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1. Common variation in a long non-coding RNA gene modulates variation of circulating TGF-β2 levels in metastatic colorectal cancer patients (Alliance)

Author: Julia C.F. Quintanilha, Alexander B. Sibley, Yingmiao Liu, Donna Niedzwiecki, Susan Halabi, Layne Rogers, Bert O’Neil, Hedy Kindler, William Kelly, Alan Venook, Howard L. McLeod, Mark J. Ratain, Andrew B. Nixon, Federico Innocenti, and Kouros Owzar
Subjects: Cancer, Common germline variation, Genome-wide analysis study, Circulating protein biomarkers, Protein quantitative trait loci, Inflammatory markers, Biotechnology, TP248.13-248.65, Genetics, QH426-470
Abstract: Abstract Background Herein, we report results from a genome-wide study conducted to identify protein quantitative trait loci (pQTL) for circulating angiogenic and inflammatory protein markers in patients with metastatic colorectal cancer (mCRC). The study was conducted using genotype, protein marker, and baseline clinical and demographic data from CALGB/SWOG 80405 (Alliance), a randomized phase III study designed to assess outcomes of adding VEGF or EGFR inhibitors to systemic chemotherapy in mCRC patients. Germline DNA derived from blood was genotyped on whole-genome array platforms. The abundance of protein markers was quantified using a multiplex enzyme-linked immunosorbent assay from plasma derived from peripheral venous blood collected at baseline. A robust rank-based method was used to assess the statistical significance of each variant and protein pair against a strict genome-wide level. A given pQTL was tested for validation in two external datasets of prostate (CALGB 90401) and pancreatic cancer (CALGB 80303) patients. Bioinformatics analyses were conducted to further establish biological bases for these findings. Results The final analysis was carried out based on data from 540,021 common typed genetic variants and 23 protein markers from 869 genetically estimated European patients with mCRC. Correcting for multiple testing, the analysis discovered a novel cis-pQTL in LINC02869, a long non-coding RNA gene, for circulating TGF-β2 levels (rs11118119; AAF = 0.11; P-value
Published: 2024
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2. 313 A phase 1 evaluation of tebotelimab, a bispecific PD-1 x LAG-3 DART® molecule, in combination with margetuximab in patients with advanced HER2+ neoplasms

Author: Xiaoyu Zhang, Sanjeev Kaul, Paul Moore, Jason Luke, Bartosz Chmielowski, Hedy Kindler, Francine Chen, George Blumenschein, Erika Hamilton, Shakeela Bahadur, Cesar Santa-Maria, Janine Koucheki, Jichao Sun, John Muth, Patrick Kaminker, and Bradley Sumrow
Subjects: Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Published: 2020
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3. Associations of artificially sweetened beverage intake with disease recurrence and mortality in stage III colon cancer: Results from CALGB 89803 (Alliance).

Author: Brendan J Guercio, Sui Zhang, Donna Niedzwiecki, Yanping Li, Ana Babic, Vicente Morales-Oyarvide, Leonard B Saltz, Robert J Mayer, Rex B Mowat, Renaud Whittom, Alexander Hantel, Al Benson, Daniel Atienza, Michael Messino, Hedy Kindler, Alan Venook, Shuji Ogino, Emilie S Zoltick, Meir Stampfer, Kimmie Ng, Kana Wu, Walter C Willett, Edward L Giovannucci, Jeffrey A Meyerhardt, and Charles S Fuchs
Subjects: Medicine, Science
Abstract: PurposeObservational studies have demonstrated increased colon cancer recurrence and mortality in states of excess energy balance, as denoted by factors including sedentary lifestyle, diabetes, increased dietary glycemic load, and increased intake of sugar-sweetened beverages. Nonetheless, the relation between artificially sweetened beverages, a popular alternative for sugar-sweetened beverages, and colon cancer recurrence and survival is unknown.MethodsWe analyzed data from 1,018 patients with stage III colon cancer who prospectively reported dietary intake during and after chemotherapy while enrolled in a National Cancer Institute-sponsored trial of adjuvant chemotherapy. Using Cox proportional hazards regressions, we assessed associations of artificially sweetened beverage intake with cancer recurrence and mortality.ResultsPatients consuming one or more 12-ounce servings of artificially sweetened beverages per day experienced an adjusted hazard ratio for cancer recurrence or mortality of 0.54 (95% confidence interval, 0.36 to 0.80) when compared to those who largely abstained (Ptrend = .004). Similarly, increasing artificially sweetened beverage intake was also associated with a significant improvement in both recurrence-free survival (Ptrend = .005) and overall survival (Ptrend = .02). Substitution models demonstrated that replacing a 12-ounce serving of a sugar-sweetened beverage with an isovolumetric serving of an artificially sweetened beverage per day was associated with a 23% lower risk of cancer recurrence and mortality (relative risk, 0.77; 95% confidence interval, 0.63 to 0.95; P = .02).ConclusionHigher artificially sweetened beverage consumption may be associated with significantly reduced cancer recurrence and death in patients with stage III colon cancer. This association may be mediated by substitution for sugar-sweetened alternatives. Further studies are needed to confirm these findings.
Published: 2018
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4. Sugar-sweetened beverage intake and cancer recurrence and survival in CALGB 89803 (Alliance).

Author: Michael A Fuchs, Kaori Sato, Donna Niedzwiecki, Xing Ye, Leonard B Saltz, Robert J Mayer, Rex B Mowat, Renaud Whittom, Alexander Hantel, Al Benson, Daniel Atienza, Michael Messino, Hedy Kindler, Alan Venook, Shuji Ogino, Kana Wu, Walter C Willett, Edward L Giovannucci, and Jeffrey A Meyerhardt
Subjects: Medicine, Science
Abstract: BACKGROUND:In colon cancer patients, obesity, sedentary lifestyle, and high dietary glycemic load have been associated with increased risk of cancer recurrence. High sugar-sweetened beverage intake has been associated with obesity, diabetes, and cardio-metabolic diseases, but the influence on colon cancer survival is unknown. METHODS:We assessed the association between sugar-sweetened beverage consumption on cancer recurrence and mortality in 1,011 stage III colon cancer patients who completed food frequency questionnaires as part of a U.S. National Cancer Institute-sponsored adjuvant chemotherapy trial. Hazard ratios (HRs) and 95% confidence intervals (CIs) were calculated with Cox proportional hazard models. RESULTS:Patients consuming ≥ 2 servings of sugar-sweetened beverages per day experienced an adjusted HR for disease recurrence or mortality of 1.67 (95% CI, 1.04-2.68), compared with those consuming
Published: 2014
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5. IASLC Lung Cancer Staging Project: The New Database to Inform Revisions in the Ninth Edition of the TNM Classification of Lung Cancer

Author: Hisao Asamura, Katherine K. Nishimura, Dorothy J. Giroux, Kari Chansky, Antje Hoering, Valerie Rusch, Ramón Rami-Porta, Luiz Henrique Araujo, David Beer, Pietro Bertoglio, Ricardo Beyruti, Andrea Billè, Souheil Boubia, Elisabeth Brambilla, A.K. Cangir, David Carbone, Vanessa Cilento, Casey Connolly, Gail Darling, Frank Detterbeck, Daniel Dibaba, Xavier Benoit D’Journo, Jessica Donington, Wilfried Eberhardt, John Edwards, Jeremy Erasmus, Wentao Fang, Dean Fennell, Kwun Fong, Françoise Galateau-Sallé, Oliver Gautschi, Ritu R. Gill, Dorothy Giroux, Meredith Giuliani, Jin Mo Goo, Seiki Hasegawa, Fred Hirsch, Hans Hoffman, Wayne Hofstetter, James Huang, Philippe Joubert, Kemp Kernstine, Keith Kerr, Young Tae Kim, Dong Kwan Kim, Hedy Kindler, Yolande Lievens, Hui Liu, Donald E. Low, Gustavo Lyons, Heber MacMahon, Alyson Mahar, Mirella Marino, Edith M. Marom, José-María Matilla, Jan van Meerbeeck, Luis M. Montuenga, Andrew Nicholson, Katie Nishimura, Anna Nowak, Isabelle Opitz, Meinoshin Okumura, Raymond U. Osarogiagbon, Harvey Pass, Marc de Perrot, Helmut Prosch, David Rice, Andreas Rimner, Adam Rosenthal, Enrico Rufﬁni, Shuji Sakai, Paul Van Schil, Navneet Singh, Francisco Suárez, Ricardo M. Terra, William D. Travis, Ming S. Tsao, Paula Ugalde, Shun-ichi Watanabe, Ignacio Wistuba, Murry Wynes, and Yasushi Yatabe
Subjects: Pulmonary and Respiratory Medicine, Oncology
Published: 2023

6. Characterizing the distribution of alterations in mesothelioma and their correlation to morphology

Author: Heather I-Hsuan Chen-Yost, Melissa Y Tjota, Guimin Gao, Owen Mitchell, Hedy Kindler, Jeremy Segal, Aliya N Husain, Jeffrey Mueller, and Jefree J Schulte
Subjects: General Medicine
Abstract: Objectives Mesothelioma is a lethal disease that arises from the serosal lining of organ cavities. Several recurrent alterations have been observed in pleural and peritoneal mesotheliomas, including in BAP1, NF2, and CDKN2A. Although specific histopathologic parameters have been correlated with prognosis, it is not as well known whether genetic alterations correlate with histologic findings. Methods We reviewed 131 mesotheliomas that had undergone next-generation sequencing (NGS) at our institutions after pathologic diagnosis. There were 109 epithelioid mesotheliomas, 18 biphasic mesotheliomas, and 4 sarcomatoid mesotheliomas. All our biphasic and sarcomatoid cases arose in the pleura. Of the epithelioid mesotheliomas, 73 were from the pleura and 36 were from the peritoneum. On average, patients were 66 years of age (range, 26-90 years) and predominantly male (92 men, 39 women). Results The most common alterations identified were in BAP1, CDKN2A, NF2, and TP53. Twelve mesotheliomas did not show a pathogenic alteration on NGS. For epithelioid mesotheliomas in the pleura, the presence of an alteration in BAP1 correlated with low nuclear grade (P = .04), but no correlation was found in the peritoneum (P = .62). Similarly, there was no correlation between the amount of solid architecture in epithelioid mesotheliomas and any alterations in the pleura (P = .55) or peritoneum (P = .13). For biphasic mesotheliomas, cases with either no alteration detected or with an alteration in BAP1 were more likely to be epithelioid predominant (>50% of the tumor, P = .0001), and biphasic mesotheliomas with other alterations detected and no alteration in BAP1 were more likely to be sarcomatoid predominant (>50% of the tumor, P = .0001). Conclusions This study demonstrates a significant association between morphologic features associated with a better prognosis and an alteration in BAP1.
Published: 2023

7. Management of Patients With Pancreatic Cancer Using the 'Right Track' Model

Author: Allison Rosenzweig, Jordan Berlin, Suresh Chari, Hedy Kindler, Lynn Matrisian, Allison Mayoral, Jeannine Mills, Nicholas Nissen, Vincent Picozzi, Fatima Zelada-Arenas, and Jason Fleming
Subjects: Cancer Research, Oncology
Abstract: Pancreatic cancer is one of the few cancer types in the US with incidence and death rates continuing to rise. As the disease threatens to become the second leading cause of cancer-related deaths in the country, it is imperative to review the best practices currently available to extend and improve patient lives. To provide a roadmap for healthcare professionals detecting, diagnosing, and caring for patients with pancreatic cancer as a supplement to national guidelines focused on recommended treatment regimens, the Pancreatic Cancer Action Network (PanCAN)’s Scientific and Medical Affairs staff and expert Scientific and Medical Advisory Board have created a series of position statements. The statements are based upon scientific evidence and clinical observations published in the literature and research conducted through PanCAN’s internal programs and initiatives. This review summarizes the rationale and sources for these position statements related to diagnosis, treatment, and care for pancreatic cancer and provides information about resources to make these recommendations accessible to patients and their medical teams. Pancreatic cancer is a complex and extremely challenging disease. Beyond treatment recommendations outlined in national guidelines, steps can be taken to help patients feel better and live longer. Under the framework of the “Right Track” model—right team, right tests, right treatments, data sharing—PanCAN’s position statements can provide supplementary guidance to healthcare professionals for the short- and long-term management of patients with the disease.
Published: 2023

8. Adjuvant nab-Paclitaxel + Gemcitabine in Resected Pancreatic Ductal Adenocarcinoma: Results From a Randomized, Open-Label, Phase III Trial

