMART Registry achieved its recruitment target in August 2019, with 2014 patients enrolled. The baseline demographics demonstrated that patients were generally older, with greater co‐morbidity, and on more contemporary medical therapy than in the key CRT trials. The results of the SMART Registry will determine which programming and optimization techniques are effective in this real‐world population.

Published
2021

13. A US Population Health Survey on the Impact of COVID-19 Using the EQ-5D-5L

Author

Ning Yan Gu, Nadine K. Zawadzki, A. Simon Pickard, Xiayu Jiao, Roy S. Zawadzki, Feng Xie, S. Crawford, Cynthia L. Gong, and Joel W. Hay

Subjects
Adult, Adolescent, Health Status, Population, Population health, 01 natural sciences, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Quality of life, EQ-5D, Surveys and Questionnaires, Internal Medicine, Humans, Medicine, Medical history, 030212 general & internal medicine, 0101 mathematics, Young adult, education, Pandemics, Aged, Original Research, education.field_of_study, Population Health, SARS-CoV-2, business.industry, 010102 general mathematics, COVID-19, Middle Aged, Mental health, Quality of Life, Underweight, medicine.symptom, business, Demography
Abstract

Background The COVID-19 pandemic has resulted in negative impacts on the economy, population health, and health-related quality-of-life (HRQoL). Objective To assess the impact of COVID-19 on US population HRQoL using the EQ-5D-5L. Design We surveyed respondents on physical and mental health, demographics, socioeconomics, brief medical history, current COVID-19 status, sleep, dietary, financial, and spending changes. Results were compared to online and face-to-face US population norms. Predictors of EQ-5D-5L utility were analyzed using both standard and post-lasso OLS regressions. Robustness of regression coefficients against unmeasured confounding was analyzed using the E-Value sensitivity analysis. Subjects Amazon MTurk workers (n=2776) in the USA. Main Measures EQ-5D-5L utility and VAS scores by age group. Key Results We received n=2746 responses. Subjects 18–24 years reported lower mean (SD) health utility (0.752 (0.281)) compared with both online (0.844 (0.184), p=0.001) and face-to-face norms (0.919 (0.127), p

Published
2021

14. 2021 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure

Author

John G F Cleland, A J S Coats, Marco Metra, John J.V. McMurray, Anne Kathrine Skibelund, Dimitrios Farmakis, Haran Burri, Tiny Jaarsma, Martine Gilard, Massimo F Piepoli, Roy S. Gardner, Frank Ruschitzka, Michael Böhm, Carolyn S.P. Lam, Javed Butler, Susanna Price, Andreas Baumbach, Ovidiu Chioncel, Alexander R. Lyon, Claudio Muneretto, Theresa McDonagh, Marianna Adamo, Jelena Čelutkienė, Ewa A. Jankowska, Alexandre Mebazaa, Giuseppe M.C. Rosano, Maria G Crespo-Leiro, Arno W. Hoes, Richard Mindham, Mitja Lainscak, Stephane Heymans, Cardiologie, MUMC+: MA Med Staf Spec Cardiologie (9), RS: Carim - H02 Cardiomyopathy, Mcdonagh, Theresa A, Metra, Marco, Adamo, Marianna, Gardner, Roy S, Baumbach, Andrea, Böhm, Michael, Burri, Haran, Butler, Javed, Čelutkienė, Jelena, Chioncel, Ovidiu, Cleland, John G F, Coats, Andrew J S, Crespo-Leiro, Maria G, Farmakis, Dimitrio, Gilard, Martine, Heymans, Stephane, Hoes, Arno W, Jaarsma, Tiny, Jankowska, Ewa A, Lainscak, Mitja, Lam, Carolyn S P, Lyon, Alexander R, Mcmurray, John J V, Mebazaa, Alexandre, Mindham, Richard, Muneretto, Claudio, Francesco Piepoli, Massimo, Price, Susanna, Rosano, Giuseppe M C, Ruschitzka, Frank, and Kathrine Skibelund, Anne

Subjects
diagnosis, medicine.medical_treatment, heart failure, cardiac resynchronization therapy, Guideline, neuro-hormonal antagonist, pharmacotherapy, VENTRICULAR ASSIST DEVICE, QUALITY-OF-LIFE, multidisciplinary management, Medicine, ejection fraction, CARDIAC-RESYNCHRONIZATION THERAPY, Ejection fraction, advanced heart failure, transplantation, Guidelines, acute heart failure, arrhythmias, comorbidities, hospitalization, mechanical circulatory support, natriuretic peptides, neuro-hormonal antagonists, Chronic Disease, Humans, Stroke Volume, Cardiac Resynchronization Therapy, Heart Failure, diagnosi, PRESERVED EJECTION FRACTION, BRAIN NATRIURETIC PEPTIDE, Cardiology, CORONARY-ARTERY-DISEASE, Cardiology and Cardiovascular Medicine, medicine.medical_specialty, comorbiditie, ACUTE MYOCARDIAL-INFARCTION, IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR, Cardiac resynchronization therapy, arrhythmia, Pharmacotherapy, Internal medicine, natriuretic peptide, business.industry, guidelines, medicine.disease, WORSENING RENAL-FUNCTION, Transplantation, Heart failure, AORTIC-VALVE-REPLACEMENT, business
Abstract

These are the clinical practice guidelines from the European Society of Cardiology for the diagnosis and treatment of acute and chronic heart failure, from 2021.

Published
2021

15. Multiparameter diagnostic sensor measurements during clinically stable periods and worsening heart failure in ambulatory patients

Author

Gabor Zoltan Duray, Devi Nair, Zayd Eldadah, Viktoria A. Averina, Pramodsingh H. Thakur, Branislav Stancak, Qi An, Yi Zhang, John P. Boehmer, Eric Hammill, Charn Sriratanasathavorn, Kevin J. Ferrick, Roy S Gardner, and Ramesh Wariar

Subjects
Male, lcsh:Diseases of the circulatory (Cardiovascular) system, medicine.medical_specialty, Population, Prognostication, Decompensation, 030204 cardiovascular system & hematology, 03 medical and health sciences, 0302 clinical medicine, Heart Rate, Internal medicine, Original Research Articles, Heart rate, medicine, Humans, 030212 general & internal medicine, Original Research Article, education, Third heart sound, Aged, Heart Failure, education.field_of_study, Ejection fraction, business.industry, Weight change, medicine.disease, Hospitalization, Ambulatory monitoring, lcsh:RC666-701, Heart failure, Ambulatory, Cardiology, CRT, Cardiology and Cardiovascular Medicine, business
Abstract

Aims This study aims to characterize the range of implantable device‐based sensor values including heart sounds, markers of ventilation, thoracic impedance, activity, and heart rate for patients with heart failure (HF) when patients were deemed to be in clinically stable periods against the time course of acute decompensation and recovery from HF events. Methods and results The MultiSENSE trial followed 900 patients implanted with a COGNIS CRT‐D for up to 1 year. Chronic, ambulatory diagnostic sensor data were collected and evaluated during clinically stable periods (CSP: unchanged NYHA classification, no adverse events, and weight change ≤2.27 kg), and in the timeframe leading up to and following HF events (HF admissions or unscheduled visits with intravenous HF treatment). Physiologic sensor data from 1667 CSPs occurring in 676 patients were compared with those data leading up to and following 192 HF events in 106 patients. Overall, the mean age was 66.6 years, and the population were predominantly male (73%). Patients were primarily in NYHA II (67%), with a mean LVEF of 29.6% and median NT‐proBNP of 754.5 pg/mL. Sensor values during CSP were poorer in patients who had HF events during the study period than those without HF events, including first heart sound (S1: 2.18 ± 0.84 mG vs. 2.62 ± 0.95 mG, P = 0.002), third heart sound (S3: 1.13 ± 0.36 mG vs. 0.91 ± 0.30 mG, P

Published
2021

16. ROLE OF INTER LEUKIN 10 AND TUMOR NECROSIS FACTOR-ΑLPHA IN PANCREATITIS

Author

Mukherjee.J. R, Mukherjee. B, Roy. S, Jana. D, Bandopadhyay. S, and Mukhopadhyay. M

Subjects
03 medical and health sciences, 0302 clinical medicine, business.industry, 030220 oncology & carcinogenesis, Cancer research, Medicine, 030211 gastroenterology & hepatology, Tumor necrosis factor alpha, business
Abstract

Background: Pancreatic acinar cell injury triggers the synthesis and release of pro-inammatory cytokines and chemokines. The involvement of several pro-inammatory and anti-inammatory cytokines, such as in interleukin (IL)-1, IL-1β, IL-6, IL-8, IL-10, IL-18, IL-33 and tumor necrosis factor-α is involved in the pathogenesis of pancreatitis. Aim: This study aims to validate the role of activation of TNF-alpha and IL-10 as a biomaker marker in patients with Pancreatitis in Indian subcontinent.Material and methods: 50 Patients of Pancreatitis attending general surgery OPD and admitted to General Surgery department of SSKM Hospital, Kolkata, West Bengal, India were taken. Result: It was found that in alcoholic, the mean TNF - α (mean±s.d.) of the patients was 19.4027 ± 8.3275 pg/ml. In ascites, the mean TNF - α (mean±s.d.) of the patients was 19.9767 ± 2804 pg/ml. In chronic, the mean TNF - α (mean±s.d.) of the patients was 18.8533 ± 8.4674 pg/ml. In gall stone, the mean TNF - α (mean±s.d.) of the patients was 16.3421 ± 9.9499 pg/ml. In osteoarthritis, the mean TNF - α (mean±s.d.) of the patients was 12.4750 ± 8.3085 pg/ml. Distribution of mean TNF - α vs. association was not statistically signicant (p=0.7309).Conclusion: It was found that IL10 was higher in Ascites patients though it was not statistically signicant. TNF alpha was higher in Ascites patients. TNF alpha was higher in normal Pancreatitis.

Published
2021

17. Comprehensive Adult Medical Eye Evaluation Preferred Practice Pattern®

Author

David C. Musch, Kevin M. Miller, Francis S. Mah, Steven P. Dunn, Steven J Gedde, David K. Wallace, Christina J. Flaxel, and Roy S. Chuck

Subjects
Adult, medicine.medical_specialty, Eye Diseases, business.industry, Vision Tests, Academies and Institutes, Vision Disorders, MEDLINE, Ophthalmology, Text mining, medicine, Humans, Medical physics, Practice Patterns, Physicians', business, Delivery of Health Care, Physical Examination, Quality of Health Care
Published
2021

18. The classical causes of heart failure

Author

Colette E. Jackson and Roy S Gardner

Subjects
medicine.medical_specialty, business.industry, Internal medicine, Heart failure, Cardiology, Medicine, business, medicine.disease
Abstract

This chapter discusses the ‘classical causes’ of heart failure. Heart failure is the common endpoint of a diverse range of cardiovascular and non-cardiovascular conditions. The list of potential causes of this syndrome continues to expand as the knowledge of the pathophysiology of heart failure increases. In western societies, coronary heart disease and hypertension are the commonest causes of heart failure. However, valvular heart disease, arrhythmias, and alcohol are also frequently implicated. The prevalence of heart failure secondary to coronary heart disease has increased in recent years, due in part to improved survival following acute myocardial infarction. The chapter then highlights the importance of establishing an aetiology of heart failure. Establishing the aetiology of heart failure is important, but it is often challenging for the clinician. Several causes of heart failure frequently coexist and determining the primary aetiology can be difficult: one cause may obviously dominate, but frequently patients may have multiple contributing aetiologies.

Published
2022

19. Broadening the infection prevention and control network globally; 2017 Geneva IPC-think tank (part 3)

Author

Zingg, W, Storr, J, Park, BJ, Jernigan, JA, Harbarth, S, Grayson, ML, Tacconelli, E, Allegranzi, B, Cardo, D, Pittet, D, Abbas, M, Ahmad, R, Ailegranzi, B, Andremont, A, Bell, M, Borg, M, Carmeli, Y, Castro-Sanchez, E, Conly, J, Eggimann, P, Gastmeier, P, Hernandez, M, Hetwaldt, L, Holmes, A, Kilpatrick, C, Kolwaite, A, Krause, K-H, Larson, E, Masson-Roy, S, Mehtar, S, Mendelson, M, Lin, LM, Moldovan, A, Monnet, D, Ndoye, B, Nthumba, P, Ogunsola, F, Park, B, Perencevich, E, Samore, M, Seto, WH, Srinivasan, A, Tarrant, C, Tomczyk, S, Talaat, M, Villegas, MV, Voss, A, Walsh, T, Widmer, A, 2017 Geneva-IPC Think Tank, Abbas, M., Ahmad, R., Allegranzi, B., Andremont, A., Bell, M., Borg, M., Cardo, D., Carmeli, Y., Castro-Sanchez, E., Conly, J., Eggimann, P., Gastmeier, P., Grayson, M.L., Harbarth, S., Hernandez, M., Herwaldt, L., Holmes, A., Jernigan, J.A., Kilpatrick, C., Kolwaite, A., Krause, K.H., Larson, E., Masson-Roy, S., Mehtar, S., Mendelson, M., Lin, L.M., Moldovan, A., Monnet, D., Ndoye, B., Nthumba, P., Ogunsola, F., Park, B., Perencevich, E., Pittet, D., Samore, M., Seto, W.H., Srinivasan, A., Storr, J., Tacconelli, E., Tarrant, C., Tomczyk, S., Talaat, M., Villegas, M.V., Voss, A., Walsh, T., Widmer, A., Zingg, W., Abbas, Mohamed, Conly, John, Eggimann, Philippe, Krause, Karl-Heinz, Moldovan, Andréea Anamaria, Monnet, Dominique Ndiouga, Ndoye, Babacar, Tomczyk, Sara Marie, Widmer, Andréas, NIHR knowledge mobilisation fellowship, and National Institute for Health Research

Subjects
0301 basic medicine, Biomedical Research, Global Health, Antimicrobial Stewardship, WHO, 0302 clinical medicine, ECDC, Drug Resistance, Multiple, Bacterial, Infection control, Antimicrobial stewardship, Hand Hygiene, Pharmacology (medical), 030212 general & internal medicine, Pharmacology & Pharmacy, Intersectoral Collaboration, health care economics and organizations, Public, Environmental & Occupational Health, ddc:616, Cross Infection, Public relations, National, Institutional, Anti-Bacterial Agents, Infectious Diseases, International, Public Health, Life Sciences & Biomedicine, Switzerland, Microbiology (medical), medicine.medical_specialty, Infection prevention and control, 030106 microbiology, Control (management), 2017 Geneva-IPC Think Tank, Change, World Health Organization, Microbiology, lcsh:Infectious and parasitic diseases, 03 medical and health sciences, Patient safety, CDC, Collaboration, Networks, parasitic diseases, Control network, medicine, Humans, lcsh:RC109-216, cardiovascular diseases, Infection Control, Science & Technology, business.industry, Public health, Research, Public Health, Environmental and Occupational Health, International health, United States, Group Processes, QR, Stewardship, Centers for Disease Control and Prevention, U.S, business, RA
Abstract

Background Healthcare-associated infection (HAI) is a major challenge for patient safety worldwide, and is further complicated by antimicrobial resistance (AMR) due to excessive antimicrobial use in both humans and animals. Existing infection prevention and control (IPC) networks must be strengthened and adapted to better address the global challenges presented by emerging AMR. Methods In June 2017, 42 international experts convened in Geneva, Switzerland, to discuss two key areas for strengthening the global IPC network: 1) broadening collaboration in IPC; and 2) how to bring the fields IPC and AMR control together. Results The US Centers for Disease Prevention and Control, the European Centre for Disease Prevention and Control, and the World Health Organization (WHO) convened together with international experts to discuss collaboration and networks, demonstrating the participating organizations’ commitment to close collaboration in IPC. The challenge of emerging AMR can only be addressed by strengthening this collaboration across international organisations and between public health and academia. The WHO SAVE LIVES: Clean Your Hands initiative is an example of a successful collaboration between multiple global stakeholders including academia and international public health organisations; it can be used as a model. IPC-strategies are included within the four pillars to combat AMR: surveillance, IPC, antimicrobial and diagnostic stewardship, research and development. The prevention of transmission of multidrug-resistant microorganisms is a patient safety issue, and must be strengthened in the fight against AMR. Conclusions The working group determined that international organisations should take the lead in creating new networks, which will in turn attract academia and other stakeholders to join. At the same time, they should invest in bringing existing IPC and AMR networks under one umbrella. Transmission of multidrug-resistant microorganisms in hospitals and in the community threatens the success of antimicrobial stewardship programmes, and thus, research and development in IPC should be addressed as an enhanced global priority.

Published
2019

20. Osimertinib in ResectedEGFR-Mutated Non–Small-Cell Lung Cancer

Author

Konstantin Laktionov, Yi-Long Wu, Shun Lu, Kye-Young Lee, Thomas John, Terufumi Kato, Masahiro Tsuboi, Chong-Jen Yu, Jonathan W. Goldman, Manuel Domine, Yuri Rukazenkov, C. Grohe, Lingmin Zeng, Laura Bonanno, Jie He, Huu-Vinh Vu, Sang-We Kim, Frances A. Shepherd, Filippo de Marinis, Margarita Majem, Ajlan Atasoy, Rachel Hodge, Roy S. Herbst, Charuwan Akewanlop, Clinical sciences, Medical Oncology, and Laboratory for Medical and Molecular Oncology

Subjects
Adult, Male, Carcinoma, Non-Small-Cell Lung/drug therapy, ErbB Receptors/genetics, medicine.medical_treatment, 030204 cardiovascular system & hematology, Gene mutation, Protein Kinase Inhibitors/adverse effects, Disease-Free Survival, 03 medical and health sciences, Pneumonectomy, 0302 clinical medicine, Double-Blind Method, Carcinoma, medicine, Aniline Compounds/adverse effects, Humans, Osimertinib, 030212 general & internal medicine, Epidermal growth factor receptor, Lung Neoplasms/drug therapy, Lung cancer, Aged, Neoplasm Staging, Cancer staging, integumentary system, biology, business.industry, Antineoplastic Agents/adverse effects, General Medicine, Middle Aged, Acrylamides/adverse effects, medicine.disease, respiratory tract diseases, Respiratory pharmacology, Chemotherapy, Adjuvant, Lymphatic Metastasis, oncology, Cancer research, biology.protein, Female, mutation, Neoplasm Recurrence, Local, aged, 80 and over, business
Abstract

BACKGROUND: Osimertinib is standard-of-care therapy for previously untreated epidermal growth factor receptor (EGFR) mutation-positive advanced non-small-cell lung cancer (NSCLC). The efficacy and safety of osimertinib as adjuvant therapy are unknown. METHODS: In this double-blind, phase 3 trial, we randomly assigned patients with completely resected EGFR mutation-positive NSCLC in a 1:1 ratio to receive either osimertinib (80 mg once daily) or placebo for 3 years. The primary end point was disease-free survival among patients with stage II to IIIA disease (according to investigator assessment). The secondary end points included disease-free survival in the overall population of patients with stage IB to IIIA disease, overall survival, and safety. RESULTS: A total of 682 patients underwent randomization (339 to the osimertinib group and 343 to the placebo group). At 24 months, 90% of the patients with stage II to IIIA disease in the osimertinib group (95% confidence interval [CI], 84 to 93) and 44% of thosein the placebo group (95% CI, 37 to 51) were alive and disease-free (overall hazard ratio for disease recurrence or death, 0.17; 99.06% CI, 0.11 to 0.26; P

Published
2020

21. Atezolizumab for First-Line Treatment of PD-L1–Selected Patients with NSCLC

Author

Niels Reinmuth, Simonetta Mocci, Filippo de Marinis, Roy S. Herbst, David R. Spigel, Kimberly Komatsubara, Hiroshi Kuriki, Jacek Jassem, Alan Sandler, Mustafa Ozguroglu, Wei Zou, Alain Vergnenegre, Mark McCleland, Giuseppe Giaccone, Enriqueta Felip, X. Wen, Masahiro Morise, Carlos H. Barrios, Yu Deng, Z. Andric, Sarayut Lucien Geater, and Ida Enquist

Subjects
Oncology, medicine.medical_specialty, Chemotherapy, biology, business.industry, medicine.drug_class, medicine.medical_treatment, General Medicine, 030204 cardiovascular system & hematology, medicine.disease, Monoclonal antibody, Clinical trial, 03 medical and health sciences, 0302 clinical medicine, Atezolizumab, Internal medicine, PD-L1, Monoclonal, medicine, Carcinoma, biology.protein, 030212 general & internal medicine, business, Survival analysis
Abstract

Background The efficacy and safety of the anti–programmed death ligand 1 (PD-L1) monoclonal antibody atezolizumab, as compared with those of platinum-based chemotherapy, as first-line trea...

Published
2020

23. Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling

Author

Roy S. Herbst, Kit Fuhrman, David L. Rimm, Yuting Liu, Jon Zugazagoitia, Swati Gupta, Kurt A. Schalper, and Scott N. Gettinger

Subjects
Male, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, medicine.medical_treatment, Programmed Cell Death 1 Receptor, Antigens, Differentiation, Myelomonocytic, non-small cell lung cancer (NSCLC), Article, 03 medical and health sciences, 0302 clinical medicine, Immune system, Antigen, Antigens, CD, Carcinoma, Non-Small-Cell Lung, Internal medicine, Biomarkers, Tumor, Carcinoma, Humans, Medicine, Progression-free survival, Immune Checkpoint Inhibitors, Aged, Aged, 80 and over, Tissue microarray, business.industry, Macrophages, Immunotherapy, Middle Aged, medicine.disease, Progression-Free Survival, Blockade, 030104 developmental biology, 030220 oncology & carcinogenesis, Leukocyte Common Antigens, Female, business
Abstract

Purpose: Only a minority of patients with advanced non–small cell lung cancer (NSCLC) truly benefits from single-agent PD-1 checkpoint blockade, and more robust predictive biomarkers are needed. Experimental Design: We assessed tumor samples from 67 immunotherapy-treated NSCLC cases represented in a tissue microarray, 53 of whom had pretreatment samples and received monotherapy. Using GeoMx Digital Spatial Profiling System (NanoString Technologies), we quantified 39 immune parameters simultaneously in four tissue compartments defined by fluorescence colocalization [tumor (panCK+), leucocytes (CD45+), macrophages (CD68+), and nonimmune stroma]. Results: A total of 156 protein variables were generated per case. In the univariate unadjusted analysis, we found 18 markers associated with outcome in spatial context, five of which remained significant after multiplicity adjustment. In the multivariate analysis, high levels of CD56 and CD4 measured in the CD45 compartment were the only markers that were predictive for all clinical outcomes, including progression-free survival (PFS, HR: 0.24, P = 0.006; and HR: 0.31, P = 0.011, respectively), and overall survival (OS, HR: 0.26, P = 0.014; and HR: 0.23, P = 0.007, respectively). Then, using an orthogonal method based on multiplex immunofluorescence and cell counting (inForm), we validated that high CD56+ immune cell counts in the stroma were associated with PFS and OS in the same cohort. Conclusions: This pilot scale discovery study shows the potential of the digital spatial profiling technology in the identification of spatially informed biomarkers of response to PD-1 checkpoint blockade in NSCLC. We identified a number of relevant candidate immune predictors in spatial context that deserve validation in larger independent cohorts.

