774 results on '"Vincenzo Valentini"'
Search Results
2. May we routinely spare hippocampal region in primary central nervous system lymphoma during whole brain radiotherapy?
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Ciro Mazzarella, Silvia Chiesa, Lucrezia Toppi, Stefan Hohaus, Simona Gaudino, Francesco D’Alo, Nicola Dinapoli, Resta Davide, Tiziano Zinicola, Serena Bracci, Antonella Martino, Francesco Beghella Bartoli, Elisabetta Lepre, Roberta Bertolini, Silvia Mariani, Cesare Colosimo, Vincenzo Frascino, Gian Carlo Mattiucci, Maria Antonietta Gambacorta, Vincenzo Valentini, and Mario Balducci
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PCNSL ,Hippocampal sparing ,WBRT ,IMRT ,Neuro-toxicity ,Personalized treatment ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Purpose One of the main limiting factors of whole-brain radiation therapy (WBRT) for primary central nervous system lymphoma (PCNSL) is the impairment of neurocognitive functions (NCFs), which is mainly caused by radiation-induced injury to the hippocampus. With a view to preventing NCF impairment and personalizing treatment, we explored the feasibility of sparing the hippocampus during WBRT by correlating the sites of PCNSL lesions with the hippocampus. Methods and materials Pre-treatment MR images from patients who underwent WBRT between 2010 and January 2020—and post-radiotherapy images in cases of relapse—were imported into the Varian Eclipse treatment-planning system and registered with the simulation CT. We constructed three 3-dimensional envelopes around the hippocampus at distances of 5, 10 and 15 mm and also contoured primary lesions and recurrences. Results We analyzed 43 patients with 66 primary lesions: 9/66 (13.6%) involved the hippocampus and 11/66 (16.7%) were located within 5 mm of it. Thirty-six lesions (54.5%) were situated more than 15 mm from the hippocampus, while 10/66 (15.2%) were between 5 and 15 mm from it. The most common location was in deep brain structures (31%). Thirty-five of the 66 lesions relapsed: in field in 14/35 (40%) and outfield in 21/35 (60%) in different sites. Globally, 16/35 recurrences (45.7%) were located in the hippocampus or within 5 mm of it. Conclusion These data show that routinely sparing the hippocampus is not feasible. This approach could be considered in selected patients, when the lesion is more than 15 mm from the hippocampus.
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- 2023
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3. Post-traumatic growth in oncological patients during the COVID-19 pandemic
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Letizia Lafuenti, Loredana Dinapoli, Ludovica Mastrilli, Vezio Savoia, Marinella Linardos, Riccardo Masetti, Giampaolo Tortora, Vincenzo Valentini, Giovanni Scambia, and Daniela P. R. Chieffo
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cancer ,covid-19 ,post-traumatic growth ,resilience ,Medicine ,Psychology ,BF1-990 - Abstract
Background Post-traumatic growth (PTG) is defined as “positive psychological change experienced as a result of the struggle with high-ly challenging life circumstances”. Diagnosis of cancer leads to many psychological challenges. The recent pandemic forced oncological patients to face other multiple stressors. Resilience is a target of interest for PTG. The aim of this study is to analyze relationships between cancer trauma, COVID-19 pandemic stress, PTG and resilience over time. Participants and procedure One hundred forty-six patients (124 females, 22 males) in active oncological treatment were enrolled from September 2020: 45.2% (n = 66) diagnosed with gynecological cancer, 23.3% (n = 34) with breast cancer, 15.1% (n = 22) with lung cancer, 16.5% (n = 24) with other cancers. We conducted a prospective longitudinal study on oncological patients evaluated at: diag-nosis (T0), 6 (T1) and 12 months (T2) by means of the following self-administered tests: Distress Thermometer (DT), Hospi-tal Anxiety and Depression Scale (HADS), Impact of Event Scale Revised (IES-R), Post-traumatic Growth Inventory (PTGI), Perceived Stress Scale (PSS), Connor-Davidson Resilience Scale (CD-RISC). Results DT decreased over time (T0 vs. T2, p < .001). HADS decreased from T0 to T2 (p < .001). The PTG subscales regarding new possibilities and appreciating life improved comparing T0 vs. T2 (p = .029; p = .013), as well as the total index of PTG (p = .027). The IES avoidance subscale score decreased over time (T0 vs. T1, p = .035). Conclusions For some patients, the cancer experience is characterized not only by psychological distress but also by the presence and growth of positive aspects, such as the tendency to positively reconsider the value and importance of life, health and social relationships.
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- 2023
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4. The Italian version of the Pediatric Quality of Life Inventory™ (PEDSQL™) 3.0 healthcare satisfaction hematology/oncology module: reliability and validity in radiation oncology
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Elisa Marconi, Francesco Beghella Bartoli, Elisa Meldolesi, Silvia Mariani, Giulia Panza, Alessia Nardangeli, Loredana Dinapoli, Teresa Carmen Lees, Antonella Guido, Angela Mastronuzzi, Antonio Ruggiero, Maria Antonietta Gambacorta, Vincenzo Valentini, Mario Balducci, Daniela Pia Rosaria Chieffo, and Silvia Chiesa
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Pediatric Quality of Life ,Health-related quality of life ,Healthcare satisfaction ,Psychometric properties ,Translation ,Pediatric Radiotherapy ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Abstract Background Health-related quality of life (HRQOL) measurement has become an important health care outcome even in oncological pediatric scenario. During radiation therapy care path, pediatric patients and their relatives may suffer from emotional and psychosocial distress not only related to cancer diagnosis, but also due to the procedure and the required daily routine. Despite the high prevalence of psychosocial consequences in this setting, instruments that inquire pediatric HRQOL and healthcare satisfaction have rarely been studied in Italy. Purpose of this study was to investigate reliability and linguistic validation of the PedsQL™ healthcare satisfaction Hematology/Oncology module from its original English version to Italian language. Methods Three phases standard procedure of cross-culture adaptation were used to create Italian version of PedsQL™ healthcare satisfaction Hematology/Oncology module. Forward translations and backward translations were performed. Finally, a pilot-testing for understandability of the ‘pre-final’ version was conducted with parents of children attending our Radiotherapy Center using two methodologies of Cognitive Interviewing (“Think-aloud Interviews” and “Respondent Debriefing”), in order to obtain the final Italian version of the PedsQL™ healthcare satisfaction Hematology/Oncology module. Results Twenty-five parents (2 father, 23 mothers) were recruited during their children’s radiotherapy treatment and the grammatically and conceptually acceptable pre-final version of the PedsQL™ Healthcare Satisfaction Hematology/Oncology Module was administered. The questionnaire was well understood reflecting its linguistic adaptation. Compliance with questionnaire administration was optimal. All subjects stated that the questions were interesting to express their opinion, most of them reported that all the questions of each section were clearly comprehensible and easy to understand, suggesting minimal changes that were double-checked with back translation. Furthermore, six of them spontaneously asked to complete the questionnaire in order to review the assistance received during radiotherapy. Conclusion Our Italian version of the PedsQL™ 3.0 Healthcare Satisfaction Hematology/Oncology Module seems to be a valid and functional instrument to indagate Healthcare Satisfaction.
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- 2023
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5. Lung cancer multi-omics digital human avatars for integrating precision medicine into clinical practice: the LANTERN study
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Filippo Lococo, Luca Boldrini, Charles-Davies Diepriye, Jessica Evangelista, Camilla Nero, Sara Flamini, Angelo Minucci, Elisa De Paolis, Emanuele Vita, Alfredo Cesario, Salvatore Annunziata, Maria Lucia Calcagni, Marco Chiappetta, Alessandra Cancellieri, Anna Rita Larici, Giuseppe Cicchetti, Esther G.C. Troost, Róza Ádány, Núria Farré, Ece Öztürk, Dominique Van Doorne, Fausto Leoncini, Andrea Urbani, Rocco Trisolini, Emilio Bria, Alessandro Giordano, Guido Rindi, Evis Sala, Giampaolo Tortora, Vincenzo Valentini, Stefania Boccia, Stefano Margaritora, and Giovanni Scambia
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Lung cancer ,Artificial intelligence (AI) ,Digital human avatars (DHA) ,Personalize medicine ,Machine learning ,System medicine ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background The current management of lung cancer patients has reached a high level of complexity. Indeed, besides the traditional clinical variables (e.g., age, sex, TNM stage), new omics data have recently been introduced in clinical practice, thereby making more complex the decision-making process. With the advent of Artificial intelligence (AI) techniques, various omics datasets may be used to create more accurate predictive models paving the way for a better care in lung cancer patients. Methods The LANTERN study is a multi-center observational clinical trial involving a multidisciplinary consortium of five institutions from different European countries. The aim of this trial is to develop accurate several predictive models for lung cancer patients, through the creation of Digital Human Avatars (DHA), defined as digital representations of patients using various omics-based variables and integrating well-established clinical factors with genomic data, quantitative imaging data etc. A total of 600 lung cancer patients will be prospectively enrolled by the recruiting centers and multi-omics data will be collected. Data will then be modelled and parameterized in an experimental context of cutting-edge big data analysis. All data variables will be recorded according to a shared common ontology based on variable-specific domains in order to enhance their direct actionability. An exploratory analysis will then initiate the biomarker identification process. The second phase of the project will focus on creating multiple multivariate models trained though advanced machine learning (ML) and AI techniques for the specific areas of interest. Finally, the developed models will be validated in order to test their robustness, transferability and generalizability, leading to the development of the DHA. All the potential clinical and scientific stakeholders will be involved in the DHA development process. The main goals aim of LANTERN project are: i) To develop predictive models for lung cancer diagnosis and histological characterization; (ii) to set up personalized predictive models for individual-specific treatments; iii) to enable feedback data loops for preventive healthcare strategies and quality of life management. Discussion The LANTERN project will develop a predictive platform based on integration of multi-omics data. This will enhance the generation of important and valuable information assets, in order to identify new biomarkers that can be used for early detection, improved tumor diagnosis and personalization of treatment protocols. Ethics Committee approval number 5420 − 0002485/23 from Fondazione Policlinico Universitario Agostino Gemelli IRCCS – Università Cattolica del Sacro Cuore Ethics Committee. Trial registration clinicaltrial.gov - NCT05802771.
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- 2023
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6. Editorial: Artificial intelligence in process modelling in oncology
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Carlos Fernandez-Llatas, Roberto Gatta, Fernando Seoane, and Vincenzo Valentini
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process mining ,process modelling ,artificial intelligence ,pattern of care ,clinical processes ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2023
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7. Magnetic resonance guided SBRT reirradiation in locally recurrent prostate cancer: a multicentric retrospective analysis
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Luca Boldrini, Angela Romano, Giuditta Chiloiro, Stefanie Corradini, Viola De Luca, Valeria Verusio, Andrea D’Aviero, Alessandra Castelluccia, Anna Rita Alitto, Francesco Catucci, Gianmarco Grimaldi, Christian Trapp, Juliane Hörner-Rieber, Domenico Marchesano, Vincenzo Frascino, Gian Carlo Mattiucci, Vincenzo Valentini, Piercarlo Gentile, and Maria Antonietta Gambacorta
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Prostate cancer ,Radiotherapy ,Reirradiation ,MRgRT ,SBRT ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Aims Reirradiation of prostate cancer (PC) local recurrences represents an emerging challenge for current radiotherapy. In this context, stereotactic body radiation therapy (SBRT) allows the delivery of high doses, with curative intent. Magnetic Resonance guided Radiation Therapy (MRgRT) has shown promising results in terms of safety, feasibility and efficacy of delivering SBRT thanks to the enhanced soft tissue contrast and the online adaptive workflow. This multicentric retrospective analysis evaluates the feasibility and efficacy of PC reirradiation, using a 0.35 T hybrid MR delivery unit. Methods Patients affected by local recurrences of PC and treated in five institutions between 2019 and 2022 were retrospectively collected. All patients had undergone previous Radiation Therapy (RT) in definitive or adjuvant setting. Re-treatment MRgSBRT was delivered with a total dose ranging from 25 to 40 Gy in 5 fractions. Toxicity according to CTCAE v 5.0 and treatment response were assessed at the end of the treatment and at follow-up. Results Eighteen patients were included in this analysis. All patients had previously undergone external beam radiation therapy (EBRT) up to a total dose of 59.36 to 80 Gy. Median cumulative biologically effective dose (BED) of SBRT re-treatment was 213,3 Gy (103,1-560), considering an α/β of 1.5. Complete response was achieved in 4 patients (22.2%). No grade ≥ 2 acute genitourinary (GU) toxicity events were recorded, while gastrointestinal (GI) acute toxicity events occurred in 4 patients (22.2%). Conclusion The low rates of acute toxicity of this experience encourages considering MRgSBRT a feasibile therapeutic approach for the treatment of clinically relapsed PC. Accurate gating of target volumes, the online adaptive planning workflow and the high definition of MRI treatment images allow delivering high doses to the PTV while efficiently sparing organs at risk (OARs).
