title: Differences in the Acute Toxic Effects of Breast Radiotherapy by Fractionation Schedule: Comparative Analysis of Physician-Assessed and Patient-Reported Outcomes in a Large Multicenter Cohort.
abstract: OBJECTIVE
  Randomized trials have established the long-term safety and efficacy of hypofractionated whole-breast radiotherapy, but little is known about the acute toxic effects experienced by patients treated with hypofractionation as compared with conventional fractionation, particularly in real-world settings and from the patient's own perspective.
  
  
  OBJECTIVE
  To evaluate prospectively collected data on acute toxic effects and patient-reported outcomes in a cohort treated with varying radiation fractionation schemes in practices collaborating in the Michigan Radiation Oncology Quality Consortium (MROQC).
  
  
  METHODS
  We compared toxic effects in patients receiving hypofractionation (HF) vs conventional fractionation (CF) during treatment (through 7 days after treatment) and in follow-up (posttreatment days 8-210), after adjustment for sociodemographic, clinical, and treatment characteristics. The MROQC includes academic and community radiation oncology practices across Michigan. All 2604 patients who received adjuvant whole-breast radiotherapy after lumpectomy for unilateral breast cancer at MROQC participating sites from October 2011 through June 2014 were registered; we analyzed 2309 for whom there was a comprehensive physician toxicity evaluation within 1 week of completion of radiotherapy and at least 1 weekly toxicity evaluation during treatment.
  
  
  METHODS
  Hypofractionation vs CF.
  
  
  METHODS
  Physicians reported dermatitis, pain, fatigue, and other common toxic effects associated with breast radiotherapy at baseline, weekly during radiotherapy, and in follow-up. Patients who consented also rated their own experiences, including breast pain, fatigue, and being bothered by symptoms.
  
  
  RESULTS
  Of the 2309 evaluable patients, 578 received HF. During treatment, after adjustment for sociodemographic, clinical, and treatment factors, patients receiving CF had significantly higher maximum physician-assessed skin reaction (moist desquamation, 28.5% vs 6.6%, P < .001; grade ≥2 dermatitis, 62.6% vs 27.4%, P < .001), self-reported pain (moderate/severe pain, 41.1% vs 24.2%, P = .003), burning/stinging bother (often/always, 38.7% vs 15.7%, P = .002), hurting bother (33.5% vs 16.0%, P = .001), swelling bother (29.6% vs 15.7%, P = .03), and fatigue (29.7% vs 18.9%, P = .02) but slightly greater absence of skin induration in follow-up (84.5% vs 81.2%, P = .02). No significant differences were observed in any other measured outcomes during follow-up extending through 6 months.
  
  
  CONCLUSIONS
  Hypofractionation not only improves convenience but also may reduce acute pain, fatigue, and the extent to which patients are bothered by dermatitis in patients with breast cancer undergoing whole-breast radiotherapy.
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor2Center for Bioethics and Social Science in Medicine, Ann Arbor.
authors.forename: Reshma
authors.initials: R
authors.lastname: Jagsi
authors.affiliation: Center for Cancer Biostatistics, University of Michigan School of Public Health, Ann Arbor.
authors.forename: Kent A
authors.initials: KA
authors.lastname: Griffith
authors.affiliation: McLaren Northern Michigan, Petoskey.
authors.forename: Thomas P
authors.initials: TP
authors.lastname: Boike
authors.affiliation: Henry Ford Hospital, Detroit, Michigan.
authors.forename: Eleanor
authors.initials: E
authors.lastname: Walker
authors.affiliation: 21st Century Oncology, Detroit, Michigan.
authors.forename: Teamour
authors.initials: T
authors.lastname: Nurushev
authors.affiliation: Beaumont Health System, Royal Oak, Michigan.
authors.forename: Inga S
authors.initials: IS
authors.lastname: Grills
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor.
authors.forename: Jean M
authors.initials: JM
authors.lastname: Moran
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor.
authors.forename: Mary
authors.initials: M
authors.lastname: Feng
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor.
authors.forename: James
authors.initials: J
authors.lastname: Hayman
authors.affiliation: Department of Radiation Oncology, University of Michigan, Ann Arbor.
authors.forename: Lori J
authors.initials: LJ
authors.lastname: Pierce
mesh_terms: D000368:Aged; D001943:Breast Neoplasms / Q000473:pathology / Q000532:radiotherapy* / Q000601:surgery; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D015412:Mastectomy, Segmental; D008824:Michigan; D008875:Middle Aged; D011237:Predictive Value of Tests; D011446:Prospective Studies; D011832:Radiation Injuries / Q000175:diagnosis* / Q000209:etiology / Q000517:prevention & control; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D012307:Risk Factors; D057566:Self Report; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome