Phase 2 trial of accelerated, hypofractionated whole-breast irradiation of 39 Gy in 13 fractions followed by a tumor bed boost sequentially delivering 9 Gy in 3 fractions in early-stage breast cancer

Int J Radiat Oncol Biol Phys. 2013 Dec 1;87(5):1037-42. doi: 10.1016/j.ijrobp.2013.09.019.

Abstract

Purpose: To report a phase 2 trial of accelerated, hypofractionated whole-breast irradiation (AH-WBI) delivered as a daily dose of 3 Gy to the whole breast followed by a tumor bed boost.

Methods and materials: Two hundred seventy-six patients diagnosed with breast cancer (pT1-2 and pN0-1a) who had undergone breast-conserving surgery in which the operative margins were negative were treated with AH-WBI delivered as 39 Gy in 13 fractions of 3 Gy to the whole breast once daily over 5 consecutive working days, and 9 Gy in 3 sequential fractions of 3 Gy to a lumpectomy cavity, all within 3.2 weeks.

Results: After a median follow-up period of 57 months (range: 27-75 months), the rate of 5-year locoregional recurrence was 1.4% (n=4), whereas that of disease-free survival was 97.4%. No grade 3 skin toxicity was reported during the follow-up period. Qualitative physician cosmetic assessments of good or excellent were noted in 82% of the patients at 2 months after the completion of AH-WBI. The global cosmetic outcome did not worsen over time, and a good or excellent cosmetic outcome was reported in 82% of the patients at 3 years. The mean pretreatment percentage breast retraction assessment was 12.00 (95% confidence interval [CI]: 11.14-12.86). The mean value of percentage breast retraction assessment increased to 13.99 (95% CI: 12.17-15.96) after 1 year and decreased to 13.54 (95% CI: 11.84-15.46) after 3 years but was not significant (P>.05).

Conclusions: AH-WBI consisting of 39 Gy in 13 fractions followed by a tumor bed boost sequentially delivering 9 Gy in 3 fractions can be delivered with excellent disease control and tolerable skin toxicity in patients with early-stage breast cancer after breast-conserving surgery.

Publication types

  • Clinical Trial, Phase II

MeSH terms

  • Adult
  • Aged
  • Breast / pathology
  • Breast / radiation effects
  • Breast Neoplasms / mortality
  • Breast Neoplasms / pathology
  • Breast Neoplasms / radiotherapy*
  • Breast Neoplasms / surgery
  • Disease-Free Survival
  • Dose Fractionation, Radiation
  • Feasibility Studies
  • Female
  • Follow-Up Studies
  • Humans
  • Mastectomy, Segmental
  • Middle Aged
  • Neoplasm Recurrence, Local
  • Neoplasm Staging
  • Prognosis
  • Radiation Injuries / complications
  • Radiation Injuries / pathology
  • Skin / pathology
  • Skin / radiation effects