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

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 p...

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Autores principales:	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
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	Quality of life Patient reported outcome measures Dyspnea Fatigue Pain Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
Acceso en línea:	https://doaj.org/article/84a1938cdab54b1daefba478f0804a58
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spelling	oai:doaj.org-article:84a1938cdab54b1daefba478f0804a582021-11-08T11:02:03ZCardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer10.1186/s12885-021-08916-z1471-2407https://doaj.org/article/84a1938cdab54b1daefba478f0804a582021-11-01T00:00:00Zhttps://doi.org/10.1186/s12885-021-08916-zhttps://doaj.org/toc/1471-2407Abstract 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. Trial registration Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively.Hilde Van ParijsVincent Vinh-HungChristel FontaineGuy StormeClaire VerschraegenDung M. NguyenNele AdriaenssensNam P. NguyenOlena GorobetsMark De RidderBMCarticleQuality of lifePatient reported outcome measuresDyspneaFatiguePainNeoplasms. Tumors. Oncology. Including cancer and carcinogensRC254-282ENBMC Cancer, Vol 21, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	Quality of life Patient reported outcome measures Dyspnea Fatigue Pain Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282
spellingShingle	Quality of life Patient reported outcome measures Dyspnea Fatigue Pain Neoplasms. Tumors. Oncology. Including cancer and carcinogens RC254-282 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 Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
description	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. Trial registration Trial registration number ClinicalTrials.gov NCT00459628 , April 12, 2007 prospectively.
format	article
author	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
author_facet	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
author_sort	Hilde Van Parijs
title	Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
title_short	Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
title_full	Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
title_fullStr	Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
title_full_unstemmed	Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
title_sort	cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer
publisher	BMC
publishDate	2021
url	https://doaj.org/article/84a1938cdab54b1daefba478f0804a58
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Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer

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