Patient-Reported Cosmetic Outcomes With Radiotherapy in Early Breast Cancer
As reported in the Journal of Clinical Oncology by Shaitelman et al, 3-year outcomes of a phase III noninferiority trial indicate that hypofractionated whole-breast irradiation (HF-WBI) followed by a tumor bed boost is not inferior to conventionally fractionated whole-breast irradiation (CF-WBI) followed by a tumor bed boost in patient-reported adverse cosmetic outcomes.
In the multicenter trial, 287 women with stage 0 to II breast cancer who underwent margin-negative segmental mastectomy were randomly assigned between 2011 and 2014 to receive HF-WBI with 42.56 Gy in 16 fractions plus 10 to 12.5 Gy in 4 to 5 fractions (n = 138) or CF-WBI with 50 Gy in 25 fractions plus 10 to 14 Gy in 5 to 7 fractions. Randomization was stratified by chemotherapy, surgical margin status, cosmesis, and breast size.
The trial tested the hypothesis that HF-WBI is not inferior to CF-WBI with regard to the proportion of patients with adverse cosmetic outcome 3 years after radiation as assessed by the Breast Cancer Treatment Outcomes Scale. Outcomes were assessed in the intention-to-treat population.
Cosmetic Outcomes
A total of 286 patients received the protocol-specified radiation dose (1 in the HF-WBI group did not), 30% received chemotherapy, and 36.9% had large breast size. Median follow-up was 4.1 years.
Three-year adverse cosmetic outcome rates were 8.2% with HF-WBI vs 13.6% with CF-WBI (5.4% lower with HF-WBI; P for noninferiority = .002). Among 71 patients receiving chemotherapy, the adverse cosmetic outcome rate was 4.1% higher with HF-WBI vs CF-WBI (with the 90% upper confidence limit of 15.0% not meeting the noninferiority threshold of 10.0%). Among women with large breast size (n = 106 with bra cup size D or larger), the adverse cosmetic outcome rate was 18.6% lower with HF-WBI (with the 90% upper confidence limit of −8.0% meeting the noninferiority criterion).
Poor or fair photographically assessed cosmesis was reported for 35.4% of HF-WBI patients vs 28.8% of CF-WBI patients (P = .31). Local recurrence-free survival at 3 years was 99% in both groups (P = .37).
The investigators concluded, “Three years after WBI followed by a tumor bed boost, outcomes with hypofractionation and conventional fractionation are similar. Tumor bed boost, chemotherapy, and larger breast size do not seem to be strong contraindications to HF-WBI.”
The study was funded by ASCO’s Conquer Cancer Foundation, Breast Cancer Research Foundation, Cancer Prevention and Research Institute of Texas, National Cancer Institute, Andrew Sabin Family Fellowship, and others.
Benjamin D. Smith, MD, of The University of Texas MD Anderson Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: See study authors’ full disclosures at jco.ascopubs.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