Published
2020

24. Adherence to prescribed medications in patients with heart failure: insights from liquid chromatography–tandem mass spectrometry-based urine analysis

Author

Joanne Simpson, Caroline Haig, Mark C. Petrie, Roy S Gardner, Pankaj Gupta, Yannis Tsorlalis, Maciej Tomaszewski, Iain B. Squire, Colette E. Jackson, John J.V. McMurray, and Pardeep S. Jhund

Subjects
medicine.medical_specialty, Urinalysis, medicine.medical_treatment, Angiotensin-Converting Enzyme Inhibitors, Urine, Angiotensin Receptor Antagonists, Mineralocorticoid receptor, Tandem Mass Spectrometry, Liquid chromatography–mass spectrometry, Internal medicine, Humans, Medicine, Pharmacology (medical), In patient, Heart Failure, biology, medicine.diagnostic_test, business.industry, Angiotensin-converting enzyme, Original Articles, medicine.disease, Heart failure, biology.protein, Diuretic, Cardiology and Cardiovascular Medicine, business, Chromatography, Liquid
Abstract

Aims None of the existing studies on adherence have directly measured levels of all medications (or their metabolites) in patients with heart failure (HF). Methods and results We used liquid chromatography–tandem mass spectrometry to measure the presence of prescribed drugs (diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists) in the urine of patients reviewed 4–6 weeks after hospitalization with HF. Patients were unaware that adherence was being assessed. Of the 341 patients studied, 281 (82.4%) were adherent, i.e. had all prescribed drugs of interest detectable in their urine. Conversely, 60 patients (17.6%) were partially or completely non-adherent. Notably, 24 of the 60 were non-adherent to only diuretic therapy and only seven out of all 341 patients studied (2.1%) were completely non-adherent to all prescribed HF drugs. There were no major differences in baseline characteristics between adherent and non-adherent patients. Conclusion Non-adherence, assessed using a single spot urine measurement of drug levels, was confirmed in one of five patients evaluated 4–6 weeks after hospitalization with HF.

Published
2020

25. Clinical impact of COVID-19 on patients with cancer (CCC19): a cohort study

Author

Dimitrios Farmakiotis, Susie Owenby, Arturo Loaiza-Bonilla, Mansi R. Shah, Matthew Puc, Vadim S. Koshkin, Ahmad Daher, Prakash Peddi, Cameron Rink, Heloisa P. Soares, Eneida R. Nemecek, Mehmet Asim Bilen, Sanjay Mishra, Lidia Schapira, Amit Verma, Ali Raza Khaki, Chih-Yuan Hsu, Sandy DiLullo, Mark Bonnen, Jeanna Knoble, Carla Casulo, Umit Topaloglu, Jorge A. Garcia, Geoffrey Shouse, Praveen Vikas, Clarke A. Low, Archana Ajmera, George D. Demetri, Leyre Zubiri, Grace Glace, Shannon K. McWeeney, Susan Yackzan, Pamela C Egan, Rachel P. Rosovsky, Salvatore Del Prete, Anthony P. Gulati, Lane R. Rosen, Andy Futreal, Merry Jennifer Markham, Sabitha Prabhakaran, Alicia K. Morgans, Sarah Nagle, Lisa Weissmann, Albert C. Yeh, Ziad Bakouny, Stephanie Berg, David Gill, Marcus Messmer, Ryan Nguyen, Terence Duane Rhodes, Vikram M. Narayan, Matthew D. Galsky, Arielle Elkrief, Lori J. Rosenstein, Roy S. Herbst, Justin Shaya, Thorvardur R. Halfdanarson, Douglas B. Johnson, Orestis A. Panagiotou, Sanjay G. Revankar, Toni K. Choueiri, Yu Shyr, Fiona Busser, Kaitlin M. Kelleher, Nicole M. Kuderer, Paul L. Weinstein, Anup Kasi, Grace Shaw, Adam J. Olszewski, Catherine Curran, Samuel M. Rubinstein, Angelo Cabal, Michael H. Bar, John F. Deeken, Vivek Subbiah, Abdul Hai Mansoor, Hina Khan, Rana R. McKay, Catherine Stratton, Saurabh Dahiya, Marc A. Rovito, John Philip, Sanjay Shete, Oscar K. Serrano, Julie Fu, Daniel W. Bowles, Candice Schwartz, Tian Zhang, Pier Vitale Nuzzo, Eric H. Bernicker, Wenxin Xu, Genevieve M. Boland, Sarah Wall, Babar Bashir, Solange Peters, Neeta K. Venepalli, Sandeep H. Mashru, William A. Wood, Anne H. Angevine, Mary F. Mulcahy, Gilberto Lopes, Justin F. Gainor, Jessica Hawley, Monika Joshi, Christopher R. Friese, Navid Hafez, Heather H. Nelson, Gregory J. Riely, Jordan Kharofa, Nilo Azad, Chintan Shah, Gerald Batist, Mary Salazar, Rosemary Zacks, Alice Zhou, Lawrence E. Feldman, Paul Fu, Gary H. Lyman, Nathaniel Bouganim, John A. Steinharter, Shilpa Gupta, Matthias Weiss, Peter Paul Yu, Susan Van Loon, Jamie Stratton, Karen Vega-Luna, Tyler Masters, Christopher Lemmon, Aakash Desai, Bryan A. Faller, Jessica M. Clement, Zhuoer Xie, Keith Stockerl-Goldstein, Corrie A. Painter, Gabrielle Bouchard, Rulla M. Tamimi, Daruka Mahadevan, Rimma Belenkaya, Jill S. Barnholtz-Sloan, Jarushka Naidoo, Amelie G. Ramirez, Philip E. Lammers, Elizabeth A. Griffiths, Michael J. Gurley, X. Li, Jonathan Riess, Syed A. Ahmad, Daniel Blake Flora, Salma K. Jabbour, Jared D. Acoba, Neeraj Agarwal, Ang Li, Sarah Mushtaq, Firas Wehbe, Tanios Bekaii-Saab, Donald C. Vinh, Emily Hsu, Ryan Monahan, Petros Grivas, Harry Menon, John M. Nakayama, Janice M. Mehnert, Elizabeth Marie Wulff-Burchfield, Sara Matar, Paul E. Oberstein, Mary M. Pasquinelli, Axel Grothey, Jack West, John C. Leighton, Dawn L. Hershman, Leslie A. Fecher, Aditya Bardia, Sumit A. Shah, Barbara Logan, Kerry L. Reynolds, Michael A. Thompson, Robert L. Rice, Erin Cook, Trisha Wise-Draper, Christine Bestvina, Daniel Castellano, Paolo Caimi, K. M.Steve Lo, Ruben A. Mesa, Maheen Z. Abidi, Alvaro G. Menendez, Daniel G. Stover, Colleen Lewis, Bertrand Routy, Deborah B. Doroshow, Carmen C. Solorzano, M. Wasif Saif, Rohit Bishnoi, Michael Glover, David D. Chism, Briana Barrow, Christopher McNair, Dimpy P. Shah, Erin A. Gillaspie, Andrea J. Zimmer, Andrew Schmidt, Jessica K. Altman, Michelle Marcum, Rawad Elias, Balazs Halmos, Karen Stauffer, Gayathri Nagaraj, Ardaman Shergill, Mark E. Dailey, Catherine Handy Marshall, Pramod K. Srivastava, Shuchi Gulati, Alokkumar Jha, Mateo Bover Larroya, Mark A. Lewis, Young Soo Rho, James L. Chen, Eli Van Allen, Julie Tsu Yu Wu, Antonio Giordano, Amit Kulkarni, Joerg Rathmann, Donna R. Rivera, Narjust Duma, Maryam B. Lustberg, Theresa M. Carducci, Jeremy L. Warner, Elizabeth Robilotti, Patricia LoRusso, Rohit Jain, Amit Sanyal, Nizar M. Tannir, Kent Hoskins, Nathan A. Pennell, Brian I. Rini, Suki Subbiah, COVID-19 and Cancer Consortium, Abidi, M., Acoba, J.D., Agarwal, N., Ahmad, S., Ajmera, A., Altman, J., Angevine, A.H., Azad, N., Bar, M.H., Bardia, A., Barnholtz-Sloan, J., Barrow, B., Bashir, B., Belenkaya, R., Berg, S., Bernicker, E.H., Bestvina, C., Bishnoi, R., Boland, G., Bonnen, M., Bouchard, G., Bowles, D.W., Busser, F., Cabal, A., Caimi, P., Carducci, T., Casulo, C., Chen, J.L., Clement, J.M., Chism, D., Cook, E., Curran, C., Daher, A., Dailey, M., Dahiya, S., Deeken, J., Demetri, G.D., DiLullo, S., Duma, N., Elias, R., Faller, B., Fecher, L.A., Feldman, L.E., Friese, C.R., Fu, P., Fu, J., Futreal, A., Gainor, J., Garcia, J., Gill, D.M., Gillaspie, E.A., Giordano, A., Glace, M.G., Grothey, A., Gulati, S., Gurley, M., Halmos, B., Herbst, R., Hershman, D., Hoskins, K., Jain, R.K., Jabbour, S., Jha, A., Johnson, D.B., Joshi, M., Kelleher, K., Kharofa, J., Khan, H., Knoble, J., Koshkin, V.S., Kulkarni, A.A., Lammers, P.E., Leighton, J.C., Lewis, M.A., Li, X., Li, A., Lo, KMS, Loaiza-Bonilla, A., LoRusso, P., Low, C.A., Lustberg, M.B., Mahadevan, D., Mansoor, A.H., Marcum, M., Markham, M.J., Handy Marshall, C., Mashru, S.H., Matar, S., McNair, C., McWeeney, S., Mehnert, J.M., Menendez, A., Menon, H., Messmer, M., Monahan, R., Mushtaq, S., Nagaraj, G., Nagle, S., Naidoo, J., Nakayama, J.M., Narayan, V., Nelson, H.H., Nemecek, E.R., Nguyen, R., Nuzzo, P.V., Oberstein, P.E., Olszewski, A.J., Owenby, S., Pasquinelli, M.M., Philip, J., Prabhakaran, S., Puc, M., Ramirez, A., Rathmann, J., Revankar, S.G., Rho, Y.S., Rhodes, T.D., Rice, R.L., Riely, G.J., Riess, J., Rink, C., Robilotti, E.V., Rosenstein, L., Routy, B., Rovito, M.A., Saif, M.W., Sanyal, A., Schapira, L., Schwartz, C., Serrano, O., Shah, M., Shah, C., Shaw, G., Shergill, A., Shouse, G., Soares, H.P., Solorzano, C.C., Srivastava, P.K., Stauffer, K., Stover, D.G., Stratton, J., Stratton, C., Subbiah, V., Tamimi, R., Tannir, N.M., Topaloglu, U., Van Allen, E., Van Loon, S., Vega-Luna, K., Venepalli, N., Verma, A.K., Vikas, P., Wall, S., Weinstein, P.L., Weiss, M., Wise-Draper, T., Wood, W.A., Xu, W.V., Yackzan, S., Zacks, R., Zhang, T., Zimmer, A.J., and West, J.

Subjects
Prognostic variable, medicine.medical_specialty, business.industry, Cancer, General Medicine, Odds ratio, Aged, Antiviral Agents/therapeutic use, Azithromycin/therapeutic use, Betacoronavirus, Cause of Death, Comorbidity, Coronavirus Infections/drug therapy, Coronavirus Infections/epidemiology, Coronavirus Infections/mortality, Databases, Factual, Female, Humans, Hydroxychloroquine/therapeutic use, Male, Middle Aged, Neoplasms/epidemiology, Neoplasms/mortality, Neoplasms/therapy, Pandemics, Pneumonia, Viral/drug therapy, Pneumonia, Viral/epidemiology, Pneumonia, Viral/mortality, Prognosis, Risk Factors, 030204 cardiovascular system & hematology, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Cohort, Clinical endpoint, Medicine, 030212 general & internal medicine, business, Cause of death, Cohort study
Abstract

Summary Background Data on patients with COVID-19 who have cancer are lacking. Here we characterise the outcomes of a cohort of patients with cancer and COVID-19 and identify potential prognostic factors for mortality and severe illness. Methods In this cohort study, we collected de-identified data on patients with active or previous malignancy, aged 18 years and older, with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection from the USA, Canada, and Spain from the COVID-19 and Cancer Consortium (CCC19) database for whom baseline data were added between March 17 and April 16, 2020. We collected data on baseline clinical conditions, medications, cancer diagnosis and treatment, and COVID-19 disease course. The primary endpoint was all-cause mortality within 30 days of diagnosis of COVID-19. We assessed the association between the outcome and potential prognostic variables using logistic regression analyses, partially adjusted for age, sex, smoking status, and obesity. This study is registered with ClinicalTrials.gov, NCT04354701, and is ongoing. Findings Of 1035 records entered into the CCC19 database during the study period, 928 patients met inclusion criteria for our analysis. Median age was 66 years (IQR 57–76), 279 (30%) were aged 75 years or older, and 468 (50%) patients were male. The most prevalent malignancies were breast (191 [21%]) and prostate (152 [16%]). 366 (39%) patients were on active anticancer treatment, and 396 (43%) had active (measurable) cancer. At analysis (May 7, 2020), 121 (13%) patients had died. In logistic regression analysis, independent factors associated with increased 30-day mortality, after partial adjustment, were: increased age (per 10 years; partially adjusted odds ratio 1·84, 95% CI 1·53–2·21), male sex (1·63, 1·07–2·48), smoking status (former smoker vs never smoked: 1·60, 1·03–2·47), number of comorbidities (two vs none: 4·50, 1·33–15·28), Eastern Cooperative Oncology Group performance status of 2 or higher (status of 2 vs 0 or 1: 3·89, 2·11–7·18), active cancer (progressing vs remission: 5·20, 2·77–9·77), and receipt of azithromycin plus hydroxychloroquine (vs treatment with neither: 2·93, 1·79–4·79; confounding by indication cannot be excluded). Compared with residence in the US-Northeast, residence in Canada (0·24, 0·07–0·84) or the US-Midwest (0·50, 0·28–0·90) were associated with decreased 30-day all-cause mortality. Race and ethnicity, obesity status, cancer type, type of anticancer therapy, and recent surgery were not associated with mortality. Interpretation Among patients with cancer and COVID-19, 30-day all-cause mortality was high and associated with general risk factors and risk factors unique to patients with cancer. Longer follow-up is needed to better understand the effect of COVID-19 on outcomes in patients with cancer, including the ability to continue specific cancer treatments. Funding American Cancer Society, National Institutes of Health, and Hope Foundation for Cancer Research.

Published
2020

26. Waypoint shift manifolds for object color evaluation and comparison

Author

Maxim W. Derhak, Lin Luo, and Roy S. Berns

Subjects
Waypoint, Object color, business.industry, Computer science, General Chemical Engineering, Human Factors and Ergonomics, Computer vision, General Chemistry, Artificial intelligence, business
Published
2020

28. The 3-year outcomes of corneal tattooing for severely disfigured corneas

Author

Roy S. Chuck, Ji Won Kwon, Jimmy K. Lee, Jinho Jeong, and Jonathan Fay

Subjects
Adult, Male, medicine.medical_specialty, Adolescent, genetic structures, Ophthalmologic Surgical Procedures, Pupil, Cornea, Young Adult, 03 medical and health sciences, Corneal Opacity, 0302 clinical medicine, Ophthalmology, medicine, Humans, Child, Strabismus, Band keratopathy, Aged, Retrospective Studies, Tattooing, business.industry, Cosmesis, Middle Aged, medicine.disease, eye diseases, medicine.anatomical_structure, 030221 ophthalmology & optometry, Etiology, Female, sense organs, Corneal tattooing, Phthisis bulbi, business, 030217 neurology & neurosurgery
Abstract

To evaluate the efficacy of corneal tattooing for various clinical applications. The medical charts of 62 eyes of 62 patients who underwent corneal tattooing between March 2016 and August 2017 were retrospectively reviewed. The causes of opacity and various methods of corneal tattooing were analyzed. Among our 62 patients, 38 were males and 24 were females. Average age was 48.47 ± 15.30 (range, 12–74) years old. The mean follow-up period was 40.19 ± 2.34 (range, 36–43) months. The most common causes of corneal opacity were ocular trauma (33 eyes, 53.2%), prior retinal surgery (9 eyes, 14.5%), congenital etiologies (8 eyes, 12.9%) and measles (5 eyes, 8.0%). The most common associated ocular findings were strabismus (23 eyes, 37.0%), phthisis bulbi (17 eyes, 27.4%) and band keratopathy (13 eyes, 20.9%). Cosmetic outcomes improved without serious complications in all cases. Corneal tattooing is a viable option with an expanding set of indications, such as discolored previous corneal tattoos, white pupil due to inoperable cataract with clear cornea and dense corneal opacities in blind eyes. Elective corneal tattooing seems to be a viable and convenient method to improve cosmesis with minimal complications and high patient satisfaction.

Published
2020

29. Classification and choice of antiarrhythmic therapies

Author

Anna K. Barton, Gary A Wright, Mark McGowan, Roy S. Gardner, and Alison Smyth

Subjects
medicine.medical_specialty, business.industry, medicine, Pharmacology (medical), Pharmacology (nursing), Intensive care medicine, business
Published
2020

30. Ambulatory Monitoring of Heart Sounds via an Implanted Device Is Superior to Auscultation for Prediction of Heart Failure Events

Author

Pramodsingh H. Thakur, Michael Cao, Christopher Schulze, Qi An, Yi Zhang, Devi Nair, John P. Boehmer, Roy S Gardner, Brian Kwan, and Ramesh Hariharan

Subjects
medicine.medical_specialty, medicine.diagnostic_test, business.industry, Auscultation, 030204 cardiovascular system & hematology, medicine.disease, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Heart failure, Heart sounds, Ambulatory, medicine, Cardiology, 030212 general & internal medicine, Cardiology and Cardiovascular Medicine, business, Implanted device, Third heart sound
Abstract

Objectives To compare the relationship between the third heart sound (S3) measured by implantable cardiac devices (devS3) and auscultation (ausS3) and evaluate their prognostic power for predicting heart failure events (HFEs). Methods In the MultiSENSE study, devS3 was measured daily with continuous values while ausS3 was assessed at study visits with discrete grades. They were compared between patients with and without HFEs at baseline and against each other directly. Cox proportional hazard models were developed between follow-up visits (FUs) and over the whole study. Simulations were performed on devS3 to match limitations of auscultation. Results Nine hundred patients were studied, of whom 106 patients experienced 192 HFEs. Two S3 sensing modalities correlated with each other but at baseline only devS3 differentiated patients with or without HFEs (p Conclusions S3 measured from implantable cardiac devices has stronger prognostic power to predict episodes of future HF events than that of auscultation.

Published
2020

31. The impact of slippage on the data quality of head-worn eye trackers

Author

Ignace T. C. Hooge, Thiago Santini, Diederick C Niehorster, Roy S. Hessels, Enkelejda Kasneci, and Marcus Nyström

Subjects
Adult, Male, Head-mounted eye tracking, Eye Movements, Computer science, BitTorrent tracker, Experimental and Cognitive Psychology, Article, 050105 experimental psychology, Pupil, 03 medical and health sciences, 0302 clinical medicine, Software, Arts and Humanities (miscellaneous), Developmental and Educational Psychology, Humans, 0501 psychology and cognitive sciences, Computer vision, Eye Movement Measurements, General Psychology, Facial expression, business.industry, Mobile eye tracking, 05 social sciences, Data quality, Eye movement, Gaze, Data Accuracy, Wearable eye tracking, Head Movements, Eye tracking, Female, Natural behavior, Psychology (miscellaneous), Artificial intelligence, business, 030217 neurology & neurosurgery
Abstract

Mobile head-worn eye trackers allow researchers to record eye-movement data as participants freely move around and interact with their surroundings. However, participant behavior may cause the eye tracker to slip on the participant’s head, potentially strongly affecting data quality. To investigate how this eye-tracker slippage affects data quality, we designed experiments in which participants mimic behaviors that can cause a mobile eye tracker to move. Specifically, we investigated data quality when participants speak, make facial expressions, and move the eye tracker. Four head-worn eye-tracking setups were used: (i) Tobii Pro Glasses 2 in 50 Hz mode, (ii) SMI Eye Tracking Glasses 2.0 60 Hz, (iii) Pupil-Labs’ Pupil in 3D mode, and (iv) Pupil-Labs’ Pupil with the Grip gaze estimation algorithm as implemented in the EyeRecToo software. Our results show that whereas gaze estimates of the Tobii and Grip remained stable when the eye tracker moved, the other systems exhibited significant errors (0.8–3.1∘ increase in gaze deviation over baseline) even for the small amounts of glasses movement that occurred during the speech and facial expressions tasks. We conclude that some of the tested eye-tracking setups may not be suitable for investigating gaze behavior when high accuracy is required, such as during face-to-face interaction scenarios. We recommend that users of mobile head-worn eye trackers perform similar tests with their setups to become aware of its characteristics. This will enable researchers to design experiments that are robust to the limitations of their particular eye-tracking setup. Electronic supplementary material The online version of this article (10.3758/s13428-019-01307-0) contains supplementary material, which is available to authorized users.

Published
2020

32. Hepatic angiomyolipoma: an international multicenter analysis on diagnosis, management and outcome

Author

Johann Pratschke, Robert A. de Man, Wenzel Schöning, Joal D. Beane, Silvia Pellegrino, Valérie Paradis, Michael A. Nalesnik, Steven Sun, Verena Tripke, Moritz Schmelzle, Olivier Soubrane, Jan N. M. IJzermans, Hauke Lang, Anne J. Klompenhouwer, Roy S. Dwarkasing, Valérie Vilgrain, Eliza W. Beal, Michael Doukas, David A. Geller, Timothy M. Pawlik, Surgery, Radiology & Nuclear Medicine, Pathology, and Gastroenterology & Hepatology

Subjects
Adult, Male, medicine.medical_specialty, Databases, Factual, Hepatic Angiomyolipoma, medicine.medical_treatment, Angiomyolipoma, Patient characteristics, Liver transplantation, Malignancy, Resection, 03 medical and health sciences, 0302 clinical medicine, Biopsy, medicine, Hepatectomy, Humans, Retrospective Studies, Hepatology, medicine.diagnostic_test, business.industry, Liver Neoplasms, Gastroenterology, Middle Aged, medicine.disease, Magnetic Resonance Imaging, Treatment Outcome, Multicenter study, 030220 oncology & carcinogenesis, Diagnosis management, Female, 030211 gastroenterology & hepatology, Radiology, Tomography, X-Ray Computed, business
Abstract

Background Hepatic angiomyolipoma (HAML) may easily be misdiagnosed as a malignancy. The study aim was to assess diagnostic dilemmas, clinical management and outcome of this rare tumor. Methods This retrospective international multicenter study included all patients with pathologically proven HAML diagnosed between 1997 and 2017. Data on patient characteristics, diagnostic work-up, management and follow-up were analyzed. Results Thirty-eight patients were included, 32 female. Median age was 56yrs (i.q.r. 43–64) and median HAML-diameter was 57.5 mm (i.q.r. 38.5–95.3). Thirty patients had undergone CT and 27/38 MRI of the liver, diagnostic biopsy was performed in 19/38. Initial diagnosis was incorrect in 15/38 patients, of which 13 were thought to have malignancy. In 84% biopsy resulted in a correct preoperative diagnosis. Twenty-nine patients were managed with surgical resection, 4/38 with surveillance and 3/38 with liver transplantation. Recurrence after resection occurred in two cases. No HAML related deaths or progression to malignancy were documented. Conclusion HAML diagnosis proved problematic even in hepatobiliary expertise centers. Biopsy is indicated and may provide valuable additional information when HAML diagnosis is considered on cross-sectional imaging, especially when surgical resection imposes a risk of complications. Conservative management with regular imaging follow-up might be justified when biopsy confirms (classic type) HAML.

Published
2020

33. Frequency regulation with heat pumps using robust MPC with affine policies

Author

Felix Bünning, Joseph Warrington, Philipp Heer, Roy S. Smith, and John Lygeros

Subjects
0209 industrial biotechnology, Computer science, business.industry, 020208 electrical & electronic engineering, Robust optimization, 02 engineering and technology, Thermal energy storage, Track (rail transport), law.invention, Renewable energy, 020901 industrial engineering & automation, Control and Systems Engineering, law, 0202 electrical engineering, electronic engineering, information engineering, Thermal mass, Affine transformation, Process engineering, business, Energy (signal processing), Heat pump
Abstract

The increase in the renewable energy sources connected to the electricity grid has resulted in an increased need for frequency regulation. On the demand side, frequency regulation services can be provided by electrified heating/cooling systems exploiting the energy stored in thermal mass of buildings. To provide such services a first principles model of the building is needed, which is often difficult to obtain in practice. This issue can be overcome by using a buffer storage between the heating/cooling source and the building. Here, we present a solution based on robust optimization to offer frequency regulation reserves with such a system comprising a heat pump, a thermal storage in the form of a warm water buffer tank, and heating demand from a building that needs to be served. We mitigate the problem of limited thermal storage by introducing affine policies on uncertain variables. In three experiments with a real heat pump and warm water buffer storage and an emulated heating demand, we demonstrate that the system can indeed offer reserves and can successfully track a regulation signal while meeting the heating demand at all times.