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- 2023
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8. A multi-centric evaluation of self-learning GAN based pseudo-CT generation software for low field pelvic magnetic resonance imaging
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Jessica Prunaretty, Gorkem Güngör, Thierry Gevaert, David Azria, Simon Valdenaire, Panagiotis Balermpas, Luca Boldrini, Michael David Chuong, Mark De Ridder, Leo Hardy, Sanmady Kandiban, Philippe Maingon, Kathryn Elizabeth Mittauer, Enis Ozyar, Thais Roque, Lorenzo Colombo, Nikos Paragios, Ryan Pennell, Lorenzo Placidi, Kumar Shreshtha, M. P. Speiser, Stephanie Tanadini-Lang, Vincenzo Valentini, and Pascal Fenoglietto
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pseudo-CT ,artificial intelligence ,MRI ,pelvis ,cycle GAN ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose/objectivesAn artificial intelligence-based pseudo-CT from low-field MR images is proposed and clinically evaluated to unlock the full potential of MRI-guided adaptive radiotherapy for pelvic cancer care.Materials and methodIn collaboration with TheraPanacea (TheraPanacea, Paris, France) a pseudo-CT AI-model was generated using end-to-end ensembled self-supervised GANs endowed with cycle consistency using data from 350 pairs of weakly aligned data of pelvis planning CTs and TrueFisp-(0.35T)MRIs. The image accuracy of the generated pCT were evaluated using a retrospective cohort involving 20 test cases coming from eight different institutions (US: 2, EU: 5, AS: 1) and different CT vendors. Reconstruction performance was assessed using the organs at risk used for treatment. Concerning the dosimetric evaluation, twenty-nine prostate cancer patients treated on the low field MR-Linac (ViewRay) at Montpellier Cancer Institute were selected. Planning CTs were non-rigidly registered to the MRIs for each patient. Treatment plans were optimized on the planning CT with a clinical TPS fulfilling all clinical criteria and recalculated on the warped CT (wCT) and the pCT. Three different algorithms were used: AAA, AcurosXB and MonteCarlo. Dose distributions were compared using the global gamma passing rates and dose metrics.ResultsThe observed average scaled (between maximum and minimum HU values of the CT) difference between the pCT and the planning CT was 33.20 with significant discrepancies across organs. Femoral heads were the most reliably reconstructed (4.51 and 4.77) while anal canal and rectum were the less precise ones (63.08 and 53.13). Mean gamma passing rates for 1%1mm, 2%/2mm, and 3%/3mm tolerance criteria and 10% threshold were greater than 96%, 99% and 99%, respectively, regardless the algorithm used. Dose metrics analysis showed a good agreement between the pCT and the wCT. The mean relative difference were within 1% for the target volumes (CTV and PTV) and 2% for the OARs.ConclusionThis study demonstrated the feasibility of generating clinically acceptable an artificial intelligence-based pseudo CT for low field MR in pelvis with consistent image accuracy and dosimetric results.
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- 2023
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9. Art and digital technologies to support resilience during the oncological journey: The Art4ART project
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Luca Tagliaferri, Loredana Dinapoli, Calogero Casà, Giuseppe Ferdinando Colloca, Fabio Marazzi, Patrizia Cornacchione, Ciro Mazzarella, Valeria Masiello, Silvia Chiesa, Francesco Beghella Bartoli, Elisa Marconi, Marika D'Oria, Alfredo Cesario, Daniela Pia Rosaria Chieffo, Vincenzo Valentini, and Maria Antonietta Gambacorta
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Digital health ,Cancer ,Radiotherapy ,Resilience ,Patient-centered care ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Introduction: New digital technologies can become a tool for welcoming the patient through the artistic dimension. Cancer patients, in particular, need support that accompanies and supports them throughout their treatment. Materials and methods: The Art4ART project consist in the structural proposal to cancer patients of a web-based digital platform containing several forms of art as video-entertainments; a multimedia immersive room; an art-based welcoming of the patients with several original paintings; an environment with a peacefulness vertical garden; a reconceptualization of the chemotherapy-infusion seats. Data regarding patients’ preference and choices will be stored and analysed also using artificial intelligence (AI) algorithm to measure and predict impact indicators regarding clinical outcomes (survival and toxicity), psychological indicators. Moreover, the same digital platform will contribute to a better organization of the activities. Discussion: Through the systematic acquisition of patient preferences and through integration with other clinical parameters, it will be possible to measure the clinical, psychological, organisational, and social impact of the newly implemented Art4ART project. The use of digital technology leads us to apply the reversal of viewpoint from therapeutic acts to patient-centred care.
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- 2022
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10. Eligibility for the 4 Pharmacological Pillars in Heart Failure With Reduced Ejection Fraction at Discharge
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Domenico D'Amario, Daniele Rodolico, Agni Delvinioti, Renzo Laborante, Chiara Iacomini, Carlotta Masciocchi, Attilio Restivo, Giuseppe Ciliberti, Mattia Galli, Antonio Donato Paglianiti, Antonio Iaconelli, Andrea Zito, Jacopo Lenkowicz, Stefano Patarnello, Alfredo Cesario, Vincenzo Valentini, and Filippo Crea
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4 pillars ,cautions ,comprehensive therapy ,contraindications ,heart failure with reduced ejection fraction ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
Background Guidelines recommend using multiple drugs in patients with heart failure (HF) with reduced ejection fraction, but there is a paucity of real‐world data on the simultaneous initiation of the 4 pharmacological pillars at discharge after a decompensation event. Methods and Results A retrospective data mart, including patients diagnosed with HF, was implemented. Consecutively admitted patients with HF with reduced ejection fraction were selected through an automated approach and categorized according to the number/type of treatments prescribed at discharge. The prevalence of contraindications and cautions for HF with reduced ejection fraction treatments was systematically assessed. Logistic regression models were fitted to assess predictors of the number of treatments (≥2 versus
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- 2023
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11. A Machine Learning Predictive Model of Bloodstream Infection in Hospitalized Patients
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Rita Murri, Giulia De Angelis, Laura Antenucci, Barbara Fiori, Riccardo Rinaldi, Massimo Fantoni, Andrea Damiani, Stefano Patarnello, Maurizio Sanguinetti, Vincenzo Valentini, Brunella Posteraro, and Carlotta Masciocchi
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bloodstream infections ,machine learning ,prediction ,Medicine (General) ,R5-920 - Abstract
The aim of the study was to build a machine learning-based predictive model to discriminate between hospitalized patients at low risk and high risk of bloodstream infection (BSI). A Data Mart including all patients hospitalized between January 2016 and December 2019 with suspected BSI was built. Multivariate logistic regression was applied to develop a clinically interpretable machine learning predictive model. The model was trained on 2016–2018 data and tested on 2019 data. A feature selection based on a univariate logistic regression first selected candidate predictors of BSI. A multivariate logistic regression with stepwise feature selection in five-fold cross-validation was applied to express the risk of BSI. A total of 5660 hospitalizations (4026 and 1634 in the training and the validation subsets, respectively) were included. Eleven predictors of BSI were identified. The performance of the model in terms of AUROC was 0.74. Based on the interquartile predicted risk score, 508 (31.1%) patients were defined as being at low risk, 776 (47.5%) at medium risk, and 350 (21.4%) at high risk of BSI. Of them, 14.2% (72/508), 30.8% (239/776), and 64% (224/350) had a BSI, respectively. The performance of the predictive model of BSI is promising. Computational infrastructure and machine learning models can help clinicians identify people at low risk for BSI, ultimately supporting an antibiotic stewardship approach.
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- 2024
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12. Correction: Lung cancer multi-omics digital human avatars for integrating precision medicine into clinical practice: the LANTERN study
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Filippo Lococo, Luca Boldrini, Charles-Davies Diepriye, Jessica Evangelista, Camilla Nero, Sara Flamini, Angelo Minucci, Elisa De Paolis, Emanuele Vita, Alfredo Cesario, Salvatore Annunziata, Maria Lucia Calcagni, Marco Chiappetta, Alessandra Cancellieri, Anna Rita Larici, Giuseppe Cicchetti, Esther G. C. Troost, Róza Ádány, Núria Farré, Ece Öztürk, Dominique Van Doorne, Fausto Leoncini, Andrea Urbani, Rocco Trisolini, Emilio Bria, Alessandro Giordano, Guido Rindi, Evis Sala, Giampaolo Tortora, Vincenzo Valentini, Stefania Boccia, Stefano Margaritora, and Giovanni Scambia
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2023
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13. Clinical adoption patterns of 0.35 Tesla MR-guided radiation therapy in Europe and Asia
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Berend J. Slotman, Mary Ann Clark, Enis Özyar, Myungsoo Kim, Jun Itami, Agnès Tallet, Jürgen Debus, Raphael Pfeffer, PierCarlo Gentile, Yukihiro Hama, Nicolaus Andratschke, Olivier Riou, Philip Camilleri, Claus Belka, Magali Quivrin, BoKyong Kim, Anders Pedersen, Mette van Overeem Felter, Young Il Kim, Jin Ho Kim, Martin Fuss, and Vincenzo Valentini
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MRI-guided radiotherapy ,MR-IGRT ,Stereotactic body radiotherapy ,SBRT ,Stereotactic ablative radiation therapy ,SABR ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Magnetic resonance-guided radiotherapy (MRgRT) utilization is rapidly expanding, driven by advanced capabilities including better soft tissue imaging, continuous intrafraction target visualization, automatic triggered beam delivery, and the availability of on-table adaptive replanning. Our objective was to describe patterns of 0.35 Tesla (T)-MRgRT utilization in Europe and Asia among early adopters of this novel technology. Methods Anonymized administrative data from all 0.35T-MRgRT treatment systems in Europe and Asia were extracted for patients who completed treatment from 2015 to 2020. Detailed treatment information was analyzed for all MR-linear accelerators (linac) and -cobalt systems. Results From 2015 through the end of 2020, there were 5796 completed treatment courses delivered in 46,389 individual fractions. 23.5% of fractions were adapted. Ultra-hypofractionated (UHfx) dose schedules (1–5 fractions) were delivered for 63.5% of courses, with 57.8% of UHfx fractions adapted on-table. The most commonly treated tumor types were prostate (23.5%), liver (14.5%), lung (12.3%), pancreas (11.2%), and breast (8.0%), with increasing compound annual growth rates (CAGRs) in numbers of courses from 2015 through 2020 (pancreas: 157.1%; prostate: 120.9%; lung: 136.0%; liver: 134.2%). Conclusions This is the first comprehensive study reporting patterns of utilization among early adopters of a 0.35T-MRgRT system in Europe and Asia. Intrafraction MR image-guidance, advanced motion management, and increasing adoption of on-table adaptive RT have accelerated a transition to UHfx regimens. MRgRT has been predominantly used to treat tumors in the upper abdomen, pelvis and lungs, and increasingly with adaptive replanning, which is a radical departure from legacy radiotherapy practices.
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- 2022
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14. Development of a prognostic model of overall survival in oropharyngeal cancer from real-world data: PRO.M.E.THE.O.
