The REQUITE Project: Validating predictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve quality of life in cancer survivors.

Abstract

85 Background: To present the REQUITE project (Validating Predictive Models and Biomarkers of Radiotherapy (RT) toxicity to reduce side-effects and improve quality-of-life in cancer survivors) and first results on the enrollment and acute toxicity (tox) of prostate cancer (Pca) patients (pts). Methods: The European Union funded REQUITE project involves centers in Europe and the USA. The main objectives of the project are to: carry out a multicentre, cohort study collecting blood samples, standardized epidemiology and treatment data, longitudinal side-effect and quality of life data (before and after treatment, years 1 and 2); produce a centralized database and biobank of DNA for 5,300 patients; validate clinical/dosimetric predictors of RT tox and incorporate biomarker data. The project focuses on cancers of the breast, lung and prostate. For PCa the primary endpoint is rectal bleeding at 2 years. Results: A centralized database was established for data collection, including storage of complete dosimetric information in DICOM RT format. Enrollment started in April 2014 and will end in August 2018. In the first 16 months 909 PCa pts were enrolled: 10% low risk, 33% intermediate and 57% high risk. 63% pts received exclusive RT (neoadjuvant hormone therapy in 62%) and 37% post-prostatectomy; 97% external beam RT (prescription doses: 60-85Gy, 2Gy equivalent, alpha/beta=3Gy), while 3% received brachytherapy. Data on acute tox at RT end (measured by CTCAE 4.03) are available for 496 pts. 79 G2-G3 GI tox were reported, with proctitis and diarrhea having the higher prevalence (45 and 30 events respectively). 74 pts exhibited G2-G3 GU tox, with 34 pts reporting multiple symptoms and frequency and urgency having the higher prevalence (43 and 30 events respectively, 25 pts both). Conclusions: REQUITE is proving the feasibility of a prospective standardized collection of epidemiological/clinical/dosimetric/toxicity data coupled to centralized storing of biological material. Meanwhile a large database is being created, which will be of value also for future research in the field of radioinduced side effects. REQUITE is funded by a European Union FP7 grant (601826).