Published
2020

34. The use of 4-Demethyl-4-cholesteryloxypenclomedine [DM-CHOC-PEN] as Therapy in Adolescent and Young Adult (AYA) Subjects with Advanced Malignancies Involving the Central Nervous System (CNS)

Author

Roy S. Weiner, Philip Friedlander, Lee Roy Morgan, M. Bhandari, Marcus L. Ware, and Tallat Mahmood

Subjects
Pediatrics, medicine.medical_specialty, medicine.anatomical_structure, business.industry, Central nervous system, medicine, Young adult, business, humanities
Abstract

In 2020 about 89,000 adolescents and young adults (AYA) (ages 15 to 39) were estimated to be diagnosed with cancer in the United States, 23,890 had CNS and spinal nervous system(SNS) involvement—accounting for one twentieth or five percent of the number cancer diagnoses in the United States. The estimated deaths for this group was18,020 deaths in 2020 (1).

Published
2021

35. Radiological patterns of uveal melanoma liver metastases in correlation to genetic status

Author

Erwin Brosens, Kaspar W. Geul, Dion Paridaens, Miguel C Jansen, Michael C Y Tang, Wojtek Drabarek, Annelies de Klein, Nicole C. Naus, Roy S. Dwarkasing, Emine Kilic, Robert M. Verdijk, Serdar Yavuzyigitoglu, Jolanda Vaarwater, Ophthalmology, Clinical Genetics, Radiology & Nuclear Medicine, and Pathology

Subjects
Cancer Research, Pathology, medicine.medical_specialty, Article, Metastasis, Text mining, SDG 3 - Good Health and Well-being, medicine, BAP1, choroidal melanoma, RC254-282, medicine.diagnostic_test, business.industry, Melanoma, SF3B1, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Magnetic resonance imaging, medicine.disease, Primary tumor, eye melanoma, Oncology, Radiological weapon, Eye melanoma, uveal melanoma, business, liver metastases
Abstract

This study reports the role played by the mutation status of Uveal Melanoma (UM) in relation to hepatic metastatic patterns as seen on imaging modalities. Radiological images were obtained from 123 patients treated at the Erasmus Medical Center Rotterdam or the Rotterdam Eye Hospital. Radiological images were derived from either computed tomography or magnetic resonance imaging. Hepatic metastatic patterns were classified by counting the number of metastases found in the liver. Miliary metastatic pattern (innumerable small metastases in the entire liver) was analyzed separately. Mutation status was determined in 85 patients. Median disease-free survival (DFS) and survival with metastases differed significantly between each of the metastatic patterns (respectively, p = 0.009, p &lt, 0.001), both in favor of patients with less hepatic metastases. The mutation status of the primary tumor was not correlated with any hepatic tumor profiles (p = 0.296). Of the patients who had a solitary metastasis (n = 18), 11 originated from a primary BAP1-mutated tumors and one from a primary SF3B1-mutated tumor. Of the patients who had a miliary metastasis pattern (n = 24), 17 had a primary BAP1-mutated tumor and two had a primary SF3B1-mutated tumor. Chromosome 8p loss was significantly more in patients with more metastases (p = 0.045). Moreover, the primary UMs of patients with miliary metastases harbored more chromosome 8p and 1p loss, compared to patients with single solitary metastasis (p = 0.035 and p = 0.026, respectively). In conclusion, our study shows that there is an inverse correlation of the number of metastasis with the DFS and metastasized survival, indicating separate growth patterns. We also revealed that the number and type of metastases is irrelevant to the prognostic mutation status of the tumor, showing that both BAP1- and SF3B1-mutated UM can result in solitary and miliary metastases, indicating that other processes lay ground to the different metastatic patterns.

Published
2021

36. 364 KRAS mutations in patients with nonsquamous non–small-cell lung cancer: prevalence and relationship with PD-L1 expression, tumor mutation burden and smoking status

Author

Delvys Rodriguez-Abreu, Byoung Chul Cho, M.C. Garassino, J. Kobie, Gilberto de Castro, Kazuo Kasahara, Bin Zhao, Gilberto Lopes, Shirish M. Gadgeel, Enriqueta Felip, Yi-Long Wu, Tony Sk Mok, Hande Turna, Martin Reck, Michael Boyer, Roy S. Herbst, Razvan Cristescu, M. Catherine Pietanza, Yongjin Li, Mark Ayers, Edward B. Garon, Dariusz M. Kowalski, Rina Hui, and Hidehito Horinouchi

Subjects
Pharmacology, Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, Mutation, business.industry, medicine.medical_treatment, Immunology, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Pembrolizumab, medicine.disease_cause, Placebo, medicine.disease, Internal medicine, medicine, Molecular Medicine, Immunology and Allergy, Immunohistochemistry, KRAS, business, Lung cancer, Exome, RC254-282
Abstract

BackgroundPembrolizumab is a standard-of-care first-line treatment for advanced/metastatic NSCLC, either as monotherapy (for patients with PD-L1 tumor proportion score [TPS] ≥1%) or combined with platinum chemotherapy. An improved OS benefit has been demonstrated for both pembrolizumab monotherapy and pembrolizumab plus chemotherapy in patients with higher tumor PD-L1 expression, and for pembrolizumab monotherapy in patients with higher tissue tumor mutation burden (tTMB). Mutations in KRAS occur relatively frequently in patients with nonsquamous NSCLC but infrequently in those with squamous NSCLC; most mutations are in codon 12. Notably, the pembrolizumab OS treatment effect was not diminished in patients with KRAS G12C mutations in phase 3 studies evaluating pembrolizumab monotherapy and pembrolizumab in combination with chemotherapy.1 2 Herein we describe prevalence of KRAS mutations among patients with advanced nonsquamous NSCLC from two phase 3 clinical studies evaluating first-line pembrolizumab (KEYNOTE-042 and KEYNOTE-189) and the relationship of such mutations with select patient characteristics.MethodsKEYNOTE-042 (NCT02220894) evaluated pembrolizumab versus platinum-based chemotherapy for advanced PD-L1–positive NSCLC (any histology) without EGFR/ALK alterations. KEYNOTE-189 (NCT02578680) evaluated pembrolizumab plus platinum-based chemotherapy versus platinum-based chemotherapy alone for metastatic nonsquamous NSCLC without EGFR/ALK alterations irrespective of tumor PD-L1 expression. Whole-exome sequencing of tumor tissue and matched normal DNA (blood) was performed for patients with nonsquamous histology. PD-L1 TPS was evaluated using the PD-L1 IHC 22C3 pharmDx assay (Agilent Technologies, Carpinteria, CA, USA). Prevalence of KRAS mutations and their relationships with TMB, PD-L1 TPS, and smoking status were analyzed descriptively.Results590 patients with nonsquamous NSCLC were included in these analyses (KEYNOTE-042, n=301; KEYNOTE-189, n=289). Overall, 42.9% of patients had tTMB ≥175 mut/exome, 81.4% were current/former smokers and, 40.3%, 42.7%, and 16.9% had PD-L1 TPS ≥50%, 1–49% and KRAS G12C, G12D, and G12V mutations occurred in 11.0%, 4.1%, and 5.4% of patients, respectively. Prevalence of KRAS mutations by patient characteristics is summarized in the table (table 1). KRAS G12C mutations occurred almost exclusively in current/former smokers. KRAS G12C was enriched in tumors with tTMB ≥175 mut/exome and tumors with PD-L1 TPS ≥50%. Prevalence was highest in tumors with both tTMB ≥175 mut/exome and PD-L1 TPS ≥50%.Abstract 364 Table 1KRAS Mutation PrevalenceConclusionsKRAS G12C mutations occurred with moderate frequency in patients with nonsquamous NSCLC, with most occurring in current/former smokers. KRAS G12C mutations occurred at higher frequency in patient subgroups defined by higher tTMB and PD-L1 TPS.AcknowledgementsMedical writing assistance was provided by Christabel Wilson, MSc, of ICON plc (North Wales, PA, USA), funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationKEYNOTE-042, ClinicalTrials.gov, NCT02220894; KEYNOTE-189, ClinicalTrials.gov, NCT02578680ReferencesGadgeel S, Rodriguez-Abreu D, Felip E, et al. KRAS mutational status and efficacy in KEYNOTE-189: pembrolizumab (pembro) plus chemotherapy (chemo) vs placebo plus chemo as first-line therapy for metastatic non-squamous NSCLC. Ann Oncol 2019;30(suppl 11):xi64-xi5.Herbst RS, Lopes G, Kowalski DM, et al. Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in KEYNOTE-042. Ann Oncol 2019;30(suppl 11):xi63-xi4.Ethics ApprovalFor both trials, the protocol and all amendments were approved by the appropriate ethics committee at each center, the study was conducted in accordance with the standards of Good Clinical Practice. Patients provided written informed consent before enrollment.

Published
2021

37. 457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC)

Author

Daniel Shao Weng Tan, Razvan Cristescu, Alexandra Snyder, Matthew A. Gubens, Lawrence Fong, Martin Gutierrez, Charu Aggarwal, Enriqueta Felip, Joanne Wy Chiu, Giovanna Finocchiaro, Myung-Ju Ahn, Hua Ma, Gregory Landers, John Palcza, Jianda Yuan, James Chih-Hsin Yang, Jong Seok Lee, J. Kobie, Andrea D. Basso, Edward B. Garon, Wei-Sen Lam, Matthew D. Hellmann, Alexander Luft, and Roy S. Herbst

Subjects
Pharmacology, Oncology, Cancer Research, medicine.medical_specialty, Combination therapy, business.industry, Immunology, non-small cell lung cancer (NSCLC), Phases of clinical research, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Pembrolizumab, medicine.disease, Interim analysis, Clinical trial, chemistry.chemical_compound, chemistry, Internal medicine, medicine, Clinical endpoint, Molecular Medicine, Immunology and Allergy, Lenvatinib, business, RC254-282
Abstract

BackgroundT-cell–inflamed gene expression profile (TcellinfGEP) and tumor mutational burden (TMB) are clinically validated biomarkers that independently predict pembrolizumab response. This study investigated prospective TcellinfGEP and TMB assessment in evaluating first-line pembrolizumab-based combination therapies; the different treatment combinations evaluated may provide insight into the unique biology of each biomarker subgroup.MethodsKEYNOTE-495/KeyImPaCT is a group-sequential, adaptively randomized, multisite, open-label, phase 2 study investigating first-line pembrolizumab plus the VEGF/FGFR inhibitor lenvatinib, CTLA-4 inhibitor quavonlimab (MK-1308), or LAG-3 inhibitor favezelimab (MK-4280) in patients with advanced NSCLC. DNA and RNA were extracted from tumor tissue to determine TcellinfGEP and TMB; patients were assigned to one of four biomarker-defined subgroups (TcellinfGEPlowTMBlow, TcellinfGEPlowTMBhigh, TcellinfGEPhighTMBlow, TcellinfGEPhighTMBhigh) and randomly assigned 1:1:1 to receive pembrolizumab (200mg IV Q3W)+lenvatinib (20mg oral QD), pembrolizumab+quavonlimab (75mg IV Q6W), or pembrolizumab+favezelimab (200mg [n=30] or 800mg [n=34] Q3W; the initial prespecified dose was 200mg but changed to 800mg based on emerging data). The primary end point was investigator-assessed ORR per RECIST v1.1. Multiple interim analyses will be performed until the prespecified clinical signal is observed. The first interim analysis for each combination therapy occurred after ≥10 patients had ≥12 weeks of follow-up.ResultsAt the data cutoff (January 11, 2021), 208 patients were treated (pembrolizumab+lenvatinib, n=72; pembrolizumab+quavonlimab, n=72; pembrolizumab+favezelimab 200mg, n=30; pembrolizumab+favezelimab 800mg, n=34). The overall assay success rate for testing and determining TcellinfGEP and TMB was 94%. In patients treated with pembrolizumab+lenvatinib, pembrolizumab+quavonlimab, or pembrolizumab+favezelimab, ORRs were generally highest in the TcellinfGEPhighTMBhigh subgroup (table 1); response rates were similar across combinations within this subgroup. ORR was low across combinations within the TcellinfGEPlowTMBlow subgroup. Treatment-related adverse events (TRAEs) occurred in 88%, 65%, 57%, and 59% of patients in the pembrolizumab+lenvatinib, pembrolizumab+quavonlimab, pembrolizumab+favezelimab 200mg and pembrolizumab+favezelimab 800mg arms, respectively. Consistent with the known TRAEs of these agents, most TRAEs were grade 1 or 2 in severity except in the pembrolizumab+lenvatinib arm (grade 3–5, 63%). Three deaths from TRAEs occurred (pembrolizumab+lenvatinib [n=2], brain hemorrhage and myocardial infarction; pembrolizumab+favezelimab 800 mg [n=1], pneumonitis).Abstract 457 Table 1Confirmed ORR by Therapy and Biomarker StatusConclusionsThese data demonstrate the feasibility and clinical usefulness of prospective TcellinfGEP and TMB assessment to study the clinical activity of three first-line pembrolizumab-based combination therapies in patients with advanced NSCLC. Although sample sizes were small, the TcellinfGEPhighTMBhigh subgroup demonstrated the best response among the biomarker subgroups for all three combination therapies; further validation is needed to determine additional signals and may be addressed as more mature data become available.AcknowledgementsJeanne Fahey, PhD, of Merck & Co., Inc., Kenilworth, New Jersey, USA, provided critical review of the abstract. Elisha Dettman PhD, Mark Ayers MS, and Andrey Loboda PhD of Merck & Co., Inc., Kenilworth, New Jersey, USA, provided critical review of study translational data. Medical writing and/or editorial assistance was provided by Shane Walton, PhD, and Lei Bai, PhD, of ApotheCom (Yardley, PA, USA). This assistance was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.Trial RegistrationClinicalTrials.gov, NCT03516981Ethics ApprovalThe study protocol and all amendments were approved by the relevant institutional review board or ethics committee at each study site. All patients provided written informed consent to participate in the clinical trial.

Published
2021

38. Outcomes after perioperative SARS-CoV-2 infection in patients with proximal femoral fractures: an international cohort study

Author

Khatri, C, Ward, AE, Nepogodiev, D, Ahmed, I, Chaudhry, D, Dhaif, F, Bankhad-Kendall, B, Kaafarani, H, Bretherton, C, Mahmood, A, Marais, L, Parsons, N, Bhangu, A, Metcalfe, A, Siaw-Acheampong, K, Dawson, BE, Evans, JP, Glasbey, JC, Gujjuri, RR, Heritage, E, Jones, CS, Kamarajah, SK, Keatley, JM, Lawday, S, Li, E, Mckay, SC, Pellino, G, Tiwari, A, Simoes, JFF, Trout, IM, Venn, ML, Wilkin, RJW, Ademuyiwa, AO, Agarwal, A, Al Ameer, E, Alderson, D, Alser, O, Arnaud, AP, Augestad, KM, Bankhead-Kendall, B, Benson, RA, Chakrabortee, S, Blanco-Colino, R, Brar, A, Bravo, A Minaya, Breen, KA, Buarque, I Lima, Caruana, E, Cunha, MF, Davidson, GH, Desai, A, Di Saverio, S, Edwards, J, Elhadi, M, Farik, S, Fiore, M, Fitzgerald, JE, Ford, S, Gallo, G, Ghosh, D, Gomes, GMA, Griffiths, E, Halkias, C, Harrison, EM, Hutchinson, P, Isik, A, Kolias, A, Lawani, I, Lederhuber, H, Leventoglu, S, Loffler, MW, Martin, J, Mashbari, H, Mazingi, D, Mohan, H, Moore, R, Moszkowicz, D, Ng-Kamstra, JS, Metallidis, S, Moug, S, Niquen, M, Ntirenganya, F, Outani, O, Pata, F, Pinkney, TD, Pockney, P, Radenkovic, D, Ramos-De la Medina, A, Roberts, K, Santos, I, Schache, A, Schnitzbauer, A, Stewart, GD, Shaw, R, Shu, S, Soreide, K, Spinelli, A, Sundar, S, Tabiri, S, Townend, P, Tsoulfas, G, van Ramshorst, G, Vidya, R, Vimalachandran, D, Wright, N, Mak, JKC, Kulkarni, R, Sharma, N, Nankivell, P, Tirotta, F, Parente, A, Breik, O, Kisiel, A, Cato, LD, Saeed, S, Pathanki, AM, Almond, M, Kamal, M, Chebaro, A, Lecolle, K, Truant, S, El Amrani, M, Zerbib, P, Pruvot, FR, Mathieu, D, Surmei, E, Mattei, L, Marin, H, Dudek, J, Singhal, T, El-Hasani, S, Nehra, D, Walters, A, Cuschieri, J, Ho, M, Wade, RG, Johnstone, J, Bourke, G, Brunelli, A, Elkadi, H, Otify, M, Pompili, C, Burke, JR, Bagouri, E, Chowdhury, M, Abual-Rub, Z, Kaufmann, A, Munot, S, Lo, T, Young, A, Kowal, M, Wall, J, Peckham-Cooper, A, Winter, SC, Belcher, E, Stavroulias, D, Di Chiara, F, Wallwork, K, Qureishi, A, Lami, M, Sravanam, S, Mastoridis, S, Shah, K, Chidambaram, S, Smillie, R, Shaw, AV, Bandyopadhyay, S, Cernei, C, Jeyaretna, D, Ganau, M, Piper, RJ, Duck, E, Brown, S, Jelley, C, Tucker, SC, Bond-Smith, G, Griffin, XL, Tebala, GD, Neal, N, Vatish, M, Noton, TM, Ghattaura, H, Maher, M, Fu, H, Risk, OBF, Majd, Soleymani H, Sinha, S, Shankar, S, Aggarwal, A, Kharkar, H, Lakhoo, K, Verberne, C, Senent-Boza, A, Sanchez-Arteaga, A, Benitez-Linero, I, Manresa-Manresa, F, Tallon-Aguilar, L, Melero-Cortes, L, Fernandez-Marin, MR, Duran-Munoz-Cruzado, VM, Ramallo-Solis, I, Beltran-Miranda, P, Pareja-Ciuro, F, Anton-Eguia, BT, Dawson, AC, Drane, A, Oliva Mompean, F, Gomez-Rosado, J, Reguera-Rosal, J, Valdes-Hernandez, J, Capitan-Morales, L, del Toro Lopez, MD, Patel, M, Shabana, A, Alanbuki, A, Usman, O, Tang, A, Beamish, AJ, Price, C, Bosanquet, D, Magowan, D, Solari, F, Williams, G, Nassa, H, Smith, L, Elliott, L, Mccabe, G, Holroyd, D, Jamieson, NB, Mariani, NM, Nicastro, V, Li, Z, Parkins, K, Spencer, N, Harries, R, Egan, RJ, Motter, D, Jenvey, C, Mahoney, R, Fine, N, Minto, T, Henry, A, Gill, C, Dunne, N, Sarma, DR, Godbole, C, Carlos, W, Tewari, N, Jeevan, D, Naredla, P, Khajuria, A, Connolly, H, Robertson, S, Sweeney, C, Di Taranto, G, Shanbhag, S, Dickson, K, McEvoy, K, Skillman, J, Sait, M, Al-omishy, H, Baig, M, Heer, B, Lunevicius, R, Sheel, ARG, Sundhu, M, Santini, AJA, Fathelbab, MSAT, Hussein, KMA, Nunes, QM, Jones, RP, Shahzad, K, Haq, I, Baig, MMAS, Hughes, JL, Kattakayam, A, Rajput, K, Misra, N, Shah, SB, Clynch, AL, Georgopoulou, N, Sharples, HM, Apampa, AA, Nzenwa, IC, Sud, A, Podolsky, D, Coleman, NL, Callahan, MP, Dunstan, M, Beak, P, Gerogiannis, I, Ebrahim, A, Alwadiya, A, Goyal, A, Phillips, A, Bhalla, A, Demetriou, C, Grimley, E, Theophilidou, E, Ogden, E, Malcolm, FL, Davies-Jones, G, Ng, JCK, Mirza, M, Hassan, M, Elmaleh, N, Daliya, P, Williams, S, Bateman, A, Chia, Z, A'Court, J, Konarski, A, Faulkner, G, Talwar, R, Patel, K, Askari, A, Jambulingam, PS, Shaw, S, Maity, A, Hatzantonis, C, Sagar, J, Kudchadkar, S, Cirocchi, N, Chan, CH, Eberbach, H, Bayer, J, Erdle, B, Sandkamp, R, Breen, K, Velmahos, G, Maurer, LR, El Moheb, M, Gaitanidis, A, Naar, L, Christensen, MA, Kapoen, C, Langeveld, K, El Hechi, M, Mokhtari, A, Main, B, Maccabe, T, Newton, C, Blencowe, NS, Fudulu, DP, Bhojwani, D, Baquedano, M, Caputo, M, Rapetto, F, Flannery, O, Hassan, A, Ward, A, Tadross, D, Majkowski, L, Blundell, C, Forlani, S, Nair, R, Guha, S, Brown, SR, Steele, C, Kelty, CJ, Newman, T, Lee, M, Chetty, G, Lye, G, Balasubramanian, SP, Shah, Sureshkumar N, Sherif, M, Al-mukhtar, A, Whitehall, E, Giblin, A, Wells, F, Sharkey, A, Adamec, A, Madan, S, Konsten, J, Van Heinsbergen, M, Sou, A, Simpson, D, Hamilton, E, Blair, J, Jimeno Fraile, J, Morales-Garcia, D, Carrillo-Rivas, M, Toledo Martinez, E, Pascual, A, Landaluce-Olavarria, A, Gonzalez De Miguel, M, Gomez Cruzado, Fernandez L, Begona, E, Lecumberri, D, Calvo Rey, A, Prada Hervella, GM, Dos Santos Carregal, L, Rodriguez, Fernandez MI, Freijeiro, M, El Drubi Vega, S, Van den Eynde, J, Oosterlinck, W, Van den Eynde, R, Sermon, A, Boeckxstaens, A, Cordonnier, A, De Coster, J, Jaekers, J, Politis, C, Miserez, M, Galipienso Eri, M, Garcia Montesino, JD, Dellonder Frigole, J, Noriego Munoz, D, Lizzi, V, Vovola, F, Arminio, A, Cotoia, A, Sarni, AL, Bekheit, M, Kamera, BS, Elhusseini, M, Sharma, P, Ahmeidat, A, Gradinariu, G, Cymes, W, Hannah, A, Mignot, G, Shaikh, S, Agilinko, J, Sgro, A, Rashid, MM, Milne, K, McIntyre, J, Akhtar, MA, Turnbull, A, Brunt, A, Stewart, KE, Wilson, MSJ, Rutherford, D, McGivern, K, Massie, E, Duff, S, Moura, F, Brown, BC, Khan, A, Asaad, P, Wadham, B, Aneke, IA, Collis, J, Warburton, H, Thomas, M, Pearce, L, Fountain, DM, Laurente, R, Sigamoney, KV, Dasa, M, George, K, Naqui, Z, Galhoum, M, Lipede, C, Gabr, A, Radhakrishnan, A, Hasan, MT, Kalenderov, R, Pathmanaban, O, Colombo, F, Chelva, R, Subba, K, Abou-Foul, AK, Khalefa, M, Hossain, F, Moores, T, Pickering, L, Shah, J, 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Barros, J, Correia, S, Rodrigues, M, Cardoso, P, Teixeira, J, Soares, AP, Morais, H, Pereira, R, Revez, T, Manso, MI, Domingues, JC, Henriques, P, Ribeiro, R, Ribeiro, VI, Cardoso, N, Sousa, S, dos Santos, SM, Miranda, P, Garrido, R, Ferreira, MP, Ascensao, J, Costeira, B, Cunha, C, Rodrigues, LR, Fernandes, MS, Azevedo, P, Ribeiro, J, Lourenco, I, Gomes, H, Mendinhos, G, Pinto, AN, dos Santos, GM, Taflin, H, Abdou, H, Diaz, J, Richmond, M, Clark, J, O'Meara, L, Hanna, N, Cooper, Z, Salim, A, Hirji, SA, Brown, A, Chung, C, Hansen, L, Okafor, BU, Roxo, V, Raut, CP, Jolissaint, JS, Mahvi, DA, Reinke, C, Ross, S, Thompson, K, Manning, D, Perkins, R, Volpe, A, Merola, S, Ssentongo, A, Ssentongo, P, Oh, JS, Hazelton, J, Maines, J, Gusani, N, Garner, M, Horvath, S, Martin, RCG, Bhutiani, N, Choron, R, Peck, G, Soliman, F, Rehman, S, Abbas, A, Soliman, A, Kim, B, Jones, C, Dauer, MDE, Renza-Stingone, E, Hernandez, E, Gokcen, E, Kropf, E, Sufrin, H, Hirsch, H, Ross, H, Engel, J, Sewards, J, Poggio, J, Sanserino, K, Rae, L, Philp, M, Metro, M, McNelis, P, Petrov, R, Pazionis, T, Quintana, M, Jackson, H, Lumenta, DB, Nischwitz, SP, Richtig, E, Pau, M, Srekl-Filzmaier, P, Eibinger, N, Michelitsch, B, Fediuk, M, Papinutti, A, Seidel, G, Kahn, J, Cohnert, TU, Kantor, E, Kahiu, J, Hossain, N, Hosny, S, Sultana, A, Taggarsi, M, Vitone, L, Lambert, J, Vaz, OP, Sarantitis, I, Shrestha, D, Timbrell, S, Shugaba, A, Jones, GP, Gardner, A, Tripathi, SS, Greenhalgh, MS, Emerson, H, Vejsbjerg, K, McCormick, W, Fisher, A, Singisetti, K, Aawsaj, Y, Barry, C, Blanco, J, Vanker, R, Ghobrial, M, Jones, G, Kanthasamy, S, Fawi, H, Awadallah, M, Chen, F, Cheung, J, Tingle, S, Abbadessa, F, Sachdeva, A, Rai, B, Chan, CD, McPherson, I, Booth, K, Ali, FM, Pandanaboyana, S, Grainger, T, Nandhra, S, Patience, A, Rogers, A, Roy, C, Williams, T, Dawe, N, McCaffer, C, Riches, J, Bhattacharya, S, Moir, J, Kalson, NS, Ahmed, HE, Mellor, C, Saleh, C, Koshy, RM, Hammond, J, Sanderson, L, Wahed, S, Phillips, AW, Ghosh, K, Rogers, LJ, Labib, PL, Miller, D, Minto, G, Hope, N, Marchbank, A, Emslie, K, Panahi, P, Ho, B, Perkins, C, Clough, E, Roy, H, Enemosah, I, Campbell, R, Natale, J, Gohil, K, Rela, M, Raza, N, Menakaya, C, Webb, JI, Antar, M, Modi, N, Sofat, R, Noel, J, Nunn, R, Adegbola, S, Eriberto, F, Sharma, V, Tanna, R, Lodhia, S, Carvalho, L, Osorio, C, Antunes, J, Lourenco, S, Balau, P, Godinho, M, Pereira, A, Keller, DS, Smart, NJ, Apollo - University of Cambridge Repository, Collaborative, COVIDSurg, and ​Robotics and image-guided minimally-invasive surgery (ROBOTICS)