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Francesco Miccichè, Giuditta Chiloiro, Silvia Longo, Rosa Autorino, Mariangela Massaccesi, Jacopo Lenkowicz, Pierluigi Bonomo, Isacco Desideri, Liliana Belgioia, Almalina Bacigalupo, Elisa D’Angelo, Federica Bertolini, Anna Merlotti, Nerina Denaro, Pierfrancesco Franco, Francesco Bussu, Gaetano Paludetti, Umberto Ricardi, and Vincenzo Valentini
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Otorhinolaryngology ,RF1-547 - Published
- 2022
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15. New fractionations in breast cancer: a dosimetric study of 3D‐CRT versus VMAT
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Antonio Piras, Sebastiano Menna, Andrea D’Aviero, Fabio Marazzi, Alberto Mazzini, Davide Cusumano, Mariangela Massaccesi, Gian Carlo Mattiucci, Antonino Daidone, Vincenzo Valentini, and Luca Boldrini
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early breast cancer ,hypofractionated treatment ,radiotherapy ,three‐dimensional conformal radiation therapy ,volumetric modulated arc therapy ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 - Abstract
Abstract Introduction Adjuvant radiation therapy (RT) following primary surgery in women affected by early breast cancer (EBC) plays a central role in reducing local recurrences and overall mortality. The FAST‐FORWARD trial recently demonstrated that 1‐week hypofractionated adjuvant RT is not inferior to the standard schedule in terms of local relapse, cosmetic outcomes and toxicity. The aim of this in silico study was to evaluate the dosimetric aspects of a 1‐week RT course, administered through volumetric modulated arc therapy (VMAT), compared with traditional three‐dimensional conformal radiation therapy (3D‐CRT) with tangential fields. Methods Patients affected by left‐side EBC undergoing adjuvant RT were selected. ESTRO guidelines for the clinical target volume (CTV) delineation and FAST‐FORWARD protocol for CTV to planning target volume (PTV) margin definition were followed. Total prescribed dose was 26 Gy in five fractions. The homogeneity index (HI) and the global conformity index (GCI) were taken into account for planning and dose distribution optimisation purposes. Both 3D‐CRT tangential fields and VMAT plans were generated for each patient. Results The analysis included 21 patients. PTV coverage comparison between 3D‐CRT and VMAT plans showed significant increases for GCI (P
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- 2022
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16. A process mining approach for clinical guidelines compliance: real-world application in rectal cancer
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Mariachiara Savino, Giuditta Chiloiro, Carlotta Masciocchi, Nikola Dino Capocchiano, Jacopo Lenkowicz, Benedetta Gottardelli, Maria Antonietta Gambacorta, Vincenzo Valentini, and Andrea Damiani
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process mining ,conformance checking ,process discovery ,clinical guidelines ,computer-interpretable clinical guidelines ,rectal cancer ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
In the era of evidence-based medicine, several clinical guidelines were developed, supporting cancer management from diagnosis to treatment and aiming to optimize patient care and hospital resources. Nevertheless, individual patient characteristics and organizational factors may lead to deviations from these standard recommendations during clinical practice. In this context, process mining in healthcare constitutes a valid tool to evaluate conformance of real treatment pathways, extracted from hospital data warehouses as event log, to standard clinical guidelines, translated into computer-interpretable formats. In this study we translate the European Society of Medical Oncology guidelines for rectal cancer treatment into a computer-interpretable format using Pseudo-Workflow formalism (PWF), a language already employed in pMineR software library for Process Mining in Healthcare. We investigate the adherence of a real-world cohort of rectal cancer patients treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, data associated with cancer diagnosis and treatment are extracted from hospital databases in 453 patients diagnosed with rectal cancer. PWF enables the easy implementation of guidelines in a computer-interpretable format and visualizations that can improve understandability and interpretability of physicians. Results of the conformance checking analysis on our cohort identify a subgroup of patients receiving a long course treatment that deviates from guidelines due to a moderate increase in radiotherapy dose and an addition of oxaliplatin during chemotherapy treatment. This study demonstrates the importance of PWF to evaluate clinical guidelines adherence and to identify reasons of deviations during a treatment process in a real-world and multidisciplinary setting.
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- 2023
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17. GENERATOR HEART FAILURE DataMart: An integrated framework for heart failure research
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Domenico D’Amario, Renzo Laborante, Agni Delvinioti, Jacopo Lenkowicz, Chiara Iacomini, Carlotta Masciocchi, Alice Luraschi, Andrea Damiani, Daniele Rodolico, Attilio Restivo, Giuseppe Ciliberti, Donato Antonio Paglianiti, Francesco Canonico, Stefano Patarnello, Alfredo Cesario, Vincenzo Valentini, Giovanni Scambia, and Filippo Crea
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heart failure ,big data ,artificial intelligence ,machine learning ,datamart ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
BackgroundHeart failure (HF) is a multifaceted clinical syndrome characterized by different etiologies, risk factors, comorbidities, and a heterogeneous clinical course. The current model, based on data from clinical trials, is limited by the biases related to a highly-selected sample in a protected environment, constraining the applicability of evidence in the real-world scenario. If properly leveraged, the enormous amount of data from real-world may have a groundbreaking impact on clinical care pathways. We present, here, the development of an HF DataMart framework for the management of clinical and research processes.MethodsWithin our institution, Fondazione Policlinico Universitario A. Gemelli in Rome (Italy), a digital platform dedicated to HF patients has been envisioned (GENERATOR HF DataMart), based on two building blocks: 1. All retrospective information has been integrated into a multimodal, longitudinal data repository, providing in one single place the description of individual patients with drill-down functionalities in multiple dimensions. This functionality might allow investigators to dynamically filter subsets of patient populations characterized by demographic characteristics, biomarkers, comorbidities, and clinical events (e.g., re-hospitalization), enabling agile analyses of the outcomes by subsets of patients. 2. With respect to expected long-term health status and response to treatments, the use of the disease trajectory toolset and predictive models for the evolution of HF has been implemented. The methodological scaffolding has been constructed in respect of a set of the preferred standards recommended by the CODE-EHR framework.ResultsSeveral examples of GENERATOR HF DataMart utilization are presented as follows: to select a specific retrospective cohort of HF patients within a particular period, along with their clinical and laboratory data, to explore multiple associations between clinical and laboratory data, as well as to identify a potential cohort for enrollment in future studies; to create a multi-parametric predictive models of early re-hospitalization after discharge; to cluster patients according to their ejection fraction (EF) variation, investigating its potential impact on hospital admissions.ConclusionThe GENERATOR HF DataMart has been developed to exploit a large amount of data from patients with HF from our institution and generate evidence from real-world data. The two components of the HF platform might provide the infrastructural basis for a combined patient support program dedicated to continuous monitoring and remote care, assisting patients, caregivers, and healthcare professionals.
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- 2023
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18. Predictive and prognostic value of inflammatory markers in locally advanced rectal cancer (PILLAR) – A multicentric analysis by the Italian Association of Radiotherapy and Clinical Oncology (AIRO) Gastrointestinal Study Group
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Giuditta Chiloiro, Angela Romano, Silvia Mariani, Gabriella Macchia, Diana Giannarelli, Luciana Caravatta, Pierfrancesco Franco, Luca Boldrini, Alessandra Arcelli, Almalina Bacigalupo, Liliana Belgioia, Antonella Fontana, Elisa Meldolesi, Giampaolo Montesi, Rita Marina Niespolo, Elisa Palazzari, Cristina Piva, Vincenzo Valentini, and Maria Antonietta Gambacorta
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Rectal cancer ,Neoadjuvant radiotherapy ,Inflammatory markers ,Prognostic factors ,Predictive factors ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: Patients (pts) affected with locally advanced rectal cancer (LARC) may respond differently to neoadjuvant chemoradiotherapy (nCRT). The identification of reliable biomarkers able to predict oncological outcomes could help in the development of risk-adapted treatment strategies. It has been suggested that inflammation parameters may have a role in predicting tumor response to nCRT and survival outcomes and in rectal cancer, but no definitive conclusion can be drawn at present. The aim of the current study is to evaluate the role of baseline inflammatory markers as prognostic and predictive factors in a large multicentric Italian cohort of LARC pts. Methods: Patients diagnosed with LARC from January 2002 to December 2019 in 9 Italian centers were retrospectively collected. Patients underwent long-course RT with chemotherapy based on fluoropyrimidine ± oxaliplatin followed by surgery. Inflammatory markers were retrieved based on a pre-treatment blood sample including HEI (hemo-eosinophils inflammation index), SII (systemic index of inflammation), NLR (neutrophil-to-lymphocyte ratio), PLR (platelet-to-lymphocyte ratio) and MLR (monocyte-to-lymphocyte ratio). Outcomes of interest were pathological complete response (pCR), disease-free survival (DFS), and overall survival (OS). Results: 808 pts were analyzed. pCR rate was 22 %, 5yOS and 5yDFS were 84.0% and 63.1% respectively. Multivariate analysis identified that a NLR cut-off value >1.2 and SII cut-off value >500 could predict pCR (p = 0.05 and 0.009 respectively). In addition to age, extramesorectal nodes and RT dose, MLR >0.18 (p = 0.03) and HEI = 3 (p = 0.05) were independent prognostic factors for DFS. Finally, age, RT dose, MLR with a cut-off >0.35 (p = 0.028) and HEI = 3 (p = 0.045) were independent predictors of OS. Conclusions: Higher values of baseline composite inflammatory markers can serve as predictors of lower pCR rates and worse survival outcomes in LARC patients undergoing nCRT. More reliable data from prospective studies could lead to the integration of these inexpensive and easy-to-derive tools into clinical practice.
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- 2023
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19. Prognostic Score in Radiotherapy Practice for Palliative Treatments (PROPHET) Study for Bone Metastases: An Investigation Into the Clinical Effect on Treatment Prescription
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Francesco Cellini, MD, Alessia Di Rito, MD, Giambattista Siepe, MD, Francesco Pastore, MD, Elisabetta Lattanzi, MD, Ilaria Meaglia, MD, Angelo Tozzi, MD, Stefania Manfrida, MD, Silvia Longo, MD, Simonetta Saldi, MD, Raffaele Cassese, MD, Fabio Arcidiacono, MD, Michele Fiore, MD, Valeria Masiello, MD, Ciro Mazzarella, MD, Antonio Diroma, MD, Francesco Miccichè, MD, Francesca Maurizi, MD, Luca Dominici, MD, Marta Scorsetti, MD, Mario Santarelli, MD, Vincenzo Fusco, MD, Cynthia Aristei, MD, Francesco Deodato, MD, Maria A. Gambacorta, MD, PhD, Ernesto Maranzano, MD, Paolo Muto, MD, Vincenzo Valentini, MD, Alessio G. Morganti, MD, Lorenza Marino, MD, Costanza M. Donati, MD, and Rossella Di Franco, MD
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Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Purpose: Bone metastases frequently occur during malignant disease. Palliative radiation therapy (PRT) is a crucial part of palliative care because it can relieve pain and improve patients’ quality of life. Often, a clinician's survival estimation is too optimistic. Prognostic scores (PSs) can help clinicians tailor PRT indications to avoid over- or undertreatment. Although the PS is supposed to aid radiation oncologists (ROs) in palliative-care scenarios, it is unclear what type of support, and to what extent, could impact daily clinical practice. Methods and Materials: A national-based investigation of the prescriptive decisions on simulated clinical cases was performed in Italy. Nine clinical cases from real-world clinical practice were selected for this study. Each case description contained complete information regarding the parameters defining the prognosis class according to the PS (in particular, the Mizumoto Prognostic Score, a validated PS available in literature and already applied in some clinical trials). Each case description contained complete information regarding the parameters defining the prognosis class according to the PS. ROs were interviewed through questionnaires, each comprising the same 3 questions per clinical case, asking (1) the prescription after detailing the clinical case features but not the PS prognostic class definition; (2) whether the RO wanted to change the prescription once the PS prognostic class definition was revealed; and (3) in case of a change of the prescription, a new prescriptive option. Three RO categories were defined: dedicated to PRT (RO-d), nondedicated to PRT (RO-nd), and resident in training (IT). Interviewed ROs were distributed among different regions of the country. Results: Conversion rates, agreements, and prescription trends were investigated. The PS determined a statistically significant 11.12% of prescription conversion among ROs. The conversion was higher for the residents and significantly higher for worse prognostic scenario subgroups, respectively. The PS improved prescriptive agreement among ROs (particularly for worse-prognostic-scenario subgroups). Moreover, PS significantly increased standard prescriptive approaches (particularly for worse-clinical-case presentations). Conclusions: To the best of our knowledge, the PROPHET study is the first to directly evaluate the potential clinical consequences of the regular application of any PS. According to the Prophet study, a prognostic score should be integrated into the clinical practice of palliative radiation therapy for bone metastasis and training programs in radiation oncology.