Author: Margaret A. Tempero, Uwe Pelzer, Eileen M. O'Reilly, Jordan Winter, Do-Youn Oh, Chung-Pin Li, Giampaolo Tortora, Heung-Moon Chang, Charles D. Lopez, Tanios Bekaii-Saab, Andrew H. Ko, Armando Santoro, Joon Oh Park, Marcus S. Noel, Giovanni Luca Frassineti, Yan-Shen Shan, Andrew Dean, Hanno Riess, Eric Van Cutsem, Jordan Berlin, Philip Philip, Malcolm Moore, David Goldstein, Josep Tabernero, Mingyu Li, Stefano Ferrara, Yvan Le Bruchec, George Zhang, Brian Lu, Andrew V. Biankin, Michele Reni, Richard Epstein, Paul Vasey, Jeremy Shapiro, Matthew Burge, Yu Jo Chua, Marion Harris, Nick Pavlakis, Niall Tebbutt, Gerald Prager, Christian Dittrich, Friedrich Längle, Kathrin Philipp-Abbrederis, Richard Greil, Herbert Stöger, Michael Girschikofsky, Thomas Kuehr, Jean-Luc Van Laethem, Stéphanie Laurent, Neesha Dhani, Yoo Joung Ko, Scot Dowden, Petr Kavan, Mustapha Édouard Tehfe, Eugen Kubala, Milan Kohoutek, Per Pfeiffer, Mette Yilmaz, Vibeke Parner, Tapio Salminen, Leena-Maija Soveri, Eija Korkeila, Pia Osterlund, Julien Taieb, David Tougeron, Pascal Artru, François Xavier Caroli-Bosc, Rosine Guimbaud, Antony Turpin, Thomas Walter, Jean Baptiste Bachet, Volker Kunzmann, Florian Kreth, Andreas Block, Marino Venerito, Helmut Oettle, Meinolf Karthaus, Jörg Trojan, Gunnar Folprecht, Markus Lerch, Frank Kullmann, Marcel Reiser, Volker Heinemann, Marcus-Alexander Wörns, Holger Schulz, Benjamin Garlipp, Thomas Yau, Lam Stephen Chan, Balazs Juhasz, László Landherr, Tamas Pinter, György Bodoky, Zsuzsanna Kahán, Raymond McDermott, Derek Power, Luca Gianni, Salvatore Siena, Michele Milella, Alfredo Falcone, Rossana Berardi, Cinzia Bagalà, Francesco Di Costanzo, Fausto Roila, Andrea Ardizzoni, Evaristo Maiello, Silvia Fanello, Johanna Wilmink, Jan Willem de Groot, Geert Creemers, Eduardo Barroso, Tânia Rodrigues, Cristina Sarmento, Cheng Ean Chee, David Tai, Teresa Macarulla Mercade, Manuel Hidalgo Medina, Alfredo Carrato Mena, Joan Maurel Santasusana, Maria Jose Flor Oncala, Carlos Gomez Martin, Rafael Lopez, Andres Muñoz, Ruth Vera Garcia, Inmaculada Ales, Berta Laquente Sáez, Fernando Rivera, Javier Sastre, Cheng-Chung Wu, Yu-Wen Tien, De-Chuan Chan, Tsann-Long Hwang, Jeffry Evans, Jonathan Wadsley, Pippa Corrie, Andrew Biankin, Andrew Ko, Dana Cardin, Elena Chiorean, Johanna Bendell, Anne Noonan, Hedy Kindler, Nishan Fernando, Muhammad Beg, Thomas George, Marcus Noel, Noelle LoConte, Francis Arena, James Posey, Rajat Malhotra, Charles Lopez, Davendra Sohal, Robert McWilliams, Warren Brenner, Mark Womack, Rahul Seth, Renuka lyer, Nathan Bahary, Robert Marsh, Robert Ramirez, Cynthia Chua, James Reeves, Gulam Manji, Anthony El-Khoueiry, Robert Weaver, Vaibhav Sahai, Wells Messersmith, Robert Dreicer, Ahmed Zakari, Andrea Bullock, Benjamin Musher, Mitesh Borad, Edward Kim, David Bajor, Tim Huyck, Hassan Hatoum, Henry Xiong, Boris Pasche, Jill Lacy, Olugbenga Olowokure, Allen Cohn, Donald Richards, Robert Martin, Andrew Paulson, Paul Fanta, Smitha Krishnamurthi, Paul Oberstein, Jyotsna Fuloria, Institut Català de la Salut, [Tempero MA] University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, CA. [Pelzer U] Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Berlin, Germany. [O'Reilly EM] Memorial Sloan Kettering Cancer Center, New York, NY. [Winter J] Thomas Jefferson University Hospital, Philadelphia, PA. [Oh DY] Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea. Integrated Major in Innovative Medical Science, Seoul National University Graduate School, Seoul, South Korea. [Li CP] Division of Clinical Skills Training, Department of Medical Education, Taipei Veterans General Hospital, Taipei, Taiwan. Division of Gastroenterology and Hepatology, Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. School of Medicine, College of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan. [Tabernero J] Vall d'Hebron Hospital Universitari, Barcelona, Spain. Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. IOB-Quiron, UVic-UCC, Barcelona, Spain, and Vall d'Hebron Barcelona Hospital Campus
Subjects: Cancer Research, Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Immunologic Factors::Adjuvants, Immunologic [CHEMICALS AND DRUGS], acciones y usos químicos::acciones farmacológicas::efectos fisiológicos de los fármacos::factores inmunitarios::adyuvantes inmunitarios [COMPUESTOS QUÍMICOS Y DROGAS], terapéutica::terapéutica::farmacoterapia::protocolos antineoplásicos::terapéutica::farmacoterapia::protocolos de quimioterapia antineoplásica combinada [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], diagnóstico::pronóstico::resultado del tratamiento [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Other subheadings::Other subheadings::/drug therapy [Other subheadings], Diagnosis::Prognosis::Treatment Outcome [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Quimioteràpia combinada, Oncology, Adjuvants immunològics - Ús terapèutic, Therapeutics::Therapeutics::Drug Therapy::Antineoplastic Protocols::Therapeutics::Drug Therapy::Antineoplastic Combined Chemotherapy Protocols [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], neoplasias::neoplasias::neoplasias::neoplasias por localización::neoplasias del sistema digestivo::neoplasias pancreáticas::neoplasias::neoplasias por localización::carcinoma ductal pancreático [ENFERMEDADES], Pàncrees - Càncer - Tractament, Neoplasms::Neoplasms::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Pancreatic Neoplasms::Neoplasms::Neoplasms by Site::Carcinoma, Pancreatic Ductal [DISEASES], APACT Investigators
Abstract: PURPOSE This randomized, open-label trial compared the efficacy and safety of adjuvant nab-paclitaxel + gemcitabine with those of gemcitabine for resected pancreatic ductal adenocarcinoma (ClinicalTrials.gov identifier: NCT01964430 ). METHODS We assigned 866 treatment-naive patients with pancreatic ductal adenocarcinoma to nab-paclitaxel (125 mg/m2) + gemcitabine (1,000 mg/m2) or gemcitabine alone to one 30-40 infusion on days 1, 8, and 15 of six 28-day cycles. The primary end point was independently assessed disease-free survival (DFS). Additional end points included investigator-assessed DFS, overall survival (OS), and safety. RESULTS Two hundred eighty-seven of 432 patients and 310 of 434 patients completed nab-paclitaxel + gemcitabine and gemcitabine treatment, respectively. At primary data cutoff (December 31, 2018; median follow-up, 38.5 [interquartile range [IQR], 33.8-43 months), the median independently assessed DFS was 19.4 ( nab-paclitaxel + gemcitabine) versus 18.8 months (gemcitabine; hazard ratio [HR], 0.88; 95% CI, 0.729 to 1.063; P = .18). The median investigator-assessed DFS was 16.6 (IQR, 8.4-47.0) and 13.7 (IQR, 8.3-44.1) months, respectively (HR, 0.82; 95% CI, 0.694 to 0.965; P = .02). The median OS (427 events; 68% mature) was 40.5 (IQR, 20.7 to not reached) and 36.2 (IQR, 17.7-53.3) months, respectively (HR, 0.82; 95% CI, 0.680 to 0.996; P = .045). At a 16-month follow-up (cutoff, April 3, 2020; median follow-up, 51.4 months [IQR, 47.0-57.0]), the median OS (511 events; 81% mature) was 41.8 ( nab-paclitaxel + gemcitabine) versus 37.7 months (gemcitabine; HR, 0.82; 95% CI, 0.687 to 0.973; P = .0232). At the 5-year follow-up (cutoff, April 9, 2021; median follow-up, 63.2 months [IQR, 60.1-68.7]), the median OS (555 events; 88% mature) was 41.8 versus 37.7 months, respectively (HR, 0.80; 95% CI, 0.678 to 0.947; P = .0091). Eighty-six percent ( nab-paclitaxel + gemcitabine) and 68% (gemcitabine) of patients experienced grade ≥ 3 treatment-emergent adverse events. Two patients per study arm died of treatment-emergent adverse events. CONCLUSION The primary end point (independently assessed DFS) was not met despite favorable OS seen with nab-paclitaxel + gemcitabine.
Published: 2023

9. Supplementary Figures 1-4 from Genomic Heterogeneity as a Barrier to Precision Medicine in Gastroesophageal Adenocarcinoma

Author: Daniel V. Catenacci, Adam J. Bass, Jeeyun Lee, Viktor Adalsteinsson, Yu Imamura, Jon Davison, Denisse Rotem, Greg Gydush, Sarah Reed, Justin Rhoades, Samuel S. Freeman, Gavin Ha, Andres Gelrud, Uzma Siddiqui, Kyle Hogarth, Paul Chang, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Yuan Ji, Haley A. Coleman, Bruce M. Wollison, Matthew D. Ducar, Aaron R. Thorner, Andrew Dunford, David J. Oh, Agoston T. Agoston, Rick Lanman, Hideo Baba, Masayuki Watanabe, Lea O'Keefe, Katie S. Nason, Byung-Hoon Min, Min-Gew Choi, Kyoung-Mee Kim, Rebecca J. Nagy, John Hart, Shu-Yuan Xiao, Namrata Setia, Christopher Weber, Carrie Fitzpatrick, Rajani Kanteti, Melissa Maranto, Samantha Lomnicki, Emily O'Day, Kenisha Allen, Manish R. Sharma, Blase Polite, Hedy Kindler, Heewon Kwak, Lindsay Alpert, Mirazul Islam, Steven Maron, Yang Liu, Sarah Derks, Matthew D. Stachler, and Eirini Pectasides
Abstract: Supplementary Fig. 1: Mutation rate and ploidy for each individual patient's primary and metastatic sample (cohort 1);Supplementary Fig. 2: Validation of genomic heterogeneity within primary tumor and between primary tumor and lymph node (LN) metastases detected by next generation sequencing (NGS) with fluorescent in situ hybridization (FISH) and immunohistochemistry (IHC);Supplementary Fig. 3: PANGEA: Platform clinical trial of molecularly driven therapies in patients with previously untreated GEA;Supplementary Fig. 4: Biomarker profiling of PANGEA where the biomarker profiling of the metastatic tumor did not lead to treatment reassignment relative to treatments assigned based upon the primary tumor
Published: 2023

10. Data from Genomic Heterogeneity as a Barrier to Precision Medicine in Gastroesophageal Adenocarcinoma

Author: Daniel V. Catenacci, Adam J. Bass, Jeeyun Lee, Viktor Adalsteinsson, Yu Imamura, Jon Davison, Denisse Rotem, Greg Gydush, Sarah Reed, Justin Rhoades, Samuel S. Freeman, Gavin Ha, Andres Gelrud, Uzma Siddiqui, Kyle Hogarth, Paul Chang, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Yuan Ji, Haley A. Coleman, Bruce M. Wollison, Matthew D. Ducar, Aaron R. Thorner, Andrew Dunford, David J. Oh, Agoston T. Agoston, Rick Lanman, Hideo Baba, Masayuki Watanabe, Lea O'Keefe, Katie S. Nason, Byung-Hoon Min, Min-Gew Choi, Kyoung-Mee Kim, Rebecca J. Nagy, John Hart, Shu-Yuan Xiao, Namrata Setia, Christopher Weber, Carrie Fitzpatrick, Rajani Kanteti, Melissa Maranto, Samantha Lomnicki, Emily O'Day, Kenisha Allen, Manish R. Sharma, Blase Polite, Hedy Kindler, Heewon Kwak, Lindsay Alpert, Mirazul Islam, Steven Maron, Yang Liu, Sarah Derks, Matthew D. Stachler, and Eirini Pectasides
Abstract: Gastroesophageal adenocarcinoma (GEA) is a lethal disease where targeted therapies, even when guided by genomic biomarkers, have had limited efficacy. A potential reason for the failure of such therapies is that genomic profiling results could commonly differ between the primary and metastatic tumors. To evaluate genomic heterogeneity, we sequenced paired primary GEA and synchronous metastatic lesions across multiple cohorts, finding extensive differences in genomic alterations, including discrepancies in potentially clinically relevant alterations. Multiregion sequencing showed significant discrepancy within the primary tumor (PT) and between the PT and disseminated disease, with oncogene amplification profiles commonly discordant. In addition, a pilot analysis of cell-free DNA (cfDNA) sequencing demonstrated the feasibility of detecting genomic amplifications not detected in PT sampling. Lastly, we profiled paired primary tumors, metastatic tumors, and cfDNA from patients enrolled in the personalized antibodies for GEA (PANGEA) trial of targeted therapies in GEA and found that genomic biomarkers were recurrently discrepant between the PT and untreated metastases. Divergent primary and metastatic tissue profiling led to treatment reassignment in 32% (9/28) of patients. In discordant primary and metastatic lesions, we found 87.5% concordance for targetable alterations in metastatic tissue and cfDNA, suggesting the potential for cfDNA profiling to enhance selection of therapy.Significance: We demonstrate frequent baseline heterogeneity in targetable genomic alterations in GEA, indicating that current tissue sampling practices for biomarker testing do not effectively guide precision medicine in this disease and that routine profiling of metastatic lesions and/or cfDNA should be systematically evaluated. Cancer Discov; 8(1); 37–48. ©2017 AACR.See related commentary by Sundar and Tan, p. 14.See related article by Janjigian et al., p. 49.This article is highlighted in the In This Issue feature, p. 1
Published: 2023

11. Table S6 from Integrative Molecular Characterization of Malignant Pleural Mesothelioma

Author: Erik Zmuda, Hongxin Zhang, Hailei Zhang, Jiashan Zhang, Jean C. Zenklusen, Marjorie G. Zauderer, Liming Yang, Shogo Yamamoto, Ye Wu, Tina Wong, Ignacio Wistuba, Lisa Wise, Matthew D. Wilkerson, Daniel J. Weisenberger, John N. Weinstein, Joellen Weaver, Jing Wang, Zhining Wang, Yunhu Wan, Douglas Voet, Luciano S. Viana, Umadevi Veluvolu, Nico van Zandwijk, David J. Van Den Berg, Federico Valdivieso, Tohru Tsujimura, Kane Tse, Anne Tsao, Eric Thompson, Nina Thiessen, Barry S Taylor, Kenji Tatsuno, Roy Tarnuzzer, Donghui Tan, Angela Tam, Qiang Sun, Josh Stuart, Chip Stewart, Paul Spellman, Matthew G. Soloway, Heidi J. Sofia, Tara Skelly, Payal Sipahimalani, Janae V. Simons, Henrique C. S. Silveira, Ilya Shmulevich, Yuichi Shiraishi, Yan Shi, Robert Sheridan, Troy Shelton, Candace Shelton, David T Severson, Tanguy Seiwert, Steven E. Schumacher, Nikolaus Schultz, Jacqueline E. Schein, Cristovam Scapulatempo-Neto, Ayuko Sato, Chris Sander, Gordon Saksena, Sara Sadeghi, Valerie Rusch, Jeffrey Roach, Robert C. Rintoul, William G Richards, David Rice, Sheila M. Reynolds, Rui M. Reis, Glen Reid, Gloria Ravegnini, Doris M. Rassl, Nilsa C. Ramirez, Todd Pihl, Charles M. Perou, Robert Penny, Nathan A. Pennell, Arjun Pennathur, Joseph Paulauskis, Harvey I. Pass, Joel S. Parker, Hatice Osmanbeyoglu, Angelica Ochoa, Yulia Newton, Rashi Naresh, Takashi Nakano, Karen Mungall, Andrew J. Mungall, Lisle E. Mose, Scott Morris, Cesar Moran, Richard A. Moore, Gordon B. Mills, Piotr A. Mieczkowski, Matthew Meyerson, Shaowu Meng, Jonathan Melamed, Sam Meier, Michael Mayo, Marco A. Marra, David Mallory, Dennis T. Maglinte, Yussanne Ma, James Luketich, Yiling Lu, Adhemar Longatto-Filho, Laxmi Lolla, Eric Minwei Liu, Wenbin Liu, Jia Liu, Pei Lin, Tara M. Lichtenberg, Kristen M. Leraas, Darlene Lee, Michael S. Lawrence, Peter W. Laird, Phillip H. Lai, David J. Kwiatkowski, Kozo Kuribayashi, Ritika Kundra, Thomas Krausz, Nobuyuki Kondo, Jaegil Kim, Katayoon Kasaian, Rupa S. Kanchi, Corbin D. Jones, Steven J.M. Jones, Stuart R. Jefferys, Carolyn M. Hutter, Aliya Husain, Alan P. Hoyle, Robert A. Holt, Katherine A. Hoadley, Zachary Heins, David I. Heiman, D. Neil Hayes, David Haussler, Seiki Hasegawa, Guangwu Guo, Benjamin Gross, Chandra Goparaju, Gad Getz, Mark Gerken, Nils Gehlenborg, Julie M. Gastier-Foster, Johanna Gardner, Jianjiong Gao, Françoise Galateau Sallé, Stacey B. Gabriel, Shiro Fukuda, Martin L. Ferguson, Michael Feldman, Rajiv Dhir, Noreen Dhalla, John A. Demchok, Timothy DeFreitas, Assunta De Rienzo, Ludmila Danilova, Erin Curley, Daniel Crain, Leslie Cope, Carrie Cibulskis, Sudha Chudamani, Eric Chuah, Juok Cho, Lucian Chirieac, Dorothy Cheung, Andrew D. Cherniack, Andre L. Carvalho, Rebecca Carlsen, Flávio M. Cárcano, Lauren Averett Byers, Denise Brooks, Moiz S. Bootwalla, Tom Bodenheimer, Craig Bielski, Rameen Beroukhim, Carmen Behrens, Michael Becich, Stephen B. Baylin, Saianand Balu, Miruna Balasundaram, J. Todd Auman, Joshua Armenia, Pavana Anur, Adrian Ally, Marc Ladanyi, Peter Campbell, Bruce W. Robinson, Hiroyuki Aburatani, Ronglai Shen, A. Gordon Robertson, Jonathan A. Fletcher, Michael S. Noble, Lauren A. Byers, Rehan Akbani, Jean Claude Zenklusen, Ina Felau, Jay Bowen, Kristen Leraas, Tara Lichtenberg, Jenette Creaney, Anne S. Tsao, Raphael Bueno, Hedy Kindler, Harvey Pass, Valerie W. Rusch, Henrique C. Silveira, Aliya N. Husain, Junya Fujimoto, Françoise Galateau-Sallé, Lucian R. Chirieac, Sanja Dacic, William D. Travis, Achim A. Jungbluth, Patrice Desmeules, David T. Severson, Havish Kantheti, Lisa Iype, Vesteinn Thorsson, David L. Gibbs, Lixia Diao, Carl M. Gay, Manaswi Gupta, Kiley Graim, Jumpei Takeshita, Yoshitaka Sekido, Hatice U. Osmanbeyoglu, Rupa Kanchi, Reanne Bowlby, Ewan A. Gibb, Esther Drill, Patrick Tarpey, David Heiman, Juliann Shih, Francisco Sanchez-Vega, and Julija Hmeljak
Abstract: Table S6 contains results from the analysis of DNA methylation in SETD2 mutated and BAP1 inactivated samples.
Published: 2023

12. Supplementary Figure Legends from Genomic Heterogeneity as a Barrier to Precision Medicine in Gastroesophageal Adenocarcinoma

