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



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.



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; P = .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≥.14). The linear effect of time was significant for BCTOS measures of functional status (P = .001, improved with time) and breast pain (P = .002, improved with time).



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. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2886-2894. © 2016 American Cancer Society.
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cameron W
CW
Swanick
Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Xiudong
X
Lei
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Simona F
SF
Shaitelman
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Pamela J
PJ
Schlembach
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Elizabeth S
ES
Bloom
Department of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michelle C
MC
Fingeret
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Eric A
EA
Strom
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Welela
W
Tereffe
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Wendy A
WA
Woodward
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Michael C
0000-0002-2089-7551
MC
Stauder
Department of Radiation Oncology, University of Florida Health Cancer Center at Orlando Health, Orlando, Florida.
Tomas
T
Dvorak
Department of Breast Surgical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Alastair M
AM
Thompson
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Thomas A
TA
Buchholz
Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.|Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Benjamin D
BD
Smith
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001943:Breast Neoplasms / Q000532:radiotherapy*; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D018714:Radiotherapy, Adjuvant
breast cancer; cosmesis; hypofractionation; patient-reported outcomes; whole-breast irradiation