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- 2023
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20. A predictive model of polymetastatic disease from a multicenter large retrospectIve database on colorectal lung metastases treated with stereotactic ablative radiotherapy: The RED LaIT-SABR study
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Luca Nicosia, Davide Franceschini, Francesca Perrone-Congedi, Alessandro Molinari, Marianna Alessandra Gerardi, Michele Rigo, Rosario Mazzola, Marco Perna, Vieri Scotti, Andrei Fodor, Aurelia Iurato, Francesco Pasqualetti, Giovanni Gadducci, Silvia Chiesa, Rita Marina Niespolo, Alessio Bruni, Anna Cappelli, Elisa D'Angelo, Paolo Borghetti, Alessandro Di Marzo, Andrea Ravasio, Berardino De Bari, Matteo Sepulcri, Dario Aiello, Gianluca Mortellaro, Claudia Sangalli, Marzia Franceschini, Giampaolo Montesi, Francesco Maria Aquilanti, Gianluigi Lunardi, Riccardo Valdagni, Ivan Fazio, Giovanni Scarzello, Vittorio Vavassori, Ernesto Maranzano, Stefano Maria Magrini, Stefano Arcangeli, Maria Antonietta Gambacorta, Vincenzo Valentini, Fabiola Paiar, Sara Ramella, Nadia Gisella Di Muzio, Mauro Loi, Barbara Alicja Jereczek-Fossa, Franco Casamassima, Mattia Falchetto Osti, Marta Scorsetti, and Filippo Alongi
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Stereotactic ablative radiotherapy ,SABR ,SBRT ,Colorectal cancer ,Oligometastatic disease ,Predictive factors ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Aim: Stereotactic ablative radiotherapy (SABR) showed increasing survival in oligometastatic patients. Few studies actually depicted oligometastatic disease (OMD) evolution and which patient will remain disease-free and which will rapidly develop a polymetastatic disease (PMD) after SABR. Therefore, apart from the number of active metastases, there are no clues on which proven factor should be considered for prescribing local treatment in OMD. The study aims to identify predictive factors of polymetastatic evolution in lung oligometastatic colorectal cancer patients. Methods: This international Ethical Committee approved trial (Prot. Negrar 2019-ZT) involved 23 Centers and 450 lung oligometastatic patients. Primary end-point was time to the polymetastatic conversion (tPMC). Additionally, oligometastases number and cumulative gross tumor volume (cumGTV) were used as combined predictive factors of tPMC. Oligometastases number was stratified as 1, 2–3, and 4–5; cumGTV was dichotomized to the value of 10 cc. Results: The median tPMC in the overall population was 26 months. Population was classified in the following tPMC risk classes: low-risk (1–3 oligometastases and cumGTV ≤ 10 cc) with median tPMC of 35.1 months; intermediate-risk (1–3 oligometastases and cumGTV > 10 cc), with median tPMC of 13.9 months, and high-risk (4–5 oligometastases, any cumGTV) with median tPMC of 9.4 months (p = 0.000). Conclusion: The present study identified predictive factors of polymetastatic evolution after SABR in lung oligometastatic colorectal cancer. The results demonstrated that the sole metastases number is not sufficient to define the OMD since patients defined oligometastatic from a numerical point of view might rapidly progress to PMD when the cumulative tumor volume is high. A tailored approach in SABR prescription should be pursued considering the expected disease evolution after SABR, with the aim to avoid unnecessary treatment and toxicity in those at high risk of polymetastatic spread, and maximize local treatment in those with a favorable disease evolution.
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- 2023
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21. BRIDGE −1 TRIAL: BReak Interval Delayed surgery for Gastrointestinal Extraperitoneal rectal cancer, a multicentric phase III randomized trial
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Giuditta Chiloiro, Elisa Meldolesi, Barbara Corvari, Angela Romano, Brunella Barbaro, Claudio Coco, Antonio Crucitti, Domenico Genovesi, Marco Lupattelli, Giovanna Mantello, Roberta Menghi, Mattia Falchetto Osti, Roberto Persiani, Lucio Petruzziello, Riccardo Ricci, Luigi Sofo, Chiara Valentini, Antonino De Paoli, Vincenzo Valentini, and Maria Antonietta Gambacorta
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Rectal cancer ,Surgical Interval ,Neoadjuvant chemoradiotherapy ,Personalized treatment ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Design: Neoadjuvant chemoradiotherapy (nCRT) followed by surgery is the standard of care for locally advanced rectal cancer (LARC).Several studies have shown a correlation between a longer interval between the end of nCRT and surgery (surgical interval - SI) and an increased pathological complete response (pCR) rate, with a maximum obtained between 10 and 13 weeks.The primary endpoint of this multicenter, 2-arm randomised trial is to investigate SI lengthening, evaluating the difference in terms of complete response (CR) and Tumor Regression Grade (TRG)1 rate in the two arms. Secondly, the impact of SI lengthening on survival outcomes and quality of life (QoL) will be investigated. Methods: Intermediate-risk LARC patients undergoing nCRT will be prospectively included in the study. nCRT will be administered with a total dose of 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum of 45 Gy in 25 fractions on the whole pelvis. Chemotherapy with oral capecitabine will be administered continuously.The patients achieving a clinical major or complete response assessed at clinical-instrumental re-evaluation at 7–8 weeks after treatment completion, will be randomized into two groups, to undergo surgery or local excision at 9–11 weeks (control arm) or at 13–16 weeks (experimental arm). Pathological response will be assessed on the surgical specimen using the AJCC TNM v.7 and the TRG according to Mandard. Patients will be followed up to evaluate toxicity and QoL.The promoter center of the trial will conduct the randomization process through an automated procedure to prevent any possible bias.For sample size calculation, using CR difference of 20% as endpoint, 74 patients per arm will be enrolled. Conclusions: The results of this study may prospectively provide a new time frame for the clinical re-evaluation for complete/major responders patients in order to increase the CR rate to nCRT.Trial registration:ClinicalTrials.gov Identifier: NCT03581344.
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- 2022
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22. Applicability of a pathological complete response magnetic resonance-based radiomics model for locally advanced rectal cancer in intercontinental cohort
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Luca Boldrini, Jacopo Lenkowicz, Lucia Clara Orlandini, Gang Yin, Davide Cusumano, Giuditta Chiloiro, Nicola Dinapoli, Qian Peng, Calogero Casà, Maria Antonietta Gambacorta, Vincenzo Valentini, and Jinyi Lang
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Radiotherapy ,Radiomics ,Rectum ,Magnetic resonance imaging ,Intensity modulated radiation therapy ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Predicting pathological complete response (pCR) in patients affected by locally advanced rectal cancer (LARC) who undergo neoadjuvant chemoradiotherapy (nCRT) is a challenging field of investigation, but many of the published models are burdened by a lack of reliable external validation. Aim of this study was to evaluate the applicability of a magnetic resonance imaging (MRI) radiomic-based pCR model developed and validated in Europe, to a different cohort of patients from an intercontinental cancer center. Methods The original model was based on two clinical and two radiomics features extracted from T2-weighted 1.5 T MRI of 161 LARC patients acquired before nCRT, considered as training set. Such model is here validated using the T2-w 1.5 and 3 T staging MRI of 59 LARC patients with different clinical characteristics consecutively treated in mainland Chinese cancer center from March 2017 to January 2018. Model performance were evaluated in terms of area under the receiver operator characteristics curve (AUC) and relative parameters, such as accuracy, specificity, negative and positive predictive value (NPV and PPV). Results An AUC of 0.83 (CI 95%, 0.71–0.96) was achieved for the intercontinental cohort versus a value of 0.75 (CI 95%, 0.61–0.88) at the external validation step reported in the original experience. Considering the best cut-off threshold identified in the first experience (0.26), the following predictive performance were obtained: 0.65 as accuracy, 0.64 as specificity, 0.70 as sensitivity, 0.91 as NPV and 0.28 as PPV. Conclusions Despite the introduction of significant different factors, the proposed model appeared to be replicable on a real-world data extra-European patients’ cohort, achieving a TRIPOD 4 level.
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- 2022
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23. Bayesian network structure for predicting local tumor recurrence in rectal cancer patients treated with neoadjuvant chemoradiation followed by surgery
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Biche Osong, Carlotta Masciocchi, Andrea Damiani, Inigo Bermejo, Elisa Meldolesi, Giuditta Chiloiro, Maaike Berbee, Seok Ho Lee, Andre Dekker, Vincenzo Valentini, Jean-Pierre Gerard, Claus Rödel, Krzysztof Bujko, Cornelis van de Velde, Joakim Folkesson, Aldo Sainato, Robert Glynne-Jones, Samuel Ngan, Morten Brændengen, David Sebag-Montefiore, and Johan van Soest
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Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background and Purpose: Tumor recurrence, a characteristic of malignant tumors, is the biggest concern for rectal cancer survivors. The epidemiology of the disease calls for a pressing need to improve healthcare quality and patient outcomes. Prediction models such as Bayesian networks, which can probabilistically reason under uncertainty, could assist caregivers with patient management. However, some concerns are associated with the standard approaches to developing these structures in medicine. Therefore, this study aims to compare Bayesian network structures that stem from these two techniques. Materials and Methods: A retrospective analysis was performed on 6754 locally advanced rectal cancer (LARC) patients enrolled in 14 international clinical trials. Local tumor recurrence at 2, 3, and 5-years was defined as the endpoints of interest. Five rectal cancer treating physicians from three countries elicited the expert structure. The algorithmic structure was inferred from the data with the hill-climbing algorithm. Structural performance was assessed with calibration plots and area under the curve values. Results: The area under the curve for the expert structure on the training and validation data was above 0.9 and 0.8, respectively, for all the time points. However, the algorithmic structure had superior predictive performance over the expert structure for all time points of interest. Conclusion: We have developed and internally validated a Bayesian networks structure from experts’ opinions, which can predict the risk of a LARC patient developing a tumor recurrence at 2, 3, and 5 years. Our result shows that the algorithmic-based structures are more performant and less interpretable than expert-based structures.
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- 2022
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24. Local tuning of radiomics-based model for predicting pathological response to neoadjuvant chemoradiotherapy in locally advanced rectal cancer
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Bin Tang, Jacopo Lenkowicz, Qian Peng, Luca Boldrini, Qing Hou, Nicola Dinapoli, Vincenzo Valentini, Peng Diao, Gang Yin, and Lucia Clara Orlandini
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Radiomics ,Rectum ,Predictive models ,Pathological complete response ,LASSO ,Medical technology ,R855-855.5 - Abstract
Abstract Purpose This study aims to further enhance a validated radiomics-based model for predicting pathologic complete response (pCR) after chemo‑radiotherapy in locally advanced rectal cancer (LARC) for use in clinical practice. Methods A generalized linear model (GLM) to predict pCR in LARC patients previously trained in Europe and validated with an external inter-continental cohort (59 patients), was first examined with further 88 intercontinental patient datasets to assess its reproducibility; then new radiomics and clinical features, and validation methods were investigated to build a new model for enhancing the pCR prediction for patients admitted to our department. The patients were divided into training group (75%) and validation group (25%) according to their demographic. The least absolute shrinkage and selection operator (LASSO) logistic regression was used to reduce the dimensionality of the extracted features of the training group and select the optimal ones; the performance of the reference GLM and enhanced models was compared through the area under curve (AUC) of the receiver operating characteristics. Results The value of AUC of the reference model was 0.831 (95% CI, 0.701–0.961), and 0.828 (95% CI, 0.700–0.956) in the original and new validation cohorts, respectively, showing a reproducibility in the applicability of the GLM model. Eight features were found to be significant with LASSO and used to establish an enhanced model. The AUC of the enhanced model of 0.926 (95% CI, 0.859–0.993) for training, and 0.926 (95% CI, 0.767–1.00) for the validation group shows better performance than the reference model. Conclusions The GLM model shows good reproducibility in predicting pCR in LARC; the enhanced model has the potential to improve prediction accuracy and may be a candidate in clinical practice.
