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

BMC Cancer

Olena Gorobets¹  Nam P. Nguyen²  Claire Verschraegen³  Dung M. Nguyen⁴  Hilde Van Parijs⁵  Mark De Ridder⁵  Christel Fontaine⁵  Nele Adriaenssens⁵  Guy Storme⁵  Vincent Vinh-Hung⁶ 

[1] Centre Hospitalier Universitaire (CHU) de Martinique, Fort-de-France, France;Ukrainian Military Medical Academy, Kiev, Ukraine;Howard University, Washington, DC, USA;Ohio State University, Columbus, OH, USA;School of Medicine, Vietnam National University, Ho Chi Minh City, Vietnam;Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium;Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, 101 Laarbeeklaan, 1090, Brussels, Belgium;Centre Hospitalier Universitaire (CHU) de Martinique, Fort-de-France, France;

关键词: Quality of life;    Patient reported outcome measures;    Dyspnea;    Fatigue;    Pain;   

DOI  :  10.1186/s12885-021-08916-z

来源: Springer

【 摘 要 】

BackgroundLong-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.MethodsAmong 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.ResultsAt 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.ConclusionModern radiation therapy can significantly improve long-term PRO.Trial registrationTrial registration number ClinicalTrials.govNCT00459628, April 12, 2007 prospectively.

【 授权许可】

CC BY