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Peer-reviewedCC BY 4.0Clinical and Translational Radiation Oncology

Early and late CTCAE and patient-reported outcomes following breast radiotherapy in the REQUITE cohort

33 more authors
28 affiliations
  1. 1Mannheim Comprehensive Cancer Center, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
  2. 2Department of Radiation Oncology, Universitätsmedizin Mannheim, Medical Faculty Mannheim, Heidelberg University, Mannheim, Germany
  3. 3University of Leicester, United Kingdom
  4. 4Grupo Genética en Cáncer y Enfermedades Raras, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain
  5. 5Fundación Pública Galega de Medicina Xenómica, Santiago de Compostela, Spain
  6. 6Hereditary Cancer Genetics Group, Vall d'Hebron Institute of Oncology (VHIO), Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
  7. 7Programa de Doctorat en Biomedicina, Universitat de Barcelona (UB), Barcelona, Spain
  8. 8Department of Radiation Oncology, Vall d'Hebron Hospital Universitari, Vall d'Hebron Barcelona Hospital Campus, Barcelona, Spain
  9. 9University of Manchester, Christie Hospital NHS Foundation Trust, United Kingdom
  10. 10Fédération Universitaire d'Oncologie Radiothérapie d'Occitanie Méditerranée, ICM, Univ Montpellier INSERM U1194 IRCM, Montpellier, France
  11. 11Patient Advocate, United Kingdom
  12. 12Department of Human Structure and Repair, Ghent University, Ghent, Belgium
  13. 13Division of Cancer Epidemiology, German Cancer Research Center (DKFZ), Heidelberg, Germany
  14. 14Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  15. 15University of Cambridge, United Kingdom
  16. 16Wellcome Sanger Institute, United Kingdom
  17. 17Medical Faculty Heidelberg, Heidelberg University, Germany
  18. 18Leicester Cancer Research Centre, University of Leicester, Leicester, UK
  19. 19Medical College of Wisconsin, USA
  20. 20UZ Leuven, Belgium
  21. 21Department of Radiation Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
  22. 22Radiation Oncology Department, Hospital Clinic of Barcelona, Spain
  23. 23Departments of Radiation Oncology & Genetics and Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, USA
  24. 24MAASTRO Clinic, Maastricht, Netherlands
  25. 25Division of Personalized Early Detection of Prostate Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany
  26. 26The Christie NHS Foundation Trust, United Kingdom
  27. 27Department of Radiation Oncology, Hospital Clínico Universitario de Santiago de Compostela, Servizo Galego de Saúde (SERGAS), Santiago de Compostela, Spain
  28. 28Ghent University Hospital, Belgium

Abstract

Purpose: The international REQUITE study and its follow-up studies (RADprecise/REQUITEplus) prospectively collected longitudinal data from patients undergoing radiotherapy for breast, prostate, or lung cancer. We present data from 2057 women with breast cancer, describing patient-reported outcomes and acute and late adverse effects.

Methods: Patients were recruited between April 2014 and October 2016. Eligible patients received external-beam photon radiotherapy after breast-conserving surgery, had no metastasis at inclusion, no other malignancy within the previous five years, and no prior breast irradiation. Blood samples were collected before radiotherapy for genotyping, molecular analysis, and biobanking. Standardised assessments included CTCAE v4, EORTC QLQ-C30 and BR23, MFI, GPAQ, and DICOM/DVH data. Follow-up continued annually for two years, extending to eight years at eligible sites.

Results: Acute side effects peaked at end of radiotherapy, with erythema in 83–89% of patients. Grade ≥ 2 acute effects, including pain (11% versus 4.3%) and skin ulceration (4.8% versus 0.8%), were more frequent with normofractionation than hypofractionation. Grade ≥ 2 late effects affected between 0.6% and 16.8% of patients; skin induration was the most frequent late effect. Patient-reported outcome scores varied over time, with functional scale scores at two years similar to or higher than at baseline.

Conclusion: REQUITE provides real-world evidence of acute and late outcomes following normo- and hypofractionation, broadly consistent with published randomised trials. The dataset, combining clinical adverse effects, quality of life, dosimetric, and genetic data, is a resource for personalised radiotherapy research (www.requite.eu).