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- 2022
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25. THUNDER 2: THeragnostic Utilities for Neoplastic DisEases of the Rectum by MRI guided radiotherapy
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Giuditta Chiloiro, Davide Cusumano, Luca Boldrini, Angela Romano, Lorenzo Placidi, Matteo Nardini, Elisa Meldolesi, Brunella Barbaro, Claudio Coco, Antonio Crucitti, Roberto Persiani, Lucio Petruzziello, Riccardo Ricci, Lisa Salvatore, Luigi Sofo, Sergio Alfieri, Riccardo Manfredi, Vincenzo Valentini, and Maria Antonietta Gambacorta
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Magnetic Resonance guided Radiation Therapy ,Rectal cancer ,Chemoradiotherapy ,Early Regression Index ,Radiomics ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Neoadjuvant chemoradiation therapy (nCRT) is the standard treatment modality in locally advanced rectal cancer (LARC). Since response to radiotherapy (RT) is dose dependent in rectal cancer, dose escalation may lead to higher complete response rates. The possibility to predict patients who will achieve complete response (CR) is fundamental. Recently, an early tumour regression index (ERI) was introduced to predict pathological CR (pCR) after nCRT in LARC patients. The primary endpoints will be the increase of CR rate and the evaluation of feasibility of delta radiomics-based predictive MRI guided Radiotherapy (MRgRT) model. Methods Patients affected by LARC cT2-3, N0-2 or cT4 for anal sphincter involvement N0-2a, M0 without high risk features will be enrolled in the trial. Neoadjuvant CRT will be administered using MRgRT. The initial RT treatment will consist in delivering 55 Gy in 25 fractions on Gross Tumor Volume (GTV) plus the corresponding mesorectum and 45 Gy in 25 fractions on the drainage nodes. Chemotherapy with 5-fluoracil (5-FU) or oral capecitabine will be administered continuously. A 0.35 Tesla MRI will be acquired at simulation and every day during MRgRT. At fraction 10, ERI will be calculated: if ERI will be inferior than 13.1, the patient will continue the original treatment; if ERI will be higher than 13.1 the treatment plan will be reoptimized, intensifying the dose to the residual tumor at the 11th fraction to reach 60.1 Gy. At the end of nCRT instrumental examinations are to be performed in order to restage patients. In case of stable disease or progression, the patient will undergo surgery. In case of major or complete clinical response, conservative approaches may be chosen. Patients will be followed up to evaluate toxicity and quality of life. The number of cases to be enrolled will be 63: all the patients will be treated at Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Discussion This clinical trial investigates the impact of RT dose escalation in poor responder LARC patients identified using ERI, with the aim of increasing the probability of CR and consequently an organ preservation benefit in this group of patients. Trial registration ClinicalTrials.gov Identifier: NCT04815694 (25/03/2021).
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- 2022
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26. Ventricular tachycardia ablation through radiation therapy (VT-ART) consortium: Concept description of an observational multicentric trial via matched pair analysis
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Francesco Cellini, Maria Lucia Narducci, Chiara Pavone, Gianluigi Bencardino, Francesco Perna, Gaetano Pinnacchio, Silvia Chiesa, Mariangela Massaccesi, Maria Antonietta Gambacorta, Stefania Manfrida, Silvia Longo, Alice Mannocci, Giuseppe Di Gregorio, Luca Boldrini, Luca Tagliaferri, Luca Indovina, Lorenzo Placidi, Gerardina Stimato, Francesco Raffaele Spera, Roberto Scacciavillani, Filippo Crea, Vincenzo Valentini, and Gemma Pelargonio
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radiotherapy ,ventricular tachycardia ,stereotactic arrhythmia radioablation (STAR) ,stereotactic body radiation therapy (SBRT) ,radioablation ,clinical trial ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
IntroductionMonomorphic ventricular tachycardia (VT) is a life-threatening condition often observed in patients with structural heart disease. Ventricular tachycardia ablation through radiation therapy (VT-ART) for sustained monomorphic ventricular tachycardia seems promising, effective, and safe. VT-ART delivers focused, high-dose radiation, usually in a single fraction of 25 Gy, allowing ablation of VT by inducing myocardial scars. The procedure is fully non-invasive; therefore, it can be easily performed in patients with contraindications to invasive ablation procedures. Definitive data are lacking, and no direct comparison with standard procedures is available.DiscussionThe aim of this multicenter observational study is to evaluate the efficacy and safety of VT-ART, comparing the clinical outcome of patients undergone to VT-ART to patients not having received such a procedure. The two groups will not be collected by direct, prospective accrual to avoid randomization among the innovative and traditional arm: A retrospective selection through matched pair analysis will collect patients presenting features similar to the ones undergone VT-ART within the consortium (in each center independently). Our trial will enroll patients with optimized medical therapy in whom endocardial and/or epicardial radiofrequency ablation (RFA), the gold standard for VT ablation, is either unfeasible or fails to control VT recurrence. Our primary outcome is investigating the difference in overall cardiovascular survival among the group undergoing VT-ART and the one not exposed to the innovative procedure. The secondary outcome is evaluating the difference in ventricular event-free survival after the last procedure (i.e., last RFA vs. VT-ART) between the two groups. An additional secondary aim is to evaluate the reduction in the number of VT episodes comparing the 3 months before the procedure to the ones recorded at 6 months (from the 4th to 6th month) following VT-ART and RFA, respectively. Other secondary objectives include identifying the benefits of VT-ART on cardiac function, as evaluated through an electrocardiogram, echocardiographic, biochemical variables, and on patient quality of life. We calculated the sample size (in a 2:1 ratio) upon enrolling 149 patients: 100 in the non-exposed control group and 49 in the VT-ART group. Progressively, on a multicentric basis supervised by the promoting center in the VT-ART consortium, for each VT-ART patient enrollment, a matched pair patient profile according to the predefined features will be shared with the consortium to enroll a patient that has not undergone VT-ART.ConclusionOur trial will provide insight into the efficacy and safety of VT-ART through a matched pair analysis, via an observational, multicentric study of two groups of patients with or without VT-ART in the multicentric consortium (with subgroup stratification into dynamic cohorts).
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- 2023
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27. Integration of art and technology in personalized radiation oncology care: Experiences, evidence, and perspectives
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Calogero Casà, Loredana Dinapoli, Elisa Marconi, Silvia Chiesa, Patrizia Cornacchione, Francesco Beghella Bartoli, Serena Bracci, Alessandra Salvati, Sara Scalise, Giuseppe Ferdinando Colloca, Daniela Pia Rosaria Chieffo, Maria Antonietta Gambacorta, Vincenzo Valentini, and Luca Tagliaferri
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radiotherapy ,technology ,art ,digital ,personalization ,oncology ,Public aspects of medicine ,RA1-1270 - Abstract
Cancer diagnoses expose patients to traumatic stress, sudden changes in daily life, changes in the body and autonomy, with even long-term consequences, and in some cases, to come to terms with the end-of-life. Furthermore, rising survival rates underline that the need for interventions for emotional wellbeing is in growing demand by patients and survivors. Cancer patients frequently have compliance problems, difficulties during treatment, stress, or challenges in implementing healthy behaviors. This scenario was highlighted during the COVID-19 emergency. These issues often do not reach the clinical attention of dedicated professionals and could also become a source of stress or burnout for professionals. So, these consequences are evident on individual, interpersonal, and health system levels. Oncology services have increasingly sought to provide value-based health care, considering resources invested, with implications for service delivery and related financing mechanisms. Value-based health care can improve patient outcomes, often revealed by patient outcome measures while seeking balance with economical budgets. The paper aims to show the Gemelli Advanced Radiation Therapy (ART) experience of personalizing the patients' care pathway through interventions based on technologies and art, the personalized approach to cancer patients and their role as “co-stars” in treatment care. The paper describes the vision, experiences, and evidence that have guided clinical choices involving patients and professionals in a co-constructed therapeutic pathway. We will explore this approach by describing: the various initiatives already implemented and prospects, with particular attention to the economic sustainability of the paths proposed to patients; the several pathways of personalized care, both from the patient's and healthcare professional perspective, that put the person's experience at the Gemelli ART Center. The patient's satisfaction with the treatment and economic outcomes have been considered. The experiences and future perspectives described in the manuscript will focus on the value of people's experiences and patient satisfaction indicators, patients, staff, and the healthcare organization.
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- 2023
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28. Cryoablation in Locoregional Management of Complex Unresectable Chest Neoplasms
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Roberto Iezzi, Andrea Contegiacomo, Alessandro Posa, Nico Attempati, Ernesto Punzi, Alessandro Tanzilli, Stefano Margaritora, Maria Teresa Congedo, Alessandra Cassano, Emilio Bria, Luca Tagliaferri, Vincenzo Valentini, Cesare Colosimo, and Riccardo Manfredi
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cryoablation ,lung tumors ,interventional radiology ,Computer applications to medicine. Medical informatics ,R858-859.7 - Abstract
Rationale and Objectives: The aim of our retrospective study was to assess the safety and feasibility of cryoablation in high-risk patients with complex chest neoplastic lesions. Materials and Methods: Twenty patients with complex chest malignancies, both primary and secondary, located in the mediastinum, lung, and chest wall, underwent percutaneous CT-guided cryoablation treatments. Procedural success as well as complications were evaluated. Results: A total of 24 neoplastic lesions were treated (mean diameter: 27 mm; range: 7–54 mm). Technical success was obtained in all patients, without major complications or intraprocedural death. A pneumothorax not requiring a drainage tube placement was registered in 50% of patients, while 3/24 patients had a grade 3 pneumothorax requiring a chest tube placement. Conclusion: Percutaneous CT-guided cryoablation seems a safe and feasible treatment for complex thoracic lesions.
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- 2021
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29. The Porto European Cancer Research Summit 2021
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Ulrik Ringborg, Anton Berns, Julio E. Celis, Manuel Heitor, Josep Tabernero, Joachim Schüz, Michael Baumann, Rui Henrique, Matti Aapro, Partha Basu, Regina Beets‐Tan, Benjamin Besse, Fátima Cardoso, Fátima Carneiro, Guy vanden Eede, Alexander Eggermont, Stefan Fröhling, Susan Galbraith, Elena Garralda, Douglas Hanahan, Thomas Hofmarcher, Bengt Jönsson, Olli Kallioniemi, Miklós Kásler, Eva Kondorosi, Jan Korbel, Denis Lacombe, José Carlos Machado, José M. Martin‐Moreno, Francoise Meunier, Péter Nagy, Paolo Nuciforo, Simon Oberst, Júlio Oliveiera, Maria Papatriantafyllou, Walter Ricciardi, Alexander Roediger, Bettina Ryll, Richard Schilsky, Grazia Scocca, Raquel Seruca, Marta Soares, Karen Steindorf, Vincenzo Valentini, Emile Voest, Elisabete Weiderpass, Nils Wilking, Amanda Wren, and Laurence Zitvogel
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Cancer Mission ,cancer research/care/prevention continuum ,clinical/prevention trials ,comprehensive cancer centres ,infrastructures for translational cancer research ,outcomes research ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Key stakeholders from the cancer research continuum met in May 2021 at the European Cancer Research Summit in Porto to discuss priorities and specific action points required for the successful implementation of the European Cancer Mission and Europe's Beating Cancer Plan (EBCP). Speakers presented a unified view about the need to establish high‐quality, networked infrastructures to decrease cancer incidence, increase the cure rate, improve patient's survival and quality of life, and deal with research and care inequalities across the European Union (EU). These infrastructures, featuring Comprehensive Cancer Centres (CCCs) as key components, will integrate care, prevention and research across the entire cancer continuum to support the development of personalized/precision cancer medicine in Europe. The three pillars of the recommended European infrastructures – namely translational research, clinical/prevention trials and outcomes research – were pondered at length. Speakers addressing the future needs of translational research focused on the prospects of multiomics assisted preclinical research, progress in Molecular and Digital Pathology, immunotherapy, liquid biopsy and science data. The clinical/prevention trial session presented the requirements for next‐generation, multicentric trials entailing unified strategies for patient stratification, imaging, and biospecimen acquisition and storage. The third session highlighted the need for establishing outcomes research infrastructures to cover primary prevention, early detection, clinical effectiveness of innovations, health‐related quality‐of‐life assessment, survivorship research and health economics. An important outcome of the Summit was the presentation of the Porto Declaration, which called for a collective and committed action throughout Europe to develop the cancer research infrastructures indispensable for fostering innovation and decreasing inequalities within and between member states. Moreover, the Summit guidelines will assist decision making in the context of a unique EU‐wide cancer initiative that, if expertly implemented, will decrease the cancer death toll and improve the quality of life of those confronted with cancer, and this is carried out at an affordable cost.
