Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer.

Hilde Van Parijs, Vincent Vinh - Hung, Christel Fontaine, Guy Storme, Claire Verschraegen, Dung M. Nguyen, Nele Adriaenssens, Nam P Nguyen, Olena Gorobets, Mark De Ridder

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Abstract

Background Long-term prospective patient-reported outcomes (PRO) after breast cancer adjuvant radiotherapy is scarce. TomoBreast compared conventional radiotherapy (CR) with tomotherapy (TT), on the hypothesis that TT might reduce lung-heart toxicity. Methods Among 123 women consenting to participate, 64 were randomized to CR, 59 to TT. CR delivered 50 Gy in 25 fractions/5 weeks to breast/chest wall and regional nodes if node-positive, with a sequential boost (16 Gy/8 fractions/1.6 weeks) after lumpectomy. TT delivered 42 Gy/15 fractions/3 weeks to breast/chest wall and regional nodes if node-positive, 51 Gy simultaneous-integrated-boost in patients with lumpectomy. PRO were assessed using the European Organization for Research and Treatment of Cancer questionnaire QLQ-C30. PRO scores were converted into a symptom-free scale, 100 indicating a fully symptom-free score, 0 indicating total loss of freedom from symptom. Changes of PRO over time were analyzed using the linear mixed-effect model. Survival analysis computed time to > 10% PRO-deterioration. A post-hoc cardiorespiratory outcome was defined as deterioration in any of dyspnea, fatigue, physical functioning, or pain. Results At 10.4 years median follow-up, patients returned on average 9 questionnaires/patient, providing a total of 1139 PRO records. Item completeness was 96.6%. Missingness did not differ between the randomization arms. The PRO at baseline were below the nominal 100% symptom-free score, notably the mean fatigue-free score was 64.8% vs. 69.6%, pain-free was 75.4% vs. 75.3%, and dyspnea-free was 84.8% vs. 88.5%, in the TT vs. CR arm, respectively, although the differences were not significant. By mixed-effect modeling on early ≤2 years assessment, all three scores deteriorated, significantly for fatigue, P ≤ 0.01, without effect of randomization arm. By modeling on late assessment beyond 2 years, TT versus CR was not significantly associated with changes of fatigue-free or pain-free scores but was associated with a significant 8.9% improvement of freedom from dyspnea, P = 0.035. By survival analysis of the time to PRO deterioration, TT improved 10-year survival free of cardiorespiratory deterioration from 66.9% with CR to 84.5% with TT, P = 0.029. Conclusion Modern radiation therapy can significantly improve long-term PRO.
Original languageEnglish
Article number1177
Number of pages11
JournalBMC Cancer
Volume21
DOIs
Publication statusPublished - 4 Nov 2021

Bibliographical note

Funding Information:
TomoBreast was supported in part by grant SCIE2006–30 Stichting tegen Kanker - Fondation contre le Cancer, Belgium. The funding bodies played no role in the design of the study and collection, analysis, and interpretation of data and in writing the manuscript.

Funding Information:
We are deeply grateful to the technologists, nurses, and physicists of the Brussels University Hospital for patient management, to Stephanie Fortier of the James, Ohio State University for revision help, to Claudia Copeland of Carpe Diem Biomedical Writing & Editing for scientific English editing, and, foremost, we are indebted to our patients for participating to TomoBreast. We are grateful to our colleagues of the Ohio State University Comprehensive Cancer Center, Columbus, OH, USA, who presented part of the study at the San Antonio Breast Cancer Symposium, December 10-14, 2019. All patients gave signed informed consent to participate. All codes are publicly available through The Comprehensive R Archive Network https://cran.r-project.org/

Publisher Copyright:
© 2021, The Author(s).

Copyright:
Copyright 2022 Elsevier B.V., All rights reserved.

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