Subjects
Male, medicine.medical_specialty, Multivariate analysis, MORTALITY-RATES, hip, SURGERY, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), MULTICENTER, COVIDSurg Collaborative, 1117 Public Health and Health Services, Cohort Studies, Medicine, General & Internal, Internal medicine, General & Internal Medicine, medicine, Dementia, Humans, Prospective Studies, Aged, 80 and over, COMPLICATIONS, Science & Technology, HIP-FRACTURES, business.industry, Hip Fractures, SARS-CoV-2, COVID-19, 1103 Clinical Sciences, General Medicine, Femoral fracture, Perioperative, medicine.disease, Heart failure, trauma management, Medicine, Surgery, business, Life Sciences & Biomedicine, Femoral Fractures, Kidney disease, Cohort study, 1199 Other Medical and Health Sciences
Abstract

ObjectivesStudies have demonstrated high rates of mortality in people with proximal femoral fracture and SARS-CoV-2, but there is limited published data on the factors that influence mortality for clinicians to make informed treatment decisions. This study aims to report the 30-day mortality associated with perioperative infection of patients undergoing surgery for proximal femoral fractures and to examine the factors that influence mortality in a multivariate analysis.SettingProspective, international, multicentre, observational cohort study.ParticipantsPatients undergoing any operation for a proximal femoral fracture from 1 February to 30 April 2020 and with perioperative SARS-CoV-2 infection (either 7 days prior or 30-day postoperative).Primary outcome30-day mortality. Multivariate modelling was performed to identify factors associated with 30-day mortality.ResultsThis study reports included 1063 patients from 174 hospitals in 19 countries. Overall 30-day mortality was 29.4% (313/1063). In an adjusted model, 30-day mortality was associated with male gender (OR 2.29, 95% CI 1.68 to 3.13, p80 years (OR 1.60, 95% CI 1.1 to 2.31, p=0.013), preoperative diagnosis of dementia (OR 1.57, 95% CI 1.15 to 2.16, p=0.005), kidney disease (OR 1.73, 95% CI 1.18 to 2.55, p=0.005) and congestive heart failure (OR 1.62, 95% CI 1.06 to 2.48, p=0.025). Mortality at 30 days was lower in patients with a preoperative diagnosis of SARS-CoV-2 (OR 0.6, 95% CI 0.6 (0.42 to 0.85), p=0.004). There was no difference in mortality in patients with an increase to delay in surgery (p=0.220) or type of anaesthetic given (p=0.787).ConclusionsPatients undergoing surgery for a proximal femoral fracture with a perioperative infection of SARS-CoV-2 have a high rate of mortality. This study would support the need for providing these patients with individualised medical and anaesthetic care, including medical optimisation before theatre. Careful preoperative counselling is needed for those with a proximal femoral fracture and SARS-CoV-2, especially those in the highest risk groups.Trial registration numberNCT04323644

Published
2021

39. EGFR High Copy Number Together with High EGFR Protein Expression Predicts Improved Outcome for Cetuximab-based Therapy in Squamous Cell Lung Cancer: Analysis from SWOG S0819, a phase III trial of chemotherapy with or without Cetuximab in advanced NSCLC

Author

Karen Kelly, James Moon, Fred R. Hirsch, Mary W. Redman, Thomas J. Semrad, Philip C. Mack, Marileila Varella-Garcia, Christopher J. Rivard, Francesco Agustoni, Roy S. Herbst, and David R. Gandara

Subjects
Pulmonary and Respiratory Medicine, Oncology, Adult, Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, medicine.medical_treatment, Cetuximab, Gene Expression, medicine.disease_cause, Article, Young Adult, Antineoplastic Agents, Immunological, Internal medicine, Carcinoma, Non-Small-Cell Lung, medicine, Humans, Lung cancer, neoplasms, Survival analysis, Aged, Aged, 80 and over, Chemotherapy, Proportional hazards model, business.industry, Middle Aged, medicine.disease, ErbB Receptors, Treatment Outcome, Immunohistochemistry, Biomarker (medicine), Female, KRAS, business, medicine.drug, Forecasting
Abstract

Background The phase III S0819 trial investigated addition of cetuximab to first-line chemotherapy (CT) in NSCLC. Subgroup analyses suggested an OS benefit among patients with EGFR copy number gain in squamous cell carcinomas (SCC), (HR = 0.58 [0.39-0.86], P = .0071). A more detailed model based on EGFR FISH, EGFR IHC and KRAS mutation status was evaluated to yield a more precise predictive paradigm of cetuximab-based therapy in advanced NSCLC. Methods FISH was performed using the Colorado Scoring Criteria; H-Score was used to quantify EGFR IHC expression (cut-off ≥ 200). A Cox model was used to assess treatment effects for OS and PFS within biomarker and clinical subgroups. KRAS mutation was analyzed using Therascreen. The false discovery rate controlled for multiple comparisons. S0819 ClinicalTrials.gov Identifier: NCT00946712. Results Of 1,313 eligible patients, assay results were obtained for FISH on 976 patients (41% positive), for IHC on 945 patients (31% positive), and KRAS mutation status on 627 patients (26% positive). In SCC patients, OS was significantly improved with addition of cetuximab when both EGFR FISH and EGFR IHC were positive (N = 58), (OS HR: 0.32 [95% CI 0.18-0.59]; P = .0002, q = 0.08), median 12.6 versus 4.6 months. The results were independent of KRAS mutation status. In Non-SCC, no predictive value of EGFR IHC, EGFR FISH status and/or KRAS status was seen. Conclusions In NSCLC SCC, a combination index of EGFR FISH plus EGFR IHC results was associated with improved OS when cetuximab was added to CT, representing a potential predictive molecular paradigm for patients suitable for EGFR-antibody therapy.

Published
2021

40. Five year survival update from KEYNOTE-010

Author

Margarita Majem, Silvia Novello, Roy S. Herbst, A. Samkari, J. Kobie, Bilal Piperdi, Dong Wan Kim, Michael Boyer, Radj Gervais, Byoung Chul Cho, Edward B. Garon, Erin Jensen, Jose Luis Perez-Gracia, Paul Baas, Wu Chou Su, Isabelle Monnet, Matthew A. Gubens, Ji Youn Han, and Martin Forster

Subjects
Pulmonary and Respiratory Medicine, Oncology, PD-L1, medicine.medical_specialty, Lung Neoplasms, Randomization, medicine.medical_treatment, Docetaxel, Pembrolizumab, Antibodies, Monoclonal, Humanized, B7-H1 Antigen, Carcinoma, Non-Small-Cell Lung, Internal medicine, medicine, Humans, Chemotherapy, chemotherapy, non‒small-cell lung cancer, pembrolizumab, business.industry, Hazard ratio, Non‒small-cell lung cancer, Confidence interval, Neoplasm Recurrence, Local, Previously treated, business, Non-small-cell lung cancer, medicine.drug, Programmed death
Abstract

Introduction: In the KEYNOTE-010 study, pembrolizumab improved overall survival (OS) versus docetaxel in patients with previously treated, advanced NSCLC with programmed death-ligand 1 (PD-L1) tumor proportion score (TPS) >= 50% and >= 1%. We report 5-year efficacy and safety follow-up for the KEYNOTE-010 study. Methods: Patients were randomized to pembrolizumab 2 mg/kg or 10 mg/kg once every 3 weeks or docetaxel 75 mg/m(2) once every 3 weeks for up to 35 cycles (2 y). Patients who completed pembrolizumab treatment and subsequently had recurrence could receive second-course pembrolizumab for up to 17 cycles (1 y). Pembrolizumab doses were pooled in this analysis. Results: A total of 1034 patients were randomized (pembrolizumab, n = 691; docetaxel, n = 343). Median study follow-up was 67.4 months (range: 60.0-77.9). The hazard ratio (95% confidence interval) for OS was 0.55 (0.44. 0.69) for patients with PD-L1 TPS >= 50% and 0.70 (0.61. 0.80) with PD-L1 TPS >= 1%. The 5-year OS rates for pembrolizumab versus docetaxel were 25.0% versus 8.2% in patients with PD-L1 TPS >= 50% and 15.6% versus 6.5% with PD-L1 TPS >= 1%. Among 79 patients who completed 35 cycles/2 years of pembrolizumab, the OS rate 3 years after completion (similar to 5 y from randomization) was 83.0%. A total of 21 patients received second-course pembrolizumab; 11 (52.4%) had an objective response after starting the second course and 15 (71.4%) were alive at data cutoff. Exploratory biomarker analysis revealed that higher tissue tumor mutational burden (>= 175 mutations per exome) was associated with improved outcomes with pembrolizumab. Conclusions: Pembrolizumab continued to provide long-term benefit than docetaxel in patients with previously treated advanced NSCLC with PD-L1 TPS >= 50% and >= 1%. Our findings confirm pembrolizumab as a standard-of-care treatment in the second-line or later setting. (C) 2021 Published by Elsevier Inc. on behalf of International Association for the Study of Lung Cancer.

Published
2021

41. Atezolizumab for PD-L1–Selected Patients with NSCLC

Author

David R. Spigel, Roy S. Herbst, and Hiroshi Kuriki

Subjects
Oncology, medicine.medical_specialty, Lung Neoplasms, biology, business.industry, MEDLINE, General Medicine, Antibodies, Monoclonal, Humanized, medicine.disease, B7-H1 Antigen, Text mining, Atezolizumab, Carcinoma, Non-Small-Cell Lung, Internal medicine, PD-L1, Monoclonal, biology.protein, Carcinoma, medicine, Humans, Antibody, business
Published
2021

43. Surgical site infection after gastrointestinal surgery in children: An international, multicentre, prospective cohort study