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- 2021
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30. A machine-learning parsimonious multivariable predictive model of mortality risk in patients with Covid-19
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Rita Murri, Jacopo Lenkowicz, Carlotta Masciocchi, Chiara Iacomini, Massimo Fantoni, Andrea Damiani, Antonio Marchetti, Paolo Domenico Angelo Sergi, Giovanni Arcuri, Alfredo Cesario, Stefano Patarnello, Massimo Antonelli, Rocco Bellantone, Roberto Bernabei, Stefania Boccia, Paolo Calabresi, Andrea Cambieri, Roberto Cauda, Cesare Colosimo, Filippo Crea, Ruggero De Maria, Valerio De Stefano, Francesco Franceschi, Antonio Gasbarrini, Ornella Parolini, Luca Richeldi, Maurizio Sanguinetti, Andrea Urbani, Maurizio Zega, Giovanni Scambia, Vincenzo Valentini, and The Gemelli against Covid Group
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Medicine ,Science - Abstract
Abstract The COVID-19 pandemic is impressively challenging the healthcare system. Several prognostic models have been validated but few of them are implemented in daily practice. The objective of the study was to validate a machine-learning risk prediction model using easy-to-obtain parameters to help to identify patients with COVID-19 who are at higher risk of death. The training cohort included all patients admitted to Fondazione Policlinico Gemelli with COVID-19 from March 5, 2020, to November 5, 2020. Afterward, the model was tested on all patients admitted to the same hospital with COVID-19 from November 6, 2020, to February 5, 2021. The primary outcome was in-hospital case-fatality risk. The out-of-sample performance of the model was estimated from the training set in terms of Area under the Receiving Operator Curve (AUROC) and classification matrix statistics by averaging the results of fivefold cross validation repeated 3-times and comparing the results with those obtained on the test set. An explanation analysis of the model, based on the SHapley Additive exPlanations (SHAP), is also presented. To assess the subsequent time evolution, the change in paO2/FiO2 (P/F) at 48 h after the baseline measurement was plotted against its baseline value. Among the 921 patients included in the training cohort, 120 died (13%). Variables selected for the model were age, platelet count, SpO2, blood urea nitrogen (BUN), hemoglobin, C-reactive protein, neutrophil count, and sodium. The results of the fivefold cross-validation repeated 3-times gave AUROC of 0.87, and statistics of the classification matrix to the Youden index as follows: sensitivity 0.840, specificity 0.774, negative predictive value 0.971. Then, the model was tested on a new population (n = 1463) in which the case-fatality rate was 22.6%. The test model showed AUROC 0.818, sensitivity 0.813, specificity 0.650, negative predictive value 0.922. Considering the first quartile of the predicted risk score (low-risk score group), the case-fatality rate was 1.6%, 17.8% in the second and third quartile (high-risk score group) and 53.5% in the fourth quartile (very high-risk score group). The three risk score groups showed good discrimination for the P/F value at admission, and a positive correlation was found for the low-risk class to P/F at 48 h after admission (adjusted R-squared = 0.48). We developed a predictive model of death for people with SARS-CoV-2 infection by including only easy-to-obtain variables (abnormal blood count, BUN, C-reactive protein, sodium and lower SpO2). It demonstrated good accuracy and high power of discrimination. The simplicity of the model makes the risk prediction applicable for patients in the Emergency Department, or during hospitalization. Although it is reasonable to assume that the model is also applicable in not-hospitalized persons, only appropriate studies can assess the accuracy of the model also for persons at home.
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- 2021
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31. Tuning the optimal diffusion-weighted MRI parameters on a 0.35-T MR-Linac for clinical implementation: A phantom study
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Matteo Nardini, Amedeo Capotosti, Lorenzo Nicola Mazzoni, Davide Cusumano, Luca Boldrini, Giuditta Chiloiro, Angela Romano, Vincenzo Valentini, Luca Indovina, and Lorenzo Placidi
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MRI ,DWI ,MR-linac ,diffusion ,ADC ,MRgRT ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PurposeThis study aims to assess the quality of a new diffusion-weighted imaging (DWI) sequence implemented on an MR-Linac MRIdian system, evaluating and optimizing the acquisition parameters to explore the possibility of clinically implementing a DWI acquisition protocol in a 0.35-T MR-Linac.Materials and methodsAll the performed analyses have been carried out on two types of phantoms: a homogeneous 24-cm diameter polymethylmethacrylate (PMMA) sphere (SP) and a homemade phantom (HMP) constating in a PMMA cylinder filled with distilled water with empty sockets into which five cylindrical vials filled with five different concentrations of methylcellulose water solutions have been inserted. SP was used to evaluate the dependence of diffusion gradient inhomogeneity artifacts on gantry position. Four diffusion sequences with b-values of 500 s/mm2 and 3 averages have been acquired: three with diffusion gradients in the three main directions (phase direction, read direction, slice direction) and one with the diffusion gradients switched off. The dependence of diffusion image uniformity and SNR on the number of averages in the MR sequences was also investigated to determine the optimal number of averages. Finally, the ADC values of HMP have been computed and then compared between images acquired in the scanners at 0.35 and 1.5 T.ResultsIn order to acquire high-quality artifact-free DWI images, the “slice” gradient direction has been identified to be the optimal one and 0° to be the best gradient angle. Both the SNR ratio and the uniformity increase with the number of averages. A threshold value of 80 for SNR and 85% for uniformity was adopted to choose the best number of averages. By making a compromise between time and quality and limiting the number of b-values, it is possible to reduce the acquisition time to 78 s. The Passing–Bablok test showed that the two methods, with 0.35 and 1.5 T scanners, led to similar results.ConclusionThe quality of the DWI has been accurately evaluated in relation to different sequence parameters, and optimal parameters have been identified to select a clinical protocol for the acquisition of ADC maps sustainable in the workflow of a hybrid radiotherapy system with a 0.35-T MRI scanner.
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- 2022
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32. Use of information and communication technologies (ICTs) in cancer multidisciplinary team meetings: an explorative study based on EU healthcare professionals
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Karolien Goffin, Jordi Ponce, Ramon Salazar, Vincenzo Valentini, Daniele Regge, Joan Prades, Cristina Coll-Ortega, Josep M Borras, Claudio Lombardo, Lissandra Dal Lago, Eugen Javor, and Johan de Munter
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Medicine - Abstract
Objectives Multidisciplinary teams in cancer care are increasingly using information and communication technology (ICT), hospital health information system (HIS) functionalities and ICT-driven care components. We aimed to explore the use of these tools in multidisciplinary team meetings (MTMs) and to identify the critical challenges posed by their adoption based on the perspective of professionals representatives from European scientific societies.Design This qualitative study used discussion of cases and focus group technique to generate data. Thematic analysis was applied.Setting Healthcare professionals working in a multidisciplinary cancer care environment.Participants Selection of informants was carried out by European scientific societies in accordance with professionals’ degree of experience in adopting the implementation of ICT and from different health systems.Results Professionals representatives of 9 European scientific societies were involved. Up to 10 ICTs, HIS functionalities and care components are embedded in the informational and decision-making processes along three stages of MTMs. ICTs play a key role in opening MTMs to other institutions (eg, by means of molecular tumour boards) and information types (eg, patient-reported outcome measures), and in contributing to the internal efficiency of teams. While ICTs and care components have their own challenges, the information technology context is characterised by the massive generation of unstructured data, the lack of interoperability between systems from different hospitals and HIS that are conceived to store and classify information rather than to work with it.Conclusions The emergence of an MTM model that is better integrated in the wider health system context and incorporates inputs from patients and support systems make traditional meetings more dynamic and interconnected. Although these changes signal a second transition in the development process of multidisciplinary teams, they occur in a context marked by clear gaps between the information and management needs of MTMs and the adequacy of current HIS.
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- 2022
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33. KIT 1 (Keep in Touch) Project—Televisits for Cancer Patients during Italian Lockdown for COVID-19 Pandemic: The Real-World Experience of Establishing a Telemedicine System
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Calogero Casà, Barbara Corvari, Francesco Cellini, Patrizia Cornacchione, Andrea D’Aviero, Sara Reina, Silvia Di Franco, Alessandra Salvati, Giuseppe Ferdinando Colloca, Alfredo Cesario, Stefano Patarnello, Mario Balducci, Alessio Giuseppe Morganti, Vincenzo Valentini, Maria Antonietta Gambacorta, and Luca Tagliaferri
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telemedicine ,digital health ,radiation oncology ,Medicine - Abstract
To evaluate the adoption of an integrated eHealth platform for televisit/monitoring/consultation during the COVID-19 pandemic. Methods: During the lockdown imposed by the Italian government during the COVID19 pandemic spread, a dedicated multi-professional working group was set up in the Radiation Oncology Department with the primary aim of reducing patients’ exposure to COVID-19 by adopting de-centralized/remote consultation methodologies. Each patient’s clinical history was screened before the visit to assess if a traditional clinical visit would be recommended or if a remote evaluation was to be preferred. Real world data (RWD) in the form of patient-reported outcomes (PROMs) and patient reported experiences (PREMs) were collected from patients who underwent televisit/teleconsultation through the eHealth platform. Results: During the lockdown period (from 8 March to 4 May 2020) a total of 1956 visits were managed. A total of 983 (50.26%) of these visits were performed via email (to apply for and to upload of documents) and phone call management; 31 visits (1.58%) were performed using the eHealth system. Substantially, all patients found the eHealth platform useful and user-friendly, consistently indicating that this type of service would also be useful after the pandemic. Conclusions: The rapid implementation of an eHealth system was feasible and well-accepted by the patients during the pandemic. However, we believe that further evidence is to be generated to further support large-scale adoption.
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- 2023
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34. Successful ventricular tachycardia radioablation in a patient with previous chemical pleurodesis: A case report
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Chiara Pavone, Roberto Scacciavillani, Maria Lucia Narducci, Francesco Cellini, Gemma Pelargonio, Gianluigi Bencardino, Francesco Perna, Francesco Spera, Gaetano Pinnacchio, Tommaso Sanna, Vincenzo Valentini, and Filippo Crea
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ventricular tachycardia ,stereotactic arrhythmia radioablation ,chemical pleurodesis ,case report ,epicardial ventricular tachycardia ablation ,Diseases of the circulatory (Cardiovascular) system ,RC666-701 - Abstract
IntroductionStereotactic arrhythmia radioablation (STAR) is a novel technique for the ablation of ventricular tachycardia in patients with contraindications to standard procedures, i.e., radiofrequency ablation.Case presentationWe report the case of a 73-year-old man with non-ischemic dilated cardiomyopathy and recurrent VT episodes. Electroanatomic mapping showed VT prevalently of epicardial origin, but direct epicardial access through subxyphoid puncture could not be performed due to pleuropericardial adhesions from a past history of chemical pleurodesis. STAR was performed, with no VT recurrence at 6 months follow-up.ConclusionsPrevious experiences with STAR have demonstrated its importance in the management of patients with refractory VT in whom other ablation strategies were not successful. Our case report highlights the use of STAR as a second choice in a patient with an unfavorable VT anatomical location and technical limitations to an optimal radiofrequency ablation. Moreover, it confirms STAR's effectiveness in the ablation of complex transmural lesions, which are more often associated with non-ischemic structural heart disease.
