REQUITE: A prospective multicentre cohort study of patients undergoing radiotherapy for breast, lung or prostate cancer.
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Seibold Petra, Webb Adam, Aguado-Barrera Miguel E, Azria David, Bourgier Celine, Brengues Muriel, Briers Erik, Bultijnck Renée, Calvo-Crespo Patricia, Carballo Ana, Choudhury Ananya, Cicchetti Alessandro, Claßen Johannes, Delmastro Elena, Dunning Alison M, Elliott Rebecca M, Fachal Laura, Farcy-Jacquet Marie-Pierre, Gabriele Pietro, Garibaldi Elisabetta, Gómez-Caamaño Antonio, Gutiérrez-Enríquez Sara, Higginson Daniel S, Johnson Kerstie, Lobato-Busto Ramón, Mollà Meritxell, Müller Anusha, Payne Debbie, Peleteiro Paula, Post Giselle, Rancati Tiziana, Rattay Tim, Reyes Victoria, Rosenstein Barry S, De Ruysscher Dirk, De Santis Maria Carmen, Schäfer Jörg, Schnabel Thomas, Sperk Elena, Symonds R Paul, Stobart Hilary, Taboada-Valladares Begoña, Talbot Christopher J, Valdagni Riccardo, Vega Ana, Veldeman Liv, Ward Tim, Weißenberger Christian, West Catharine M L, Chang-Claude Jenny, REQUITE consortium
Аннотация
METHODS: An international, prospective cohort study recruited cancer patients in 26 hospitals in eight countries between April 2014 and March 2017. Target recruitment was 5300 patients. Eligible patients had breast, prostate or lung cancer and planned potentially curable radiotherapy. Radiotherapy was prescribed according to local regimens, but centres used standardised data collection forms. Pre-treatment blood samples were collected. Patients were followed for a minimum of 12 (lung) or 24 (breast/prostate) months and summary descriptive statistics were generated.
RESULTS: The study recruited 2069 breast (99% of target), 1808 prostate (86%) and 561 lung (51%) cancer patients. The centralised, accessible database includes: physician- (47,025 forms) and patient- (54,901) reported outcomes; 11,563 breast photos; 17,107 DICOMs and 12,684 DVHs. Imputed genotype data are available for 4223 patients with European ancestry (1948 breast, 1728 prostate, 547 lung). Radiation-induced lymphocyte apoptosis (RILA) assay data are available for 1319 patients. DNA (n = 4409) and PAXgene tubes (n = 3039) are stored in the centralised biobank. Example prevalences of 2-year (1-year for lung) grade ≥2 CTCAE toxicities are 13% atrophy (breast), 3% rectal bleeding (prostate) and 27% dyspnoea (lung).
CONCLUSION: The comprehensive centralised database and linked biobank is a valuable resource for the radiotherapy community for validating predictive models and biomarkers.
PATIENT SUMMARY: Up to half of cancer patients undergo radiation therapy and irradiation of surrounding healthy tissue is unavoidable. Damage to healthy tissue can affect short- and long-term quality-of-life. Not all patients are equally sensitive to radiation "damage" but it is not possible at the moment to identify those who are. REQUITE was established with the aim of trying to understand more about how we could predict radiation sensitivity. The purpose of this paper is to provide an overview and summary of the data and material available. In the REQUITE study 4400 breast, prostate and lung cancer patients filled out questionnaires and donated blood. A large amount of data was collected in the same way. With all these data and samples a database and biobank were created that showed it is possible to collect this kind of information in a standardised way across countries. In the future, our database and linked biobank will be a resource for research and validation of clinical predictors and models of radiation sensitivity. REQUITE will also enable a better understanding of how many people suffer with radiotherapy toxicity.