Author

Harrison E. M., Drake T. M., Ghosh D., Ademuyiwa A. O., Bhangu A., Fitzgerald J. E., Glasbey J., Borda-Luque G., Costas-Chavarri A., Ntirenganya F., Fergusson S. J., Ingabire J. C. A., Ismail L., Lilford R., Mihaljevic A. L., Morton D., Mutabazi A. Z., Adisa A. O., Ots R., Pinkney T., Poskus T., Shaw C. A., Verjee A., Runigamugabo E., Khatri C., Mohan M., Jaffry Z., Altamini A., Kirby A., Soreide K., Cornick J., Iyer D., King S., Arthur T., Nahar S. N., Waterman A., Lawini I., Rouse T., Correa J. C., Salem H. K., Worku M., Arnaud A., Kalles V., Aguilera M. L., Recinos G., Quek R., Altibi A., Whitaker J., Bent Z., Al-Slaibi I., Tahboub H., Alser O. H., Shu S., Mironescu A., Bratu M., Altwijri A., Alsaggaf M. U., Jubran A. F., Seisay S., Jeyakumar J., Senanayake K., Abdulbagi O., Raptis D., Kong C., Suresh S., Scott M., Grizhja B., Ymeri S., Galiqi G., Klappenbach R., Antezana D., Beleno A. E. M., Costa C., Sanchez B., Aviles S., Modolo M. M., Fermani C. G., Balmaceda R., Villalobos S., Carmona J. M., Hamill D., Deutschmann P., Sandler S., Cox D., Nataraja R., Sharpin C., Ljuhar D., Gray D., Haines M., Niranjan N., D'Amours S., Ashtari M., Franco H., Mitul A. R., Karim S., Aman N. F., Estee M. M., Salma U., Razzaque J., Hamidkanta T., Tori S., Alamin Md. S., Roy S., Al Amin Md. S., Haque M., Faruq A., Iftekhar F., O'Shea M., Padmore G., Jonnalagadda R., Litvin A., Filatau A., Paulouski D., Shubianok M., Shachykava T., Khokha D., Khokha V., Djivoh F., Lawani I., Dossou F., Seto D. M., Gbessi D. G., Noukpozounkou B., Souaibou Y. I., Keke K. R., Hodonou F., Ahounou E., Alihonou T., Denakpo M., Ahlonsou G., Bedada A. G., Nsengiyumva C., Kwizera S., Barendegere V., Choi P., Stock S., Jamal L., Firdouse M., Zani A., Azzie G., Kushwaha S., Agarwal A., Chen T. -L., Yip C., Montes I., Zapata F., Sierra S., Lanau M. I. V., Arango M. C. M., Restrepo I. M., Giraldo R. S. R., Mendozaarango M., Domini E., Karlo R., Mihanovic J., Youssef M., Elfeki H., Thabet W., Sanad A., Tawfik G., Zaki A., Abdel-Hameed N., Mostafa M., Omar M. F. W., Ghanem A., Abdallah E., Denewer A., Emara E., Rashad E., Sakr A., Elashry R., Emile S., Khafagy T., Elhamouly S., Elfarargy A., Mamdouhmohamed A., Saiednagy G., Esam A., Elwy E., Hammad A., Khallaf S., Ibrahim E., Saidbadr A., Moustafa A., Eldosoukymohammed A., Elgheriany M., Abdelmageed E., Al Raouf E. A., Elbanby E., Elmasry M., Morsyfarahat M., Yahyamansor E., Magdyhegazy E., Gamal E., Gamal H., Kandil H., Maherabdelrouf D., Moaty M., Gamal D., El-Sagheer N., Salah M., Magdy S., Salah A., Essam A., Ali A., Badawy M., Ahmed S., Mohamed M., Assal A., Sleem M., Ebidy M., Abdelrazek A., Zahran D., Adam N., Nazir M., Hassanein A. B., Ismail A., Elsawy A., Mamdouh R., Mabrouk M., Ahmed L. A. M., Hassabalnaby M., Magdy E., Abd-Elmawla M., Fahim M., Mowafy B., Mahmoud M. I., Allam M., Alkelani M., El Gendy N. H., Aboul-Naga M. S., Alaael-Din R., Elgendy A. H., Ismail M., Shalaby M., Elsharkawy A. A., Moghazy M. E., Elbisomy K. H., Shakshouk H. A. G., Hamed M. F., Ebidy M. M., Abdelkader M., Karkeet M., Ahmed H., Adel I., Omar M. E., Ibrahim M., Ghoneim O., Hesham O., Gamal S., Hilal K., Arafa O., Awad S. A., Salem M., Elsherif F. A., Elsabbagh N., Aboelsoud M. R., Rida A. H. E. F., Hossameldin A., Hany E., Asar Y. H., Anwar N., Gadelkarim M., Abdelhady S., Morshedy E. M., Saad R., Soliman N., Salama M., Ezzat E., Mohamed A., Ibrahim A., Fergany A., Mohammed S., Reda A., Allam Y., Saad H. A., Abdelfatah A., Fathy A. M., El-Sehily A., Kasem E. A., Hassan A. T. A., Mohammed A. R., Saad A. G., Elfouly Y., Elfouly N., Hassaan A., Mohammed M. M., Elhoseny G., Magdy M., Elkhalek E. A., Zakaria Y., Ezzat T., El Dahab A. A., Kelany M., Arafa S., Hassan O. M. M., Badwi N. M., Sleem A. S., Abdelbadeai K., Abdullah M. A., Lokman M., Bahar S., Radyabdelazeam A., Adelshone A., Hasnan M. B., Zulkifli A., Kamarulzamil S. N. A., Elhendawy A., Latif A., Adnan A. B., Shaharuddin S., Majid A. H. H. A., Amreia M., Al-Marakby D., Salma M., Basir E. R. M., Ali C. D. M., Ata A. Y., Nasr M., Rezq A., Sheta A., Tariq S., Sallam A., Darwish A. K. Z., Elmihy S., El Hadry S., Farag A., Hajah H., Seliem A., Aglan A., Zohair A., Essam M., Moussa O., El-Gizawy E., Samy M., Ali S., Elhalawany E., Ata A., Elhalawany M., Nashat M., Soliman S., Elazab A., Abdelaziz M. A., Ibrahim K., Ibrahim A. M., Gado A., Hantour U., Eldeen E. A., Loaloa M. R., Abouzaid A., Ahmedbahaaeldin M., Hashad E., Sroor F., Gamil D., Mahmoudabdulhakeem E., Zakaria M., Mohamed F., Abubakr M., Ali E., Magdy H., Ramadan M., Abdelatymohamed M., Mansour S., Abdulazizamin H., Rabiemohamed A., Saami M., Ahmedredaelsayed N., Tarek A., Mohyeldeenmahmoud S., El Sayed I. M., Yusufshawky M., Mousasalem M., El-Din S. A., Soliman N. A., Talaat M., Abdelmoenelhusseiny S. A. -D. A., Abdullah N., Elshaar M., Abdelfatahibraheem A., Abdulaziz H., Ismail M. K., Hamdymadkor M., Abdelaty M., Kader S. M., Mohamedsalah O., Eldafrawy M., Zakieldeeb A., Mahmoudeid M., Attia A., El-Dien K. S., Shwky A., Badenjki M. A., Soliman A., Al Attar S. M., Sayed F., Abdelsabour F., Azizeldine M. G., Shawqi M., Hashim A., Aamer A., Raouf A. M. A., Abdelshakour M., Mahmoud B., Mahmoud M. A., Qenawy M., Rashed A. M., Dahy A., Sayed M., Shamsedine A. W., Mohamed B., Hasan A., Saad M. M., Abdulbassit K., Khalidabdelatif N., Elzahed N., Elkashash A., Bekhet N. M., Hafez S., Gad A., Maher M. E., Abdelsameea A., Hafez M., Sabe A., Ahmed A., Shahine A., Dawood K., Gaafar S., Husseiny R., Aboelmagd O., Mesbah N., Emadeldin H., Almeligy A., Bekhet A. H., Hasan D., Alhady K., Sabe A. K., Elnajjar M. A., Aboelella M., Hamsho W., Hassan I., Saad H., Abdelazim G., Mahmoud H., Wael N., Kandil A. M., Magdy A., Saidelkholy S., Adel B., Dabbour K., Elsherbiney S., Mattar O., Abdrabou A. K., Aly M. Y. M., Geuoshy A., Elnagar A., Abdelmotaleb I., Saleh A. A., Mohammedbakry H., Saeed M., Mahmoud S., Tawfik B., Ismail S. A., Zakaria E., Gad M. O., Elhelbawy M., Bassem M., Khaledabdel-Latif N., Maraie N., Elhadary N. M., Semeda N., Rabiemohamed S., Bakry H. M., Essam A. A., Tarek D., Ashour K., Elhadad A., Abdel-Aty A., Rakha I., Matter S. M., Abdelhamed R., Abdelkader O., Soliman Y., Ghanem S., Farouk S. A. M., Ibrahim E. M., El-Taher E., Mahrousbadr M., El-Sawy R. E. A., Bakr A., Al Rafati A. A. R., Saar S., Reinsoo A., Talving P., Seyoum N., Worku T., Fitsum A., Tolonen M., Leppaniemi A., Sallinen V., Parmentier B., Peycelon M., Irtan S., Dardenne S., Robert E., Maillot B., Courboin E., Arnaud A. P., Hascoet J., Abbo O., Kaci A. A., Prudhomme T., Ballouhey Q., Grosos C., Fourcade L., Cecilia T., Jean-Francois C., Helene F. -C., Delforge X., Haraux E., Dousset B., Schiavone R., Gaujoux S., Marret J. -B., Haffreingue A., Rod J., Renaux-Petel M., Lecompte J. -F., Breaud J., Gastaldi P., Taieb C., Claire R., Anis E., Bustangi N., Lopez M., Scalabre A., Grella M. G., Mariani A., Podevin G., Schmitt F., Hervieux E., Broch A., Muller C., Tabiri S., Kojo A. T. T., Bandoh D., Abantanga F., Kyereh M., Asumah H., Appiah E. K., Wondoh P., Gyedu A., Dally C., Amoah K. A. M., Yifieyeh A., Agbedinu K., Owusu F., Amoako-Boateng M., Dayie M., Hagan R., Debrah S., Ohene-Yeboah M., Clegg-Lampety J. -N., Etwire V., Dakubo J., Essoun S., Bonney W., Glover-Addy H., Osei-Nketiah S., Amoako J., Adu-Aryee N., Appeadu-Mensah W., Bediako-Bowan A., Dedey F., Ekow M., Akatibo E., Yakubu M., Kordorwu H. E. K., Asare-Bediako K., Tackie E., Aaniana K., Acquah E., Opoku-Agyeman R., Avoka A., Kusi K., Maison K., Gyamfi F. E., Naabarnabas G., Abdul-Latif S., Taahamoako P., Davor A., Dassah V., Dagoe E., Kwakyeafriyie P., Akoto E., Ackom E., Mensah E., Atkins E. T., Coompson C. L., Ivros N., Ferousis C., Agalianos C., Kyriazanos I., Barkolias C., Tselos A., Tzikos G., Voulgaris E., Lytras D., Bamicha A., Psarianos K., Stefanopoulos A., Patoulias I., Sfougaris D., Valioulis I., Balalis D., Korkolis D., Manatakis D. K., Kyrou G., Karabelias G., Papaskarlatos I. -A., Konstantina K., Zampitis N., Germanos S., Papailia A., Theodosopoulos T., Gkiokas G., Mitroudi M., Panteli C., Feidantsis T., Farmakis K., Kyziridis D., Ioannidis O., Parpoudi S., Gemenetzis G., Parasyris S., Anthoulakis C., Nikoloudis N., Margaritis M., Aguilera-Arevalo M. -L., Coyoy-Gaitan O., Rosales J., Tale L., Soley R., Barrios E., Rodriguez S. T. T., Pazgalvez C., Herreracruz D., Rosenberg G. S., Matheu A., Cohen D. M., Paul M., Charles A., Lam J. C. Y., Yeung M. H. A., Fok C. Y. J., Li K. H. G., Lai A. C. -H., Cheung Y. H. E., Wong H. Y., Leung K. W., Lee T. S. B., Lam W. H., Dao W., Kwok S. H. -W., Chan T. -Y. K., Ng Y. K., Liu Q., Foo C. C., Yang J., Kumar B., Bhatnagar A., Upadhyaya V., Kumar S., Muddebihal U., Dar W., Kc J., Alexander P., Aruldas N., Adella F. J., Rulie A. S., Iskandar F., Setiawan J., Evajelista C. V., Natalie H., Arlindawati, Gunawan R., Karismaningtyas H., Mata L., Andika F., Hasanah A., Widiastini T. A., Purwaningsih N., Mukin A. D. F., Rahmah D., Nurqistan H., Arsyad H., Adhitama N., Jeo W., Sutandi N., Clarissa A., Gultom P. A., Billy M., Haloho A., Amandito R., Johanna N., Lee F., Dorani R. M. N. R., Glynn M., Alherz M., Goh W., Shiwani H. A., Sproule L., Conlon K. C., Bala M., Kedar A., Turati L., Bianco F., Steccanella F., Gallo G., Trompetto M., Clerico G., Papandrea M., Sammarco G., Sacco R., Benevento A., Pata F., Giavarini L., Giglio M. C., Bucci L., Pagano G., Sollazzo V., Peltrini R., Luglio G., Birindelli A., Di Saverio S., Tugnoli G., Paludi M. A., Mingrone P., Pata D., Selvaggi F., Selvaggi L., Pellino G., Di Martino N., Curletti G., Aonzo P., Galleano R., Berti S., Francone E., Boni S., Lorenzon L., Lo Conte A., Balducci G., Confalonieri G., Pesenti G., Gavagna L., Vasquez G., Targa S., Occhionorelli S., Andreotti D., Pata G., Aquilino F., Chetta N., Picciariello A., Abdelkhalek M., Belli A., de Franciscis S., Bigaran A., Favero A., Basso S. M. M., Salusso P., Perino M., Mochet S., Sasia D., Riente F., Migliore M., Merlini D., Basilico S., Corbellini C., Lazzari V., Macchitella Y., Bonavina L., Angelieri D., Coletta D., Falaschi F., Catani M., Reali C., Malavenda M., Del Basso C., Ribaldi S., Coletti M., Natili A., Depalma N., Iannone I., Antoniozzi A., Rossi D., Gui D., Perrotta G., Ripa M., Giardino F. R., Foco M., Vicario E., Coccolini F., Ansaloni L., Nita G. E., Leone N., Bondurri A., Maffioli A., Simioni A., de Boni D., Pasquali S., Goldin E., Vendramin E., Ciccioli E., Tedeschi U., Bortolasi L., Violi P., Campagnaro T., Conci S., Lazzari G., Iacono C., Guglielmi A., Manfreda S., Rinaldi A., Ringressi M. N., Brunoni B., Salamone G., Mangiapane M., de Marco P., la Brocca A., Tutino R., Silvestri V., Licari L., Fontana T., Cocorullo N. F. G., Sileri P., Arcudi C., Bsisu I., Aljboor K., Abusalem L., Alnusairat A., Qaissieh A., Al-Dakka E., Ababneh A., Halhouli O., Yusufali T., Mohammed H., Lando J., Parker R., Ndegwa W., Jokubauskas M., Gribauskaite J., Venskutonis D., Kuliavas J., Dulskas A., Samalavicius N. E., Jasaitis K., Parseliunas A., Nevieraite V., Montrimaite M., Slapelyte E., Dainius E., Riauka R., Subocius Z. D. A., Venclauskas L., Gulbinas A., Bradulskis S., Kasputyte S., Mikuckyte D., Kiudelis M., Zilinskas J., Jankus T., Petrikenas S., Pazusis M., Urniezius Z., Vilcinskas M., Banaitis V. J., Gaizauskas V., Grisin E., Mazrimas P., Rackauskas R., Drungilas M., Lagunavicius K., Lipnickas V., Majauskyte D., Jotautas V., Abaliksta T., Uscinas L., Simutis G., Ladukas A., Danys D., Laugzemys E., Mikalauskas S., Sruogiene E. Z., Visinskas P., Zilinskiene R., Dragatas D., Burmistrovas A., Tverskis Z., Vaicius A., Mazelyte R., Zadoroznas A., Kaselis N., Ziubryte G., Rahantasoa F. C. F. P., Samison L. H., Rasoaherinomenjanahary F., Tolotra T. E. C., Mukuzunga C., Msosa V., Kwatiwani C., Msiska N., Chai F. Y., Asilah S. M. D., Syibrah K. Z., Chin P. X., Salleh A., Riswan N. Z., Roslani A. C., Chong H. -Y., Aziz N. A., Poh K. -S., Chai C. -A., Taher M. M., Kosai N. R., Aziz D. N. A., Rajan R., Julaihi R., Jethwani D. L., Yahaya M. T., Abdullah N. A. N., Mathew S. W., Chung K. J., Nirumal M. K., Tze R. G. E., Ali S. A. W. E. W., Gan Y. Y., Ting J. R. S., Sii S. S. Y., Koay K. L., Tan Y. K., Cheah A. E. Z., Wong C. Y., Mat T. N. T., Chow C. Y. N., Har P. A. L., Der Y., Tew Y. 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O., Oshati O., Ihediwa G., Adenekan B., Nwinee V., Alakaloko F., Ademuyiwa A., Elebute O., Lawal A., Bode C., Olugbemi M., Adesina A., Faturoti O., Odutola O., Adebola O., Onuoha C., Taiwo O., Williams O., Balogun F., Ajai O., Oludara M., Njokanma I., Osuoji R., Kache S., Ajah J., Makama J., Adamu A., Baba S., Aliyu M., Aliyu S., Ukwenya Y., Aliyu H., Sholadoye T., Daniyan M., Ogunsua O., Anyanwu L. -J., Sheshe A., Mohammad A., Olori S. D., Mshelbwala P., Odeyemi B., Samson G., Timothy O. K., Samuel S. A., Ajiboye A., Amole I., Abiola O., Olaolorun A., Veen T., Kanani A., Styles K., Herikstad R., Larsen J. W., Soreide J. A., Jensen E., Gran M., Aahlin E. K., Gaarder T., Monrad-Hansen P. W., Naess P. A., Lauzikas G., Wiborg J., Holte S., Augestad K., Banipal G., Monteleone M., Moe T., Schultz J., Al-Taher T., Hamdan A., Salman A., Saadeh R., Musleh A., Jaradat D., Abushamleh S., Hanoun S., Qumbos A. A., Hamarshi A., Taher A. A., Qawasmi I., Qurie K., Altarayra M., Ghannam M., Shaheen A., Herebat A., Abdelhaq A., Shalabi A., Abu-Toyour M., Asi F., Shamasneh A., Atiyeh A., Mustafa M., Zaatreh R., Dabboor M., Alaloul E., Baraka H., Meqbil J., Al-Buhaisi A., Elshami M., Afana S., Jaber S., Alyacoubi S., Abuowda Y., Idress T., Abuqwaider E., Al-Saqqa S. W., Bowabsak A., Eljamassi A., Hasanain D., Al-Farram H., Firwana A., Hamdan M., Awad I., Ashour A., Al Barrawi F. E., Al-Khatib A., Al-Faqawi M., Fares M., Elmashala A., Adawi M., Adawi I., Khreishi R., Ghaben A., Nadeem N., Saqlain M., Abbasy J., Alvi A. R., Gala T., Shahzad N., Bhopal K. F., Iftikhar Z., Butt M. T., Ul Razi S. A., Niazi A. K., Raza I., Baluch F., Raza A., Bani-Sadar A., Qureshi A. U., Adil M., Javaid M., Waqar M., Khan M., Arshad M., Amjad M., Vega G. M. M., Cardozo J. T., Roche M. O., Servin G. R. P., Lohse H. A. S., Lopez L. I. P., Cardozo R. A. M., Espinoza F., Rojas A. D. P., Sanchez D., Samaniego C. S., Torres S. G., Calua A. 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R., Negoi I., Beuran M., Ciubotaru C., Alphonse M., Uzabumwana N., Duhoranenayo D., Jovine E., Zanini N., Landolfo G., Aljiffry M., Idris F., Alghamdi M. S. A., Maghrabi A., Altaf A., Khalifah E., Gudal A., Albiety A., Alkaaki A., Alshareef R., Khoja A., Nawawi A., Najjar M., Turkustani S., Sahel S., Alzahrani A., Alghamdi A., Alhazmi W., Al Saied G., Alamoudi M., Riaz M. M., Hassanain M., Alhassan B., Altamimi A., Alyahya R., Alsubaie N., Albastawis F., Nouh T., Khan R., Radojkovic M., Jeremic L., Nestorovic M., Law J. H., Tan K. S. K., Tan R. C. K., Tan J. K., Joel L. W. L., Lieske B., Chan X. W., Leong F. Q. H., Chong C. S., Koh S., Lee K. Y., Lee K. C., Pluke K., Dedekind B., Nashidengo P., Hampton M. I., Joosten J., Sobnach S., Roodt L., Sander A., Pape J., Spence R., Maistry N., Ndwambi P., Kinandu K., Tun M., du Toit F., Ellison Q., Burger S., Grobler D. C., Khulu L. B., Moore R., Jennings V., Leusink A., Kariem N., Gouws J., Chu K., Bougard H., Noor F., Dell A., Rayne S., van Straten S., Khamajeet A., Tshisola S. K., Kabongo K., Kong V., Moodley Y., Anderson F., Madiba T., du Plooy F., Hartford L., Chilton G., Karjiker P., Mabitsela M., Ndlovu S., Badicel M., Jaich R., Ruiz-Tovar J., Garcia-Florez L., Otero-Diez J. L., Ramosperez V., Aguadosuarez N., Garcia J. M., Moreno S. C., Collado M. V., Carneros V. J., Septiem J. G., Gonzalez M., Picardo A., Esteban E., Ferrero E., Ortega I., Espin-Basany E., Blanco-Colino R., Andriola V., Lorena I., Contreras E., Garciabernardo C., Pagnozzi J., Sanz S., Miyardeleon A., Dorisme A., Rodicio J., Suarez A., Stuva J., Diazvico T., Fernandez-Vega L., Soldevila-Verdeguer C., Sena-Ruiz F., Pujol-Cano N., Diaz-Jover P., Garcia-Perez J. M., Segura-Sampedro J. J., Pineno-Flores C., Ambrona-Zafra D., Craus-Miguel A., Jimenez-Morillas P., Mazzella A., Jayathilake A. B., Thalgaspitiya S. P. B., Wijayarathna L. S., Wimalge P. M. S. N., Sanni H. A., Ndajiwo A., Okenabirhie O., Homeida A., Younis A., Omer O. A., Abdulaziz M., Mussad A., Gilani A. M., Cengiz Y., Bjorklund I., Ahlqvist S., Thorell A., Wogensen F., Sokratous A., Breistrand M., Thorarinsdottir H., Sigurdadottir J., Nikberg M., Chabok A., Hjertberg M., Elbe P., Saraste D., Rutkowski W., Forlin L., Niska K., Sund M., Oswald D., Peros G., Bluelle R., Reinisch K., Frey D., Palma A., Zumbuhl L., Zuber M., Schmid R., Werder G., Nocito A., Gerosa A., Mahanty S., Widmer L. W., Muller J., Gubeli A., Zuk G., Gulcicek O. B., Altinel Y., Vartanoglu T., Kose E., Karahan S. R., Aydin M. C., Sahbaz N. A., Halicioglu I., Alis H., Sapci I., Adiyaman C., Pektas A. M., Cengiz T. B., Tansoker I., Isler V., Cevik M., Mutlu D., Ozben V., Ozmen B. B., Bayram S., Yolcu S., Kobal B. B., Toto O. F., Cakaloglu H. C., Karabulut K., Mutlu V., Ozkan B. B., Celik S., Semiz A., Bodur S., Gul E., Murutoglu B., Yildirim R., Baki B. E., Arslan E., Ulusahin M., Guner A., Walker N., Shrimanker N., Stoddart M., Cole S., Breslin R., Srinivasan R., Elshaer M., Hunter K., Al-Bahrani A., Liew I., Mairs N. G., Rocke A., Dick L., Qureshi M., Chowdhury D., Wright N., Skerritt C., Ho A., Dissanayake T., Tennakoon A., Ali W., Lim S. J., Tan C., O'Neill S., Jones C., Knight S., Nassif D., Sharma A., Warren O., White R., Mehdi A., Post N., Kalakouti E., Dashnyam E., Stourton F., Mykoniatis I., Currow C., Wong F., Gupta A., Shatkar V., Luck J., Kadiwar S., Smedley A., Wakefield R., Herrod P., Blackwell J., Lund J., Cohen F., Bandi A., Giuliani S., Bond-Smith G., Pezas T., Farhangmehr N., Urbonas T., Perenyei M., Ireland P., Blencowe N., Bowling K., Bunting D., Longstaff L., Smart N., Keogh K., Jeon H., Iqbal M. R., Khosla S., Jeffery A., Perera J., Teasdale E., Ibrahem A. A., Alhammali T., Salama Y., Kabariti R., Oram S., Kidd T., Cullen F., Owen C., Wilson M., Chiu S., Sarafilovic H., Ploski J., Evans E., Abbas A., Kamya S., Ishak N., Bisset C., Andress C., Chin Y. R., Patel P., Evans D., Haslegrave A., Boggon A., Laurie K., Connor K., Mann T., Nepogodiev D., Mansuri A., Davies R., Griffiths E., Shahbaz A. R., Eng C., Din F., Heveder A. L., Park E. H. G., Ravishankar R., McIntosh K., Yau J. D., Chan L., McGarvie S., Tang L., Lim H., Yap S., Park J., Ng Z., Mirza S., Ang Y. L., Walls L., Roy C., Paterson-Brown S., Camilleri-Brennan J., McLean K., D'Souza M., Pronin S., Henshall D. E., Ter E., Fouad D., Minocha A., English W., Morgan C., Townsend D., Maciejec L., Mahdi S., Akpenyi O., Hall E., Caydiid H., Rob Z., Abbott T., Torrance H. D., Irwin G., Johnston R., Gani M., Gravante G., Rajmohan S., Majid K., Dindyal S., Smith C., Palliyil M., Patel S., Nicholson L., Harvey N., Baillie K., Shillito S., Kershaw S., Bamford R., Orton P., Reunis E., Tyler R., Soon W., Jama G. M., Dhillon D., Patel K., Nanthakumaran S., Heard R., Chen K. Y., Barmayehvar B., Datta U., Kamarajah S. K., Iftekhartani S., Monaghan E., Donnelly P., Walker M., Parakh J., Blacker S., Kaul A., Paramasivan A., Farag S., Nessa A., Awadallah S., Lim J., Cheankhunng J., Gash K., Kiran R. P., Murray A., Etchill E., Dasari M., Puyana J., Haddad N., Zielinski M., Choudhry A., Caliman C., Beamon M., Duane T., Narayanan R., Swaroop M., Myers J., Deal R., Schadde E., Hemmila M., Napolitano L., To K., Makupe A., Musowoya J., Maimbo M., van der Naald N., Kumwenda D., Reece-Smith A., Otten K., Verbeek A., Prins M., Suarez A. A. B., Deane C., Dijan E., Elfiky M., Koskenvuo L., Thollot A., Limoges B., Capito C., Alexandre C., Kotobi H., Leroux J., Pinnagoda K., Henric N., Azzis O., Rosello O., Francois P., Etienne S., Buisson P., Hmila S., Clegg-Lamptey J. -N., Imoro O., Abem O. E., Papageorgiou D., Soulou V., Asturias S., Pena L., Connor D. B. O., Luc A. R., Russo A. A., Ruzzenente A., Taddei A., Cona C., Bottini C., Pascale G., Rotunno G., Solaini L., Pascale M. M., Notarnicola M., Corbellino M., Sacco M., Ubiali P., Cautiero R., Bocchetti T., Muzio E., Guglielmo V., Morandi E., Mao P., de Luca E., Ali F. M., Strupas K., Kondrotas P., Baltrunas R., Kutkevicius J., Ignatavicius P., Tan C. L., Siaw J. Y., Yam S. Y., Wilson L., Aziz M. R. A., Bondin J., Zorrilla C. D., Majbar A., Sale D., Abdullahi L., Osagie O., Faboya O., Fatuga A., Taiwo A., Nwabuoku E., Bliksoen M., Khan Z. A., Coronel J., Miranda C., Vasquez I., Helguero-Santin L. M., Rickard J., Adedeji A., Alqahtani S., Rath M., van Niekerk M., Koto M. Z., Matos-Puig R., Israelsson L., Schuetz T., Yuksek M. A., Mericliler M., Wolf B., Fairfield C., Yong G. L., Whitehurst K., Redgrave N., Musyoka C. K., Olivier J., Lee K., Cox M., Farhan-Alanie M. M. H., Callan R., Chibuye C., Ali T. H. A., Rekhis S., Rommaneh M., Sam Z. H., Pugliesi T. B., Pardo G., Harrison, E. M., Drake, T. M., Ghosh, D., Ademuyiwa, A. O., Bhangu, A., Fitzgerald, J. E., Glasbey, J., Borda-Luque, G., Costas-Chavarri, A., Ntirenganya, F., Fergusson, S. J., Ingabire, J. C. A., Ismail, L., Lilford, R., Mihaljevic, A. L., Morton, D., Mutabazi, A. Z., Adisa, A. O., Ots, R., Pinkney, T., Poskus, T., Shaw, C. A., Verjee, A., Runigamugabo, E., Khatri, C., Mohan, M., Jaffry, Z., Altamini, A., Kirby, A., Soreide, K., Cornick, J., Iyer, D., King, S., Arthur, T., Nahar, S. N., Waterman, A., Lawini, I., Rouse, T., Correa, J. C., Salem, H. K., Worku, M., Arnaud, A., Kalles, V., Aguilera, M. 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B., Pardo, G., HUS Abdominal Center, II kirurgian klinikka, Department of Anatomy, Pertti Panula / Principal Investigator, Clinicum, M Drake, Thoma, Pata, Francesco, Ghosh, Dhruv, O Ademuyiwa, Adesoji, Arnaud, Alexi, Bhangu, Aneel, Edward Fitzgerald, J, Glasbey, Jame, M Harrison, Ewen, Lorena Aguilera, Maria, Alexander, Philip, W Al-Saqqa, Sara, Borda-Luque, Giuliano, Costas-Chavarri, Ainhoa, Ntirenganya, Faustin, J Fergusson, Stuart, C Allen Ingabire, J, Ismaïl, Lawani, Khairy Salem, Hosni, Theophilus Teddy Kojo, Anyomih, Carmela Lapitan, Marie, Lilford, Richard, L Mihaljevic, Andre, Morton, Dion, Zeta Mutabazi, Alphonse, Nepogodiev, Dmitri, O Adisa, Adewale, Ots, Riinu, Pinkney, Thoma, Poškus, Toma, Uzair Qureshi, Ahmad, Ramos-De la Medina, Antonio, Rayne, Sarah, A Shaw, Catherine, Shu, Sebastian, Spence, Richard, Smart, Neil, Tabiri, Stephen, Verjee, Azmina, Runigamugabo, Emmy, Khatri, Chetan, Mohan, Midhun, Jaffry, Zahra, Altamini, Afnan, Kirby, Andrew, Soreide, Kjetil, Recinos, Gustavo, Cornick, Jen, Marta Modolo, Maria, King, Sebastian, Nazmum Nahar, Sayeda, Waterman, Ade, Lawini, Ismail, Agarwal, Arnav, Zani, Augusto, Firdouse, Mohammed, Rouse, Tyler, Liu, Qinyang, Camilo Correa, Juan, Talving, Peep, Worku, Mengistu, Iyer, Dushyant, Arthur, Tom, Aguilera, Marialorena, Kumar, Basant, Kumar, Sunil, Amandito, Radhian, Quek, Roy, Ansaloni, Luca, Altibi, Ahmed, Venskutonis, Donata, Zilinskas, Justa, Poskus, Toma, Whitaker, John, Tew, Yongyong, Msosa, Vanessa, Farrugia, Alexia, Borg, Elaine, Antonio, Ramos-DelaMedina, Bent, Zineb, Ademuyiwa, Adesoji, Gala, Tanzeela, Al-Slaibi, Ibrahim, Tahboub, Haya, H Alser, Osaid, Romani, Diego, Shu, Sebestian, Major, Piotr, Mironescu, Aurel, Bratu, Matei, Kourdouli, Amar, Kitts, Saint, Ubaid Alsaggaf, Mohammed, Gudal, Ahmad, Faifi Jubran, Al, Leone, Sierra, Seisay, Sam, Lieske, Bettina, Ortega, Irene, Jeyakumar, Jenifa, Senanayake, Kithsiri, Abdulbagi, Omar, Cengiz, Yucel, Raptis, Dmitri, Altinel, Yuksel, Kong, Chia, Teasdale, 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Abbott, Tom, D Torrance, Hew, Johnston, Robin, Gani, Mohammedakil, Gravante, Gianpiero, Rajmohan, Shivanchan, Majid, Kiran, Dindyal, Shiva, Smith, Christopher, Palliyil, Madanmohan, Patel, Sanjay, Nicholson, Luke, Harvey, Neil, Baillie, Katie, Shillito, Sam, Kershaw, Suzanne, Bamford, Rebecca, Orton, Peter, Reunis, Elke, Tyler, Robert, Soon, Waicheong, M Jama, Guled, Dhillon, Dharminder, Patel, Khyati, Nanthakumaran, Shayanthan, Heard, Rachel, Yan Chen, Kar, Barmayehvar, Behrad, Datta, Uttaran, K Kamarajah, Sivesh, Iftekhartani, Sobhana, Monaghan, Eimear, Donnelly, Philippa, Walker, Michael, Parakh, Jehangirshaw, Blacker, Sarah, Kaul, Anil, Paramasivan, Arjun, Farag, Sameh, Nessa, Ashrafun, Awadallah, Salwa, Lim, Jieqi, Cheankhunng, Jame, P Kiran, Ravi, Murray, Alice, Etchill, Eric, Dasari, Mohini, Puyana, Juan, Haddad, Nadeem, Zielinski, Martin, Choudhry, Asad, Caliman, Celeste, Beamon, Mieshia, Duane, Therese, Swaroop, Mamta, Myers, Jonathan, Deal, Rebecca, Schadde, Erik, Hemmila, 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Chibuye, Chali, Hassanein Ahmed Ali, Tebian, Rekhis, Syrine, Rommaneh, Muna, Hao Sam, Zi, Lawani, Ismail, Brunelli Pugliesi, Thay, Pardo, Gabriel, Blanco, Ruth, and GlobalSurg Collaborative: Aneel Bhangu, Adesoji O Ademuyiwa, Maria Lorena Aguilera, Philip Alexander, Sara W Al-Saqqa, Giuliano Borda-Luque, Ainhoa Costas-Chavarri, Thomas M Drake, Faustin Ntirenganya, J Edward Fitzgerald, Stuart J Fergusson, James Glasbey, Jc Allen Ingabire, Lawani Ismaïl, Hosni Khairy Salem, Anyomih Theophilus Teddy Kojo, Marie Carmela Lapitan, Richard Lilford, Andre L Mihaljevic, Dion Morton, Alphonse Zeta Mutabazi, Dmitri Nepogodiev, Adewale O Adisa, Riinu Ots, Francesco Pata, Thomas Pinkney, Tomas Poškus, Ahmad Uzair Qureshi, Antonio Ramos-De la Medina, Sarah Rayne, Catherine A Shaw, Sebastian Shu, Richard Spence, Neil Smart, Stephen Tabiri, Ewen M Harrison, Chetan Khatri, Midhun Mohan, Zahra Jaffry, Afnan Altamini, Andrew Kirby, Kjetil Søreide, Gustavo Recinos, Jen Cornick, Maria Marta Modolo, Dushyant Iyer, Sebastian King, Tom Arthur, Sayeda Nazmum Nahar, Ade Waterman, Michael Walsh, Arnav Agarwal, Augusto Zani, Mohammed Firdouse, Tyler Rouse, Qinyang Liu, Juan Camilo Correa, Peep Talving, Mengistu Worku, Alexis Arnaud, Vassilis Kalles, Basant Kumar, Sunil Kumar, Radhian Amandito, Roy Quek, Luca Ansaloni, Ahmed Altibi, Donatas Venskutonis, Justas Zilinskas, Tomas Poskus, John Whitaker, Vanessa Msosa, Yong Yong Tew, Alexia Farrugia, Elaine Borg, Zineb Bentounsi, Tanzeela Gala, Ibrahim Al-Slaibi, Haya Tahboub, Osaid H Alser, Diego Romani, Sebestian Shu, Piotr Major, Aurel Mironescu, Matei Bratu, Amar Kourdouli, Aliyu Ndajiwo, Abdulaziz Altwijri, Mohammed Ubaid Alsaggaf, Ahmad Gudal, Al Faifi Jubran, Sam Seisay, Bettina Lieske, Irene Ortega, Jenifa Jeyakumar, Kithsiri J Senanayake, Omar Abdulbagi, Yucel Cengiz, Dmitri Raptis, Yuksel Altinel, Chia Kong, Ella Teasdale, Gareth Irwin, Michael Stoddart, Rakan Kabariti, Sukrit Suresh, Katherine Gash, Ragavan Narayanan, Mayaba 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Souaibou, Kpèmahouton René Keke, Fred Hodonou, Ernest Yemalin Stephane Ahounou, Thierry Alihonou, Max Dénakpo, Germain Ahlonsou, Alemayehu Ginbo Bedada, Carlos Nsengiyumva, Sandrine Kwizera, Venerand Barendegere, Philip Choi, Simon Stock, Luai Jamal, Georges Azzie, Sameer Kushwaha, Tzu-Ling Chen, Chingwan Yip, Irene Montes, Felipe Zapata, Sebastian Sierra, Maria Isabel Villegas Lanau, Maria Clara Mendoza Arango, Ivan Mendoza Restrepo, Ruben Santiago Restrepo Giraldo, Edgar Domini, Robert Karlo, Jakov Mihanovic, Mohamed Youssef, Hossam Elfeki, Waleed Thabet, Aly Sanad, Gehad Tawfik, Ahmed Zaki, Noran Abdel-Hameed, Mohamed Mostafa, Muhammad Fathi Waleed Omar, Ahmed Ghanem, Emad