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- 2022
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35. Could the conservative approach be considered safe in the treatment of locally advanced rectal cancer in case of a clinical near-complete or complete response? A retrospective analysis
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Giuditta Chiloiro, Elisa Meldolesi, Martina Giraffa, Nikola Dino Capocchiano, Brunella Barbaro, Claudio Coco, Barbara Corvari, Paola De Franco, Domenico D'Ugo, Sergio Alfieri, Riccardo Manfredi, Vincenzo Valentini, and Maria Antonietta Gambacorta
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Rectal cancer ,Chemoradiotherapy ,Watch and Wait ,Clinical near complete response ,Clinical Complete Response ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background: Conservative approach has emerged as an option for the management of rectal cancer (RC) patients with a near or complete clinical response after neoadjuvant chemoradiotherapy (nCRT). The aim of this study is to assess the impact of the conservative approach by comparing patients’ survival outcomes and quality of life with those who had surgical resection. Methods: A single-institution and retrospective study including RC patients who reached a near complete or complete clinical response after nCRT from January 2010 to September 2019. Conservative approaches included local excision or watch and wait strategy; surgery approaches included anterior resection or abdominal-perineal resection.Local regrowth (LR), overall survival, disease free survival, metastasis free survival and colostomy free survival were evaluated through Kaplan-Meier curves and compared trough log-rank tests. Quality of life was measured by the following validated questionnaires: EORTC QLC30, EORTC QLQ – CR29 and Fecal Incontinence Quality of Life scale. Results: Overall 157 patients were analyzed: 105 (66,9%) underwent radical surgery and 52 (33,1%) had a conservative approach. With a median follow-up of 51 months, 2 patients in the surgical group had a local recurrence and 8 in the conservative group had a LR, respectively. Distance metastasis occurred in 7 and 1 patients of surgical and conservative group, respectively. No differences were detected in terms of survival outcomes except for colostomy free survival (p: 0,01). The conservative group showed better intestinal (p
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- 2021
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36. Delivery of online adaptive magnetic resonance guided radiotherapy based on isodose boundaries
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Claudio Votta, Davide Cusumano, Luca Boldrini, Nicola Dinapoli, Lorenzo Placidi, Gabriele Turco, Marco Valerio Antonelli, Veronica Pollutri, Angela Romano, Luca Indovina, and Vincenzo Valentini
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Dosimetric boundary ,MR-guided radiotherapy ,Image guidance gating ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Magnetic Resonance-guided Radiotherapy (MRgRT) allows direct monitoring of treated volumes. The aim of this study was to investigate the feasibility of a new gating strategy consisting in using an isodose as boundary. Forty-four patients treated for thoracic and abdominal lesions using MRgRT were enrolled. The accuracy of the new strategy was compared to the conventional one in terms of area improvement available for gating without compromising target coverage. A mean increase of 24% for lung, 15% for liver and 11% for pancreas was observed, demonstrating how the new method can be useful in challenging situations with low dose conformality.
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- 2021
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37. X-change symposium: status and future of modern radiation oncology—from technology to biology
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Stefanie Corradini, Maximilian Niyazi, Dirk Verellen, Vincenzo Valentini, Seán Walsh, Anca-L. Grosu, Kirsten Lauber, Amato Giaccia, Kristian Unger, Jürgen Debus, Bradley R. Pieters, Matthias Guckenberger, Suresh Senan, Wilfried Budach, Roland Rad, Julia Mayerle, and Claus Belka
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Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Future radiation oncology encompasses a broad spectrum of topics ranging from modern clinical trial design to treatment and imaging technology and biology. In more detail, the application of hybrid MRI devices in modern image-guided radiotherapy; the emerging field of radiomics; the role of molecular imaging using positron emission tomography and its integration into clinical routine; radiation biology with its future perspectives, the role of molecular signatures in prognostic modelling; as well as special treatment modalities such as brachytherapy or proton beam therapy are areas of rapid development. More clinically, radiation oncology will certainly find an important role in the management of oligometastasis. The treatment spectrum will also be widened by the rational integration of modern systemic targeted or immune therapies into multimodal treatment strategies. All these developments will require a concise rethinking of clinical trial design. This article reviews the current status and the potential developments in the field of radiation oncology as discussed by a panel of European and international experts sharing their vision during the “X-Change” symposium, held in July 2019 in Munich (Germany).
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- 2021
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38. Immunotherapy and radiotherapy in melanoma: a multidisciplinary comprehensive review
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Luca Tagliaferri, Valentina Lancellotta, Bruno Fionda, Monica Mangoni, Calogero Casà, Alessandro Di Stefani, Monica Maria Pagliara, Andrea D’Aviero, Giovanni Schinzari, Silvia Chiesa, Ciro Mazzarella, Stefania Manfrida, Giuseppe Ferdinando Colloca, Fabio Marazzi, Alessio Giuseppe Morganti, Maria Antonietta Blasi, Ketty Peris, Giampaolo Tortora, and Vincenzo Valentini
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melanoma ,radiotherapy ,radiation therapy ,immunotherapy ,Immunologic diseases. Allergy ,RC581-607 ,Therapeutics. Pharmacology ,RM1-950 - Abstract
Melanoma is an extremely aggressive tumor and is considered to be an extremely immunogenic tumor because compared to other cancers it usually presents a well-expressed lymphoid infiltration. The aim of this paper is to perform a multidisciplinary comprehensive review of the evidence available about the combination of radiotherapy and immunotherapy for melanoma. Radiation, in fact, can increase tumor antigens visibility and promote priming of T cells but can also exert immunosuppressive action on tumor microenvironment. Combining radiotherapy with immunotherapy provides an opportunity to increase immunostimulatory potential of radiation. We therefore provide the latest clinical evidence about radiobiological rationale, radiotherapy techniques, timing, and role both in advanced and systemic disease (with a special focus on ocular melanoma and brain, liver, and bone metastases) with a particular attention also in geriatric patients. The combination of immunotherapy and radiotherapy seems to be a safe therapeutic option, supported by a clear biological rationale, even though the available data confirm that radiotherapy is employed more for metastatic than for non-metastatic disease. Such a combination shows promising results in terms of survival outcomes; however, further studies, hopefully prospective, are needed to confirm such evidence.
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- 2022
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39. Neoadjuvant Chemoradiotherapy With Simultaneous Integrated Boost in Locally Advanced Cervical Cancer: Long Term Results of a Single-Center Experience
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Alessia Nardangeli, Rosa Autorino, Luca Boldrini, Maura Campitelli, Sara Reina, Gabriella Ferrandina, Nicolò Bizzarri, Luca Tagliaferri, Gabriella Macchia, Vincenzo Valentini, and Maria Antonietta Gambacorta
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cervical cancer ,neoadjuvant chemoradiation ,simultaneous integrated boost ,SIB-VMAT ,volumetric modulated arc therapy ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Aim of this study was to analyze the efficacy and tolerability of simultaneous integrated boost volumetric modulated arc therapy (SIB-VMAT) associated with cisplatin-based chemotherapy in preoperative setting of patients with locally advanced cervical cancer (LACC). From June 2013 to September 2019, we analyzed patients with LACC who had undergone neoadjuvant chemoradiation (CRT). A radiation dose of 39.6 Gy, 1.8 Gy/fraction was delivered to the pelvis plus a radiation dose to the primary tumor delivered with SIB-VMAT strategy for a total of 50.6Gy, 2.3Gy/fraction in 25 fractions. Cisplatin-based chemotherapy was delivered combined with radiotherapy. Radical hysterectomy plus pelvic with or without aortic lymphadenectomy was performed within 7 to 8 weeks from CRT. One hundred forty-eight patients (median age: 49.5 years; FIGO stage IB2: 7, IIA: 8, IIB: 106, IIIA: 5; IIIB: 16; IVA: 5, IVB: 1; N0: 56, N1: 92) were analyzed. The treatment was well tolerated with good compliance: no grade 3/4 gastrointestinal or genitourinary toxicity was reported; grade 3 neutropenia was described in five cases. Pathological complete response (pCR) was documented in 68 cases (46%) and 32 patients (21.6%) had microscopic residual disease. Pathological nodal involvement was observed in 23 patients (15.5%). At median follow-up of 59 months (range: 27-100), the 3-year local control was 78.5%, whereas the 3-year metastasis-free survival was 70.5%. The 3-year overall survival rate was 89.0%. Neoadjuvant CRT with SIB-VMAT followed by radical surgery results in a high rate of pathologically assessed complete response and a very encouraging local control rate, with acceptable toxicity.
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- 2022
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40. Dosimetric Impact of Inter-Fraction Variability in the Treatment of Breast Cancer: Towards New Criteria to Evaluate the Appropriateness of Online Adaptive Radiotherapy
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Martina Iezzi, Davide Cusumano, Danila Piccari, Sebastiano Menna, Francesco Catucci, Andrea D’Aviero, Alessia Re, Carmela Di Dio, Flaviovincenzo Quaranta, Althea Boschetti, Marco Marras, Domenico Piro, Flavia Tomei, Claudio Votta, Vincenzo Valentini, and Gian Carlo Mattiucci
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AI radiotherapy ,predictive modeling ,CBCT radiotherapy ,inter-fraction dose variation ,online adaptation ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
PurposeAs a discipline in its infancy, online adaptive RT (ART) needs new ontologies and ad hoc criteria to evaluate the appropriateness of its use in clinical practice. In this experience, we propose a predictive model able to quantify the dosimetric impact due to daily inter-fraction variability in a standard RT breast treatment, to identify in advance the treatment fractions where patients might benefit from an online ART approach.MethodsThe study was focused on right breast cancer patients treated using standard adjuvant RT on an artificial intelligence (AI)-based linear accelerator. Patients were treated with daily CBCT images and without online adaptation, prescribing 40.05 Gy in 15 fractions, with four IMRT tangential beams. ESTRO guidelines were followed for the delineation on planning CT (pCT) of organs at risk and targets. For each patient, all the CBCT images were rigidly aligned to pCT: CTV and PTV were manually re-contoured and the original treatment plan was recalculated. Various radiological parameters were measured on CBCT images, to quantify inter-fraction variability present in each RT fraction after the couch shifts compensation. The variation of these parameters was correlated with the variation of V95% of PTV (ΔV95%) using the Wilcoxon Mann–Whitney test. Fractions where ΔV95% > 2% were considered as adverse events. A logistic regression model was calculated considering the most significant parameter, and its performance was quantified with a receiver operating characteristic (ROC) curve.ResultsA total of 75 fractions on 5 patients were analyzed. The body variation between daily CBCT and pCT along the beam axis with the highest MU was identified as the best predictor (p = 0.002). The predictive model showed an area under ROC curve of 0.86 (95% CI, 0.82–0.99) with a sensitivity of 85.7% and a specificity of 83.8% at the best threshold, which was equal to 3 mm.ConclusionA novel strategy to identify treatment fractions that may benefit online ART was proposed. After image alignment, the measure of body difference between daily CBCT and pCT can be considered as an indirect estimator of V95% PTV variation: a difference larger than 3 mm will result in a V95% decrease larger than 2%. A larger number of observations is needed to confirm the results of this hypothesis-generating study.
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- 2022
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41. The impact of radiomics in diagnosis and staging of pancreatic cancer
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Calogero Casà, Antonio Piras, Andrea D’Aviero, Francesco Preziosi, Silvia Mariani, Davide Cusumano, Angela Romano, Ivo Boskoski, Jacopo Lenkowicz, Nicola Dinapoli, Francesco Cellini, Maria Antonietta Gambacorta, Vincenzo Valentini, Gian Carlo Mattiucci, and Luca Boldrini
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Introduction: Pancreatic cancer (PC) is one of the most aggressive tumours, and better risk stratification among patients is required to provide tailored treatment. The meaning of radiomics and texture analysis as predictive techniques are not already systematically assessed. The aim of this study is to assess the role of radiomics in PC. Methods: A PubMed/MEDLINE and Embase systematic review was conducted to assess the role of radiomics in PC. The search strategy was ‘radiomics [All Fields] AND (“pancreas” [MeSH Terms] OR “pancreas” [All Fields] OR “pancreatic” [All Fields])’ and only original articles referred to PC in humans in the English language were considered. Results: A total of 123 studies and 183 studies were obtained using the mentioned search strategy on PubMed and Embase, respectively. After the complete selection process, a total of 56 papers were considered eligible for the analysis of the results. Radiomics methods were applied in PC for assessment technical feasibility and reproducibility aspects analysis, risk stratification, biologic or genomic status prediction and treatment response prediction. Discussion: Radiomics seems to be a promising approach to evaluate PC from diagnosis to treatment response prediction. Further and larger studies are required to confirm the role and allowed to include radiomics parameter in a comprehensive decision support system.