Author: Daniel V. Catenacci, Adam J. Bass, Jeeyun Lee, Viktor Adalsteinsson, Yu Imamura, Jon Davison, Denisse Rotem, Greg Gydush, Sarah Reed, Justin Rhoades, Samuel S. Freeman, Gavin Ha, Andres Gelrud, Uzma Siddiqui, Kyle Hogarth, Paul Chang, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Yuan Ji, Haley A. Coleman, Bruce M. Wollison, Matthew D. Ducar, Aaron R. Thorner, Andrew Dunford, David J. Oh, Agoston T. Agoston, Rick Lanman, Hideo Baba, Masayuki Watanabe, Lea O'Keefe, Katie S. Nason, Byung-Hoon Min, Min-Gew Choi, Kyoung-Mee Kim, Rebecca J. Nagy, John Hart, Shu-Yuan Xiao, Namrata Setia, Christopher Weber, Carrie Fitzpatrick, Rajani Kanteti, Melissa Maranto, Samantha Lomnicki, Emily O'Day, Kenisha Allen, Manish R. Sharma, Blase Polite, Hedy Kindler, Heewon Kwak, Lindsay Alpert, Mirazul Islam, Steven Maron, Yang Liu, Sarah Derks, Matthew D. Stachler, and Eirini Pectasides
Abstract: Supplementary Figure Legends
Published: 2023

13. Data from Integrative Molecular Characterization of Malignant Pleural Mesothelioma

Author: Erik Zmuda, Hongxin Zhang, Hailei Zhang, Jiashan Zhang, Jean C. Zenklusen, Marjorie G. Zauderer, Liming Yang, Shogo Yamamoto, Ye Wu, Tina Wong, Ignacio Wistuba, Lisa Wise, Matthew D. Wilkerson, Daniel J. Weisenberger, John N. Weinstein, Joellen Weaver, Jing Wang, Zhining Wang, Yunhu Wan, Douglas Voet, Luciano S. Viana, Umadevi Veluvolu, Nico van Zandwijk, David J. Van Den Berg, Federico Valdivieso, Tohru Tsujimura, Kane Tse, Anne Tsao, Eric Thompson, Nina Thiessen, Barry S Taylor, Kenji Tatsuno, Roy Tarnuzzer, Donghui Tan, Angela Tam, Qiang Sun, Josh Stuart, Chip Stewart, Paul Spellman, Matthew G. Soloway, Heidi J. Sofia, Tara Skelly, Payal Sipahimalani, Janae V. Simons, Henrique C. S. Silveira, Ilya Shmulevich, Yuichi Shiraishi, Yan Shi, Robert Sheridan, Troy Shelton, Candace Shelton, David T Severson, Tanguy Seiwert, Steven E. Schumacher, Nikolaus Schultz, Jacqueline E. Schein, Cristovam Scapulatempo-Neto, Ayuko Sato, Chris Sander, Gordon Saksena, Sara Sadeghi, Valerie Rusch, Jeffrey Roach, Robert C. Rintoul, William G Richards, David Rice, Sheila M. Reynolds, Rui M. Reis, Glen Reid, Gloria Ravegnini, Doris M. Rassl, Nilsa C. Ramirez, Todd Pihl, Charles M. Perou, Robert Penny, Nathan A. Pennell, Arjun Pennathur, Joseph Paulauskis, Harvey I. Pass, Joel S. Parker, Hatice Osmanbeyoglu, Angelica Ochoa, Yulia Newton, Rashi Naresh, Takashi Nakano, Karen Mungall, Andrew J. Mungall, Lisle E. Mose, Scott Morris, Cesar Moran, Richard A. Moore, Gordon B. Mills, Piotr A. Mieczkowski, Matthew Meyerson, Shaowu Meng, Jonathan Melamed, Sam Meier, Michael Mayo, Marco A. Marra, David Mallory, Dennis T. Maglinte, Yussanne Ma, James Luketich, Yiling Lu, Adhemar Longatto-Filho, Laxmi Lolla, Eric Minwei Liu, Wenbin Liu, Jia Liu, Pei Lin, Tara M. Lichtenberg, Kristen M. Leraas, Darlene Lee, Michael S. Lawrence, Peter W. Laird, Phillip H. Lai, David J. Kwiatkowski, Kozo Kuribayashi, Ritika Kundra, Thomas Krausz, Nobuyuki Kondo, Jaegil Kim, Katayoon Kasaian, Rupa S. Kanchi, Corbin D. Jones, Steven J.M. Jones, Stuart R. Jefferys, Carolyn M. Hutter, Aliya Husain, Alan P. Hoyle, Robert A. Holt, Katherine A. Hoadley, Zachary Heins, David I. Heiman, D. Neil Hayes, David Haussler, Seiki Hasegawa, Guangwu Guo, Benjamin Gross, Chandra Goparaju, Gad Getz, Mark Gerken, Nils Gehlenborg, Julie M. Gastier-Foster, Johanna Gardner, Jianjiong Gao, Françoise Galateau Sallé, Stacey B. Gabriel, Shiro Fukuda, Martin L. Ferguson, Michael Feldman, Rajiv Dhir, Noreen Dhalla, John A. Demchok, Timothy DeFreitas, Assunta De Rienzo, Ludmila Danilova, Erin Curley, Daniel Crain, Leslie Cope, Carrie Cibulskis, Sudha Chudamani, Eric Chuah, Juok Cho, Lucian Chirieac, Dorothy Cheung, Andrew D. Cherniack, Andre L. Carvalho, Rebecca Carlsen, Flávio M. Cárcano, Lauren Averett Byers, Denise Brooks, Moiz S. Bootwalla, Tom Bodenheimer, Craig Bielski, Rameen Beroukhim, Carmen Behrens, Michael Becich, Stephen B. Baylin, Saianand Balu, Miruna Balasundaram, J. Todd Auman, Joshua Armenia, Pavana Anur, Adrian Ally, Marc Ladanyi, Peter Campbell, Bruce W. Robinson, Hiroyuki Aburatani, Ronglai Shen, A. Gordon Robertson, Jonathan A. Fletcher, Michael S. Noble, Lauren A. Byers, Rehan Akbani, Jean Claude Zenklusen, Ina Felau, Jay Bowen, Kristen Leraas, Tara Lichtenberg, Jenette Creaney, Anne S. Tsao, Raphael Bueno, Hedy Kindler, Harvey Pass, Valerie W. Rusch, Henrique C. Silveira, Aliya N. Husain, Junya Fujimoto, Françoise Galateau-Sallé, Lucian R. Chirieac, Sanja Dacic, William D. Travis, Achim A. Jungbluth, Patrice Desmeules, David T. Severson, Havish Kantheti, Lisa Iype, Vesteinn Thorsson, David L. Gibbs, Lixia Diao, Carl M. Gay, Manaswi Gupta, Kiley Graim, Jumpei Takeshita, Yoshitaka Sekido, Hatice U. Osmanbeyoglu, Rupa Kanchi, Reanne Bowlby, Ewan A. Gibb, Esther Drill, Patrick Tarpey, David Heiman, Juliann Shih, Francisco Sanchez-Vega, and Julija Hmeljak
Abstract: Malignant pleural mesothelioma (MPM) is a highly lethal cancer of the lining of the chest cavity. To expand our understanding of MPM, we conducted a comprehensive integrated genomic study, including the most detailed analysis of BAP1 alterations to date. We identified histology-independent molecular prognostic subsets, and defined a novel genomic subtype with TP53 and SETDB1 mutations and extensive loss of heterozygosity. We also report strong expression of the immune-checkpoint gene VISTA in epithelioid MPM, strikingly higher than in other solid cancers, with implications for the immune response to MPM and for its immunotherapy. Our findings highlight new avenues for further investigation of MPM biology and novel therapeutic options.Significance:Through a comprehensive integrated genomic study of 74 MPMs, we provide a deeper understanding of histology-independent determinants of aggressive behavior, define a novel genomic subtype with TP53 and SETDB1 mutations and extensive loss of heterozygosity, and discovered strong expression of the immune-checkpoint gene VISTA in epithelioid MPM.See related commentary by Aggarwal and Albelda, p. 1508.This article is highlighted in the In This Issue feature, p. 1494
Published: 2023

14. Supplementary Methods from Genomic Heterogeneity as a Barrier to Precision Medicine in Gastroesophageal Adenocarcinoma

Author: Daniel V. Catenacci, Adam J. Bass, Jeeyun Lee, Viktor Adalsteinsson, Yu Imamura, Jon Davison, Denisse Rotem, Greg Gydush, Sarah Reed, Justin Rhoades, Samuel S. Freeman, Gavin Ha, Andres Gelrud, Uzma Siddiqui, Kyle Hogarth, Paul Chang, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Yuan Ji, Haley A. Coleman, Bruce M. Wollison, Matthew D. Ducar, Aaron R. Thorner, Andrew Dunford, David J. Oh, Agoston T. Agoston, Rick Lanman, Hideo Baba, Masayuki Watanabe, Lea O'Keefe, Katie S. Nason, Byung-Hoon Min, Min-Gew Choi, Kyoung-Mee Kim, Rebecca J. Nagy, John Hart, Shu-Yuan Xiao, Namrata Setia, Christopher Weber, Carrie Fitzpatrick, Rajani Kanteti, Melissa Maranto, Samantha Lomnicki, Emily O'Day, Kenisha Allen, Manish R. Sharma, Blase Polite, Hedy Kindler, Heewon Kwak, Lindsay Alpert, Mirazul Islam, Steven Maron, Yang Liu, Sarah Derks, Matthew D. Stachler, and Eirini Pectasides
Abstract: Supplementary Methods
Published: 2023

15. Supplementary Data from Integrative Molecular Characterization of Malignant Pleural Mesothelioma

Author: Erik Zmuda, Hongxin Zhang, Hailei Zhang, Jiashan Zhang, Jean C. Zenklusen, Marjorie G. Zauderer, Liming Yang, Shogo Yamamoto, Ye Wu, Tina Wong, Ignacio Wistuba, Lisa Wise, Matthew D. Wilkerson, Daniel J. Weisenberger, John N. Weinstein, Joellen Weaver, Jing Wang, Zhining Wang, Yunhu Wan, Douglas Voet, Luciano S. Viana, Umadevi Veluvolu, Nico van Zandwijk, David J. Van Den Berg, Federico Valdivieso, Tohru Tsujimura, Kane Tse, Anne Tsao, Eric Thompson, Nina Thiessen, Barry S Taylor, Kenji Tatsuno, Roy Tarnuzzer, Donghui Tan, Angela Tam, Qiang Sun, Josh Stuart, Chip Stewart, Paul Spellman, Matthew G. Soloway, Heidi J. Sofia, Tara Skelly, Payal Sipahimalani, Janae V. Simons, Henrique C. S. Silveira, Ilya Shmulevich, Yuichi Shiraishi, Yan Shi, Robert Sheridan, Troy Shelton, Candace Shelton, David T Severson, Tanguy Seiwert, Steven E. Schumacher, Nikolaus Schultz, Jacqueline E. Schein, Cristovam Scapulatempo-Neto, Ayuko Sato, Chris Sander, Gordon Saksena, Sara Sadeghi, Valerie Rusch, Jeffrey Roach, Robert C. Rintoul, William G Richards, David Rice, Sheila M. Reynolds, Rui M. Reis, Glen Reid, Gloria Ravegnini, Doris M. Rassl, Nilsa C. Ramirez, Todd Pihl, Charles M. Perou, Robert Penny, Nathan A. Pennell, Arjun Pennathur, Joseph Paulauskis, Harvey I. Pass, Joel S. Parker, Hatice Osmanbeyoglu, Angelica Ochoa, Yulia Newton, Rashi Naresh, Takashi Nakano, Karen Mungall, Andrew J. Mungall, Lisle E. Mose, Scott Morris, Cesar Moran, Richard A. Moore, Gordon B. Mills, Piotr A. Mieczkowski, Matthew Meyerson, Shaowu Meng, Jonathan Melamed, Sam Meier, Michael Mayo, Marco A. Marra, David Mallory, Dennis T. Maglinte, Yussanne Ma, James Luketich, Yiling Lu, Adhemar Longatto-Filho, Laxmi Lolla, Eric Minwei Liu, Wenbin Liu, Jia Liu, Pei Lin, Tara M. Lichtenberg, Kristen M. Leraas, Darlene Lee, Michael S. Lawrence, Peter W. Laird, Phillip H. Lai, David J. Kwiatkowski, Kozo Kuribayashi, Ritika Kundra, Thomas Krausz, Nobuyuki Kondo, Jaegil Kim, Katayoon Kasaian, Rupa S. Kanchi, Corbin D. Jones, Steven J.M. Jones, Stuart R. Jefferys, Carolyn M. Hutter, Aliya Husain, Alan P. Hoyle, Robert A. Holt, Katherine A. Hoadley, Zachary Heins, David I. Heiman, D. Neil Hayes, David Haussler, Seiki Hasegawa, Guangwu Guo, Benjamin Gross, Chandra Goparaju, Gad Getz, Mark Gerken, Nils Gehlenborg, Julie M. Gastier-Foster, Johanna Gardner, Jianjiong Gao, Françoise Galateau Sallé, Stacey B. Gabriel, Shiro Fukuda, Martin L. Ferguson, Michael Feldman, Rajiv Dhir, Noreen Dhalla, John A. Demchok, Timothy DeFreitas, Assunta De Rienzo, Ludmila Danilova, Erin Curley, Daniel Crain, Leslie Cope, Carrie Cibulskis, Sudha Chudamani, Eric Chuah, Juok Cho, Lucian Chirieac, Dorothy Cheung, Andrew D. Cherniack, Andre L. Carvalho, Rebecca Carlsen, Flávio M. Cárcano, Lauren Averett Byers, Denise Brooks, Moiz S. Bootwalla, Tom Bodenheimer, Craig Bielski, Rameen Beroukhim, Carmen Behrens, Michael Becich, Stephen B. Baylin, Saianand Balu, Miruna Balasundaram, J. Todd Auman, Joshua Armenia, Pavana Anur, Adrian Ally, Marc Ladanyi, Peter Campbell, Bruce W. Robinson, Hiroyuki Aburatani, Ronglai Shen, A. Gordon Robertson, Jonathan A. Fletcher, Michael S. Noble, Lauren A. Byers, Rehan Akbani, Jean Claude Zenklusen, Ina Felau, Jay Bowen, Kristen Leraas, Tara Lichtenberg, Jenette Creaney, Anne S. Tsao, Raphael Bueno, Hedy Kindler, Harvey Pass, Valerie W. Rusch, Henrique C. Silveira, Aliya N. Husain, Junya Fujimoto, Françoise Galateau-Sallé, Lucian R. Chirieac, Sanja Dacic, William D. Travis, Achim A. Jungbluth, Patrice Desmeules, David T. Severson, Havish Kantheti, Lisa Iype, Vesteinn Thorsson, David L. Gibbs, Lixia Diao, Carl M. Gay, Manaswi Gupta, Kiley Graim, Jumpei Takeshita, Yoshitaka Sekido, Hatice U. Osmanbeyoglu, Rupa Kanchi, Reanne Bowlby, Ewan A. Gibb, Esther Drill, Patrick Tarpey, David Heiman, Juliann Shih, Francisco Sanchez-Vega, and Julija Hmeljak
Abstract: Supplementary materials and methods, as well as supplementary figures S1-S7.
Published: 2023

16. Supplementary Tables 1-8 from Genomic Heterogeneity as a Barrier to Precision Medicine in Gastroesophageal Adenocarcinoma

Author: Daniel V. Catenacci, Adam J. Bass, Jeeyun Lee, Viktor Adalsteinsson, Yu Imamura, Jon Davison, Denisse Rotem, Greg Gydush, Sarah Reed, Justin Rhoades, Samuel S. Freeman, Gavin Ha, Andres Gelrud, Uzma Siddiqui, Kyle Hogarth, Paul Chang, Kiran Turaga, Kevin Roggin, Mitchell C. Posner, Yuan Ji, Haley A. Coleman, Bruce M. Wollison, Matthew D. Ducar, Aaron R. Thorner, Andrew Dunford, David J. Oh, Agoston T. Agoston, Rick Lanman, Hideo Baba, Masayuki Watanabe, Lea O'Keefe, Katie S. Nason, Byung-Hoon Min, Min-Gew Choi, Kyoung-Mee Kim, Rebecca J. Nagy, John Hart, Shu-Yuan Xiao, Namrata Setia, Christopher Weber, Carrie Fitzpatrick, Rajani Kanteti, Melissa Maranto, Samantha Lomnicki, Emily O'Day, Kenisha Allen, Manish R. Sharma, Blase Polite, Hedy Kindler, Heewon Kwak, Lindsay Alpert, Mirazul Islam, Steven Maron, Yang Liu, Sarah Derks, Matthew D. Stachler, and Eirini Pectasides
Abstract: Supplementary Table 1. Tumor and sequencing information for Cohort 1, paired primary and metastatic gastric adenocarcinoma samples; Supplementary Table 2. 243-gene targeted panel used for sequencing of Cohort 2 samples; Supplementary Table 3: Wild type and mutant read counts for paired primary and metastatic samples in cohort 1; Supplementary Table 4. Clinical and pathologic characteristics of Cohort 2; Supplementary Table 5. Complete sequencing results of Cohort 2; Supplementary Table 6. Clinical characteristics of Cohort 3; Supplementary Table 7. Treatment assignment algorithm of PANGEA clinical trial; Supplementary Table 8. Clinical Characteristics and Response Data of evaluable patients in the PANGEA cohort (N = 21)
Published: 2023

