Longitudinal analysis of patient‐reported outcomes and cosmesis in a randomized trial of conventionally fractionated versus hypofractionated whole‐breast irradiation

Abstract

Background The authors compared longitudinal patient-reported outcomes and physician-rated cosmesis with conventionally fractionated whole-breast irradiation (CF-WBI) versus hypofractionated whole-breast irradiation (HF-WBI) within the context of a randomized trial. Methods From 2011 to 2014, a total of 287 women with American Joint Committee on Cancer stage 0 to stage II breast cancer were randomized to receive CF-WBI (at a dose of 50 grays in 25 fractions plus a tumor bed boost) or HF-WBI (at a dose of 42.56 grays in 16 fractions plus a tumor bed boost) after breast-conserving surgery. Patient-reported outcomes were assessed using the Breast Cancer Treatment Outcome Scale (BCTOS), the Functional Assessment of Cancer Therapy-Breast, and the Body Image Scale and were recorded at baseline and 0.5, 1, 2, and 3 years after radiotherapy. Physician-rated cosmesis was assessed at the same time points. Outcomes by treatment arm were compared at each time point using a 2-sided Student t test. Multivariable mixed effects growth curve models assessed the effects of treatment arm and time on longitudinal outcomes. Results Of the 287 patients enrolled, 149 were randomized to CF-WBI and 138 were randomized to HF-WBI. At 2 years, the Functional Assessment of Cancer Therapy-Breast Trial Outcome Index score was found to be modestly better in the HF-WBI arm (mean 79.6 vs 75.9 for CF-WBI; P5.02). In multivariable mixed effects models, treatment arm was not found to be associated with longitudinal outcomes after adjusting for time and baseline outcome measures (P≥0.14). The linear effect of time was significant for BCTOS measures of functional status (P=0.001, improved with time) and breast pain (P=.002, improved with time). Conclusions In this randomized trial, longitudinal outcomes did not appear to differ by treatment arm. Patient-reported functional and pain outcomes improved over time. These findings are relevant when counseling patients regarding decisions concerning radiotherapy.

Hypofractionated radiation treatment in the management of breast cancer

“…In the United States (US), the MD Anderson Cancer Center (MDACC) initiated a smaller randomized trial of HF-WBI versus CF-WBI aiming to assess differences in physician-assessed toxicity and patient-reported quality of life [16,17]. Eligibility criteria included patients ≥ 40 years of age with DCIS or T1-2 N0-1a M0 invasive cancer who underwent BCS with negative margins on ink.…”

Development and psychometric evaluation of a Dutch-translated shorter Breast Cancer Treatment Outcome Scale (Dutch BCTOS-13)

“…The original BCTOS-22 was validated in patients after completing all treatment, so also including radiotherapy in the majority of patients. Therefore, it is widely used as a PROM in radiotherapy clinical trials [23–25].…”

Long-term Patient-Reported Outcomes in Older Breast Cancer Survivors: A Population-Based Survey Study

“…However, to our knowledge, there are no studies demonstrating an association between tumor size and worse patient-reported cosmetic outcomes. In fact, in one randomized trial of standard versus hypofractionated WBI, T category was not a significant predictor of longitudinal patient-reported or physician-rated cosmesis (39). These findings suggest that tumor size may not be the most relevant predictor of patient-reported cosmetic satisfaction.…”