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- 2022
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42. A radiotherapy staff experience of gratitude during COVID-19 pandemic
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Elisa Marconi, Silvia Chiesa, Loredana Dinapoli, Elisabetta Lepre, Luca Tagliaferri, Mario Balducci, Vincenzo Frascino, Calogero Casà, Daniela Pia Rosaria Chieffo, Maria Antonietta Gambacorta, and Vincenzo Valentini
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Radiotherapy ,Gratitude ,COVID-19 ,Pandemic ,Healthcare staff ,Teamwork ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2021
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43. Interventional radiotherapy as exclusive treatment for primary nasal vestibule cancer: single-institution experience
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Luca Tagliaferri, Nadia Carra, Valentina Lancellotta, Davide Rizzo, Calogero Casà, Giancarlo Mattiucci, Claudio Parrilla, Bruno Fionda, Francesco Deodato, Patrizia Cornacchione, Maria Gambacorta, Gaetano Paludetti, Vincenzo Valentini, and Francesco Bussu
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interventional radiotherapy ,brachytherapy ,nasal vestibule cancer ,pro ,patient-reported outcomes. ,Medicine - Published
- 2020
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44. Artificial intelligence (AI) and interventional radiotherapy (brachytherapy): state of art and future perspectives
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Bruno Fionda, Luca Boldrini, Andrea D’Aviero, Valentina Lancellotta, Maria Gambacorta, György Kovács, Stefano Patarnello, Vincenzo Valentini, and Luca Tagliaferri
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artificial intelligence ,interventional radiotherapy ,brachytherapy ,personalized medicine ,machine learning ,decision supporting system. ,Medicine - Published
- 2020
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45. On-line adaptive MR guided radiotherapy for locally advanced pancreatic cancer: Clinical and dosimetric considerations
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Lorenzo Placidi, Angela Romano, Giuditta Chiloiro, Davide Cusumano, Luca Boldrini, Francesco Cellini, Gian Carlo Mattiucci, and Vincenzo Valentini
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Locally advanced pancreatic cancer ,Magnetic resonance guided radiation therapy ,Online adaptive radiotherapy ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Introduction: Magnetic Resonance-guided Radiation Therapy (MRgRT) allows online adaptations (OA) of the treatment plan to optimize daily dose distribution based on patient's anatomy, just before fraction delivery. The aim of this study is to evaluate feasibility and the dosimetric improvement of the OA workflow implemented in our institution for locally advanced pancreatic cancer (LAPC) patients, in terms of target coverage and organs at risk (OARs) sparing. Methods: We retrospectively analysed 8 LAPC patients treated with MRgRT in combination with the OA approach, using video-assisted inspiratory breath-hold for a total of 38 fractions with a dose ranging from 30 Gy to 40 Gy in 5 fractions.Dose distribution of the baseline plan was first calculated based on daily anatomy, obtaining a “predicted” plan to assess the dosimetric improvement. If the dose distribution did not meet the constraints set in the planning phase, PTV, GTV and OARs were re-contoured within a distance of 3 cm from the PTV external edge and a new online “adaptive” plan was generated. Other clinical and planning parameters were also evaluated to assess the feasibility and the dosimetic benefit of the online adaptive workflow. Results: Out of 38 total fractions, 26 (68.4%) were adapted online and 12 (31.6%) were delivered using the baseline plan. The use of the adaptive workflow resulted to be feasible in our clinical practice and advantageous in all the patients: mean PTV V95% increased by 10.8% (5.7–20.8) while mean CTV V98% of 12.6% (7.3–17.7). Also OARs V33 and V25 showed a positive trend avoiding unnecessary irradiation. Conclusion: OA workflow improves the dosimetric benefit of MRgRT, preventing the occurrence of high-doses to OARs and increasing the safety of stereotactic treatment for LAPC, without any drawback for our daily clinical practice routine.
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- 2020
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46. INTERACTS (INTErventional Radiotherapy ACtive Teaching School) consensus conference on sarcoma interventional radiotherapy (brachytherapy) endorsed by AIRO (Italian Association of Radiotherapy and Clinical Oncology)
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Luca Tagliaferri, Andrea Vavassori, Valentina Lancellotta, Vitaliana De Sanctis, Cristiana Vidali, Calogero Casà, Cynthia Aristei, Domenico Genovesi, Barbara Jereczek-Fossa, Alessio Giuseppe Morganti, György Kovács, Jose Luis Guinot, Agata Rembielak, Daniela Greto, Maria Gambacorta, Vincenzo Valentini, Vittorio Donato, Renzo Corvò, Stefano Magrini, Lorenzo Livi, and Consensus Board
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interventional radiotherapy ,brachytherapy ,soft-tissue sarcoma ,Medicine - Published
- 2020
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47. Role of radiation oncology in modern multidisciplinary cancer treatment
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Vincenzo Valentini, Luca Boldrini, Silvia Mariani, and Mariangela Massaccesi
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modern radiotherapy ,multidisciplinary cancer treatment ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Cancer care is moving from a disease‐focused management toward a patient‐centered tailored approach. Multidisciplinary management that aims to define individual, optimal treatment strategies through shared decision making between healthcare professionals and patient is a fundamental aspect of high‐quality cancer care and often includes radiation oncology. Advances in technology and radiobiological research allow to deliver ever more tailored radiation treatments in an ever easier and faster way, thus improving the efficacy, safety, and accessibility of radiation therapy. While these changes are improving quality of cancer care, they are also enormously increasing complexity of decision making, thus challenging the ability to deliver quality affordable cancer care. In this review, we provide an updated outline of the role of radiation oncology in the modern multidisciplinary treatment of cancer. Particularly, we focus on the way some developments in key areas of cancer management are challenging multidisciplinary cancer care in the different clinical settings of early, locally advanced, and metastatic disease, thus highlighting some priority areas of research.
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- 2020
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48. Reliability of ITV approach to varying treatment fraction time: a retrospective analysis based on 2D cine MR images
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Davide Cusumano, Jennifer Dhont, Luca Boldrini, Giuditta Chiloiro, Angela Romano, Claudio Votta, Silvia Longo, Lorenzo Placidi, Luigi Azario, Marco De Spirito, Dirk Verellen, and Vincenzo Valentini
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Intra-fraction motion management ,Internal target volume ,MR-guided radiotherapy ,Medical physics. Medical radiology. Nuclear medicine ,R895-920 ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Internal Target Volume (ITV) is one of the most common strategies to passively manage tumour motion in Radiotherapy (RT). The reliability of this approach is based on the assumption that the tumour motion estimated during pre-treatment 4D Computed Tomography (CT) acquisition is representative of the motion during the whole RT treatment. With the introduction of Magnetic Resonance-guided RT (MRgRT), it has become possible to monitor tumour motion during the treatment and verify this assumption. Aim of this study was to investigate the reliability of the ITV approach with respect to the treatment fraction time (TFT) in abdominal and thoracic lesions. Methods A total of 12 thoracic and 15 abdominal lesions was analysed. Before treatment, a 10-phase 4DCT was acquired and ITV margins were estimated considering the envelope of the lesion contoured on the different 4DCT phases. All patients underwent MRgRT treatment in free-breathing, monitoring the tumour position on a sagittal plane with 4 frames per second (sec). ITV margins were projected on the tumour trajectory and the percentage of treatment time in which the tumour was inside the ITV (%TT) was measured to varying of TFT. The ITV approach was considered moderately reliable when %TT ≥ 90% and strongly reliable when %TT ≥ 95%. Additional ITV margins required to achieve %TT ≥ 95% were also calculated. Results In the analysed cohort of patients, ITV strategy can be considered strongly reliable only for lung lesions with TFT ≤ 7 min (min). The ITV strategy can be considered only moderately reliable for abdominal lesions, and additional margins are required to obtain %TT ≥ 95%. Considering a TFT ≤ 4 min, additional margins of 2 mm in cranio-caudal (CC) and 1 mm in antero-posterior (AP) are suggested for pancreatic lesions, 3 mm in CC and 2 mm in AP for renal and liver ones. Conclusions On the basis of the analysed cases, the ITV approach appears to be reliable in the thorax, while it results more challenging in the abdomen, due to the higher uncertainty in ITV definition and to the observed larger intra and inter-fraction motion variability. The addition of extra margins based on the TFT may represent a valid tool to compensate such limitations.
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- 2020
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49. Stereotactic ablative body radiotherapy (SABR) combined with immunotherapy (L19-IL2) versus standard of care in stage IV NSCLC patients, ImmunoSABR: a multicentre, randomised controlled open-label phase II trial
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Relinde I. Y. Lieverse, Evert J. Van Limbergen, Cary J. G. Oberije, Esther G. C. Troost, Sine R. Hadrup, Anne-Marie C. Dingemans, Lizza E. L. Hendriks, Franziska Eckert, Crispin Hiley, Christophe Dooms, Yolande Lievens, Monique C. de Jong, Johan Bussink, Xavier Geets, Vincenzo Valentini, Giuliano Elia, Dario Neri, Charlotte Billiet, Amir Abdollahi, David Pasquier, Pierre Boisselier, Ala Yaromina, Dirk De Ruysscher, Ludwig J. Dubois, and Philippe Lambin
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Immunotherapy ,L19-IL2 ,Anti-PD-L1 ,Anti-PD-1 ,Radiotherapy ,SABR ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background About 50% of non-small cell lung cancer (NSCLC) patients have metastatic disease at initial diagnosis, which limits their treatment options and, consequently, the 5-year survival rate (15%). Immune checkpoint inhibitors (ICI), either alone or in combination with chemotherapy, have become standard of care (SOC) for most good performance status patients. However, most patients will not obtain long-term benefit and new treatment strategies are therefore needed. We previously demonstrated clinical safety of the tumour-selective immunocytokine L19-IL2, consisting of the anti-ED-B scFv L19 antibody coupled to IL2, combined with stereotactic ablative radiotherapy (SABR). Methods This investigator-initiated, multicentric, randomised controlled open-label phase II clinical trial will test the hypothesis that the combination of SABR and L19-IL2 increases progression free survival (PFS) in patients with limited metastatic NSCLC. One hundred twenty-six patients will be stratified according to their metastatic load (oligo-metastatic: ≤5 or poly-metastatic: 6 to 10) and randomised to the experimental-arm (E-arm) or the control-arm (C-arm). The C-arm will receive SOC, according to the local protocol. E-arm oligo-metastatic patients will receive SABR to all lesions followed by L19-IL2 therapy; radiotherapy for poly-metastatic patients consists of irradiation of one (symptomatic) to a maximum of 5 lesions (including ICI in both arms if this is the SOC). The accrual period will be 2.5-years, starting after the first centre is initiated and active. Primary endpoint is PFS at 1.5-years based on blinded radiological review, and secondary endpoints are overall survival, toxicity, quality of life and abscopal response. Associative biomarker studies, immune monitoring, CT-based radiomics, stool collection, iRECIST and tumour growth rate will be performed. Discussion The combination of SABR with or without ICI and the immunocytokine L19-IL2 will be tested as 1st, 2nd or 3rd line treatment in stage IV NSCLC patients in 14 centres located in 6 countries. This bimodal and trimodal treatment approach is based on the direct cytotoxic effect of radiotherapy, the tumour selective immunocytokine L19-IL2, the abscopal effect observed distant from the irradiated metastatic site(s) and the memory effect. The first results are expected end 2023. Trial registration ImmunoSABR Protocol Code: NL67629.068.18; EudraCT: 2018–002583-11 ; Clinicaltrials.gov: NCT03705403 ; ISRCTN ID: ISRCTN49817477 ; Date of registration: 03-April-2019.
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- 2020
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50. MRI in pregnant patients with suspected abdominal and pelvic cancer: a practical guide for radiologists
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Benedetta Gui, Francesco Cambi, Maura Micco, Martina Sbarra, Federica Petta, Rosa Autorino, Rosa De Vincenzo, Vincenzo Valentini, Giovanni Scambia, and Riccardo Manfredi
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Medical physics. Medical radiology. Nuclear medicine ,R895-920 - Abstract
The incidence of abdominal and pelvic cancer in pregnancy is low, but it is rising as the population of pregnant women gets older. Depending on disease stage, gestational age and patient’s preference, active surveillance as well as surgery and chemotherapy are feasible options during pregnancy. Correct diagnosis and staging of the tumor is crucial for choosing the best therapeutic approach. Moreover, a reproducible modality to assess the treatment response is requested. Magnetic resonance imaging (MRI) is commonly used with good results for the local staging and treatment response evaluation of most abdominal and pelvic cancers in nonpregnant patients, and it is considered relatively safe during pregnancy. The purpose of this article is to analyze the most relevant topics regarding the use of MRI in pregnant women with abdominal and pelvic cancer. We discuss MRI safety during pregnancy, including the use of gadolinium-based contrast agents (GBCAs), how to prepare the patient for the exam and MRI technique. This will be followed by a brief review on the most common malignancies diagnosed during pregnancy and their MRI appearance.
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- 2020
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