Abstract
IMPORTANCE The most appropriate dose fractionation for whole-breast irradiation (WBI) remains uncertain. OBJECTIVE To assess acute and 6-month toxic effects and quality of life (QOL) with conventionally fractionated WBI (CF-WBI) vs hypofractionated WBI (HF-WBI). DESIGN, SETTING, AND PARTICIPANTS Unblinded randomized trial of CF-WBI (n = 149; 50.00 Gy/25 fractions + boost [10.00-14.00Gy/5-7 fractions]) vs HF-WBI (n = 138; 42.56Gy/16 fractions + boost [10.00-12.50Gy/4-5 fractions]) following breast-conserving surgery administered in community-based and academic cancer centers to 287women 40 years or older with stage0 to II breast cancer forwhomWBI without addition of a third fieldwas recommended; 76%of study participants (n = 217)were overweight or obese. Patientswere enrolled from February 2011 through February 2014 and observed for a minimum of 6 months. INTERVENTIONS Administration of CF-WBI or HF-WBI. MAIN OUTCOMES AND MEASURES Physician-reported acute and 6-month toxic effects using National Cancer Institute Common Toxicity Criteria, and patient-reported QOL using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). All analyses were intention to treat, with outcomes compared using the ?2 test, Cochran-Armitage test, and ordinal logistic regression. RESULTS Of 287 participants, 149were randomized to CF-WBI and 138 to HF-WBI. Treatment armswerewell matched for baseline characteristics, including FACT-B total score (HF-WBI, 120.1 vs CF-WBI, 118.8; P = .46) and individual QOL items such as somewhat or more lack of energy (HF-WBI, 38%vs CF-WBI, 39%; P = .86) and somewhat or more trouble meeting family needs (HF-WBI, 10% vs CF-WBI, 14%; P = .54). Maximum physician-reported acute dermatitis (36%vs 69%; P < .001), pruritus (54%vs 81%; P < .001), breast pain (55%vs 74%; P = .001), hyperpigmentation (9% vs 20%; P = .002), and fatigue (9% vs 17%; P = .02) during irradiation were lower in patients randomized to HF-WBI. The rate of overall grade 2 or higher acute toxic effectswas less with HF-WBI than with CF-WBI (47%vs 78%; P < .001). Six months after irradiation, physicians reported less fatigue in patients randomized to HF-WBI (0% vs 6%; P = .01), and patients randomized to HF-WBI reported less lack of energy (23%vs 39%; P < .001) and less trouble meeting family needs (3%vs 9%; P = .01). Multivariable regression confirmed the superiority ofHF-WBI in terms of patient-reported lack of energy (odds ratio [OR], 0.39; 95% CI, 0.24-0.63) and trouble meeting family needs (OR, 0.34; 95%CI, 0.16-0.75). CONCLUSIONS AND RELEVANCE Treatment with HF-WBI appears to yield lower rates of acute toxic effects than CF-WBI as well as less fatigue and less trouble meeting family needs 6 months after completing radiation therapy. These findings should be communicated to patients as part of shared decision making.
Original language | English (US) |
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Pages (from-to) | 931-941 |
Number of pages | 11 |
Journal | JAMA Oncology |
Volume | 1 |
Issue number | 7 |
DOIs | |
State | Published - Oct 2015 |
ASJC Scopus subject areas
- Oncology
- Cancer Research
MD Anderson CCSG core facilities
- Assessment, Intervention, and Measurement
- Clinical Trials Office
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Susan K Peterson (Director) & Karen M Basen-Engquist (Director)
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