17. Figure S2 from Clinical Response of Live-Attenuated, Listeria monocytogenes Expressing Mesothelin (CRS-207) with Chemotherapy in Patients with Malignant Pleural Mesothelioma

Author: Dirk G. Brockstedt, Lisa M. Coussens, Elizabeth Jaffee, Aimee L. Murphy, Katherine McDougall, Anish Thomas, Gina Choe, Sushil Kumar, Takahiro Tsujikawa, Ed Lemmens, Amanda Enstrom, Chan C. Whiting, Nitya Nair, Somayeh Honarmand, Thierry Jahan, Scott Antonia, Hedy Kindler, Evan Alley, and Raffit Hassan
Abstract: Intratumoral leukocyte composition of mesothelioma representing pre- and post-therapy immunotherapy, evaluated by multiplex IHC.
Published: 2023

18. Table S1 from Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study)

Author: Elizabeth M. Jaffee, Dirk G. Brockstedt, Sandy Ferber, Amanda Enstrom, Nitya Nair, Chan Whiting, Aimee Murphy, Dan Laheru, Benjamin Musher, Noelle K. LoConte, Todd Crocenzi, Erkut Borazanci, Tony Reid, Colin Weekes, Herbert J. Zeh, Michael A. Morse, Paul Oberstein, Andrea Wang-Gillam, Hedy Kindler, Zev A. Wainberg, Andrew H. Ko, Vincent J. Picozzi, and Dung T. Le
Abstract: Baseline disease characteristics by treatment arm
Published: 2023

19. Data from Clinical Response of Live-Attenuated, Listeria monocytogenes Expressing Mesothelin (CRS-207) with Chemotherapy in Patients with Malignant Pleural Mesothelioma

Author: Dirk G. Brockstedt, Lisa M. Coussens, Elizabeth Jaffee, Aimee L. Murphy, Katherine McDougall, Anish Thomas, Gina Choe, Sushil Kumar, Takahiro Tsujikawa, Ed Lemmens, Amanda Enstrom, Chan C. Whiting, Nitya Nair, Somayeh Honarmand, Thierry Jahan, Scott Antonia, Hedy Kindler, Evan Alley, and Raffit Hassan
Abstract: Purpose:Malignant pleural mesothelioma (MPM) is an aggressive cancer associated with poor prognosis. CRS-207 is a live-attenuated Listeria monocytogenes engineered to express mesothelin, a tumor-associated antigen highly expressed in MPM. CRS-207 induces antitumor immune responses and increases susceptibility of neoplastic cells to immune-mediated killing.Patients and Methods:Patients with unresectable MPM, ECOG 0 or 1, and adequate organ and pulmonary function were enrolled in this multicenter, open-label phase Ib study. They received two priming infusions of 1 × 109 CFU CRS-207, followed by pemetrexed/cisplatin chemotherapy, and CRS-207 booster infusions. Primary objectives were safety and induction of immune response. Secondary/exploratory objectives included tumor response, progression-free survival (PFS), overall survival (OS), immune subset analysis, and gene-expression profiling of tumor.Results:Of 35 evaluable patients, 89% (31/35) had disease control with one complete response (3%), 19 partial responses (54%), and 10 stable disease (29%). The estimated median duration of response was 5.0 months (95% CI, 3.9–11.5). The median PFS and OS were 7.5 (95% CI, 7.0–9.9) and 14.7 (95% CI, 11.2–21.9) months, respectively. Tumor size reduction was observed post–CRS-207 infusion prior to chemotherapy in 11 of 35 (31%) patients. No unexpected treatment-related serious adverse events or deaths were observed. IHC analysis of pre- and post–CRS-207 treatment tumor biopsies revealed possible reinvigoration and proliferation of T cells, increased infiltration of dendritic and natural killer cells, increased CD8:Treg ratio, and a shift from immunosuppressive M2-like to proinflammatory M1-like macrophages following CRS-207 administration.Conclusions:Combination of CRS-207 and chemotherapy induced significant changes in the local tumor microenvironment and objective tumor responses in a majority of treated patients.
Published: 2023

20. Figure S1 from Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study)

Author: Elizabeth M. Jaffee, Dirk G. Brockstedt, Sandy Ferber, Amanda Enstrom, Nitya Nair, Chan Whiting, Aimee Murphy, Dan Laheru, Benjamin Musher, Noelle K. LoConte, Todd Crocenzi, Erkut Borazanci, Tony Reid, Colin Weekes, Herbert J. Zeh, Michael A. Morse, Paul Oberstein, Andrea Wang-Gillam, Hedy Kindler, Zev A. Wainberg, Andrew H. Ko, Vincent J. Picozzi, and Dung T. Le
Abstract: Progression-free survival by treatment arm: Primary Cohort
Published: 2023

21. Table S1 from Clinical Response of Live-Attenuated, Listeria monocytogenes Expressing Mesothelin (CRS-207) with Chemotherapy in Patients with Malignant Pleural Mesothelioma

Author: Dirk G. Brockstedt, Lisa M. Coussens, Elizabeth Jaffee, Aimee L. Murphy, Katherine McDougall, Anish Thomas, Gina Choe, Sushil Kumar, Takahiro Tsujikawa, Ed Lemmens, Amanda Enstrom, Chan C. Whiting, Nitya Nair, Somayeh Honarmand, Thierry Jahan, Scott Antonia, Hedy Kindler, Evan Alley, and Raffit Hassan
Abstract: Biomarkers utilized for defining immune cell lineages in IHC analysis
Published: 2023

22. Data from Results from a Phase IIb, Randomized, Multicenter Study of GVAX Pancreas and CRS-207 Compared with Chemotherapy in Adults with Previously Treated Metastatic Pancreatic Adenocarcinoma (ECLIPSE Study)

Author: Elizabeth M. Jaffee, Dirk G. Brockstedt, Sandy Ferber, Amanda Enstrom, Nitya Nair, Chan Whiting, Aimee Murphy, Dan Laheru, Benjamin Musher, Noelle K. LoConte, Todd Crocenzi, Erkut Borazanci, Tony Reid, Colin Weekes, Herbert J. Zeh, Michael A. Morse, Paul Oberstein, Andrea Wang-Gillam, Hedy Kindler, Zev A. Wainberg, Andrew H. Ko, Vincent J. Picozzi, and Dung T. Le
Abstract: Purpose:Limited options exist for patients with advanced pancreatic cancer progressing after 1 or more lines of therapy. A phase II study in patients with previously treated metastatic pancreatic cancer showed that combining GVAX pancreas (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes expressing mesothelin) resulted in median overall survival (OS) of 6.1 months, which compares favorably with historical OS achieved with chemotherapy. In the current study, we compared Cy/GVAX + CRS-207, CRS-207 alone, and standard chemotherapy in a three-arm, randomized, controlled phase IIb trial.Patients and Methods:Patients with previously treated metastatic pancreatic adenocarcinoma were randomized 1:1:1 to receive Cy/GVAX + CRS-207 (arm A), CRS-207 (arm B), or physician's choice of single-agent chemotherapy (arm C). The primary cohort included patients who had failed ≥2 prior lines of therapy, including gemcitabine. The primary objective compared OS between arms A and C in the primary cohort. The second-line cohort included patients who had received 1 prior line of therapy. Additional objectives included OS between all treatment arms, safety, and tumor responses.Results:The study did not meet its primary efficacy endpoint. At the final study analysis, median OS [95% confidence interval (CI)] in the primary cohort (N = 213) was 3.7 (2.9–5.3), 5.4 (4.2–6.4), and 4.6 (4.2–5.7) months in arms A, B, and C, respectively, showing no significant difference between arm A and arm C [P = not significant (NS), HR = 1.17; 95% CI, 0.84–1.64]. The most frequently reported adverse events in all treatment groups were chills, pyrexia, fatigue, and nausea. No treatment-related deaths occurred.Conclusions:The combination of Cy/GVAX + CRS-207 did not improve survival over chemotherapy. (ClinicalTrials.gov ID: NCT02004262)See related commentary by Salas-Benito et al., p. 5435
Published: 2023

23. Diet- and Lifestyle‐Based Prediction Models to Estimate Cancer Recurrence and Death in Patients With Stage III Colon Cancer (CALGB 89803/Alliance)

Author: En Cheng, Fang-Shu Ou, Chao Ma, Donna Spiegelman, Sui Zhang, Xin Zhou, Tiffany M. Bainter, Leonard B. Saltz, Donna Niedzwiecki, Robert J. Mayer, Renaud Whittom, Alexander Hantel, Al Benson, Daniel Atienza, Michael Messino, Hedy Kindler, Edward L. Giovannucci, Erin L. Van Blarigan, Justin C. Brown, Kimmie Ng, Cary P. Gross, Jeffrey A. Meyerhardt, and Charles S. Fuchs
Subjects: Male, Cancer Research, Models, Statistical, ORIGINAL REPORTS, Middle Aged, Prognosis, Diet, Survival Rate, Nomograms, Oncology, Chemotherapy, Adjuvant, Risk Factors, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, Humans, Multicenter Studies as Topic, Female, Neoplasm Recurrence, Local, Life Style, Aged, Follow-Up Studies, Randomized Controlled Trials as Topic
Abstract: PURPOSE Current tools in predicting survival outcomes for patients with colon cancer predominantly rely on clinical and pathologic characteristics, but increasing evidence suggests that diet and lifestyle habits are associated with patient outcomes and should be considered to enhance model accuracy. METHODS Using an adjuvant chemotherapy trial for stage III colon cancer (CALGB 89803), we developed prediction models of disease-free survival (DFS) and overall survival by additionally incorporating self-reported nine diet and lifestyle factors. Both models were assessed by multivariable Cox proportional hazards regression and externally validated using another trial for stage III colon cancer (CALGB/SWOG 80702), and visual nomograms of prediction models were constructed accordingly. We also proposed three hypothetical scenarios for patients with (1) good-risk, (2) average-risk, and (3) poor-risk clinical and pathologic features, and estimated their predictive survival by considering clinical and pathologic features with or without adding self-reported diet and lifestyle factors. RESULTS Among 1,024 patients (median age 60.0 years, 43.8% female), we observed 394 DFS events and 311 deaths after median follow-up of 7.3 years. Adding self-reported diet and lifestyle factors to clinical and pathologic characteristics meaningfully improved performance of prediction models (c-index from 0.64 [95% CI, 0.62 to 0.67] to 0.69 [95% CI, 0.67 to 0.72] for DFS, and from 0.67 [95% CI, 0.64 to 0.70] to 0.71 [95% CI, 0.69 to 0.75] for overall survival). External validation also indicated good performance of discrimination and calibration. Adding most self-reported favorable diet and lifestyle exposures to multivariate modeling improved 5-year DFS of all patients and by 6.3% for good-risk, 21.4% for average-risk, and 42.6% for poor-risk clinical and pathologic features. CONCLUSION Diet and lifestyle factors further inform current recurrence and survival prediction models for patients with stage III colon cancer.
Published: 2022

24. Phase II Prospective, Open-Label Randomized Controlled Trial Comparing Standard of Care Chemotherapy With and Without Sequential Cytoreductive Interventions for Patients with Oligometastatic Foregut Adenocarcinoma and Undetectable Circulating Tumor Deoxyribose Nucleic Acid (ctDNA) Levels

Author: Ankit, Dhiman, Charles C, Vining, Hunter D D, Witmer, Divya, Sood, Ardaman, Shergill, Hedy, Kindler, Kevin K, Roggin, Mitchell C, Posner, Osmanuddin S, Ahmed, Stanley, Liauw, Sean, Pitroda, Chih-Yi, Liao, Theodore, Karrison, Ralph, Weichselbaum, Blase, Polite, Oliver S, Eng, Daniel V T, Catenacci, and Kiran K, Turaga
Subjects: Oncology, Gastrointestinal Oncology, Surgery
Abstract: Background Metastatic adenocarcinomas of foregut origin are aggressive and have limited treatment options, poor quality of life, and a dismal prognosis. A subset of such patients with limited metastatic disease might have favorable outcomes with locoregional metastasis-directed therapies. This study investigates the role of sequential cytoreductive interventions in addition to the standard of care chemotherapy in patients with oligometastatic foregut adenocarcinoma. Methods This is a single-center, phase II, open-label randomized clinical trial. Eligible patients include adults with synchronous or metachronous oligometastatic (metastasis limited to two sites and amenable for curative/ablative treatment) adenocarcinoma of the foregut without progression after induction chemotherapy and having undetectable ctDNA. These patients will undergo induction chemotherapy and will then be randomized (1:1) to either sequential curative intervention followed by maintenance chemotherapy versus routine continued chemotherapy. The primary endpoint is progression-free survival (PFS), and a total of 48 patients will be enrolled to detect an improvement in the median PFS in the intervention arm with a hazard ratio (HR) of 0.5 with 80% power and a one-sided alpha of 0.1. Secondary endpoints include disease-free survival (DFS) in the intervention arm, overall survival (OS), ctDNA conversion rate pre/post-induction chemotherapy, ctDNA PFS, PFS2, adverse events, quality of life, and financial toxicity. Discussion This is the first randomized study that aims to prospectively evaluate the efficacy and safety of surgical/ablative interventions in patients with ctDNA-negative oligometastatic adenocarcinoma of foregut origin post-induction chemotherapy. The results from this study will likely develop pertinent, timely, and relevant knowledge in oncology. Supplementary Information The online version contains supplementary material available at 10.1245/s10434-021-11249-7.
Published: 2022

25. Abstract CT007: Phase 2-3 trial of pegargiminase plus chemotherapy versus placebo plus chemotherapy in patients with non-epithelioid pleural mesothelioma