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BibTeX
@article{bockstiegel2026early,
  title = {{Early and late CTCAE and patient-reported outcomes following breast radiotherapy in the REQUITE cohort}},
  author = {Tina Bockstiegel and Adam Webb and Miguel E. Aguado-Barrera and Ester Aguado-Flor and Manuel Altabas and Marianne Aznar and David Azria and Erik Briers and Renée Bultijnck and Jenny Chang-Claude and Alessandro Cicchetti and Maria Carmen De Santis and Alison Dunning and Laura Fachal and Olivia Fuentes-Rios and Alexandra Giraldo and Antonio Gómez-Caamaño and Sara Gutiérrez-Enríquez and Carsten Herskind and Philipp Heumann and Kerstie Johnson and Rudolf Kaaks and Sarah L. Kerns and Maarten Lambrecht and Eliana La Rocca and Meritxell Mollà and Tiziana Rancati and Victoria M. Reyes and Juan Camilo Rosas Romero and Barry S. Rosenstein and Dirk De Ruysscher and Petra Seibold and Rebecca M. Shearer and Hilary Stobart and R. Paul Symonds and Begoña Taboada-Valladares and Christopher J. Talbot and Ana Vega and Liv Veldeman and Marlon R. Veldwijk and Tim Ward and Catharine M.L. West and REQUITE/REQUITEplus/RADprecise consortia and Tim Rattay and Elena Sperk},
  journal = {Clinical and Translational Radiation Oncology},
  year = {2026},
  month = oct,
  doi = {10.1016/j.ctro.2026.101307},
  url = {https://doi.org/10.1016/j.ctro.2026.101307},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Early and late CTCAE and patient-reported outcomes following breast radiotherapy in the REQUITE cohort
AU  - Tina Bockstiegel
AU  - Adam Webb
AU  - Miguel E. Aguado-Barrera
AU  - Ester Aguado-Flor
AU  - Manuel Altabas
AU  - Marianne Aznar
AU  - David Azria
AU  - Erik Briers
AU  - Renée Bultijnck
AU  - Jenny Chang-Claude
AU  - Alessandro Cicchetti
AU  - Maria Carmen De Santis
AU  - Alison Dunning
AU  - Laura Fachal
AU  - Olivia Fuentes-Rios
AU  - Alexandra Giraldo
AU  - Antonio Gómez-Caamaño
AU  - Sara Gutiérrez-Enríquez
AU  - Carsten Herskind
AU  - Philipp Heumann
AU  - Kerstie Johnson
AU  - Rudolf Kaaks
AU  - Sarah L. Kerns
AU  - Maarten Lambrecht
AU  - Eliana La Rocca
AU  - Meritxell Mollà
AU  - Tiziana Rancati
AU  - Victoria M. Reyes
AU  - Juan Camilo Rosas Romero
AU  - Barry S. Rosenstein
AU  - Dirk De Ruysscher
AU  - Petra Seibold
AU  - Rebecca M. Shearer
AU  - Hilary Stobart
AU  - R. Paul Symonds
AU  - Begoña Taboada-Valladares
AU  - Christopher J. Talbot
AU  - Ana Vega
AU  - Liv Veldeman
AU  - Marlon R. Veldwijk
AU  - Tim Ward
AU  - Catharine M.L. West
AU  - REQUITE/REQUITEplus/RADprecise consortia
AU  - Tim Rattay
AU  - Elena Sperk
PY  - 2026
DA  - 2026/10/07
JO  - Clinical and Translational Radiation Oncology
DO  - 10.1016/j.ctro.2026.101307
UR  - https://doi.org/10.1016/j.ctro.2026.101307
AB  - Purpose: The international REQUITE study and its follow-up studies (RADprecise/REQUITEplus) prospectively collected longitudinal data from patients undergoing radiotherapy for breast, prostate, or lung cancer. We present data from 2057 women with breast cancer, describing patient-reported outcomes and acute and late adverse effects.  Methods: Patients were recruited between April 2014 and October 2016. Eligible patients received external-beam photon radiotherapy after breast-conserving surgery, had no metastasis at inclusion, no other malignancy within the previous five years, and no prior breast irradiation. Blood samples were collected before radiotherapy for genotyping, molecular analysis, and biobanking. Standardised assessments included CTCAE v4, EORTC QLQ-C30 and BR23, MFI, GPAQ, and DICOM/DVH data. Follow-up continued annually for two years, extending to eight years at eligible sites.  Results: Acute side effects peaked at end of radiotherapy, with erythema in 83–89% of patients. Grade ≥ 2 acute effects, including pain (11% versus 4.3%) and skin ulceration (4.8% versus 0.8%), were more frequent with normofractionation than hypofractionation. Grade ≥ 2 late effects affected between 0.6% and 16.8% of patients; skin induration was the most frequent late effect. Patient-reported outcome scores varied over time, with functional scale scores at two years similar to or higher than at baseline.  Conclusion: REQUITE provides real-world evidence of acute and late outcomes following normo- and hypofractionation, broadly consistent with published randomised trials. The dataset, combining clinical adverse effects, quality of life, dosimetric, and genetic data, is a resource for personalised radiotherapy research (www.requite.eu).
SN  - 2405-6308
ER  -