Abdallah, Adel Denewer, Eman Emara, Eman Rashad, Ahmad Sakr, Rehab Elashry, Sameh Emile, Toqa Khafagy, Sara Elhamouly, Arwa Elfarargy, Amna Mamdouh Mohamed, Ghada Saied Nagy, Abeer Esam, Eman Elwy, Aya Hammad, Salwa Khallaf, Eman Ibrahim, Ahmed Said Badr, Ahmed Moustafa, Amany Eldosouky Mohammed, Mohammed Elgheriany, Eman Abdelmageed, Eman Abd Al Raouf, Esraa Samir Elbanby, Maha Elmasry, Mahitab Morsy Farahat, Eman Yahya Mansor, Eman Magdy Hegazy, Esraa Gamal, Heba Gamal, Hend Kandil, Doaa Maher Abdelrouf, Mohamed Moaty, Dina Gamal, Nada El-Sagheer, Mohamed Salah, Salma Magdy, Asmaa Salah, Ahmed Essam, Ahmed Ali, Mahmoud Badawy, Sara Ahmed, Mazed Mohamed, Abdelrahman Assal, Mohamed Sleem, Mai Ebidy, Aly Abd-Elrazek, Diaaaldin Zahran, Nourhan Adam, Mohamed Nazir, Adel B Hassanein, Ahmed Ismail, Amira Elsawy, Rana Mamdouh, Mohamed Mabrouk, Lopna Ahmed Mohamed Ahmed, Mohamed Hassab Alnaby, Eman Magdy, Manar Abd-Elmawla, Marwan Fahim, Bassant Mowafy, Moustafa Ibrahim Mahmoud, Meran Allam, Muhammad Alkelani, Noran Halim El Gendy, Mariam Saad Aboul-Naga, Reham Alaa El-Din, Alyaa Halim Elgendy, Mohamed Ismail, Mahmoud Shalaby, Aya Adel Elsharkawy, Mahmoud Elsayed Moghazy, Khaled Hesham Elbisomy, Hend Abdel Gawad Shakshouk, Mohamed Fouad Hamed, Mai Mohamed Ebidy, Mostafa Abdelkader, Mohamed Karkeet, Hayam Ahmed, Israa Adel, Mohammad Elsayed Omar, Mohamed Ibrahim, Omar Ghoneim, Omar Hesham, Shimaa Gamal, Karim Hilal, Omar Arafa, Sawsan Adel Awad, Menatalla Salem, Fawzia Abdellatif Elsherif, Nourhan Elsabbagh, Moustafa R Aboelsoud, Ahmed Hossam Eldin Fouad Rida, Amr Hossameldin, Ethar Hany, Yomna Hosny Asar, Nourhan Anwar, Mohamed Gadelkarim, Samar Abdelhady, Eman Mohamed Morshedy, Reham Saad, Nourhan Soliman, Mahmoud Salama, Eslam Ezzat, Arwa Mohamed, Arwa Ibrahim, Alaa Fergany, Sara Mohammed, Aya Reda, Yomna Allam, Hanan Adel Saad, Afnan Abdelfatah, Aya Mohamed Fathy, Ahmed El-Sehily, Esraa Abdalmageed Kasem, Ahmed Tarek Abdelbaset Hassan, Ahmed Rabeih Mohammed, Abdalla Gamal Saad, Yasmin Elfouly, Nesma Elfouly, Arij Ibrahim, Amr Hassaan, Mohammed Mustafa Mohammed, Ghada Elhoseny, Mohamed Magdy, Esraa Abd Elkhalek, Yehia Zakaria, Tarek Ezzat, Ali Abo El Dahab, Mohamed Kelany, Sara Arafa, Osama Mokhtar Mohamed Hassan, Nermin Mohamed Badwi, Ahmad Saber Sleem, Hussien Ahmed, Kholoud Abdelbadeai, Mohamed Abozed Abdullah, Muhammad Amsyar Auni Lokman, Suraya Bahar, Anan Rady Abdelazeam, Abdelrahman Adelshone, Muhammad Bin Hasnan, Athirah Zulkifli, Siti Nur Alia Kamarulzamil, Abdelaziz Elhendawy, Aliang Latif, Ahmad Bin Adnan, Shahadatul Shaharuddin, Aminah Hanum Haji Abdul Majid, Mahmoud Amreia, Dina Al-Marakby, Mahmoud Salma, Mohamad Jeffrey Bin Ismail, Elissa Rifhan Mohd Basir, Citra Dewi Mohd Ali, Aya Yehia Ata, Maha Nasr, Asmaa Rezq, Ahmed Sheta, Sherif Tariq, Abd Elkhalek Sallam, Abdelrhman Kz Darwish, Sohaila Elmihy, Shady Elhadry, Ahmed Farag, Haidar Hajeh, Abdelaziz Abdelaal, Amro Aglan, Ahmed Zohair, Mahitab Essam, Omar Moussa, Esraa El-Gizawy, Mostafa Samy, Safia Ali, Esraa El Halawany, Ahmed Ata, Mohamed El Halawany, Mohamed Nashat, Samar Soliman, Alaa Elazab, Mostada Samy, Mohamed A Abdelaziz, Khaled Ibrahim, Ahmed Mohamed Ibrahim, Ammar Gado, Usama Hantour, Esraa Alm Eldeen, Mohamed Reda Loaloa, Arwa Abouzaid, Mostafa Ahmed Bahaa Eldin, Eman Hashad, Fathy Sroor, Doaa Gamil, Eman Mahmoud Abdulhakeem, Mahmoud Zakaria, Fawzy Mohamed, Marwan Abubakr, Elsayed Ali, Hesham Magdy, Menna Tallah Ramadan, Mohamed Abdelaty Mohamed, Salma Mansour, Hager Abdul Aziz Amin, Ahmed Rabie Mohamed, Mahmoud Saami, Nada Ahmed Reda Elsayed, Adham Tarek, Sabry Mohy Eldeen Mahmoud, Islam Magdy El Sayed, Amira Reda, Martina Yusuf Shawky, Mohammed Mousa Salem, Shahinaz Alaa El-Din, Noha Abdullah Soliman, Muhammed Talaat, Shahinaz Alaael-Dein, Ahmed Abd Elmoen Elhusseiny, Noha Abdullah, Mohammed Elshaar, Aya Abdelfatah Ibraheem, Hager Abdulaziz, Mohammed Kamal Ismail, Mona Hamdy Madkor, Mohamed Abdelaty, Sara Mahmoud Abdel-Kader, Osama Mohamed Salah, Mahmoud Eldafrawy, Ahmed Zaki Eldeeb, Mostafa Mahmoud Eid, Attia Attia, Khalid Salah El-Dien, Ayman Shwky, Mohamed Adel Badenjki, Abdelrahman Soliman, Samaa Mahmoud Al Attar, Farrag Sayed, Fahd Abdel Sabour, Mohammed G Azizeldine, Muhammad Shawqi, Abdullah Hashim, Ahmed Aamer, Ahmed Mahmoud Abdelraouf, Mahmoud Abdelshakour, Amal Ibrahim, Basma Mahmoud, Mohamed Ali Mahmoud, Mostafa Qenawy, Ahmed M Rashed, Ahmed Dahy, Marwa Sayed, Ahmed W Shamsedine, Bakeer Mohamed, Ahmad Hasan, Mahmoud M Saad, Khalil Abdul Bassit, Nadia Khalid Abd El-Latif, Nada Elzahed, Ahmed El Kashash, Nada Mohamed Bekhet, Sarah Hafez, Ahmed Gad, Mahmoud Elkhadragy Maher, Ahmed Abd El-Sameea, Mohamed Hafez, Ahmad Sabe, Ataa Ahmed, Ahmed Shahine, Khaled Dawood, Shireen Gaafar, Reem Husseiny, Omnia Aboelmagd, Ahmed Soliman, Nourhan Mesbah, Hossam Emadeldin, Amgad Al Meligy, Amira Hassan Bekhet, Doaa Hasan, Khaled Alhady, Ahmad Khaled Sabe, Mahmoud A Elnajjar, Majed Aboelella, Ward Hamsho, Ihab Hassan, Hala Saad, Galaleldin Abdelazim, Hend Mahmoud, Noha Wael, Ahmedali M Kandil, Ahmed Magdy, Shimaa Said Elkholy, Badr Eldin Adel, Kareem Dabbour, Saged Elsherbiney, Omar Mattar, Abdulshafi Khaled AbdRabou, Mohammed Yahia Mohamed Aly, Abdelrahman Geuoshy, Ahmedglal Elnagar, Saraibrahim Ahmed, Ibrahem Abdelmotaleb, Amr Ahmed Saleh, Hesham Mohammed Bakry, Manar Saeed, Shady Mahmoud, Badreldin Adel Tawfik, Samar Adel Ismail, Esraay Zakaria, Mariam O Gad, Mohamed Salah Elhelbawy, Monica Bassem, Noha Maraie, Nourhan Medhat Elhadary, Nourhan Semeda, Shaza Rabie Mohamed, Hesham Mohammed Bakry, A A Essam, Dina Tarek, Khlood Ashour, Alaa Elhadad, Abdulrahman Abdel-Aty, Ibrahim Rakha, Sara Mamdouh Matter, Rasha Abdelhamed, Omar Abdelkader, Ayat Hassaan, Yasmin Soliman, Amna Mohamed, Sara Ghanem, Sara Amr Mohamed Farouk, Eman Mohamed Ibrahim, Esraa El-Taher, Merna Mostafa, Mohamed Fawzy Mahrous Badr, Rofida Elsemelawy, Aya El-Sawy, Ahmad Bakr, Ahmad Abdel Razaq Al Rafati, Sten Saar, Arvo Reinsoo, Nebyou Seyoum, Tewodros Worku, Agazi Fitsum, Matti Tolonen, Ari Leppäniemi, Ville Sallinen, Benogreît Parmentier, Matthieu Peycelon, Sabine Irtan, Sabrina Dardenne, Elsa Robert, Betty Maillot, Etienne Courboin, Alexis Pierre Arnaud, Juliette Hascoet, Olivier Abbo, Amir Ait Kaci, Thomas Prudhomme, Quentin Ballouhey, Céline Grosos, Laurent Fourcade, Tolg Cecilia, Colombani Jean-Francois, Francois-Coridon Helene, Xavier Delforge, Elodie Haraux, Bertrand Dousset, Roberto Schiavone, Sebastien Gaujoux, Jean-Baptiste Marret, Aurore Haffreingue, Julien Rod, Mariette Renaux-Petel, Jean-François Lecompte, Jean Bréaud, Pauline Gastaldi, Chouikh Taieb, Raquillet Claire, Echaieb Anis, Nasir Bustangi, Manuel Lopez, Aurelien Scalabre, Maria Giovanna Grella, Aurora Mariani, Guillaume Podevin, Françoise Schmitt, Erik Hervieux, Aline Broch, Cecile Muller, Dickson Bandoh, Francis Abantanga, Martin Kyereh, Hamza Asumah, Eric Kofi Appiah, Paul Wondoh, Adam Gyedu, Charles Dally, Kwabena Agbedinu, Michael Amoah, Abiboye Yifieyeh, Kwabena Agbedinu, Frank Owusu, Mabel Amoako-Boateng, Makafui Dayie, Richmond Hagan, Sam Debrah, Micheal Ohene-Yeboah, Joe-Nat Clegg-Lampety, Victor Etwire, Jonathan Dakubo, Samuel Essoun, William Bonney, Hope Glover-Addy, Samuel Osei-Nketiah, Joachim Amoako, Niiarmah Adu-Aryee, William 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Aspasia Papailia, Theodosios Theodosopoulos, Georgios Gkiokas, Magdalini Mitroudi, Christina Panteli, Thomas Feidantsis, Konstantinos Farmakis, Dimitrios Kyziridis, Orestis Ioannidis, Styliani Parpoudi, Georgios Gemenetzis, Stavros Parasyris, Christos Anthoulakis, Nikolaos Nikoloudis, Michail Margaritis, Maria-Lorena Aguilera-Arevalo, Otto Coyoy-Gaitan, Javier Rosales, Luis Tale, Rafael Soley, Emmanuel Barrios, Servio Tulio Torres Rodriguez, Carlos Paz Galvez, Danilo Herrera Cruz, Guillermo Sanchez Rosenberg, Alejandro Matheu, David Monterroso Cohen, Marie Paul, Angeline Charles, Justin Chak Yiu Lam, Man Hon Andrew Yeung, Chi Ying Jacquelyn Fok, Ka Hin Gabriel Li, Anthony Chuk-Him Lai, Yuk Hong Eric Cheung, Hong Yee Wong, Ka Wai Leung, Tien Seng Bryan Lee, Wai Him Lam, Weihei Dao, Stephanie Hiu-Wai Kwok, Tsz-Yan Katie Chan, Yung Kok Ng, Twc Mak, Chi Chung Foo, James Yang, Ankur Bhatnagar, Vijaid Upadhyaya, Uday Muddebihal, Wasim Dar, K C Janardhan, Neerav Aruldas, Fidelis Jacklyn Adella, Anthonius Santoso Rulie, Ferdy Iskandar, Jonny Setiawan, Cicilia Viany Evajelista, Hani Natalie, Arlindawati Suyadi, Rudy Gunawan, Herlin Karismaningtyas, Lusi Padma Sulistianingsih Mata, Ferry Fitriya Ayu Andika, Afifatun Hasanah, T Ariani Widiastini, Nurlaila Ayu Purwaningsih, Annisa Dewi Fitriana Mukin, Dina Faizatur Rahmah, Hazmi Dwinanda Nurqistan, Hasbi Maulana Arsyad, Novia Adhitama, Wifanto Saditya Jeo, Nathania Sutandi, Audrey Clarissa, Phebe Anggita Gultom, Matthew Billy, Andreass Haloho, Nadya Johanna, Felix Lee, Radin Mohd Nurrahman Radin Dorani, Martha Glynn, Mohammad Alherz, Wennweoi Goh, Haaris A Shiwani, Lorraine Sproule, Kevin C Conlon, Miklosh Bala, Asaf Kedar, Luca Turati, Federica Bianco, Francesca Steccanella, Gaetano Gallo, Mario Trompetto, Giuseppe Clerico, Matteo Papandrea, Giuseppe Sammarco, Rosario Sacco, Angelo Benevento, Luisa Giavarini, Mariano Cesare Giglio, Luigi Bucci, Gianluca Pagano, Viviana Sollazzo, Roberto Peltrini, Gaetano Luglio, Arianna Birindelli, Salomone Di Saverio, Gregorio Tugnoli, Miguel Angel Paludi, Pietro Mingrone, Domenica Pata, Francesco Selvaggi, Lucio Selvaggi, Gianluca Pellino, Natale Di Martino, Gianluca Curletti, Paolo Aonzo, Raffaele Galleano, Stefano Berti, Elisa Francone, Silvia Boni, Laura Lorenzon, Annalisa Lo Conte, Genoveffa Balducci, Gianmaria Confalonieri, Giovanni Pesenti, Laura Gavagna, Giorgio Vasquez, Simone Targa, Savino Occhionorelli, Dario Andreotti, Giacomo Pata, Andrea Armellini, Deborah Chiesa, Fabrizio Aquilino, Nicola Chetta, Arcangelo Picciariello, Mohamed Abdelkhalek, Andrea Belli, Silvia De Franciscis, Annamaria Bigaran, Alessandro Favero, Stefano Mm Basso, Paola Salusso, Martina Perino, Sylvie Mochet, Diego Sasia, Francesco Riente, Marco Migliore, David Merlini, Silvia Basilicò, Carlo Corbellini, Veronica Lazzari, Yuri Macchitella, Luigi Bonavina, Daniele Angelieri, Diego Coletta, Federica Falaschi, Marco Catani, Claudia Reali, Mariastella Malavenda, Celeste Del Basso, Sergio Ribaldi, Massimo Coletti, Andrea Natili, Norma Depalma, Immacolata Iannone, Angelo Antoniozzi, Davide Rossi, Daniele Gui, Gerardo Perrotta, Matteo Ripa, Francesco Ruben Giardino, Maurizio Foco, Erika Vicario, Federico Coccolini, Gabriela Elisa Nita, Nicoletta Leone, Andrea Bondurri, Anna Maffioli, Andrea Simioni, Davide De Boni, Sandro Pasquali, Elena Goldin, Elena Vendramin, Eleonora Ciccioli, Umberto Tedeschi, Luca Bortolasi, Paola Violi, Tommaso Campagnaro, Simone Conci, Giovanni Lazzari, Calogero Iacono, Alfredo Gulielmi, Serena Manfreda, Anna Rinaldi, Maria Novella Ringressi, Beatrice Brunoni, Giuseppe Salamone, Mirko Mangiapane, Paolino De Marco, Antonella La Brocca, Roberta Tutino, Vania Silvestri, Leo Licari, Tommaso Fontana, Nicolò Falco, Gianfranco Cocorullo, Mostafa Shalaby, Pierpaolo Sileri, Claudio Arcudi, Isam Bsisu, Khaled Aljboor, Lana Abusalem, Aseel Alnusairat, Ahmad Qaissieh, Emad Al-Dakka, Ali Ababneh, Oday Halhouli, Taha Yusufali, Hussein Mohammed, Justus Lando, Robert Parker, Wairimu Ndegwa, Mantas Jokubauskas, Jolanta Gribauskaite, Justas Kuliavas, Audrius Dulskas, Narimantas E Samalavicius, Kristijonas Jasaitis, Audrius Parseliunas, Viktorija Nevieraite, Margarita Montrimaite, Evelina Slapelyte, Edvinas Dainius, Romualdas Riauka, Zilvinas Dambrauskas, Andrejus Subocius, Linas Venclauskas, Antanas Gulbinas, Saulius Bradulskis, Simona Kasputyte, Deimante Mikuckyte, Mindaugas Kiudelis, Tomas Jankus, Steponas Petrikenas, Matas Pažuskis, Zigmantas Urniežius, Mantas Vilčinskas, Vincas Jonas Banaitis, Vytautas Gaižauskas, Edvard Grisin, Povilas Mazrimas, Rokas Rackauskas, Mantas Drungilas, Karolis Lagunavicius, Vytautas Lipnickas, Dovilè Majauskyté, Valdemaras Jotautas, Tomas Abaliksta, Laimonas Uščinas, Gintaras Simutis, Adomas Ladukas, Donatas Danys, Erikas Laugzemys, Saulius Mikalauskas, Elena Zdanyte Sruogiene, Petras Višinskas, Reda Žilinskienė, Deividas Dragatas, Andrius Burmistrovas, Zygimantas Tverskis, Arturas Vaicius, Ruta Mazelyte, Antanas Zadoroznas, Nerijus Kaselis, Greta Žiubrytė, Finaritra Casimir Fleur Prudence Rahantasoa, Luc Hervé Samison, Fanjandrainy Rasoaherinomenjanahary, Todisoa Emmanuella Christina Tolotra, Cornelius Mukuzunga, Chimwemwe Kwatiwani, Nelson Msiska, Feng Yih Chai, Siti Mohd Desa Asilah, Khuzaimah Zahid Syibrah, Pui Xin Chin, Afizah Salleh, Nur Zulaika Riswan, April Camilla Roslani, Hoong-Yin Chong, Nora Abdul Aziz, Keat-Seong Poh, Chu-Ann Chai, Sandip Kumar, Mustafa Mohammed Taher, Nik Ritza Kosai, Dayang Nita Abdul Aziz, Reynu Rajan, Rokayah Julaihi, Durvesh Lacthman Jethwani, Muhammad Taqiyuddin Yahaya, Nik Azim Nik Abdullah, Susan Wndy Mathew, Kuet Jun Chung, Milaksh Kumar Nirumal, R Goh Ern Tze, Syed Abdul Wahhab Eusoffee Wan Ali, Yiing Yee Gan, Jesse Ron Swire Ting, Samuel S Y Sii, Kean Leong Koay, Yi Koon Tan, Alvin Ee Zhiun Cheah, Chui Yee Wong, Tuan Nur'Azmah Tuan Mat, Crystal Yern Nee Chow, Prisca Al Har, Yishan Der, Fitjerald Henry, Xinwei Low, Ya Theng Neo, Hian Ee Heng, Shu Ning Kong, Cheewei Gan, Yi Ting Mok, Yee Wen Tan, Kandasami Palayan, Mahadevan Deva Tata, Yih Jeng Cheong, Kuhaendran Gunaseelan, Wan Nurul 'Ain Wan Mohd Nasir, Pigeneswaren Yoganathan, Eu Xian Lee, Jian Er Saw, Li Jing Yeang, Pei Ying Koh, Shyang Yee Lim, Shuang Yi Teo, Nicole Grech, Daniela Magri, Kristina Cassar, Christine Mizzi, Malcolm Falzon, Nihaal Shaikh, Ruth Scicluna, Stefan Zammit, Sean Mizzi, Svetlana Doris Brincat, Thelma Tembo, Vu Thanh Hien Le, Tara Grima, Keith Sammut, Kurt Carabott, Ciskje Zarb, Andre Navarro, Thea Dimech, Georgette Marie Camilleri, Isaac Bertuello, Jeffrey Dalli, Karl Bonavia, Samantha Corro-Diaz, Marisol Manriquez-Reyes, Amina Abdelhamid, Abdelmalek Hrora, Sarah Benammi, Houda Bachri, Meryem Abbouch, Khaoula Boukhal, Redouane Mammar Bennai, Abdelkader Belkouchi, Mohamed Sobhi Jabal, Chaymae Benyaiche, Maarten Vermaas, Lucia Duinhouwer, Javier Pastora, Greta Wood, Maria Soledad Merlo, Akinlabi Ajao, Omobolaji Ayandipo, Taiwo Lawal, Abdussemiu Abdurrazzaaq, Muslimat Alada, Abdulrasheed Nasir, James Adeniran, Olufemi Habeeb, Ademola Popoola, Ademola Adeyeye, Ademola Adebanjo, Opeoluwa Adesanya, Adewale Adeniyi, Henry Mendel, Bashir Bello, Umar Muktar, Adedapo Osinowo, Thomas Olagboyega Olajide, Oyindamola Oshati, George Ihediwa, Babajide Adenekan, Victor Nwinee, Felix Alakaloko, Olumide Elebute, Abdulrazzaq Lawal, Chris Bode, Mojolaoluwa Olugbemi, Alaba Adesina, Olubukola Faturoti, Oluwatomi Odutola, Oluwaseyi Adebola, Clement Onuoha, Ogechukwu Taiwo, Omolara Williams, Fatai Balogun, Olalekan Ajai, Mobolaji Oludara, Iloba Njokanma, Roland Osuoji, Stephen Kache, Jonathan Ajah, Jerry Makama, Ahmed Adamu, Suleiman Baba, Mohammad Aliyu, Shamsudeen Aliyu, Yahaya Ukwenya, Halima Aliyu, Tunde Sholadoye, Muhammad Daniyan, Oluseyi Ogunsua, Lofty-John Anyanwu, Abdurrahaman Sheshe, Aminu Mohammad, Samson Olori, Philip Mshelbwala, Babatunde Odeyemi, Garba Samson, Oyediran Kehinde Timothy, Sani Ali Samuel, Anthony Ajiboye, Isaac Amole, Olajide Abiola, Akin Olaolorun, Torhild Veen, Arezo Kanani, Kristian Styles, Ragnar Herikstad, Johannes Wiik Larsen, Jon Arne Søreide, Elisabeth Jensen, Mads Gran, Eirik Kjus Aahlin, Tina Gaarder, Peter Wiel Monrad-Hansen, Pål Aksel Næss, Giedrius Lauzikas, Joachim Wiborg, Silje Holte, Knut Magne Augestad, Gurpreet Singh Banipal, Michela Monteleone, Thomas Tetens Moe, Johannes Kurt Schultz, Najwa Nadeem, Muhammad Saqlain, Jibran Abbasy, Abdul Rehman Alvi, Noman Shahzad, Kamran Faisal Bhopal, Zainab Iftikhar, Muhammad Talha Butt, Syed Asaat Ul Razi, Asdaq Ahmed, Ali Khan Niazi, Ibrahim Raza, Fatima Baluch, Ahmed Raza, Ahmad Bani-Sadar, Muhammad Adil, Awais Raza, Mahnoor Javaid, Muhammad Waqar, Maryam Ali Khan, Mohammad Mohsin Arshad, Mohammad Asim Amjad, Taher Al-Taher, Ayah Hamdan, Ayman Salman, Rana Saadeh, Aseel Musleh, Dana Jaradat, Soha Abushamleh, Sakhaa Hanoun, Amjad Abu Qumbos, Aseel Hamarshi, Ayman And Taher, Israa Qawasmi, Khalid Qurie, Marwa Altarayra, Mohammad Ghannam, Alaa Shaheen, Azher Herebat, Aram Abdelhaq, Ahmad Shalabi, Maram Abu-Toyour, Fatema Asi, Ala Shamasneh, Anwar Atiyeh, Mousa Mustafa, Rula Zaa'treh, Majd Dabboor, Enas Alaloul, Heba Baraka, Jehad Meqbil, Alaa Al-Buhaisi, Mohamedraed Elshami, Samah Afana, Sahar Jaber, Said Alyacoubi, Yousef Abuowda, Tasneem Idress, Eman Abuqwaider, Sara Al-Saqqa, Alaa Bowabsak, Alaa El Jamassi, Doaa Hasanain, Hadeel Al-Farram, Maram Salah, Aya Firwana, Marwa Hamdan, Israa Awad, Ahmad Ashour, Fayez Elian Al Barrawi, Ahmed Alkhatib, Maha Al-Faqawi, Mohamed Fares, Amjad Elmashala, Mohammad Adawi, Ihdaa Adawi, Reem Khreishi, Rose Khreishi, Ahmad Ashour, Ahed Ghaben, Gustavo Miguel Machain Vega, Jorge Torres Cardozo, Marcelo O'Higgins Roche, Gustavo Rodolfo Pertersen Servin, Helmut Alfredo Segovia Lohse, Larissa Ines Páez Lopez, Ramón Augusto Melo Cardozo, Fernando Espinoza, Angel David Pérez Rojas, Diana Sanchez, Camila Sanchez Samaniego, Shalon Guevara Torres, Alexander Canta Calua, Cesar Razuri, Nadia Ortiz, Xianelle Rodriguez, Nahilia Carrasco, Fridiz Saravia, Hector Shibao Miyasato, María Valcarcel-Saldaña, Ysabel Esthefany Alejos Bermúdez, Juan Carpio, Walter Ruiz Panez, Pedro Angel Toribio Orbegozo, Carolina Guzmán Dueñas, Kevin Turpo Espinoza, Ana Maria Sandoval Barrantes, Jorge Armando Chungui Bravo, Lorena Fuentes-Rivera, Carmen Fernández, Bárbara Málaga, Joselyn Ye, Ricardo Velasquez, Jannin Salcedo, Ana Lucia Contreras-Vergara, Angelica Genoveva Vergara Mejia, Maria Soledad Gonzales Montejo, Marilia Del Carmen Escalante Salas, Willy Alcca Ticona, Marvin Vargas, George Christian Manrique Sila, Robinson Mas, Arazzelly Del Pilar Paucar, Armando José Román Velásquez, Alina Robledo-Rabanal, Ludwing Alexander Zeta Solis, Kenny Turpo Espinoza, José Luis Hamasaki Hamaguchi, Erick Samuel Florez Farfan, Linda Alvi Madrid Barrientos, Juan Jaime Herrera Matta, John Jemuel V Mora, Menold Archee P Redota, Manuel Francisco Roxas, Maria Jesusa B Maño, Marie Dione Parreno-Sacdalan, Christel Leanne Almanon, Maciej Walędziak, Rafał Roszkowski, Michał Janik, Anna Lasek, Dorota Radkowiak, Mateusz Rubinkiewicz, Cristina Fernandes, Jose Costa-Maia, Renato Melo, Liviu Muntean, Aurel Sandu Mironescu, Lucian Corneliu Vida, Mariuca Popa, Hogea Mircea, Mihaela Vartic, Bogdan Diaconescu, Matei Razvan Bratu, Ionut Negoi, Mircea Beuran, Cezar Ciubotaru, Norbert Uzabumwana, Dieudonne Duhoranenayo, Elio Jovine, Nicola Zanini, Giovanni Landolfo, Murad Aljiffry, Faisal Idris, Mohammed Saleh A Alghamdi, Ashraf Maghrabi, Abdulmalik Altaf, Aroub Alkaaki, Ahmad Khoja, Abrar Nawawi, Sondos Turkustani, Eyad Khalifah, Adel Albiety, Sarah Sahel, Reham Alshareef, Mohammed Najjar, Ahmed Alzahrani, Ahmed Alghamdi, Wedyan Alhazmi, Ghiath Al Saied, Mohammed Alamoudi, Muhammed Masood Riaz, Mazen Hassanain, Basmah Alhassan, Abdullah Altamimi, Reem Alyahya, Norah Al Subaie, Fatema Al Bastawis, Afnan Altamimi, Thamer Nouh, Roaa Khan, Milan Radojkovic, Ljiljana Jeremic, Milica Nestorovic, Jia Hao Law, Keith Say Kwang Tan, Ryan Choon Kiat Tan, Joel Kin Tan, Lau Wen Liang Joel, Xue Wei Chan, Faith Qi Hui Leong, Choon Seng Chong, Sharon Koh, Kai Yin Lee, Kuok Chung Lee, Kent Pluke, Britta Dedekind, Puyearashid Nashidengo, Mark Ian Hampton, Johanna Joosten, Sanju Sobnach, Liana Roodt, Anthony Sander, James Pape, Niveshni Maistry, Phumudzo Ndwambi, Kamau Kinandu, Myint Tun, Frederick Du Toit, Quinn Ellison, Sule Burger, D C Grobler, Lawrence Bongani Khulu, Rachel Moore, Vicky Jennings, Astrid Leusink, Nazmie Kariem, Juan Gouws, Kathryn Chu, Heather Bougard, Fazlin Noor, Angela Dell, Stephanie Van Straten, Arvin Khamajeet, Serge Kapenda Tshisola, Kalangu Kabongo, Victor Kong, Yoshan Moodley, Frank Anderson, Thandinkosi Madiba, Flip du Plooy, Leila Hartford, Gareth Chilton, Parveen Karjiker, Matlou Ernest Mabitsela, Sibongile Ruth Ndlovu, Maria Badicel, Robert Jaich, Jaime Ruiz-Tovar, Luis Garcia-Florez, Jorge L Otero-Díez, Virginia Ramos Pérez, Nuria Aguado Suárez, Javier Minguez García, Sara Corral Moreno, Maria Vicenta Collado, Virginia Jiménez Carneros, Javier García Septiem, Mariana Gonzalez, Antonio Picardo, Enrique Esteban, Esther Ferrero, Eloy Espin-Basany, Ruth Blanco-Colino, Valeria Andriola, Lorena Solar García, Elisa Contreras, Carmen García Bernardo, Janet Pagnozzi, Sandra Sanz, Alberto Miyar de León, Asnel Dorismé, Joseluis Rodicio, Aida Suarez, Jessica Stuva, Tamara Diaz Vico, Laura Fernandez-Vega, Carla Soldevila-Verdeguer, Fatima Sena-Ruiz, Natalia Pujol-Cano, Paula Diaz-Jover, José Maria Garcia-Perez, Juan Jose Segura-Sampedro, Cristina Pineño-Flores, David Ambrona-Zafra, Andrea Craus-Miguel, Patricia Jimenez-Morillas, Angela Mazzella, A B Jayathilake, Spb Thalgaspitiya, L S Wijayarathna, Pmsn Wimalge, Hakeem Ayomi Sanni, Ogheneochuko Okenabirhie, Anmar Homeida, Abobaker Younis, Omer Abdelbagi Omer, Mustafa Abdulaziz, Ali Mussad, Ali Adam, Ida Björklund, Sandra Ahlqvist, Anders Thorell, Fredrik Wogensen, Arestis Sokratous, Michaela Breistrand, Hildur Thorarinsdottir, Johanna Sigurdadottir, Maziar Nikberg, Abbas Chabok, Maria Hjertberg, Peter Elbe, Deborah Saraste, Wiktor Rutkowski, Louise Forlin, Karoliina Niska, Malin Sund, Dennis Oswald, Georgios Peros, Rafael Bluelle, Katharina Reinisch, Daniel Frey, Adrian Palma, Dimitri Aristotle Raptis, Lucius Zumbühl, Markus Zuber, Roger Schmid, Gabriela Werder, Antonio Nocito, Alexandra Gerosa, Silke Mahanty, Lukas Werner Widmer, Julia Müller, Alissa Gübeli, Grzegorz Zuk, Osman Bilgin Gulcicek, Talar Vartanoglu, Emin Kose, Servet Rustu Karahan, Mehmet Can Aydin, Nuri Alper Sahbaz, Ilkay Halicioglu, Halil Alis, Ipek Sapci, Can Adiyaman, Ahmet Murat Pektaş, Turgut Bora Cengiz, Ilkan Tansoker, Vedatcan Işler, Muazzez Cevik, Deniz Mutlu, Volkan Ozben, Berk Baris Ozmen, Sefa Bayram, Sinem Yolcu, Berna Buse Kobal, Ömer Faruk Toto, Haluk Cem Çakaloğlu, Kagan Karabulut, Vahit Mutlu, Bahar Busra Ozkan, Saban Celik, Anil Semiz, Selim Bodur, Enisburak Gül, Busra Murutoglu, Reyyan Yildirim, Bahadir Emre Baki, Ekin Arslan, Mehmet Ulusahin, Ali Guner, Kudir Tomas, Nathan Walker, Nikhita Shrimanker, Simon Cole, Ryan Breslin, Ravi Srinivasan, Mohamed Elshaer, Kristina Hunter, Ahmed Al-Bahrani, Ignatius Liew, Nora Grace Mairs, Alistair Rocke, Lachlan Dick, Mobeen Qureshi, Debkumar Chowdhury, Naomi Wright, Clare Skerritt, Dorothy Kufeji, Adrienne Ho, Tharindra Dissanayake, Athula Tennakoon, Wadah Ali, Shujing Jane Lim, Charlene Tan, Stephen O'Neill, Catrin Jones, Stephen Knight, Dima Nassif, Abhishek Sharma, Oliver Warren, Rebecca White, Aia Mehdi, Nathan Post, Eliana Kalakouti, Enkhbat Dashnyam, Frederick Stourton, Ioannis Mykoniatis, Chelise Currow, Francisca Wong, Ashish Gupta, Veeranna Shatkar, Joshua Luck, Suraj Kadiwar, Alexander Smedley, Rebecca Wakefield, Philip Herrod, James Blackwell, Jonathan Lund, Fraser Cohen, Ashwath Bandi, Stefano Giuliani, Giles Bond-Smith, Theodore Pezas, Neda Farhangmehr, Tomas Urbonas, Miklos Perenyei, Philip Ireland, Natalie Blencowe, Kirk Bowling, David Bunting, Lydia Longstaff, Kenneth Keogh, Hyunjin Jeon, Muhammad Rafaih Iqbal, Shivun Khosla, Anna Jeffery, James Perera, Ahmad Aboelkassem Ibrahem, Tariq Alhammali, Yahya Salama, Shaun Oram, Thomas Kidd, Fraser Cullen, Christopher Owen, Michael Wilson, Seehui Chiu, Hannah Sarafilovic, Jennifer Ploski, Elizabeth Evans, Athar Abbas, Sylvia Kamya, Norzawani Ishak, Carly Bisset, Cedar Andress, Ye Ru Chin, Priya Patel, David Evans, Aidan Haslegrave, Adam Boggon, Kirsten Laurie, Katie Connor, Thomas Mann, Anahita Mansuri, Rachel Davies, Ewen Griffiths, Aized Raza Shahbaz, Calvin Eng, Farhat Din, Ariadne L'Heveder, Esther Hg Park, Ramanish Ravishankar, Kirsten McIntosh, Jih Dar Yau, Luke Chan, Susan McGarvie, Lingshan Tang, Hui Lim, Suhhuey Yap, Jay Park, Zhan Herr Ng, Shahrukh Mirza, Yun Lin Ang, Luke Walls, Chloe Roy, Simon Paterson-Brown, Julian Camilleri-Brennan, Kenneth Mclean, Michelle S D'Souza, Savva Pronin, David Ewart Henshall, Eunice Zuling Ter, Dina Fouad, Ashish Minocha, William English, Catrin Morgan, Dominic Townsend, Laura Maciejec, Shareef Mahdi, Onyinye Akpenyi, Elisabeth Hall, Hanaan Caydiid, Zakaria Rob, Tom Abbott, Hew D Torrance, Robin Johnston, Mohammed Aki Gani, Gianpiero Gravante, Shivanchan Rajmohan, Kiran Majid, Shiva Dindyal, Christopher Smith, Madanmohan Palliyil, Sanjay Patel, Luke Nicholson, Neil Harvey, Katie Baillie, Sam Shillito, Suzanne Kershaw, Rebecca Bamford, Peter Orton, Elke Reunis, Robert Tyler, Wai Cheong Soon, Guled M Jama, Dharminder Dhillon, Khyati Patel, Shayanthan Nanthakumaran, Rachel Heard, Kar Yan Chen, Behrad Barmayehvar, Uttaran Datta, Sivesh K Kamarajah, Sharad Karandikar, Sobhana Iftekhar Tani, Eimear Monaghan, Philippa Donnelly, Michael Walker, Jehangirshaw Parakh, Sarah Blacker, Anil Kaul, Arjun Paramasivan, Sameh Farag, Ashrafun Nessa, Salwa Awadallah, Jieqi Lim, James Chean Khun Ng, Ravi P Kiran, Alice Murray, Eric Etchill, Mohini Dasari, Juan Puyana, Nadeem Haddad, Martin Zielinski, Asad Choudhry, Celeste Caliman, Mieshia Beamon, Therese Duane, Mamta Swaroop, Jonathan Myers, Rebecca Deal, Erik Schadde, Mark Hemmila, Lena Napolitano, Kathleen To, Alex Makupe, Joseph Musowoya, Niels van der Naald, Dayson Kumwenda, Alex Reece-Smith, Kars Otten, Anna Verbeek, Marloes Prins, Alibeth Andres Baquero Suarez, Ruben Balmaceda, Chelsea Deane, Emilio Dijan, Mahmoud Elfiky, Laura Koskenvuo, Aurore Thollot, Bernard Limoges, Carmen Capito, Challine Alexandre, Henri Kotobi, Julien Leroux, Kalitha Pinnagoda, Nicolas Henric, Olivier Azzis, Olivier Rosello, Poddevin Francois, Sara Etienne, Philippe Buisson, Sophian Hmila, Joe-Nat Clegg-Lamptey, Osman Imoro, Owusu Emmanuel Abem, Dimitrios Papageorgiou, Vasiliki Soulou, Sabrina Asturias, Lenin Peña, Donal B O'Connor, Alberto Realis Luc, Alfio Alessandro Russo, Andrea Ruzzenente, Antonio Taddei, Camilla Cona, Corrado Bottini, Giovanni Pascale, Giuseppe Rotunno, Leonardo Solaini, Marco Maria Pascale, Margherita Notarnicola, Mario Corbellino, Michele Sacco, Paolo Ubiali, Roberto Cautiero, Tommaso Bocchetti, Elena Muzio, Vania Guglielmo, Eugenio Morandi, Patrizio Mao, Emilia de Luca, Farah Mahmoud Ali, Justas Žilinskas, Kestutis Strupas, Paulius Kondrotas, Robertas Baltrunas, Juozas Kutkevicius, Povilas Ignatavicius, Choy Ling Tan, Jia Yng Siaw, Sir Young Yam, Ling Wilson, Mohamed Rezal Abdul Aziz, John Bondin, Carmina Diaz Zorrilla, Anass Majbar, Danjuma Sale, Lawal Abdullahi, Olabisi Osagie, Omolara Faboya, Adedeji Fatuga, Agboola Taiwo, Emeka Nwabuoku, Marte Bliksøen, Zain Ali Khan, Jazmin Coronel, Cesar Miranda, Idelso Vasquez, Luis M Helguero-Santin, Jennifer Rickard, Adesina Adedeji, Saleh Alqahtani, Max Rath, Michael Van Niekerk, Modise Zacharia Koto, Roel Matos-Puig, Leif Israelsson, Tobias Schuetz, Mahmut Arif Yuksek, Meric Mericliler, Mehmet Ulusahin, Bernhard Wolf, Cameron Fairfield, Guo Liang Yong, Katharine Whitehurst, Natalie Redgrave, Caroluce K Musyoka, James Olivier, Kathryn Lee, Michael Cox, Muhamed M H Farhan-Alanie, Rory Callan, Chali Chibuye, Tebian Hassanein Ahmed Ali, Syrine Rekhis, Muna Rommaneh, Zi Hao Sam, Thays Brunelli Pugliesi, Gabriel Pardo, Ruth Blanco