Author: Peter W. Szlosarek, Ben Creelan, Thomas Sarkodie, Luke Nolan, Paul Taylor, Olga Olevsky, Federica Grosso, Diego Cortinovis, Meenali Chitnis, Amy Roy, David Gilligan, Hedy Kindler, Dionysis Papadatos-Pastos, Giovanni L. Ceresoli, Aaron Mansfield, Anne Tsao, Ken O’Byrne, Anna K. Nowak, Jeremy Steele, Michael Sheaff, Amanda Johnston, John Bomalaski, Marjorie Zauderer, and Dean A. Fennell
Subjects: Cancer Research, Oncology
Abstract: Background: Arginine deprivation with ADI-PEG20 (pegargiminase) alone or combined with chemotherapy displayed antitumor activity in early phase clinical trials of argininosuccinate synthase 1 (ASS1)-deficient cancers, including pleural mesothelioma (PM). The non-epithelioid subtype of mesothelioma is particularly aggressive and arginine-auxotrophic due to frequent ASS1 loss. ATOMIC-meso is a pivotal phase 2-3 trial comparing standard of care (SOC) chemotherapy plus pegargiminase or placebo for patients (pts) with non-epithelioid PM. Methods: In this double-blind, placebo-controlled, phase 2-3 trial, we randomly assigned ECOG PS 0-1 pts with chemonaïve non-epithelioid PM in an intention-to-treat 1:1 ratio to receive q3 week SOC chemotherapy with pemetrexed (500mg/m2 i.v.) and cisplatin (75mg/m2 i.v.) with q1 week pegargiminase (36 mg/m2 i.m.) or placebo i.m. up to 6 cycles. Carboplatin (AUC5) was permitted in the phase 3 portion instead of cisplatin. Maintenance therapy with pegargiminase or placebo was continued until progression, toxicity or 24 months. The primary end point was median OS (mOS) and secondary end points included median PFS (mPFS), safety, pharmacodynamics and immunogenicity. ORR was assessed by blinded independent central review (BICR) for the phase 2 portion only using modified RECIST or RECIST v1.1. Results: 249 pts with non-epithelioid PM (median age 71, range 28-86; male 82.7%; 48.2% biphasic and 51.8% sarcomatoid) from 5 countries were randomized between Aug 2017 and Aug 2021: 125 pts were assigned to the pegargiminase-chemotherapy group and 124 pts to the placebo-chemotherapy group. The experimental arm showed a superior mOS respect to SOC: 9.3 months (95% confidence interval [CI], 7.9-11.8) vs. 7.7 months (95% CI, 6.1-9.5) (hazard ratio [HR], 0.71; 95% CI, 0.55-0.93; p=0.023). Also, the mPFS was higher in the experimental vs. control arm: 6.2 months (95% CI, 5.8-7.4) vs. 5.6 months (95% CI, 4.14-5.91) ([HR], 0.65; 95% CI, 0.46-0.90; p=0.019). The ORR by BICR was 13.8% in the pegargiminase-chemotherapy group vs. 13.5% in the placebo-chemotherapy group (p=0.95) with more stable disease in the former (71.3% vs. 62.9%). Plasma arginine declined with a reciprocal increase in citrulline. Anti-ADI-PEG20 antibodies were detected in 97.4% of patients by week 25 on pegargiminase. Grade ≥ 3 treatment-related adverse events to pegargiminase occurred in 28.8% and to placebo in 16.9%; grade ≥ 3 drug hypersensitivity and skin reactions occurred in 3.2% and 1.6% in the experimental arm, respectively, and none on placebo. Post-study drug treatment was comparable in both arms (45.6% post-pegargiminase vs. 46.8% post-placebo). Conclusions: In this first randomized trial of an arginine-depleting chemotherapy in cancer, the pegargiminase-pemetrexed-platinum triplet prolonged survival and had a favorable safety profile in pts with non-epithelioid PM (ClinicalTrials.gov Identifier NCT02709512) Citation Format: Peter W. Szlosarek, Ben Creelan, Thomas Sarkodie, Luke Nolan, Paul Taylor, Olga Olevsky, Federica Grosso, Diego Cortinovis, Meenali Chitnis, Amy Roy, David Gilligan, Hedy Kindler, Dionysis Papadatos-Pastos, Giovanni L. Ceresoli, Aaron Mansfield, Anne Tsao, Ken O’Byrne, Anna K. Nowak, Jeremy Steele, Michael Sheaff, Amanda Johnston, John Bomalaski, Marjorie Zauderer, Dean A. Fennell. Phase 2-3 trial of pegargiminase plus chemotherapy versus placebo plus chemotherapy in patients with non-epithelioid pleural mesothelioma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 2 (Clinical Trials and Late-Breaking Research); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(8_Suppl):Abstract nr CT007.
Published: 2023

26. The IASLC Lung Cancer Staging Project: Analysis of Resection Margin Status and Proposals for Residual Tumor Descriptors for Non–Small Cell Lung Cancer

Author: John G. Edwards, Kari Chansky, Paul Van Schil, Andrew G. Nicholson, Souheil Boubia, Elisabeth Brambilla, Jessica Donington, Françoise Galateau-Sallé, Hans Hoffmann, Maurizio Infante, Mirella Marino, Edith M. Marom, Jun Nakajima, Marcin Ostrowski, William D. Travis, Ming-Sound Tsao, Yasushi Yatabe, Dorothy J. Giroux, Lynn Shemanski, John Crowley, Marc Krasnik, Hisao Asamura, Ramón Rami-Porta, Valerie Rusch, Luiz Henrique Araujo, David Beer, Pietro Bertoglio, Ricardo Beyruti, Andrea Bille, Vanessa Bolejack, James D. Brierley, A.K. Cangir, David Carbone, Gail Darling, Frank Detterbeck, Xavier Benoit D’Journo, Jessica Donnington, Wilfried Eberhardt, John Edwards, Jeremy Erasmus, Conrad Falkson, Wentao Fang, Dean Fennell, Kwun Fong, Françoise Galateau-Salle, Oliver Gautschi, Ritu Gill, Dorothy Giroux, Meredith Giuliani, Jin Mo Goo, Seiki Hasegawa, Fred Hirsch, Hans Hoffman, Wayne Hofstetter, James Huang, Philippe Joubert, Kemp Kernstine, Keith Kerr, Young Tae Kim, Hong Kwan Kim, Hedy Kindler, Yolande Lievens, Hui Liu, Donald E. Low, Gustavo Lyons, Heber MacMahon, Edith Marom, José-María Matilla, Jan van Meerbeeck, Luis M. Montuenga, Andrew Nicholson, Katie Nishimura, Anna Nowak, Isabelle Opitz, Meinoshin Okumura, Raymond U. Osarogiagbon, Harvey Pass, Marc de Perrot, Helmut Prosch, David Rice, Andreas Rimner, Enrico Ruffini, Shuji Sakai, Navneet Singh, Amy Stoll-D’Astice, Francisco Su´rez, Ricardo M. Terra, Ming S. Tsao, Paula Ugalde, David Waller, Shun-ichi Watanabe, Jacinta Wiens, Ignacio Wistuba, Liyan Jiang, Kaoru Kubota, Akif Turna, Benny Weksler, Maria Teresa Tzukazan, Martin Tammemägi, Charles Powell, David Naidich, Hongxu Liu, Samuel Armato, Alex Brunelli, Giuseppe Cardillo, Elizabeth David, Brigitte Fournier, Mark Krasnik, Kauro Kubota, Catherine Labbe, Eric Lim, Paul Martin Putora, Gaetano Rocco, Pier Luigi Filosso, Kazuya Kondo, Dong Kwan Kim, Giuseppe Giaccone, Marco Lucchi, Thomas Rice, Mark Ferguson, Prasad Adsusmilli, William Travis, Francisco Suárez, Kaura Kubota, Hisao Asamura Shun-ichi, Watanabe, Edith Marom Ramón, Rami-Porta, Ming Tsao, Ming Tsao Shun-ichi, Watanabe, Meredith Guiliani, James Brierley, Ricardo Terra, Ray Osarogiagbon, Luis Montuenga, Hongwei Wang, Françoise Galateau, Jim Mo Goo, Bill Travis, Jose Maria Matilla, Carolle St. Pierre, Ma Teresa Tzukazan, Nicholas Girard, Andreas Rimmer, Francoise Galateau, Prasad Adusumilli, Xavier D’Journo, Donald Low, Adam Rosenthal, and Int Assoc Study Lung Canc Staging
Subjects: 0301 basic medicine, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, Neoplasm, Residual, 03 medical and health sciences, 0302 clinical medicine, Carcinoma, Non-Small-Cell Lung, Cytology, medicine, Humans, Lung cancer, Biology, Lymph node, Neoplasm Staging, Retrospective Studies, Computer. Automation, business.industry, Carcinoma in situ, Margins of Excision, Prognosis, medicine.disease, Clinical trial, 030104 developmental biology, medicine.anatomical_structure, Oncology, 030220 oncology & carcinogenesis, Resection margin, Human medicine, Radiology, Non small cell, Lung cancer staging, business, Mathematics
Abstract: Objective: Our aim was to validate the prognostic relevance in NSCLC of potential residual tumor (R) descriptors, including the proposed International Association for the Study of Lung Cancer definition for uncertain resection, referred to as R(un). Methods: A total of 14,712 patients undergoing resection with full R status and survival were analyzed. The following were also evaluated: whether fewer than three N2 stations were explored, lobe-specific nodal dissection, extracapsular extension, highest lymph node station status, carcinoma in situ at the bronchial resection margin, and pleural lavage cytologic examination result. Revised categories of R0, R(un), R1, and R2 were tested for survival impact. Results: In all, 14,293 cases were R0, 263 were R1, and 156 were R2 (median survivals not reached, 33 months, and 29 months, respectively). R status correlated with T and N categories. A total of 9290 cases (63%) had three or more N2 stations explored and 6641 cases (45%) had lobespecific nodal dissection, correlated with increasing pN2. Extracapsular extension was present in 62 of 364 cases with available data (17%). The highest station was positive in 942 cases (6.4%). The pleural lavage cytologic examination result was positive in 59 of 1705 cases (3.5%): 13 had carcinoma in situ at the bronchial resection margin. After reassignment because of inadequate nodal staging in 56% of cases, 6070 cases were R0, 8185 were R(un), 301 were R1, and 156 were R2. In node-positive cases, the median survival times were 70, 50, and 30 months for RO, R(un) (p < 0.0001), and R1 (p < 0.001), respectively, with no significant difference between RO and R(un) in pN0 cases. Conclusions: R descriptors have prognostic relevance, with R(un) survival stratifying between R0 and R1. Therefore, a detailed evaluation of R factor is of particular importance in the design and analyses of clinical trials of adjuvant therapies. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Published: 2020

27. Marital Status, Living Arrangement, and Cancer Recurrence and Survival in Patients with Stage III Colon Cancer: Findings from CALGB 89803 (Alliance)

Author: Seohyuk Lee, Chao Ma, Sui Zhang, Fang-Shu Ou, Tiffany M Bainter, Donna Niedzwiecki, Leonard B Saltz, Robert J Mayer, Renaud Whittom, Alexander Hantel, Al Benson, Daniel Atienza, Hedy Kindler, Cary P Gross, Melinda L Irwin, Jeffrey A Meyerhardt, and Charles S Fuchs
Subjects: Cancer Research, Oncology, Marital Status, Chemotherapy, Adjuvant, Colonic Neoplasms, Humans, Neoplasm Recurrence, Local, Disease-Free Survival
Abstract: Background Limited and conflicting findings have been reported regarding the association between social support and colorectal cancer (CRC) outcomes. We sought to assess the influences of marital status and living arrangement on survival outcomes among patients with stage III colon cancer. Patients and Methods We conducted a secondary analysis of 1082 patients with stage III colon cancer prospectively followed in the CALGB 89803 randomized adjuvant chemotherapy trial. Marital status and living arrangement were both self-reported at the time of enrollment as, respectively, married, divorced, separated, widowed, or never-married, and living alone, with a spouse or partner, with other family, in a nursing home, or other. Results Over a median follow-up of 7.6 years, divorced/separated/widowed patients experienced worse outcomes relative to those married regarding disease free-survival (DFS) (hazards ratio (HR), 1.44 (95% CI, 1.14-1.81); P =.002), recurrence-free survival (RFS) (HR, 1.35 (95% CI, 1.05-1.73); P = .02), and overall survival (OS) (HR, 1.40 (95% CI, 1.08-1.82); P =.01); outcomes were not significantly different for never-married patients. Compared to patients living with a spouse/partner, those living with other family experienced a DFS of 1.47 (95% CI, 1.02-2.11; P = .04), RFS of 1.34 (95% CI, 0.91-1.98; P = .14), and OS of 1.50 (95% CI, 1.00-2.25; P =.05); patients living alone did not experience significantly different outcomes. Conclusion Among patients with stage III colon cancer who received uniform treatment and follow-up within a nationwide randomized clinical trial, being divorced/separated/widowed and living with other family were significantly associated with greater colon cancer mortality. Interventions enhancing social support services may be clinically relevant for this patient population. Trial Registration ClinicalTrials.gov Identifier: NCT00003835
Published: 2021

28. Abstract CT246: Phase 1b/2 study of giloralimab in combination with modified FOLFIRINOX with or without budigalimab in patients with untreated metastatic pancreatic cancer

Author: Dung T. Le, Marcia Cruz-Correa, David L. Bajor, Rocio Garcia-Carbonero, Marion Harris, Roberto Pazo-Cid, Hedy Kindler, Nelson Yee, Suneel Kamath, Maulik Patel, Hua Fang, William Henner, Patrick Hardesty, Martha Blaney, Michael McDevitt, and Talia Golan
Subjects: Cancer Research, Oncology
Abstract: Background: The 5-year survival rate for metastatic pancreatic cancer is ~3%, indicating an urgent need for novel therapies. Combination therapy with modified FOLFIRINOX (leucovorin, irinotecan, 5-fluorouracil, and oxaliplatin) and immunotherapy has been proposed for first-line metastatic pancreatic cancer to improve tolerability and clinical efficacy, respectively (NCCN, Pancreatic. 2021; Vonderheide, Annu. Rev. Med. 2020). The present study evaluates the safety, pharmacokinetics, and preliminary antitumor activity of modified FOLFIRINOX + giloralimab (CD40 agonist) with or without budigalimab (anti-PD-1) in patients with untreated metastatic pancreatic cancer. Methods: Multicenter, randomized phase 1b/2 study (NCT04807972) in patients (18-75 years) with untreated metastatic pancreatic cancer. The phase 1b (dose escalation) examines the safety dose level of giloralimab in a triplet of modified FOLFIRINOX + giloralimab + budigalimab using a Bayesian optimal interval [BOIN] design. BOIN design is utilized to guide giloralimab escalation decisions. In phase 2 (dose expansion), patients are randomized 1:1:1 to receive treatment with modified FOLFIRINOX (cohort A), modified FOLFIRINOX + giloralimab (cohort B), or modified FOLFIRINOX + giloralimab + budigalimab (cohort C). Randomization is stratified according to Eastern Cooperative Oncology Group performance status. Primary objectives are to assess the safety and tolerability of modified FOLFIRINOX + giloralimab + budigalimab (phase 1b) and to evaluate overall survival in patients treated with modified FOLFIRINOX + giloralimab with or without budigalimab (versus those receiving modified FOLFIRINOX alone; phase 2). Secondary objectives include characterizing the pharmacokinetics of giloralimab and budigalimab in combination with modified FOLFIRINOX, assessing the efficacy of modified FOLFIRINOX + giloralimab with or without budigalimab, and evaluating the safety/tolerability of modified FOLFIRINOX + giloralimab with or without budigalimab. Patients will receive giloralimab and budigalimab intravenously in combination with modified FOLFIRINOX in a 28-day cycle. Dose-limiting toxicities are assessed during the first cycle of dosing. Adverse events are evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events. Blood samples for pharmacokinetic analysis are collected at designated time points throughout the study. Responses are assessed by Response Evaluation Criteria in Solid Tumors version 1.1. Survival outcomes are described using the Kaplan-Meier method. Approximately 129 patients are planned to be included. Enrollment started in June 2021, with 7 patients enrolled as of November 2021. Citation Format: Dung T. Le, Marcia Cruz-Correa, David L. Bajor, Rocio Garcia-Carbonero, Marion Harris, Roberto Pazo-Cid, Hedy Kindler, Nelson Yee, Suneel Kamath, Maulik Patel, Hua Fang, William Henner, Patrick Hardesty, Martha Blaney, Michael McDevitt, Talia Golan. Phase 1b/2 study of giloralimab in combination with modified FOLFIRINOX with or without budigalimab in patients with untreated metastatic pancreatic cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr CT246.
Published: 2022

29. Clinical Response of Live-Attenuated

Author: Raffit, Hassan, Evan, Alley, Hedy, Kindler, Scott, Antonia, Thierry, Jahan, Somayeh, Honarmand, Nitya, Nair, Chan C, Whiting, Amanda, Enstrom, Ed, Lemmens, Takahiro, Tsujikawa, Sushil, Kumar, Gina, Choe, Anish, Thomas, Katherine, McDougall, Aimee L, Murphy, Elizabeth, Jaffee, Lisa M, Coussens, and Dirk G, Brockstedt
Subjects: Aged, 80 and over, Male, Mesothelioma, Lung Neoplasms, Pleural Neoplasms, Mesothelioma, Malignant, Pemetrexed, Middle Aged, GPI-Linked Proteins, Combined Modality Therapy, Listeria monocytogenes, Article, Survival Rate, Mesothelin, Antineoplastic Combined Chemotherapy Protocols, Tumor Microenvironment, Humans, Female, Cisplatin, Aged
Abstract: PURPOSE: Malignant pleural mesothelioma (MPM) is an aggressive cancer associated with poor prognosis. CRS-207 is a live-attenuated Listeria monocytogenes engineered to express mesothelin, a tumor-associated antigen highly expressed in MPM. CRS-207 induces antitumor immune responses and increases susceptibility of neoplastic cells to immune-mediated killing. PATIENTS AND METHODS: Patients with unresectable MPM, ECOG 0 or 1, and adequate organ and pulmonary function were enrolled in this multicenter, open-label phase Ib study. They received two priming infusions of 1 × 10(9) CFU CRS-207, followed by pemetrexed/cisplatin chemotherapy, and CRS-207 booster infusions. Primary objectives were safety and induction of immune response. Secondary/exploratory objectives included tumor response, progression-free survival (PFS), overall survival (OS), immune subset analysis, and gene-expression profiling of tumor. RESULTS: Of 35 evaluable patients, 89% (31/35) had disease control with one complete response (3%), 19 partial responses (54%), and 10 stable disease (29%). The estimated median duration of response was 5.0 months (95% CI, 3.9–11.5). The median PFS and OS were 7.5 (95% CI, 7.0–9.9) and 14.7 (95% CI, 11.2–21.9) months, respectively. Tumor size reduction was observed post–CRS-207 infusion prior to chemotherapy in 11 of 35 (31%) patients. No unexpected treatment-related serious adverse events or deaths were observed. IHC analysis of pre-and post–CRS-207 treatment tumor biopsies revealed possible reinvigoration and proliferation of T cells, increased infiltration of dendritic and natural killer cells, increased CD8:T(reg) ratio, and a shift from immunosuppressive M2-like to proinflammatory M1-like macrophages following CRS-207 administration. CONCLUSIONS: Combination of CRS-207 and chemotherapy induced significant changes in the local tumor microenvironment and objective tumor responses in a majority of treated patients.
Published: 2019

