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Randomized Controlled Trial
. 2010 Feb 11;362(6):513-20.
doi: 10.1056/NEJMoa0906260.

Long-term Results of Hypofractionated Radiation Therapy for Breast Cancer

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Randomized Controlled Trial

Long-term Results of Hypofractionated Radiation Therapy for Breast Cancer

Timothy J Whelan et al. N Engl J Med. .
Free article

Abstract

Background: The optimal fractionation schedule for whole-breast irradiation after breast-conserving surgery is unknown.

Methods: We conducted a study to determine whether a hypofractionated 3-week schedule of whole-breast irradiation is as effective as a 5-week schedule. Women with invasive breast cancer who had undergone breast-conserving surgery and in whom resection margins were clear and axillary lymph nodes were negative were randomly assigned to receive whole-breast irradiation either at a standard dose of 50.0 Gy in 25 fractions over a period of 35 days (the control group) or at a dose of 42.5 Gy in 16 fractions over a period of 22 days (the hypofractionated-radiation group).

Results: The risk of local recurrence at 10 years was 6.7% among the 612 women assigned to standard irradiation as compared with 6.2% among the 622 women assigned to the hypofractionated regimen (absolute difference, 0.5 percentage points; 95% confidence interval [CI], -2.5 to 3.5). At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic outcome (absolute difference, 1.5 percentage points; 95% CI, -6.9 to 9.8).

Conclusions: Ten years after treatment, accelerated, hypofractionated whole-breast irradiation was not inferior to standard radiation treatment in women who had undergone breast-conserving surgery for invasive breast cancer with clear surgical margins and negative axillary nodes. (ClinicalTrials.gov number, NCT00156052.)

Comment in

  • Hypofractionated radiotherapy for breast cancer.
    Haviland JS, Yarnold JR, Bentzen SM. Haviland JS, et al. N Engl J Med. 2010 May 13;362(19):1843; author reply 1843-4. doi: 10.1056/NEJMc1002798. N Engl J Med. 2010. PMID: 20463347 No abstract available.

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