Subjects
Male, paediatric, Cohort Studies, 0302 clinical medicine, Primary outcome, gastro-enterologic surgery, Risk Factors, Prospective Studies, 030212 general & internal medicine, paediatrics, Prospective cohort study, Child, Digestive System Surgical Procedures, Original Research, lcsh:R5-920, Paediatric surgery, Health Policy, Human development (humanity), 3142 Public health care science, environmental and occupational health, 3. Good health, CONGENITAL-ANOMALIES, 030220 oncology & carcinogenesis, Child, Preschool, surgical infection, Female, lcsh:Medicine (General), Surgical site infection, Cohort study, Human, AFRICA, medicine.medical_specialty, CARE-ASSOCIATED INFECTION, Adolescent, lcsh:Infectious and parasitic diseases, NO, 03 medical and health sciences, MIDDLE-INCOME COUNTRIES, medicine, Humans, Surgical Wound Infection, lcsh:RC109-216, In patient, Human Development Index, business.industry, Kirurgi, Risk Factor, Public Health, Environmental and Occupational Health, Infant, Newborn, Infant, Digestive System Surgical Procedure, GLOBAL BURDEN, 3126 Surgery, anesthesiology, intensive care, radiology, Surgery, Prospective Studie, Cohort Studie, business
Abstract

Background: Surgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world. Methods: This international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231. Findings: Between Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p

Published
2020

44. Agriculture and the Information Revolution

Author

Lucille A. Linden, William O. Rasmussen, Patricia A. Myer, Roy S. Rauschkolb, C.T.K. Ching, Charlotte B. Travieso, and V. Philip Rasmussen

Subjects
Economy, Agriculture, business.industry, Political science, Information revolution, business
Published
2021

45. Large Data Bases, Networks, and Service Groups

Author

Patricia A. Myer, V. Philip Rasmussen, William O. Rasmussen, Charlotte B. Travieso, C.T.K. Ching, Roy S. Rauschkolb, and Lucille A. Linden

Subjects
Service (business), Computer science, business.industry, Telecommunications, business
Published
2021

46. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer

Author

Lyudmila Bazhenova, Scott N. Gettinger, Fred R. Hirsch, Mary W. Redman, Thomas E. Stinchcombe, Susan S. Tavernier, Hui Yu, Karen Kelly, Lawrence H. Schwartz, Jeffrey D. Bradley, Roy S. Herbst, Philip C. Mack, Katherine Minichiello, Louise Highleyman, Vassiliki A. Papadimitrakopoulou, David R. Gandara, Natasha B. Leighl, Suresh S. Ramalingam, and Joseph M. Unger

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Ipilimumab, Internal medicine, Carcinoma, Non-Small-Cell Lung, Antineoplastic Combined Chemotherapy Protocols, medicine, Clinical endpoint, Humans, Online First, Lung cancer, Lung, Original Investigation, business.industry, Research, Epithelial Cells, medicine.disease, Interim analysis, Chemotherapy regimen, Nivolumab, Docetaxel, Response Evaluation Criteria in Solid Tumors, Carcinoma, Squamous Cell, business, Comments, medicine.drug
Abstract