30. The IASLC Lung Cancer Staging Project: Summary of Proposals for Revisions of the Classification of Lung Cancers with Multiple Pulmonary Sites of Involvement in the Forthcoming Eighth Edition of the TNM Classification

Author: Frank C. Detterbeck, Andrew G. Nicholson, Wilbur A. Franklin, Edith M. Marom, William D. Travis, Nicolas Girard, Douglas A. Arenberg, Vanessa Bolejack, Jessica S. Donington, Peter J. Mazzone, Lynn T. Tanoue, Valerie W. Rusch, John Crowley, Hisao Asamura, Ramón Rami-Porta, Peter Goldstraw, David Ball, David G. Beer, Ricardo Beyruti, Kari Chansky, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, Douglas Flieder, Myrna Godoy, Jin Mo Goo, Lawrence R. Goodman, Jim Jett, Paul de Leyn, Alberto Marchevsky, Heber MacMahon, David Naidich, Morohito Okada, Marina Perlman, Charles Powell, Paul van Schil, Arne Warth, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A.I. Blanco Orozco, M.A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M.T. González Budiño, G. González Casaurrán, J.A. Gullón Blanco, J. Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J.M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J.C. Peñalver Cuesta, J.S. Park, H. Pass, M.J. Pavón Fernández, M. Rosenberg, E. Ruffini, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, K. Yokoi, and Nackaerts, Kristiaan
Subjects: 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Pathology, Lung Neoplasms, Medizin, Disease, Adenocarcinoma, 1102 Cardiovascular Medicine And Haematology, Metastasis, 03 medical and health sciences, 0302 clinical medicine, Non-small cell lung cancer, Meta-Analysis as Topic, Internal medicine, Histologic type, Non–small cell lung cancer, Humans, Medicine, Oncology & Carcinogenesis, Lung cancer staging, Multiple tumors, Lung cancer, Neoplasm Staging, Lung, business.industry, 1103 Clinical Sciences, Neoplasms, Second Primary, Prognosis, medicine.disease, TNM classification, Editorial, 030104 developmental biology, Systematic review, medicine.anatomical_structure, IASLC Staging and Prognostic Factors Committee, Advisory Boards, Multiple Pulmonary Sites Workgroup and Participating Institutions, IASLC Staging and Prognostic Factors Committee Advisory Boards Multiple Pulmonary Sites Workgroup and Participating Institutions, 030220 oncology & carcinogenesis, business
Abstract: Introduction Patients with lung cancer who harbor multiple pulmonary sites of disease have been challenging to classify; a subcommittee of the International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee was charged with developing proposals for the eighth edition of the tumor, node, and metastasis (TNM) classification to address this issue. Methods A systematic literature review and analysis of the International Association for the Study of Lung Cancer database was performed to develop proposals for revision in an iterative process involving multispecialty international input and review. Results Details of the evidence base are summarized in other articles. Four patterns of disease are recognized; the clinical presentation, pathologic correlates, and biologic behavior of these suggest specific applications of the TNM classification rules. First, it is proposed that second primary lung cancers be designated with a T, N, and M category for each tumor. Second, tumors with a separate tumor nodule of the same histologic type (either suspected or proved) should be classified according to the location of the separate nodule relative to the index tumor—T3 for a same-lobe, T4 for a same-side (different lobe), and M1a for an other-side location—with a single N and M category. Third, multiple tumors with prominent ground glass (imaging) or lepidic (histologic) features should be designated by the T category of the highest T lesion, the number or m in parentheses (#/m) to indicate the multiplicity, and a collective N and M category for all. Finally, it is proposed that diffuse pneumonic-type lung cancers be designated by size (or T3) if in one lobe, T4 if involving multiple same-side lobes, and M1a if involving both lungs with a single N and M category for all areas of involvement. Conclusion We propose to tailor TNM classification of multiple pulmonary sites of lung cancer to reflect the unique aspects of four different patterns of presentation. We hope that this will lead to more consistent classification and clarity in communication and facilitate further research in the nature and optimal treatment of these entities.
Published: 2016

31. The IASLC Lung Cancer Staging Project : a renewed call to participation

Author: Dorothy J. Giroux, Paul Van Schil, Hisao Asamura, Ramón Rami-Porta, Kari Chansky, John J. Crowley, Valerie W. Rusch, Kemp Kernstine, Valerie Rusch, Luiz Henrique Araujo, Paul Beckett, David Beer, Pietro Bertoglio, Ricardo Beyruti, Andrea Bille, Vanessa Bolejack, Souheil Boubia, Elisabeth Brambilla, James D. Brierley, A.K. Cangir, David Carbone, John Crowley, Gail Darling, Frank Detterbeck, Xavier Benoit D’Journo, Jessica Donnington, Wilfried Eberhardt, John Edwards, Jeremy Erasmus, Wentao Fang, Dean Fennell, Kwun Fong, Françoise Galateau-Salle, Oliver Gautschi, Ritu Gill, Dorothy Giroux, Jin Mo Goo, Seiki Hasegawa, Fred Hirsch, Hans Hoffman, Wayne Hofstetter, James Huang, Philippe Joubert, Keith Kerr, Young Tae Kim, Hong Kwan Kim, Hedy Kindler, Yolande Lievens, Hui Liu, Donald E. Low, Gustavo Lyons, Heber MacMahon, Mirella Marino, Edith Marom, José-María Matilla, Jan van Meerbeeck, Luis M. Montuenga, Andrew Nicholson, Anna Nowak, Isabelle Opitz, Meinoshin Okumura, Raymond U. Osarogiagbon, Harvey Pass, Marc de Perrot, Helmut Prosch, David Rice, Andreas Rimner, Enrico Ruffini, Shuji Sakai, Navneet Singh, Amy Stoll-D’Astice, Francisco Suárez, Ricardo M. Terra, William D. Travis, Ming S. Tsao, Paula Ugalde, Shun-ichi Watanabe, Jacinta Wiens, Ignacio Wistuba, Yasushi Yatabe, Liyan Jiang, Kaoru Kubota, Eric Lim, Paul Martin Putora, Akif Turna, Pier Luigi Filosso, Kazuya Kondo, Dong Kwan Kim, Giuseppe Giaccone, Marco Lucchi, Eugene Blackwell, Thomas Rice, William Travis, Andrew G. Nicholson, Ming Tsao, James Brierley, Jun Nakajima, Françoise Galateau, Bill Travis, Jim Mo Goo, Luis Montuenga, Hong Wei Wang, Katie Nishimura, Int Assoc Study Lung Canc Staging, and Eberhardt, Wilfried (Beitragende*r)
Subjects: Male, 0301 basic medicine, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, Databases, Factual, Electronic data capture, Medizin, Lung cancer, Lung cancer databases, Lung cancer staging, TNM classification, Oncology, 03 medical and health sciences, 0302 clinical medicine, Cancer control, medicine, Humans, Neoplasm Staging, business.industry, Cancer, medicine.disease, 030104 developmental biology, 030220 oncology & carcinogenesis, Family medicine, Female, Human medicine, Biostatistics, business
Abstract: Over the past two decades, the International Association for the Study of Lung Cancer (IASLC) Staging Project has been a steady source of evidence-based recommendations for the TNM classification for lung cancer published by the Union for International Cancer Control and the American Joint Committee on Cancer. The Staging and Prognostic Factors Committee of the IASLC is now issuing a call for participation in the next phase of the project, which is designed to inform the ninth edition of the TNM classification for lung cancer. Following the case recruitment model for the eighth edition database, volunteer site participants are asked to submit data on patients whose lung cancer was diagnosed between January 1, 2011, and December 31, 2019, to the project by means of a secure, electronic data capture system provided by Cancer Research And Biostatistics in Seattle, Washington. Alternatively, participants may transfer existing data sets. The continued success of the IASLC Staging Project in achieving its objectives will depend on the extent of international participation, the degree to which cases are entered directly into the electronic data capture system, and how closely externally submitted cases conform to the data elements for the project. (C) 2018 International Association for the Study of Lung Cancer. Published by Elsevier Inc.
Published: 2018

32. The IASLC Lung Cancer Staging Project:External Validation of the Revision of the TNM Stage Groupings in the Eighth Edition of the TNM Classification of Lung Cancer

Author: Kari Chansky, Frank C. Detterbeck, Andrew G. Nicholson, Valerie W. Rusch, Eric Vallières, Patti Groome, Catherine Kennedy, Mark Krasnik, Michael Peake, Lynn Shemanski, Vanessa Bolejack, John J. Crowley, Hisao Asamura, Ramón Rami-Porta, Peter Goldstraw, David Ball, David G. Beer, Ricardo Beyruti, John Crowley, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, James Huang, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Anna Nowak, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A. I. Blanco Orozco, M. A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M. T. González Budiño, G. González Casaurrán, J. A. Gullón Blanco, J. Hernández Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J. M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J. C. Peñalver Cuesta, J.S. Park, H. Pass, M. J. Pavón Fernández, M. Rosenberg, E. Ruffini, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, K. Yokoi, van Meerbeeck, Jan, et al., and IASLC Staging and Prognostic Factors Committee
Subjects: Male, 0301 basic medicine, Oncology, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pathology, Lung Neoplasms, Multivariate analysis, Staging, UICC, 03 medical and health sciences, 0302 clinical medicine, International database, Internal medicine, Validation, Humans, Medicine, Stage (cooking), Lung cancer, Neoplasm Staging, AJCC, business.industry, Confounding, External validation, Reproducibility of Results, Cancer, medicine.disease, Survival Analysis, National Cancer Database, 030104 developmental biology, 030220 oncology & carcinogenesis, Female, Human medicine, Lung cancer staging, business
Abstract: INTRODUCTION: Revisions to the TNM stage classifications for lung cancer, informed by the international database (N = 94,708) of the International Association for the Study of Lung Cancer (IASLC) Staging and Prognostic Factors Committee, need external validation. The objective was to externally validate the revisions by using the National Cancer Data Base (NCDB) of the American College of Surgeons.METHODS: Cases presenting from 2000 through 2012 were drawn from the NCDB and reclassified according to the eighth edition stage classification. Clinically and pathologically staged subsets of NSCLC were analyzed separately. The T, N, and overall TNM classifications were evaluated according to clinical, pathologic, and "best" stage (N = 780,294). Multivariate analyses were carried out to adjust for various confounding factors. A combined analysis of the NSCLC cases from both databases was performed to explore differences in overall survival prognosis between the two databases.RESULTS: The databases differed in terms of key factors related to data source. Survival was greater in the IASLC database for all stage categories. However, the eighth edition TNM stage classification system demonstrated consistent ability to discriminate TNM categories and stage groups for clinical and pathologic stage.CONCLUSIONS: The IASLC revisions made for the eighth edition of lung cancer staging are validated by this analysis of the NCDB database by the ordering, statistical differences, and homogeneity within stage groups and by the consistency within analyses of specific cohorts.
Published: 2017

33. The IASLC Mesothelioma Staging Project: Proposals for Revisions of the N Descriptors in the Forthcoming Eighth Edition of the TNM Classification for Pleural Mesothelioma

Author: David Rice, Kari Chansky, Anna Nowak, Harvey Pass, Hedy Kindler, Lynn Shemanski, Isabelle Opitz, Sergi Call, Seiki Hasegawa, Kemp Kernstine, Cansel Atinkaya, Federico Rea, Philippe Nafteux, Valerie W. Rusch, Peter Goldstraw, Ramón Rami-Porta, Hisao Asamura, David Ball, David Beer, Ricardo Beyruti, Vanessa Bolejack, John Crowley, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Andrew G. Nicholson, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Kouki Inai, Lee Krug, Kristiaan Nackaerts, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, Hasan Batirel, Andrea Bille, Ugo Pastorino, Ayten K. Cangir, Susana Cedres, Joseph S. Friedberg, Francoise Galateau-Salle, Seiki Hasagawa, Kemp H. Kernstine, Brian McCaughan, Cansel Atinkaya Ozturk, Marc de Perrot, David C. Rice, Robert Rintoul, Lorenzo Spaggiari, Domenico Galetta, K.N. Syrigos, Charles Thomas, Walter Weder, Masahiro Yoshimura, Nackaerts, Kristiaan, University of Zurich, Rice, David, and Eberhardt, Wilfried (Beitragende*r)
Subjects: Oncology, Mesothelioma, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, 10255 Clinic for Thoracic Surgery, Pleural Neoplasms, education, Settore MED/21 - Chirurgia Toracica, Medizin, 610 Medicine & health, 030204 cardiovascular system & hematology, Cancer staging, Database, 03 medical and health sciences, 0302 clinical medicine, Nodal metastases, Internal medicine, Cox proportional hazards regression, Humans, Medicine, Lung cancer, Survival analysis, Neoplasm Staging, Mesothelioma, Malignant, business.industry, Pleural mesothelioma, Hazard ratio, respiratory system, medicine.disease, Surgery, respiratory tract diseases, 2740 Pulmonary and Respiratory Medicine, 030220 oncology & carcinogenesis, 2730 Oncology, Lung cancer staging, business
Abstract: Nodal categories for malignant pleural mesothelioma are derived from the lung cancer staging system and have not been adequately validated. The International Association for the Study of Lung Cancer developed a multinational database to generate evidence-based recommendations to inform the eighth edition of the TNM classification of malignant pleural mesothelioma.Data from 29 centers were entered prospectively (n = 1566) or by transfer of retrospective data (n = 1953). Survival according to the seventh edition N categories was evaluated using Kaplan-Meier survival curves and Cox proportional hazards regression analysis. Survival was measured from the date of diagnosis.There were 2432 analyzable cases: 1603 had clinical (c) staging, 1614 had pathologic (p) staging, and 785 had both. For clinically staged tumors there was no separation in Kaplan-Meier curves between cN0, cN1 or cN2 (cN1 versus cN0 hazard ratio [HR] = 1.06, p = 0.77 and cN2 versus cN1 HR = 1.04, p = 0.85). For pathologically staged tumors, patients with pN1 or pN2 tumors had worse survival than those with pN0 tumors (HR = 1.51, p 0.0001) but no survival difference was noted between those with pN1 and pN2 tumors (HR = 0.99, p = 0.99). Patients with both pN1 and pN2 nodal involvement had poorer survival than those with pN2 tumors only (HR = 1.60, p = 0.007) or pN0 tumors (HR = 1.62, p0.0001).A recommendation to collapse both clinical and pN1 and pN2 categories into a single N category comprising ipsilateral, intrathoracic nodal metastases (N1) will be made for the eighth edition staging system. Nodes previously categorized as N3 will be reclassified as N2.
Published: 2016

34. Malignant Pleural Mesothelioma

Author: Valerie W. Rusch, Kari Chansky, Anna K. Nowak, David Rice, Hedy Kindler, Ritu R. Gill, William D. Travis, and Harvey Pass
Published: 2016

35. The IASLC Mesothelioma Staging Project: Proposals for the M Descriptors and for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Mesothelioma

