REQUITE study
Background
Approximately half of all cancer patients receive radiotherapy as part of their cancer treatment. The dose of radiation given is limited because of a risk of damaging the normal tissues and organs that surround the tumour. Patients vary in how they react to radiation. About 5% of patients (5 out of every 100) are sensitive and at risk of having side effects. It is known that genetics influence a patient's risk of developing side-effects and a number of assays/approaches have been explored to assess a patient's sensitivity to radiation. In recent years, researchers have developed predictive models and biological tests to try to identify before the start of treatment those patients who are sensitive. However, these methods are not yet ready to use in the clinic.
Goal
In recent years predictive models have been developed that attempt to identify, before the start of radiotherapy, patients at risk of long-term side-effects. These emerging models require systematic validation in a multi-centre collaborative setting. There are an increasing number of datasets available for validation but they are variable in terms of the data collected. The goal of the REQUITE project is to validate known predictors of adverse reactions after radiotherapy to develop prediction models to become clinically useful.
Methods
This multi-centre observational study is one of the largest study of its kind collecting blood samples and standardised data longitudinally from 4,400 cancer patients, including yearly follow-up data on side-effects following radiotherapy. Several hospitals in seven European countries (Belgium, France, Germany, Italy, The Netherlands, Spain, UK) and in the US participate in this study. Patients were enrolled until 2017 and followed up in the first two to three years after radiotherapy. In Germany, hospitals in Mannheim, Karlsruhe, Freiburg, Darmstadt, Speyer, Ludwigshafen and Baden-Baden were involved.
This prospective observational study enables validation of models that predict a patient's risk of developing long-term side-effects following radiotherapy. It will also allow for the validation of promising biomarkers / approaches and will be a unique (eventually widely accessible) resource for studying the relationships between side-effects and quality-of-life.
Since side-effects can occur years after treatment, assessment of symptoms beyond the first two years after treatment is important. Therefore, the follow-up of the patients is being extended to a minimum of five years after radiotherapy.
For further information
Collaborations
University of Manchester, Great Britain
The Christie NHS Foundation Research, Manchester, Great Britain
University of Leicester, Great Britain
Praxis für Strahlentherapie an der Stadtklinik Baden-Baden, Germany
Klinikum Darmstadt GmbH, Germany
Zentrum für Strahlentherapie Freiburg, Germany
Städtisches Klinikum Karlsruhe, Germany
St. Vincentius-Kliniken gAG Karlsruhe, Germany
Klinikum der Stadt Ludwigshafen GmbH, Germany
Universitätsklinikum Mannheim, Germany
Strahlentherapie Speyer, Germany.
University Hospital Ghent, Belgium
University Hospital Leuven, Belgium
Institut du Cancer de Montpellier, France
Instituto Nazionale dei Tumori, Milan, Italy
Maastricht Radiation Oncology, The Netherlands
Vall D'Hebron Institute of Oncology, Barcelona, Spain
Fundación Pública Galega Medicina Xenómica, Santiago de Compostela, Spain
Mount Sinai, New York, USA
Funding
European Union
German Federal Office for Radiation Protection / BfS (follow-up extension)
ERA PerMed (follow-up extension), see also RADprecise project
Selected publications
Seibold P & Webb A (...) Chang-Claude J: REQUITE: A prospective multicentre cohort study of patients undergoing radiotherapy for breast, lung or prostate cancer. Radiother Oncol. 2019 Sep;138:59-67. doi: 10.1016/j.radonc.2019.04.034. PMID: 31146072 https://pubmed.ncbi.nlm.nih.gov/31146072
West C, Azria D, Chang-Claude J, Davidson S, Lambin P, Rosenstein B, De Ruysscher D, Talbot C, Thierens H, Valdagni R, Vega A, Yuille M. The REQUITE project: validating predictive models and biomarkers of radiotherapy toxicity to reduce side-effects and improve quality of life in cancer survivors. Clin Oncol (R Coll Radiol). 2014 Dec;26(12):739-42. doi: 10.1016/j.clon.2014.09.008. PMID: 25267305 https://pubmed.ncbi.nlm.nih.gov/25267305