TY - JOUR
T1 - Five-Year Longitudinal Analysis of Patient-Reported Outcomes and Cosmesis in a Randomized Trial of Conventionally Fractionated Versus Hypofractionated Whole-Breast Irradiation
AU - Weng, Julius K.
AU - Lei, Xiudong
AU - Schlembach, Pamela
AU - Bloom, Elizabeth S.
AU - Shaitelman, Simona F.
AU - Arzu, Isidora Y.
AU - Chronowski, Gregory
AU - Dvorak, Tomas
AU - Grade, Emily
AU - Hoffman, Karen
AU - Perkins, George
AU - Reed, Valerie K.
AU - Shah, Shalin J.
AU - Stauder, Michael C.
AU - Strom, Eric A.
AU - Tereffe, Welela
AU - Woodward, Wendy A.
AU - Hortobagyi, Gabriel N.
AU - Hunt, Kelly K.
AU - Buchholz, Thomas A.
AU - Smith, Benjamin D.
N1 - Funding Information:
This work was supported by a Career Development Award from the American Society of Clinical Oncology Conquer Cancer Foundation, which is funded by the Breast Cancer Research Foundation (to B.D.S.). Additional support was provided by the Cancer Prevention and Research Institute of Texas Grant RP160674 (to B.D.S.) and the National Cancer Institute Grants R01 CA207216 (to B.D.S.) and R01 1CA225646 (to B.D.S.). Support was provided, in part, by the Biostatistics Shared Resource and the Assessment, Intervention and Measurement (AIM) Shared Resource through a Cancer Center Support Grant (CA16672, PI: P. Pisters, MD Anderson Cancer Center) from the National Cancer Institute, National Institutes of Health, and through the Duncan Family Institute for Cancer Prevention and Risk Assessment. Additional support was provided by a philanthropic gift from Ann and Clarence Cazalot. The funders had no role in the trial design, statistical analyses, decision to publish, or manuscript preparation.
Funding Information:
Disclosures: S.F.S. reports grants from NIH R21 CA252411, grants from Emerson Collective, and grants from NIH R01 CA201487, outside the submitted work. G.P. reports grants from Blue Health Intelligence/Blue Cross Blue Shield of Texas/Blue Cross Blue Shield of Illinois/Health Care Service Corporation, outside the submitted work. V.K.R. is an uncompensated consultant for Varian. K.K.H. is on the medical advisory board of Armada Health and Merck & Co. and reports grants from Lumicell and OncoNano, outside the submitted work. T.A.B. is a board member of a new company, Empyrean, that makes radiation oncology equipment. B.D.S. reports royalty and equity interest in Oncora Medical and grants from Varian Medical Systems, outside the submitted work. All other authors report no conflicts of interest.
Publisher Copyright:
© 2021 Elsevier Inc.