Author: Valerie W. Rusch, Kari Chansky, Hedy L. Kindler, Anna K. Nowak, Harvey I. Pass, David C. Rice, Lynn Shemanski, Françoise Galateau-Sallé, Brian C. McCaughan, Takashi Nakano, Enrico Ruffini, Jan P. van Meerbeeck, Masahiro Yoshimura, Peter Goldstraw, Ramón Rami-Porta, Hisao Asamura, David Ball, David Beer, Ricardo Beyruti, Vanessa Bolejack, John Crowley, Frank C. Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Toni Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Alan Mitchell, Andrew G. Nicholson, Anna Nowak, Michael Peake, Thomas W. Rice, Kenneth Rosenzweig, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William D. Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, H. Asamura, H. Batirel, A. Bille, U. Pastorino, S. Call, A. Cangir, S. Cedres, J. Friedberg, F. Galateau-Sallé, S. Hasagawa, K. Kernstine, H. Kindler, B. McCaughan, T. Nakano, A. Nowak, C. Atinkaya Ozturk, H. Pass, M. de Perrot, F. Rea, D. Rice, R. Rintoul, E. Ruffini, V. Rusch, L. Spaggiari, D. Galetta, K. Syrigos, C. Thomas, J.P. van Meerbeeck, P. Nafteux, J. Vansteenkiste, W. Weder, I. Optiz, M. Yoshimura, Nackaerts, Kristiaan, and IASLC Staging Prognostic Factors
Subjects: Oncology, Pulmonary and Respiratory Medicine, Mesothelioma, medicine.medical_specialty, Staging, Lung Neoplasms, Pleural Neoplasms, education, Locally advanced, Medizin, Recursive partitioning, Stage ii, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, Stage (cooking), Lung cancer, neoplasms, Survival tree, Neoplasm Staging, business.industry, Mesothelioma, Malignant, respiratory system, medicine.disease, Staging system, Surgery, respiratory tract diseases, 030228 respiratory system, TNM stage groupings, 030220 oncology & carcinogenesis, Human medicine, Stage iv, business
Abstract: Introduction: The M component and TNM stage groupings for malignant pleural mesothelioma (MPM) have been empirical. The International Association for the Study of Lung Cancer developed a multinational database to propose evidence-based revisions for the eighth edition of the TNM classification of MPM. Methods: Data from 29 centers were submitted either electronically or by transfer of existing institutional databases. The M component as it currently stands was validated by confirming sufficient discrimination (by Kaplan-Meier analysis) with respect to overall survival (OS) between the clinical MO (cM0) and cM1 categories. Candidate stage groups were developed by using a recursive partitioning and amalgamation algorithm applied to all cM0 cases. Results: Of 3519 submitted cases, 2414 were analyzable and 84 were cM1 cases. Median OS for cM1 cases was 9.7 months versus 13.4 months (p = 0.0013) for the locally advanced (T4 or N3) cM0 cases, supporting inclusion of only cM1 in the stage IV group. Exploratory analyses suggest a possible difference in OS for single- versus multiple-site cM1 cases. A recursive partitioning and amalgamation generated survival tree on the OS outcomes restricted to cM0 cases with the newly proposed (eighth edition) T and N components indicates that optimal stage groupings for the eighth edition will be as follows: stage IA (T1N0), stage IB (T2-3N0), stage II (T1-2N1), stage IIIA (T3N1), stage IIIB (T1-3N2 or any T4), and stage IV (any M1). Conclusions: This first evidence-based revision of the TNM classification for MPM leads to substantial changes in the T and N components and the stage groupings. (C) 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Published: 2016

36. The IASLC Lung Cancer Staging Project: Methodology and Validation Used in the Development of Proposals for Revision of the Stage Classification of NSCLC in the Forthcoming (Eighth) Edition of the TNM Classification of Lung Cancer

Author: Frank C. Detterbeck, Kari Chansky, Patti Groome, Vanessa Bolejack, John Crowley, Lynn Shemanski, Catherine Kennedy, Mark Krasnik, Michael Peake, Ramón Rami-Porta, Peter Goldstraw, Hisao Asamura, David Ball, David G. Beer, Ricardo Beyruti, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, James Huang, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Andrew G. Nicholson, Anna Nowak, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A. I. Blanco Orozco, M. A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M. T. González Budiño, G. González Casaurrán, J. A. Gullón Blanco, J. Hernández Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J. M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J. C. Peñalver Cuesta, J.S. Park, M. J. Pavón Fernández, M. Rosenberg, E. Ruffini, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, K. Yokoi, Ramon Rami-Porta, Dorothy J. Giroux, William D. Travis, Paul van Schil, Marcin Zielinski, Wilfried Eberhardt, Jan van Meeerbeeck, Andrew Nicholson, Kouru Kubota, Alex Bankier, Mary Beth Beasley, Douglas B. Flieder, Jin Mo Goo, Heber MacMahon, David Naidich, Charles A. Powell, Mathias Prokop, Yasushi Yatabe, Douglas A. Arenberg, Jessica S. Donington, Wilbur A. Franklin, Nicolas Girard, Peter J. Mazzone, Valerie W. Rusch, Lynn T. Tanoue, and Eberhardt, Wilfried (Beitragende*r)
Subjects: 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, Stage classification, medicine.medical_specialty, Lung Neoplasms, Databases, Factual, Medizin, 1102 Cardiovascular Medicine And Haematology, Metastasis, 03 medical and health sciences, 0302 clinical medicine, International database, Internal medicine, medicine, Histologic type, Humans, Oncology & Carcinogenesis, Stage (cooking), Lung cancer, Neoplasm Staging, business.industry, External validation, 1103 Clinical Sciences, medicine.disease, Prognosis, Surgery, 030104 developmental biology, 030220 oncology & carcinogenesis, Lung cancer staging, business
Abstract: Introduction Stage classification provides a consistent language to describe the anatomic extent of disease and is therefore a critical tool in caring for patients. The Staging and Prognostic Factors Committee of the International Association for the Study of Lung Cancer developed proposals for revision of the classification of lung cancer for the eighth edition of the tumor, node, and metastasis (TNM) classification, which takes effect in 2017. Methods An international database of 94,708 patients with lung cancer diagnosed in 1999–2010 was assembled. This article describes the process and statistical methods used to refine the lung cancer stage classification. Results Extensive analysis allowed definition of tumor, node, and metastasis categories and stage groupings that demonstrated consistent discrimination overall and within multiple different patient cohorts (e.g., clinical or pathologic stage, R0 or R-any resection status, geographic region). Additional analyses provided evidence of applicability over time, across a spectrum of geographic regions, histologic types, evaluative approaches, and follow-up intervals. Conclusions An extensive analysis has produced stage classification proposals for lung cancer with a robust degree of discriminatory consistency and general applicability. Nevertheless, external validation is encouraged to identify areas of strength and weakness; a sound validation should have discriminatory ability and be based on an independent data set of adequate size and sufficient follow-up with enough patients for each subgroup.
Published: 2016

37. The IASLC Lung Cancer Staging Project: Background Data and Proposed Criteria to Distinguish Separate Primary Lung Cancers from Metastatic Foci in Patients with Two Lung Tumors in the Forthcoming Eighth Edition of the TNM Classification for Lung Cancer

Author: Frank C. Detterbeck, Wilbur A. Franklin, Andrew G. Nicholson, Nicolas Girard, Douglas A. Arenberg, William D. Travis, Peter J. Mazzone, Edith M. Marom, Jessica S. Donington, Lynn T. Tanoue, Valerie W. Rusch, Hisao Asamura, Ramón Rami-Porta, Peter Goldstraw, David Ball, David G. Beer, Ricardo Beyruti, Vanessa Bolejack, Kari Chansky, John Crowley, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, Douglas Flieder, Myrna Godoy, Jin Mo Goo, Lawrence R. Goodman, Jim Jett, Paul de Leyn, Alberto Marchevsky, Heber MacMahon, David Naidich, Morohito Okada, Marina Perlman, Charles Powell, Paul van Schil, Arne Warth, and Nackaerts, Kristiaan
Subjects: 0301 basic medicine, Pulmonary and Respiratory Medicine, Oncology, medicine.medical_specialty, Lung Neoplasms, Medizin, Adenocarcinoma, 1102 Cardiovascular Medicine And Haematology, Metastasis, 03 medical and health sciences, 0302 clinical medicine, Meta-Analysis as Topic, Non-small cell lung cancer, Internal medicine, medicine, Humans, Non–small cell lung cancer, IASLC Staging and Prognostic Factors Committee Advisory Boards and the Multiple Pulmonary Sites Workgroup, In patient, Oncology & Carcinogenesis, Lung cancer staging, Lung cancer, Neoplasm Staging, Lung, business.industry, Background data, Cancer, Neoplasms, Second Primary, 1103 Clinical Sciences, medicine.disease, Prognosis, TNM classification, 030104 developmental biology, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Multiple tumors, business, IASLC Staging and Prognostic Factors Committee, Advisory Boards and the Multiple Pulmonary Sites Workgroup
Abstract: Introduction It can be difficult to distinguish between a second primary and a metastasis in patients with lung cancer who have more than one pulmonary site of cancer. Methods A systematic review of the literature was conducted by a subcommittee of the International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee to develop recommendations to identify second primary lung cancers. The process entailed review of knowledge relating to the mechanism of metastasis, determination of clonality, and outcomes of patients with resected tumors. Results It is easier to determine that two tumors are different than that they are the same; finding similarities does not establish that they are the same. For example, most second primary lung cancers are of the same histotype. Few criteria are reliable by themselves; these include different histologic cancer types or matching DNA breakpoints by sequencing and a comprehensive histologic assessment of resected specimens. Characteristics that are suggestive but associated with potential misclassification include the presence or absence of biomarkers, imaging characteristics, and the presence or absence of nodal involvement. Conclusions Clinical and pathologic (i.e., after resection) criteria are presented to identify two foci as separate primary lung cancers versus a metastasis. Few features are definitive; many commonly used characteristics are suggestive but associated with a substantial rate of misclassification. Careful review by a multidisciplinary tumor board, considering all available information, is recommended.
Published: 2016

38. The International Association for the Study of Lung Cancer Lung Cancer Staging Project : proposals for the revision of the clinical and pathologic staging of small cell lung cancer in the forthcoming eighth edition of the TNM classification for lung cancer

Author: Andrew G. Nicholson, Kari Chansky, John Crowley, Ricardo Beyruti, Kaoru Kubota, Andrew Turrisi, Wilfried E.E. Eberhardt, Jan van Meerbeeck, Ramón Rami-Porta, Peter Goldstraw, Hisao Asamura, David Ball, David G. Beer, Vanessa Bolejack, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Toni Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Alan Mitchell, Takashi Nakano, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A.I. Blanco Orozco, M.A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M.T. González Budiño, G. González Casaurrán, J.A. Gullón Blanco, J. Hernández Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J.M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J.C. Peñalver Cuesta, J.S. Park, H. Pass, M.J. Pavón Fernández, M. Rosenberg, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, K. Yokoi, and Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions
Subjects: 0301 basic medicine, Oncology, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Lung Neoplasms, Pleural effusion, Respiratory System, education, Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions, Medizin, Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions, 1102 Cardiovascular Medicine And Haematology, Metastasis, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Humans, 7TH EDITION, Oncology & Carcinogenesis, Lung cancer staging, Lung cancer, Pathological, neoplasms, Survival analysis, Neoplasm Staging, Science & Technology, Small cell lung cancer, business.industry, 1103 Clinical Sciences, Prognosis, medicine.disease, Small Cell Lung Carcinoma, Survival Analysis, TNM classification, Surgery, respiratory tract diseases, 030104 developmental biology, 030220 oncology & carcinogenesis, Non small cell, Human medicine, business, Life Sciences & Biomedicine
Abstract: Introduction Small cell lung cancer (SCLC) is commonly classified as either limited or extensive, but the Union for International Cancer Control TNM Classification of Malignant Tumours seventh edition (2009) recommended tumor, node, and metastasis (TNM) staging based on analysis of the International Association for the Study of Lung Cancer (IASLC) database. Methods Survival analyses were performed for clinically and pathologically staged patients presenting with SCLC from 1999 through 2010. Prognosis was compared in relation to the TNM seventh edition staging to serve as validation and analyzed in relation to proposed changes to the T descriptors found in the eighth edition. Results There were 5002 patients: 4848 patients with clinical and 582 with pathological stages. Among these, 428 had both. Survival differences were confirmed for T and N categories and maintained in relation to proposed revisions to T descriptors for seventh edition TNM categories and proposed changes in the eighth edition. There were also survival differences, notably at 12 months, in patients with brain-only single-site metastasis (SSM) compared to SSM at other sites, and SSM without a pleural effusion showed a better prognosis than other patients in the M1b category. Conclusion We confirm the prognostic value of clinical and pathological TNM staging in patients with SCLC, and recommend continued usage for SCLC in relation to proposed changes to T, N, and M descriptors for NSCLC in the eighth edition. However, for M descriptors, it remains uncertain whether survival differences in patients with SSM in the brain simply reflect better treatment options rather than better survival based on anatomic extent of disease.
Published: 2016

39. The IASLC Mesothelioma Staging Project : Proposals for Revisions of the T Descriptors in the Forthcoming Eighth Edition of the TNM Classification for Pleural Mesothelioma

Author: Anna K. Nowak, Kari Chansky, David C. Rice, Harvey I. Pass, Hedy L. Kindler, Lynn Shemanski, Andrea Billé, Robert C. Rintoul, Hasan F. Batirel, Charles F. Thomas, Joseph Friedberg, Susana Cedres, Marc de Perrot, Valerie W. Rusch, Peter Goldstraw, Ramón Rami-Porta, Hisao Asamura, David Ball, David Beer, Ricardo Beyruti, Vanessa Bolejack, John Crowley, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Andrew G. Nicholson, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, H. Asamura, H. Batirel, A. Bille, U. Pastorino, S. Call, A. Cangir, S. Cedres, J. Friedberg, F. Galateau-Salle, S. Hasagawa, K. Kernstine, H. Kindler, B. McCaughan, T. Nakano, A. Nowak, C. Atinkaya Ozturk, H. Pass, M. de Perrot, F. Rea, D. Rice, R. Rintoul, E. Ruffini, V. Rusch, L Spaggiari, D Galetta, K. Syrigos, C. Thomas, J. van Meerbeeck, P. Nafteux, J. Vansteenkiste, W. Weder, I. Optiz, M. Yoshimura, University of Zurich, Nowak, Anna K, Nowak, Anna K., Chansky, Kari, Rice, David C., Pass, Harvey I., Kindler, Hedy L., Shemanski, Lynn, Bille, Andrea, Rintoul, Robert C., Batirel, Hasan F., Thomas, Charles F., Friedberg, Joseph, Cedres, Susana, de Perrot, Marc, Rusch, Valerie W., and Nackaerts, Kristiaan
Subjects: Mesothelioma, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Staging, Lung Neoplasms, PREDICTION, 10255 Clinic for Thoracic Surgery, Pleural Neoplasms, Settore MED/21 - Chirurgia Toracica, education, Medizin, 610 Medicine & health, THERAPY, PARAMETERS, 03 medical and health sciences, 0302 clinical medicine, Prospective, T component, Humans, Mesothelioma, Malignant, Neoplasm Staging, Medicine, Lung cancer, TUMOR THICKNESS, Staging system, Pleural mesothelioma, business.industry, General surgery, CT SCANS, ASSOCIATION, respiratory system, medicine.disease, F-18-FDG PET/CT, respiratory tract diseases, 030228 respiratory system, Oncology, 2740 Pulmonary and Respiratory Medicine, 030220 oncology & carcinogenesis, VOLUME, SURVIVAL, 2730 Oncology, business, MALIGNANT MESOTHELIOMA
Abstract: Introduction: The current T component for malignant pleural mesothelioma (MPM) has been predominantly informed by surgical data sets and consensus. The International Association for the Study of Lung Cancer undertook revision of the seventh edition of the staging system for MPM with the goal of developing recommendations for the eighth edition. Methods: Data elements including detailed T descriptors were developed by consensus. Tumor thickness at three pleural levels was also recorded. An electronic data capture system was established to facilitate data submission. Results: A total of 3519 cases were submitted to the database. Of those eligible for T-component analysis, 509 cases had only clinical staging, 836 cases had only surgical staging, and 642 cases had both available. Survival was examined for T categories according to the current seventh edition staging system. There was clear separation between all clinically staged categories except T1a versus T1b (hazard ratio = 0.99, p = 0.95) and T3 versus T4 (hazard ratio = 1.22, p = 0.09), although the numbers of T4 cases were small. Pathological staging failed to demonstrate a survival difference between adjacent categories with the exception of T3 versus T4. Performance improved with collapse of T1a and T1b into a single T1 category; no current descriptors were shifted or eliminated. Tumor thickness and nodular or rindlike morphology were significantly associated with survival. Conclusions: A recommendation to collapse both clinical and pathological T1a and T1b into a T1 classification will be made for the eighth edition staging system. Simple measurement of pleural thickness has prognostic significance and should be examined further with a view to incorporation into future staging. (C) 2016 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Published: 2016

40. The IASLC Lung Cancer Staging Project: Proposals for Revision of the TNM Stage Groupings in the Forthcoming (Eighth) Edition of the TNM Classification for Lung Cancer

