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R. Valdagni
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P3.04 - Poster Session/ Biology, Pathology, and Molecular Testing (ID 235)
- Event: WCLC 2015
- Type: Poster
- Track: Biology, Pathology, and Molecular Testing
- Presentations: 1
- Moderators:
- Coordinates: 9/09/2015, 09:30 - 17:00, Exhibit Hall (Hall B+C)
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P3.04-086 - REQUITE: Validating Predictive Models and Biomarkers of RT Toxicity to Reduce Side Effects and Improve QOL (ID 2864)
09:30 - 09:30 | Author(s): R. Valdagni
- Abstract
Background:
Recently the first replicated genetic associations for radiotherapy-induced adverse reactions were reported. These should improve the power of toxicity prediction models, opening the way to an optimised radiotherapy delivery and interventions to alleviate the side effects. The European Union funded REQUITE consortium aims to validate known predictors of adverse reactions and to develop statistical models resulting in clinically useful models. The focus of the project is on breast, prostate and lung cancer. As the barrier to clinical impact is the lack of validated statistical models incorporating genetic predictors, and the barrier to validation is the lack of standardised data collection, the main objectives of the REQUITE project are the following: Perform a multi-centre cohort study collecting blood samples, epidemiology and treatment data, longitudinal side effect and quality of life (QOL) data (before and after treatment: years 1 and 2 for breast and prostate cancer; with additional 3 and 6 month timepoints for lung cancer). Produce a centralized database and biobank of DNA for 5300 patients. Validate published biomarkers of radiosensitivity. Validate clinical predictors of radiotherapy toxicity in breast, prostate and lung cancer and incorporate biomarker data. Design interventional trials to reduce long-term side effects. Provide a resource for dissemination and exploitation to the radiotherapy community.
Methods:
The central activity of the project is a multi-centre, observational study organized through WP2. Enrolment will proceed for two years in nine centres (eight in Europe and one in the United States), with another two years of follow-up. The primary endpoints are change in breast appearance at two years (breast), rectal bleeding at two years (prostate) and pneumonitis at 6 months (lung). An integrated study database is designed. Blood samples are collected before radiotherapy. Tracking, biobanking and DNA extraction is handled in WP3. Validation of biomarkers (genetic markers and apoptosis assays) as predictive factors is carried out in WP4. Some clinical factors have suggested predictive value for radiotherapy side effects, but there is no consensus. In WP5 these will be validated in existing cohorts. Finally, in WP6, predictive models will be used to design clinical interventional trials and produce protocols that seek to lower radiotherapy side effects, in those individuals at high risk of developing them, without affecting tumour control. Patient advocates will play an essential role in this effort.
Results:
Standardised data collection forms were generated. Questionnaires for collecting patient reported toxicity according to Common Toxicity Criteria for Adverse Events were developed in different languages. These forms and questionnaires are available at http://www.requite.eu/. A centralised database for electronic data capture and storage was developed. Ethical approval for the observational study was obtained in all centres. More than 1300 patients were enrolled in the REQUITE study to this date.
Conclusion:
Centralised collection of standardised data and biobanking is practical for lung cancer patients undergoing radiotherapy in routine clinical practice in a multi-centre, multi-national setting.
