Acute and short-term toxic effects of conventionally fractionated vs hypofractionated whole-breast irradiation: A randomized clinical trial

Simona F. Shaitelman, Pamela J. Schlembach, Isidora Arzu, Matthew Ballo, Elizabeth S. Bloom, Daniel Buchholz, Gregory M. Chronowski, Tomas Dvorak, Emily Grade, Karen E. Hoffman, Patrick Kelly, Michelle Ludwig, George H. Perkins, Valerie Reed, Shalin Shah, Michael C. Stauder, Eric A. Strom, Welela Tereffe, Wendy A. Woodward, Joe EnsorDonald Baumann, Alastair M. Thompson, Diana Amaya, Tanisha Davis, William Guerra, Lois Hamblin, Gabriel Hortobagyi, Kelly K. Hunt, Thomas A. Buchholz, Benjamin D. Smith

Research output: Contribution to journalArticlepeer-review

206 Scopus citations

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 languageEnglish (US)
Pages (from-to)931-941
Number of pages11
JournalJAMA Oncology
Volume1
Issue number7
DOIs
StatePublished - Oct 2015

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

MD Anderson CCSG core facilities

  • Assessment, Intervention, and Measurement
  • Clinical Trials Office

Fingerprint

Dive into the research topics of 'Acute and short-term toxic effects of conventionally fractionated vs hypofractionated whole-breast irradiation: A randomized clinical trial'. Together they form a unique fingerprint.

Cite this