PY - 2021/10
Y1 - 2021/10
N2 - Purpose: There are limited prospective data on predictors of patient-reported outcomes (PROs) after whole-breast irradiation (WBI) plus a boost. We sought to characterize longitudinal PROs and cosmesis in a randomized trial comparing conventionally fractionated (CF) versus hypofractionated (HF) WBI. Methods and Materials: From 2011 to 2014, women aged ≥40 years with Tis-T2 N0-N1a M0 breast cancer who underwent a lumpectomy with negative margins were randomized to CF-WBI (50 Gray [Gy]/25 fractions plus boost) versus HF-WBI (42.56 Gy/16 fractions plus boost). At baseline (pre-radiation), at 6 months, and yearly thereafter through 5 years, PROs included the Breast Cancer Treatment Outcome Scale (BCTOS), Functional Assessment of Cancer Therapy–Breast (FACT-B), and Body Image Scale; cosmesis was reported by the treating physician using Radiation Therapy Oncology Group cosmesis values. Multivariable mixed-effects growth curve models evaluated associations of the treatment arm and patient factors with outcomes and tested for relevant interactions with the treatment arm. Results: A total of 287 patients were randomized, completing a total of 14,801 PRO assessments. The median age was 60 years, 37% of patients had a bra cup size ≥D, 44% were obese, and 30% received chemotherapy. Through 5 years, there were no significant differences in PROs or cosmesis by treatment arm. A bra cup size ≥D was associated with worse BCTOS cosmesis (P < .001), BCTOS pain (P = .001), FACT-B Trial Outcome Index (P = .03), FACT-B Emotional Well-being (P = .03), and Body Image Scale (P = .003) scores. Physician-rated cosmesis was worse in patients who were overweight (P = .02) or obese (P < .001). No patient subsets experienced better PROs or cosmesis with CF-WBI. Conclusions: Both CF-WBI and HF-WBI confer similar longitudinal PROs and physician-rated cosmesis through 5 years of follow-up, with no relevant subsets that fared better with CF-WBI. This evidence supports broad adoption of hypofractionation with boost, including in patients receiving chemotherapy and in a population with a high prevalence of obesity. The associations of large breast size and obesity with adverse outcomes across multiple domains highlight the opportunity to engage at-risk patients in lifestyle intervention strategies, as well as to consider alternative radiation treatment regimens.
AB - Purpose: There are limited prospective data on predictors of patient-reported outcomes (PROs) after whole-breast irradiation (WBI) plus a boost. We sought to characterize longitudinal PROs and cosmesis in a randomized trial comparing conventionally fractionated (CF) versus hypofractionated (HF) WBI. Methods and Materials: From 2011 to 2014, women aged ≥40 years with Tis-T2 N0-N1a M0 breast cancer who underwent a lumpectomy with negative margins were randomized to CF-WBI (50 Gray [Gy]/25 fractions plus boost) versus HF-WBI (42.56 Gy/16 fractions plus boost). At baseline (pre-radiation), at 6 months, and yearly thereafter through 5 years, PROs included the Breast Cancer Treatment Outcome Scale (BCTOS), Functional Assessment of Cancer Therapy–Breast (FACT-B), and Body Image Scale; cosmesis was reported by the treating physician using Radiation Therapy Oncology Group cosmesis values. Multivariable mixed-effects growth curve models evaluated associations of the treatment arm and patient factors with outcomes and tested for relevant interactions with the treatment arm. Results: A total of 287 patients were randomized, completing a total of 14,801 PRO assessments. The median age was 60 years, 37% of patients had a bra cup size ≥D, 44% were obese, and 30% received chemotherapy. Through 5 years, there were no significant differences in PROs or cosmesis by treatment arm. A bra cup size ≥D was associated with worse BCTOS cosmesis (P < .001), BCTOS pain (P = .001), FACT-B Trial Outcome Index (P = .03), FACT-B Emotional Well-being (P = .03), and Body Image Scale (P = .003) scores. Physician-rated cosmesis was worse in patients who were overweight (P = .02) or obese (P < .001). No patient subsets experienced better PROs or cosmesis with CF-WBI. Conclusions: Both CF-WBI and HF-WBI confer similar longitudinal PROs and physician-rated cosmesis through 5 years of follow-up, with no relevant subsets that fared better with CF-WBI. This evidence supports broad adoption of hypofractionation with boost, including in patients receiving chemotherapy and in a population with a high prevalence of obesity. The associations of large breast size and obesity with adverse outcomes across multiple domains highlight the opportunity to engage at-risk patients in lifestyle intervention strategies, as well as to consider alternative radiation treatment regimens.
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U2 - 10.1016/j.ijrobp.2021.05.004
DO - 10.1016/j.ijrobp.2021.05.004
M3 - Article
C2 - 33992718
AN - SCOPUS:85110133438
SN - 0360-3016
VL - 111
SP - 360
EP - 370
JO - International Journal of Radiation Oncology Biology Physics
JF - International Journal of Radiation Oncology Biology Physics
IS - 2
ER -