Author: Peter Goldstraw, Kari Chansky, John Crowley, Ramon Rami-Porta, Hisao Asamura, Wilfried E.E. Eberhardt, Andrew G. Nicholson, Patti Groome, Alan Mitchell, Vanessa Bolejack, Ramón Rami-Porta, David Ball, David G. Beer, Ricardo Beyruti, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Takashi Nakano, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A.I. Blanco Orozco, M.A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M.T. González Budiño, G. González Casaurrán, J.A. Gullón Blanco, J. Hernández Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J.M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J.C. Peñalver Cuesta, J.S. Park, H. Pass, M.J. Pavón Fernández, M. Rosenberg, E. Ruffini, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, and K. Yokoi
Subjects: 0301 basic medicine, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Pathology, Lung Neoplasms, Staging, Medizin, Prognostic factors, 1102 Cardiovascular Medicine And Haematology, Lung cancer, 03 medical and health sciences, 0302 clinical medicine, Seer program, medicine, Humans, Oncology & Carcinogenesis, Stage (cooking), Neoplasm Staging, business.industry, General surgery, International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee Advisory Boards and Participating Institutions, 1103 Clinical Sciences, Prognosis, medicine.disease, International Association for the Study of Lung Cancer Staging and Prognostic Factors Committee, Advisory Boards, and Participating Institutions, 030104 developmental biology, Oncology, 030220 oncology & carcinogenesis, Neoplasm staging, Biostatistics, Lung cancer staging, business, SEER Program
Abstract: The IASLC Staging and Prognostic Factors Committee has collected a new database of 94,708 cases donated from 35 sources in 16 countries around the globe. This has now been analysed by our statistical partners at Cancer Research And Biostatistics and, in close collaboration with the members of the committee proposals have been developed for the T, N, and M categories of the 8th edition of the TNM Classification for lung cancer due to be published late 2016. In this publication we describe the methods used to evaluate the resultant Stage groupings and the proposals put forward for the 8th edition.
Published: 2016

41. The IASLC Mesothelioma Staging Project: Improving Staging of a Rare Disease Through International Participation

Author: Harvey Pass, Dorothy Giroux, Catherine Kennedy, Enrico Ruffini, Ayten K. Cangir, David Rice, Hisao Asamura, David Waller, John Edwards, Walter Weder, Hans Hoffmann, Jan P. van Meerbeeck, Anna Nowak, Valerie W. Rusch, Peter Goldstraw, Ramón Rami-Porta, David Ball, David Beer, Ricardo Beyruti, Vanessa Bolejack, Kari Chansky, John Crowley, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, Françoise Galateau-Sallé, Fergus Gleeson, Patti Groome, James Huang, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Edith M. Marom, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Andrew G. Nicholson, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, H. Asamura, H. Batirel, A. Bille, U. Pastorino, S. Call, A. Cangir, S. Cedres, J. Friedberg, F. Galateau-Salle, null Hasagawa, K. Kernstine, H. Kindler, B. McCaughan, T. Nakano, A. Nowak, C. Atinkaya Ozturk, H. Pass, M. de Perrot, F. Rea, D. Rice, R. Rintoul, E. Ruffini, V. Rusch, L. Spaggiari, D. Galetta, K. Syrigos, C. Thomas, J. van Meerbeeck, J. Vansteenkiste, W. Weder, I. Opitz, M. Yoshimura, IASLC Staging Prognostic Factors, Nackaerts, Kristiaan, University of Zurich, and Pass, Harvey
Subjects: Mesothelioma, Pulmonary and Respiratory Medicine, Registry, medicine.medical_specialty, Staging, 10255 Clinic for Thoracic Surgery, education, Medizin, 610 Medicine & health, TNM staging system, TNM, Oncology, 03 medical and health sciences, 0302 clinical medicine, medicine, Lung cancer, Staging system, health care economics and organizations, business.industry, General surgery, Cancer, respiratory system, medicine.disease, Surgery, respiratory tract diseases, Clinical trial, 030228 respiratory system, 2740 Pulmonary and Respiratory Medicine, 030220 oncology & carcinogenesis, Interest group, 2730 Oncology, Human medicine, business, Rare disease
Abstract: For nearly 40 years, there was no generally accepted staging system for malignant pleural mesothelioma. In 1994, members of the International Mesothelioma Interest Group, in collaboration with the International Association for the Study of Lung Cancer, proposed a TNM staging system based on analyses of outcomes in retrospective surgical series and small clinical trials. Subsequently accepted by the American Joint Commission on Cancer and the Union for International Cancer Control for the sixth editions of their staging manuals, this system has since been the international staging standard. However, it has significant limitations, particularly with respect to clinical staging and to the categories for lymph node staging. Here we provide an overview of the development of the International Association for the Study of Lung Cancer malignant pleural mesothelioma staging database, which was designed to address these limitations through the development of a large international data set. Analyses of this database, described in papers linked to this overview, are being used to inform revisions in the eighth editions of the American Joint Commission on Cancer and Union for International Cancer Control staging systems. ispartof: Journal of Thoracic Oncology vol:11 issue:12 pages:2082-2088 ispartof: location:United States status: published
Published: 2016

42. The IASLC Lung Cancer Staging Project: Background Data and Proposals for the Classification of Lung Cancer with Separate Tumor Nodules in the Forthcoming Eighth Edition of the TNM Classification for Lung Cancer

Author: Frank C. Detterbeck, Vanessa Bolejack, Douglas A. Arenberg, John Crowley, Jessica S. Donington, Wilbur A. Franklin, Nicolas Girard, Edith M. Marom, Peter J. Mazzone, Andrew G. Nicholson, Valerie W. Rusch, Lynn T. Tanoue, William D. Travis, Hisao Asamura, Ramón Rami-Porta, Peter Goldstraw, David Ball, David G. Beer, Ricardo Beyruti, Kari Chansky, Frank Detterbeck, Wilfried Ernst Erich Eberhardt, John Edwards, Françoise Galateau-Sallé, Dorothy Giroux, Fergus Gleeson, Patti Groome, James Huang, Catherine Kennedy, Jhingook Kim, Young Tae Kim, Laura Kingsbury, Haruhiko Kondo, Mark Krasnik, Kaoru Kubota, Antoon Lerut, Gustavo Lyons, Mirella Marino, Jan van Meerbeeck, Alan Mitchell, Takashi Nakano, Anna Nowak, Michael Peake, Thomas Rice, Kenneth Rosenzweig, Enrico Ruffini, Valerie Rusch, Nagahiro Saijo, Paul Van Schil, Jean-Paul Sculier, Lynn Shemanski, Kelly Stratton, Kenji Suzuki, Yuji Tachimori, Charles F. Thomas, William Travis, Ming S. Tsao, Andrew Turrisi, Johan Vansteenkiste, Hirokazu Watanabe, Yi-Long Wu, Paul Baas, Jeremy Erasmus, Seiki Hasegawa, Kouki Inai, Kemp Kernstine, Hedy Kindler, Lee Krug, Kristiaan Nackaerts, Harvey Pass, David Rice, Conrad Falkson, Pier Luigi Filosso, Giuseppe Giaccone, Kazuya Kondo, Marco Lucchi, Meinoshin Okumura, Eugene Blackstone, Douglas Flieder, Myrna Godoy, Jin Mo Goo, Lawrence R. Goodman, Jim Jett, Paul de Leyn, Alberto Marchevsky, Heber MacMahon, David Naidich, Morohito Okada, Marina Perlman, Charles Powell, Paul van Schil, Arne Warth, F. Abad Cavaco, E. Ansótegui Barrera, J. Abal Arca, I. Parente Lamelas, A. Arnau Obrer, R. Guijarro Jorge, D. Ball, G.K. Bascom, A.I. Blanco Orozco, M.A. González Castro, M.G. Blum, D. Chimondeguy, V. Cvijanovic, S. Defranchi, B. de Olaiz Navarro, I. Escobar Campuzano, I. Macía Vidueira, E. Fernández Araujo, F. Andreo García, K.M. Fong, G. Francisco Corral, S. Cerezo González, J. Freixinet Gilart, L. García Arangüena, S. García Barajas, P. Girard, T. Goksel, M.T. González Budiño, G. González Casaurrán, J.A. Gullón Blanco, J. Hernández Hernández, H. Hernández Rodríguez, J. Herrero Collantes, M. Iglesias Heras, J.M. Izquierdo Elena, E. Jakobsen, S. Kostas, P. León Atance, A. Núñez Ares, M. Liao, M. Losanovscky, G. Lyons, R. Magaroles, L. De Esteban Júlvez, M. Mariñán Gorospe, B. McCaughan, C. Kennedy, R. Melchor Íñiguez, L. Miravet Sorribes, S. Naranjo Gozalo, C. Álvarez de Arriba, M. Núñez Delgado, J. Padilla Alarcón, J.C. Peñalver Cuesta, J.S. Park, H. Pass, M.J. Pavón Fernández, M. Rosenberg, E. Ruffini, V. Rusch, J. Sánchez de Cos Escuín, A. Saura Vinuesa, M. Serra Mitjans, T.E. Strand, D. Subotic, S. Swisher, R. Terra, C. Thomas, K. Tournoy, P. Van Schil, M. Velasquez, Y.L. Wu, and K. Yokoi
Subjects: Pulmonary and Respiratory Medicine, Pathology, medicine.medical_specialty, Lung Neoplasms, Medizin, Adenocarcinoma, 1102 Cardiovascular Medicine And Haematology, Lung cancer, Lung cancer staging, Multiple tumors, Non-small cell lung cancer, TNM classification, Oncology, 03 medical and health sciences, 0302 clinical medicine, Meta-Analysis as Topic, medicine, Humans, Non–small cell lung cancer, Oncology & Carcinogenesis, Survival rate, Neoplasm Staging, business.industry, Background data, Nodule (medicine), Neoplasms, Second Primary, 1103 Clinical Sciences, Second primary cancer, medicine.disease, Prognosis, Survival Rate, 030228 respiratory system, 030220 oncology & carcinogenesis, IASLC Staging and Prognostic Factors Committee, Advisory Boards, Multiple Pulmonary Sites Workgroup and Participating Institutions, IASLC Staging and Prognostic Factors Committee Advisory Boards Multiple Pulmonary Sites Workgroup and Participating Institutions, Neoplasm staging, medicine.symptom, business
Abstract: Introduction Separate tumor nodules with the same histologic appearance occur in the lungs in a small proportion of patients with primary lung cancer. This article addresses how such tumors can be classified to inform the eighth edition of the anatomic classification of lung cancer. Separate tumor nodules should be distinguished from second primary lung cancer, multifocal ground glass/lepidic tumors, and pneumonic-type lung cancer, which are addressed in separate analyses. Methods Survival of patients with separate tumor nodules in the International Association for the Study of Lung Cancer database were analyzed. This was compared with a systematic literature review. Results Survival of clinically staged patients decreased according to the location of the separate tumor nodule relative to the index tumor (same lobe > same side > other side) in N0 and N-any cohorts (all M0 except possible other-side nodules). However, there was also a decrease in the proportion of patients resected; among only surgically resected or among nonresected patients no survival differences were noted. There were no survival differences between patients with same-lobe nodules and those with other T3 tumors, between patients with same-side nodules and those with T4 tumors, and patients with other-side nodules and those with other M1a tumors. The data correlated with those identified in a literature review. Conclusions Tumors with same-lobe separate tumor nodules (with the same histologic appearance) are recommended to be classified as T3, same-side nodules as T4, and other-side nodules as M1a. Thus, there is no recommended change between the seventh and eighth edition of the TNM classification of lung cancer.
Published: 2015

43. Phase I trial of orally administered CEP-701, a novel neurotrophin receptor-linked tyrosine kinase inhibitor.

Author: John L. Marshall, Hedy Kindler, John Deeken, Pankaj Bhargava, Nicholas J. Vogelzang, Naiyer Rizvi, Taina Luhtala, Stacy Boylan, Margaret Dordal, Philmore Robertson, Michael J. Hawkins, and Mark J. Ratain
Abstract: Purpose: A phase I clinical trial in patients with advanced carcinomas was conducted using the orally available neurotrophin receptor-linked tyrosine kinase receptor inhibitor, CEP-701. The objectives were to determine the maximum tolerated dose (MTD), dose-limiting toxicities, and pharmacokinetic profile of this orally administered agent. Patients and methods: A total of 30 patients were accrued to receive escalating BID doses of CEP-701 in cycles lasting 28 days. Between 3 and 6 patients were enrolled at each dose level. Once the MTD was determined, nine de novo patients were recruited to receive that level of drug. Pharmacokinetic studies were performed after the first dose, with additional sampling to assess intraindividual variability. Results: The dosages ranged from 5 mg BID to 160 mg BID. While the criteria for MTD were not met at the dose levels administered, DLTs were observed at 80 and 120 mg BID. Treatment related adverse events, especially of the gastrointestinal system, made CEP-701 poorly tolerated at dosages above 40 mg BID. While CEP-701 did not produce an objective tumor response in any patient, 7 of the 30 patients received treatment for 3 months or more, including 3 who were on study with stable disease for more than 6 months. Orally administered CEP-701 was rapidly absorbed, with a mean tmax between 1 and 3 hours. At higher dose levels, serum drug levels showed greater than dose-proportional increases by Day 28 versus Day 1. Conclusion: CEP-701 40 mg BID was well tolerated by patients with advanced malignancy and is the recommended dose level for planned phase II trials. Further study is necessary to determine the clinical efficacy of this novel new chemotherapeutic agent. [ABSTRACT FROM AUTHOR]
Published: 2005
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44. Reply to K. Masuda et al.

Author: Fennell DA, Taylor P, Gilligan D, Nakano T, Scherpereel A, Pavlakis N, van Meerbeeck JP, Aerts JGJV, Nowak AK, Kindler H, and Baas P
Subjects: Benzamides, Double-Blind Method, Humans, Pyrazines, Sulfonamides, Mesothelioma, Neurofibromin 2
Published: 2019
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45. Coffee Intake, Recurrence, and Mortality in Stage III Colon Cancer: Results From CALGB 89803 (Alliance).

Author: Guercio BJ, Sato K, Niedzwiecki D, Ye X, Saltz LB, Mayer RJ, Mowat RB, Whittom R, Hantel A, Benson A, Atienza D, Messino M, Kindler H, Venook A, Hu FB, Ogino S, Wu K, Willett WC, Giovannucci EL, Meyerhardt JA, and Fuchs CS
Subjects: Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Caffeine therapeutic use, Chemotherapy, Adjuvant methods, Colonic Neoplasms mortality, Colonic Neoplasms pathology, Combined Modality Therapy methods, Diet, Female, Humans, Life Style, Male, Middle Aged, Proportional Hazards Models, Prospective Studies, Surveys and Questionnaires, Tea, Young Adult, Coffee, Colonic Neoplasms drug therapy, Neoplasm Recurrence, Local
Abstract: Purpose: Observational studies have demonstrated increased colon cancer recurrence in states of relative hyperinsulinemia, including sedentary lifestyle, obesity, and increased dietary glycemic load. Greater coffee consumption has been associated with decreased risk of type 2 diabetes and increased insulin sensitivity. The effect of coffee on colon cancer recurrence and survival is unknown., Patients and Methods: During and 6 months after adjuvant chemotherapy, 953 patients with stage III colon cancer prospectively reported dietary intake of caffeinated coffee, decaffeinated coffee, and nonherbal tea, as well as 128 other items. We examined the influence of coffee, nonherbal tea, and caffeine on cancer recurrence and mortality using Cox proportional hazards regression., Results: Patients consuming 4 cups/d or more of total coffee experienced an adjusted hazard ratio (HR) for colon cancer recurrence or mortality of 0.58 (95% CI, 0.34 to 0.99), compared with never drinkers (Ptrend = .002). Patients consuming 4 cups/d or more of caffeinated coffee experienced significantly reduced cancer recurrence or mortality risk compared with abstainers (HR, 0.48; 95% CI, 0.25 to 0.91; Ptrend = .002), and increasing caffeine intake also conferred a significant reduction in cancer recurrence or mortality (HR, 0.66 across extreme quintiles; 95% CI, 0.47 to 0.93; Ptrend = .006). Nonherbal tea and decaffeinated coffee were not associated with patient outcome. The association of total coffee intake with improved outcomes seemed consistent across other predictors of cancer recurrence and mortality., Conclusion: Higher coffee intake may be associated with significantly reduced cancer recurrence and death in patients with stage III colon cancer., (© 2015 by American Society of Clinical Oncology.)
Published: 2015
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