This phase 3 randomized clinical trial investigates if the addition of ipilimumab to nivolumab improves the survival outcome of patients with chemotherapy-pretreated immunotherapy-naive squamous cell lung cancer., Key Points Question Does the addition of ipilimumab to nivolumab improve survival in patients with advanced chemotherapy-pretreated immunotherapy-naive squamous cell lung cancer? Findings In this randomized clinical trial of 252 patients, the addition of ipilimumab to nivolumab did not lead to improved survival in patients with advanced chemotherapy-pretreated squamous cell carcinoma. Meaning Combination therapy with nivolumab and ipilimumab is currently only indicated as first-line therapy in patients with advanced non–small cell lung cancer., Importance Nivolumab plus ipilimumab is superior to platinum-based chemotherapy in treatment-naive advanced non–small cell lung cancer (NSCLC). Nivolumab is superior to docetaxel in advanced pretreated NSCLC. Objective To determine whether the addition of ipilimumab to nivolumab improves survival in patients with advanced, pretreated, immunotherapy-naive squamous (Sq) NSCLC. Design, Setting, and Participants The Lung Cancer Master Protocol (Lung-MAP) S1400I phase 3, open-label randomized clinical trial was conducted from December 18, 2015, to April 23, 2018, randomizing patients in a 1:1 ratio to nivolumab alone or combined with ipilimumab. The median follow-up in surviving patients was 29.5 months. The trial was conducted through the National Clinical Trials Network and included patients with advanced immunotherapy-naive SqNSCLC and a Zubrod score of 0 (asymptomatic) to 1 (symptomatic but completely ambulatory) with disease progression after standard platinum-based chemotherapy. Randomization was stratified by sex and number of prior therapies (1 vs 2 or more). Data were analyzed from May 3, 2018, to February 1, 2021. Interventions Nivolumab, 3 mg/kg intravenously every 2 weeks, with or without ipilimumab, 1 mg/kg intravenously every 6 weeks, until disease progression or intolerable toxic effects. Main Outcomes and Measures The primary end point was overall survival (OS). Secondary end points included investigator-assessed progression-free survival (IA-PFS) and response per Response Evaluation Criteria in Solid Tumors (RECIST) guidelines, version 1.1. Results Of 275 enrolled patients, 252 (mean age, 67.5 years [range 41.8-90.3 years]; 169 men [67%]; 206 White patients [82%]) were deemed eligible (125 randomized to nivolumab/ipilimumab and 127 to nivolumab). The study was closed for futility at a planned interim analysis. Overall survival was not significantly different between the groups (hazard ratio [HR], 0.87; 95% CI, 0.66-1.16; P = .34). Median survival was 10 months (95% CI, 8.0-14.4 months) in the nivolumab/ipilimumab group and 11 months (95% CI, 8.6-13.7 months) in the nivolumab group. The IA-PFS HR was 0.80 (95% CI, 0.61-1.03; P = .09); median IA-PFS was 3.8 months (95% CI, 2.7-4.4 months) in the nivolumab/ipilimumab group and 2.9 months (95% CI, 1.8-4.0 months) in the nivolumab alone group. Response rates were 18% (95% CI, 12%-25%) with nivolumab/ipilimumab and 17% (95% CI, 10%-23%) with nivolumab. Median response duration was 28.4 months (95% CI, 4.9 months to not reached) with nivolumab/ipilimumab and 9.7 months with nivolumab (95% CI, 4.2-23.1 months). Grade 3 or higher treatment-related adverse events occurred in 49 of 124 patients (39.5%) who received nivolumab/ipilimumab and in 41 of 123 (33.3%) who received nivolumab alone. Toxic effects led to discontinuation in 31 of 124 patients (25%) on nivolumab/ipilimumab and in 19 of 123 (15%) on nivolumab. Conclusions and Relevance In this phase 3 randomized clinical trial, ipilimumab added to nivolumab did not improve outcomes in patients with advanced, pretreated, immune checkpoint inhibitor–naive SqNSCLC. Trial Registration ClinicalTrials.gov Identifier: NCT02785952

Published
2021

47. A Network Meta-Analysis of Cancer Immunotherapies Versus Chemotherapy for First-Line Treatment of Patients With Non-Small Cell Lung Cancer and High Programmed Death-Ligand 1 Expression

Author

Rachael McCool, Seye Abogunrin, Rossella Belleli, Roy S. Herbst, Filippo de Marinis, Giuseppe Giaccone, Daniel F. V. James, and Jacek Jassem

Subjects
Oncology, atezolizumab, Cancer Research, medicine.medical_specialty, Bevacizumab, Ipilimumab, Pembrolizumab, Review, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Atezolizumab, Internal medicine, Medicine, 030212 general & internal medicine, ipilimumab, Lung cancer, RC254-282, non-small cell lung cancer, nivolumab, business.industry, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, Carboplatin, meta-analysis, Regimen, chemistry, 030220 oncology & carcinogenesis, immunotherapy, pembrolizumab, Nivolumab, business, medicine.drug
Abstract

In the absence of head-to-head trials of first-line treatments for metastatic non-small cell lung cancer (NSCLC), synthesis of available evidence is needed. We conducted a systematic literature review and network meta-analysis of randomized controlled trials in patients with stage IV NSCLC and high programmed death-ligand 1 (PD-L1) expression. Patients with other-stage NSCLC or without PD-L1 expression and populations with < 80% stage IV NSCLC were excluded. Outcomes included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and treatment-related adverse events. English records from MEDLINE and Embase published through October 2020 were eligible, supplemented by hand searches of other sources. Three evidence networks were constructed based on histology (mixed, squamous, non-squamous). OS and PFS results were analyzed applying Bayesian fractional polynomial random-effects models. Hazard ratios over time with 95% credible intervals (CrIs) and expected differences in OS and PFS between each cancer immunotherapy regimen and the chemotherapy common comparator were generated. Seventeen clinical trials were included after screening 32,527 records. Heterogeneity and risk of bias were generally low across trials. In the mixed-histology network of PD-L1–high patients, expected OS was significantly longer with atezolizumab (estimated difference: 10.4 months [95% CrI: 1.9, 18.2]), pembrolizumab (7.2 [2.2, 12.3]), and cemiplimab (13.0 [4.2, 21.0]) versus chemotherapy but not with nivolumab (3.5 [−2.5, 10.6]) or nivolumab plus ipilimumab (6.7 [−0.5, 14.2]) versus chemotherapy. OS improvements were not significant compared with chemotherapy for any regimen in the squamous and non-squamous networks, except pembrolizumab plus chemotherapy in the non-squamous network. All regimens showed significantly longer expected PFS versus chemotherapy in the non-squamous network, whereas the increases were not significant in the mixed or squamous networks. ORR was significantly higher with pembrolizumab and cemiplimab versus chemotherapy in the mixed-histology network, with sintilimab in the non-squamous network, and with combination regimens, including pembrolizumab or atezolizumab, in the squamous and non-squamous networks, except with atezolizumab plus carboplatin, paclitaxel, and bevacizumab. Survival and safety versus chemotherapy were generally similar across cancer immunotherapies and histology networks. These findings may support treatment decisions for patients with high PD-L1 status receiving first-line treatment for NSCLC.

Published
2021

48. Calcification of the Aorta-Iliac Trajectory as a Risk Factor for Anastomotic Leakage in Colorectal Surgery: Individual Patient Data Meta-Analysis and Systematic Review

Author

Gert-Jan Kleinrensink, Anand G. Menon, Johannes Jeekel, Pim P. Edomskis, Roy S. Dwarkasing, Johan F. Lange, Vincent Edomskis, Surgery, Radiology & Nuclear Medicine, and Neurosciences

Subjects
medicine.medical_specialty, business.industry, Anastomosis, Surgical, Anastomotic Leak, General Medicine, Odds ratio, medicine.disease, Colorectal surgery, Stenosis, Arterial calcification, Risk Factors, Meta-analysis, medicine, Humans, Prospective Studies, Radiology, Risk factor, Vascular Calcification, Prospective cohort study, business, Colorectal Surgery, Aorta, Calcification
Abstract

Objective: The purpose of this review is to evaluate the relevance of vascular calcification as a potential risk factor for anastomotic leakage in colorectal surgery. Method: The Embase, Medline, PubMed, and Cochrane databases and Google Scholar were systematically searched. Studies that assessed calcification of the aorta-iliac trajectory in patients who underwent colorectal surgery were included. An independent patient data meta-analysis was performed as follows: based on the heterogeneity of the study population, a “random-effects model” or “fixed-effects model” was used to perform a multivariable logistic regression and calculate pooled Odds Ratios (OR) and 95% confidence intervals (CI). Heterogeneity was assessed using the Q-test and I2-test. Results: From a total of 457 articles retrieved, eight fell within the scope of the review, with a total of 2010 patients. Anastomotic leakage was found at a mean rate of 11.1% (SD 4.9%). In these eight studies, four different calcification scoring methods were used, which made a single structured meta-analysis not feasible. Therefore, an independent patient data meta-analysis on the most frequently used calcification scoring method was performed, including three studies with a total of 396 patients. After multivariable analyses, no significant association was found between anastomotic leakage and the amount of calcification in the aorta-iliac trajectory. The remaining three scoring methods were evaluated. In four of the five studies, vascular calcification was associated with anastomotic leakage after colorectal surgery. Conclusion: In contrast to previous studies, an individual patient data meta-analysis found no association between calcification and anastomotic leakage in colorectal surgery after multivariable analysis that considered a single calcification measurement method. In addition, this study demonstrated several scoring methods for arterial calcification and the need for a standardized technique. Therefore, the authors would recommend prospective studies using a calcification scoring method that includes grade of stenosis due to its potential to preoperatively improve perfusion by endovascular treatment.

Published
2021

49. Predicting the difficult laparoscopic cholecystectomy: development and validation of a pre-operative risk score using an objective operative difficulty grading system

Author

Nassar, A. H. M., Hodson, J., H. J., Ng, Vohra, R. S., Katbeh, T., Zino, S., Griffiths, E. A., Kirkham, A. J., Pasquali, S., Marriott, P., Johnstone, M., Spreadborough, P., Alderson, D., Fenwick, S., Elmasry, M., Nunes, Q. M., Kennedy, D., Khan, R. B., Khan, M. A. S., Magee, C. J., Jones, S. M., Mason, D., Parappally, C. P., Mathur, P., Saunders, M., Jamel, S., Haque, S. U., Zafar, S., Shiwani, M. H., Samuel, N., Dar, F., Jackson, A., Lovett, B., Dindyal, S., Winter, H., Fletcher, T., Rahman, S., Wheatley, K., Nieto, T., Ayaani, S., Youssef, H., Nijjar, R. S., Watkin, H., Naumann, D., Emesih, S., Sarmah, P. B., Lee, K., Joji, N., Lambert, J., Heath, J., Teasdale, R. L., Weerasinghe, C., Needham, P. J., Welbourn, H., Forster, L., Finch, D., Blazeby, J. M., Robb, W., Mcnair, A. G. K., Hrycaiczuk, A., Charalabopoulos, A., Kadirkamanathan, S., Tang, C. -B., Jayanthi, N. V. G., Noor, N., Dobbins, B., Cockbain, A. J., Nilsen-Nunn, A., de Siqueira, J., Pellen, M., Cowley, J. B., W. -M., Ho, Miu, V., White, T. J., Hodgkins, K. A., Kinghorn, A., Tutton, M. G., Al-Abed, Y. A., Menzies, D., Ahmad, A., Reed, J., Khan, S., Monk, D., Vitone, L. J., Murtaza, G., Joel, A., Brennan, S., Shier, D., Zhang, C., Yoganathan, T., Robinson, S. J., Mccallum, I. J. D., Jones, M. J., Elsayed, M., Tuck, L., Wayman, J., Carney, K., Aroori, S., Hosie, K. B., Kimble, A., Bunting, D. M., Fawole, A. S., Basheer, M., Dave, R. V., Sarveswaran, J., Jones, E., Kendal, C., Tilston, M. P., Gough, M., Wallace, T., Singh, S., Mockford, J. D. K. A., Issa, E., Shah, N., Chauhan, N., Wilson, T. R., Forouzanfar, A., Wild, J. R. L., Nofal, E., Bunnell, C., Madbak, K., Rao, S. T. V., Devoto, L., Siddiqi, N., Khawaja, Z., Hewes, J. C., Gould, L., Chambers, A., Rodriguez, D. U., Sen, G., Robinson, S., Bartlett, F., Rae, D. M., Stevenson, T. E. J., Sarvananthan, K., Dwerryhouse, S. J., Higgs, S. M., Old, O. J., Hardy, T. J., Shah, R., Hornby, S. T., Keogh, K., Frank, L., Al-Akash, M., Upchurch, E. A., Frame, R. J., Hughes, M., Jelley, C., Weaver, S., Roy, S., Sillo, T. O., Galanopoulos, G., Cuming, T., Cunha, P., Tayeh, S., Kaptanis, S., Heshaishi, M., Eisawi, A., Abayomi, M., Ngu, W. S., Fleming, K., Bajwa, D. S., Chitre, V., Aryal, K., Ferris, P., Silva, M., Lammy, S., Mohamed, S., Khawaja, A., Hussain, A., Ghazanfar, M. A., Bellini, M. I., Ebdewi, H., Elshaer, M., Gravante, G., Drake, B., Ogedegbe, A., Mukherjee, D., Arhi, C., Giwa, L., Iqbal, N., Watson, N. F., Aggarwal, S. K., Orchard, P., Villatoro, E., Willson, P. D., Mok, K. W. J., Woodman, T., Deguara, J., Garcea, G., Babu, B. I., Dennison, A. R., Malde, D., Lloyd, D., Satheesan, S., Al-Taan, O., Boddy, A., Slavin, J. P., Jones, R. P., Ballance, L., Gerakopoulos, S., Jambulingam, P., Mansour, S., Sakai, N., Acharya, V., Sadat, M. M., Karim, L., Larkin, D., Amin, K., Khan, A., Law, J., Jamdar, S., Smith, S. R., Sampat, K., O'Shea, K. M., Manu, M., Asprou, F. M., Malik, N. S., Chang, J., Lewis, M., Roberts, G. P., Karavadra, B., Photi, E., Hewes, J., Rodriguez, D., O'Reilly, D. A., Rate, A. J., Sekhar, H., Henderson, L. T., Starmer, B. Z., Coe, P. O., Tolofari, S., Barrie, J., Bashir, G., Sloane, J., Madanipour, S., Halkias, C., Trevatt, A. E. J., Borowski, D. W., Hornsby, J., Courtney, M. J., Virupaksha, S., Seymour, K., Hawkins, H., Bawa, S., Gallagher, P. V., Reid, A., Wood, P., Finch, J. G., Guy Finch, J., Parmar, J., Stirland, E., Gardner-Thorpe, J., Al-Muhktar, A., Peterson, M., Majeed, A., Bajwa, F. M., Martin, J., Choy, A., Tsang, A., Pore, N., Andrew, D. R., Al-Khyatt, W., Taylor, C., Bhandari, S., Subramanium, D., Toh, S. K. C., Carter, N. C., Tate, S., Pearce, B., Wainwright, D., Mercer, S. J., Knight, B., Vijay, V., Alagaratnam, S., Sinha, S., El-Hasani, S. S., Hussain, A. A., Bhattacharya, V., Kansal, N., Fasih, T., Jackson, C., Siddiqui, M. N., Chishti, I. A., Fordham, I. J., Siddiqui, Z., Bausbacher, H., Geogloma, I., Gurung, K., Tsavellas, G., Basynat, P., Shrestha, A. K., Basu, S., Chhabra, A., Harilingam, M., Rabie, M., Akhtar, M., Kumar, P., Jafferbhoy, S. F., Hussain, N., Raza, S., Haque, M., Alam, I., Aseem, R., Patel, S., Asad, M., Booth, M. I., Ball, W. R., Wood, C. P. J., Pinho-Gomes, A. C., Kausar, A., Obeidallah, M. R., Varghase, J., Lodhia, J., Bradley, D., Rengifo, C., Lindsay, D., Gopalswamy, S., Finlay, I., Wardle, S., Bullen, N., Iftikhar, S. Y., Awan, A., Ahmed, J., Leeder, P., Fusai, G., Bond-Smith, G., Psica, A., Puri, Y., Hou, D., Noble, F., Szentpali, K., Broadhurst, J., Date, R., Hossack, M. R., Goh, Y. L., Turner, P., Shetty, V., Riera, M., Macano, C. A. W., Sukha, A., Preston, S. R., Hoban, J. R., Puntis, D. J., Williams, S. V., Krysztopik, R., Kynaston, J., Batt, J., Doe, M., Goscimski, A., Jones, G. H., Hall, C., Carty, N., Panteleimonitis, S., Gunasekera, R. T., Sheel, A. R. G., Lennon, H., Hindley, C., Reddy, M., Kenny, R., Elkheir, N., Mcglone, E. R., Rajaganeshan, R., Hancorn, K., Hargreaves, A., Prasad, R., Longbotham, D. A., Vijayanand, D., Wijetunga, I., Ziprin, P., Nicolay, C. R., Yeldham, G., Read, E., Gossage, J. A., Rolph, R. C., Ebied, H., Phull, M., Khan, M. A., Popplewell, M., Kyriakidis, D., Henley, N., Packer, J. R., Derbyshire, L., Porter, J., Appleton, S., Farouk, M., Basra, M., Jennings, N. A., Ali, S., Kanakala, V., Ali, H., Lane, R., Dickson-Lowe, R., Zarsadias, P., Mirza, D., Puig, S., Al Amari, K., Vijayan, D., Sutcliffe, R., Marudanayagam, R., Hamady, Z., Prasad, A. R., Patel, A., Durkin, D., Kaur, P., Bowen, L., Byrne, J. P., Pearson, K. L., Delisle, T. G., Davies, J., Tomlinson, M. A., Johnpulle, M. A., Slawinski, C., Macdonald, A., Nicholson, J., Newton, K., Mbuvi, J., Farooq, A., Mothe, B. S., Zafrani, Z., Brett, D., Francombe, J., Barnes, J., Cheung, M., Al-Bahrani, A. Z., Preziosi, G., Urbonas, T., Alberts, J., Mallik, M., Patel, K., Segaran, A., Doulias, T., Sufi, P. A., Yao, C., Pollock, S., Manzelli, A., Wajed, S., Kourkulos, M., Pezzuto, R., Wadley, M., Hamilton, E., Jaunoo, S., Padwick, R., Sayegh, M., Newton, R. C., Hebbar, M., Farag, S. F., Spearman, J., Hamdan, M. F., D'Costa, C., Blane, C., Giles, M., Peter, M. B., Hirst, N. A., Hossain, T., Pannu, A., El-Dhuwaib, Y., Morrison, T. E. M., Taylor, G. W., Thompson, R. L. E., Mccune, K., Loughlin, P., Lawther, R., Byrnes, C. K., Simpson, D. J., Mawhinney, A., Warren, C., Mckay, D., Mcilmunn, C., Martin, S., Macartney, M., Diamond, T., Davey, P., Jones, C., Clements, J. M., Digney, R., Chan, W. M., Mccain, S., Gull, S., Janeczko, A., Dorrian, E., Harris, A., Dawson, S., Johnston, D., Mcaree, B., Ghareeb, E., Thomas, G., Connelly, M., Mckenzie, S., Cieplucha, K., Spence, G., Campbell, W., Hooks, G., Bradley, N., Hill, A. D. K., Cassidy, J. T., Boland, M., Burke, P., Nally, D. M., Khogali, E., Shabo, W., Iskandar, E., Mcentee, G. P., O'Neill, M. A., Peirce, C., Lyons, E. M., O'Sullivan, A. W., Thakkar, R., Carroll, P., Ivanovski, I., Balfe, P., Lee, M., Winter, D. C., Kelly, M. E., Hoti, E., Maguire, D., Karunakaran, P., Geoghegan, J. G., Mcdermott, F., Martin, S. T., Cross, K. S., Cooke, F., Zeeshan, S., Murphy, J. O., Mealy, K., Mohan, H. M., Nedujchelyn, Y., Ullah, M. F., Ahmed, I., Giovinazzo, F., Milburn, J., Prince, S., Brooke, E., Buchan, J., Khalil, A. M., Vaughan, E. M., Ramage, M. I., Aldridge, R. C., Gibson, S., Nicholson, G. A., Vass, D. G., Grant, A. J., Holroyd, D. J., Jones, M. A., Sutton, C. M. L. R., O'Dwyer, P., Nilsson, F., Weber, B., Williamson, T. K., Lalla, K., Bryant, A., Carter, C. R., Forrest, C. R., Hunter, D. I., Nassar, A. H., Orizu, M. N., Knight, K., Qandeel, H., Suttie, S., Belding, R., Mcclarey, A., Boyd, A. T., Guthrie, G. J. K., Lim, P. J., Luhmann, A., Watson, A. J. M., Richards, C. H., Nicol, L., Madurska, M., Harrison, E., Boyce, K. M., Roebuck, A., Ferguson, G., Pati, P., Wilson, M. S. J., Dalgaty, F., Fothergill, L., Driscoll, P. J., Mozolowski, K. L., Banwell, V., Bennett, S. P., Rogers, P. N., Skelly, B. L., Rutherford, C. L., Mirza, A. K., Lazim, T., Lim, H. C. C., Duke, D., Ahmed, T., Beasley, W. D., Wilkinson, M. D., Maharaj, G., Malcolm, C., Brown, T. H., Al-Sarireh, B., Shingler, G. M., Mowbray, N., Radwan, R., Morcous, P., Wood, S., Kadhim, A., Stewart, D. J., Baker, A. L., Tanner, N., Shenoy, H., Hafiz, S., De Marchi, J. A., Singh-Ranger, D., Hisham, E., Ainley, P., O'Neill, S., Terrace, J., Napetti, S., Hopwood, B., Rhys, T., Downing, J., Kanavati, O., Coats, M., Aleksandrov, D., Kallaway, C., Yahya, S., Templeton, A., Trotter, M., Lo, C., Dhillon, A., Heywood, N., Aawsaj, Y., Hamdan, A., Reece-Bolton, O., Mcguigan, A., Shahin, Y., Aymon, Luther, A. A., Nicholson, J. A., Rajendran, I., Boal, M., and Ritchie, J.

Subjects
Adult, Male, operative difficulty, medicine.medical_specialty, medicine.medical_treatment, Difficulty grading, difficult cholecystectomy, predictive score, surgery, laparoscopic, cholecystectomy, Surgical planning, Cohort Studies, 03 medical and health sciences, 0302 clinical medicine, Risk Factors, Preoperative Care, Humans, Medicine, Laparoscopic cholecystectomy, Framingham Risk Score, business.industry, General surgery, Reproducibility of Results, Middle Aged, medicine.disease, Pre operative, Single surgeon, Cholecystectomy, Laparoscopic, ROC Curve, 030220 oncology & carcinogenesis, Multivariate Analysis, Cholecystitis, Female, 030211 gastroenterology & hepatology, Surgery, Cholecystectomy, business, Abdominal surgery
Abstract

The prediction of a difficult cholecystectomy has traditionally been based on certain pre-operative clinical and imaging factors. Most of the previous literature reported small patient cohorts and have not used an objective measure of operative difficulty. The aim of this study was to develop a pre-operative score to predict difficult cholecystectomy, as defined by a validated intra-operative difficulty grading scale. Two cohorts from prospectively maintained databases of patients who underwent laparoscopic cholecystectomy were analysed: the CholeS Study (8755 patients) and a single surgeon series (4089 patients). Factors potentially predictive of difficulty were correlated to the Nassar intra-operative difficulty scale. A multivariable binary logistic regression analysis was then used to identify factors that were independently associated with difficult laparoscopic cholecystectomy, defined as operative difficulty grades 3 to 5. The resulting model was then converted to a risk score, and validated on both internal and external datasets. Increasing age and ASA classification, male gender, diagnosis of CBD stone or cholecystitis, thick-walled gallbladders, CBD dilation, use of pre-operative ERCP and non-elective operations were found to be significant independent predictors of difficult cases. A risk score based on these factors returned an area under the ROC curve of 0.789 (95% CI 0.773–0.806, p

Published
2019

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