Randomized Trial of Hypofractionated Postmastectomy Radiation Therapy in Women With Breast Reconstruction (RT CHARM, Alliance A221505)
In brief
16-session postmastectomy radiation had similar reconstruction complication rates
In a randomized trial, complications within 2 years affected 12.3% of women receiving 16 radiation sessions over 3 weeks and 10.2% receiving 25 sessions over 5 weeks, meeting the trial's standard for noninferiority. Recurrence and toxicity rates were also similar; implant-only reconstruction had more complications than autologous reconstruction, and longer follow-up will clarify lasting outcomes.
- Journal
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology (Q1)
- Published
- 12 October 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Matthew M Poppe, Jennifer J Le-Rademacher, Bruce G Haffty, Eric K Hansen, Jayant P Agarwal, Jamie L Wagner, et al.
- PMID
- 42863096
- DOI
- 10.1200/JCO-26-00474
Why clinicians should know about it
- Picked for Plastic and Reconstructive Surgery (paper of the day, 13 October 2026): Hypofractionated vs conventional PMRT in breast reconstruction
- Picked for Radiation Oncology (paper of the day, 13 October 2026): Randomized noninferiority trial of hypofractionated postmastectomy radiation
- Picked for Oncology and Radiation Oncology (paper of the day, 13 October 2026): Hypofractionated PMRT noninferior to conventional
Abstract
PURPOSE: Patients with breast cancer requiring postmastectomy radiation therapy (PMRT) often desire breast reconstruction. Reconstructions can be adversely affected by PMRT, and fear of reconstruction complications has discouraged adoption of short-course radiation therapy used after lumpectomy. To fill the evidence gap, we conducted a noninferiority trial of hypofractionated versus conventional PMRT in patients undergoing breast reconstruction. The primary outcome was reconstruction complication rate, a composite of wound healing, readmission, capsular contracture, unplanned reoperation, and reconstruction failure. METHODS: Women with unilateral invasive breast cancer with planned immediate or delayed reconstruction and PMRT were randomly assigned (1:1) to 50 Gy (25 fractions/5 weeks) or 42.56 Gy (16 fractions/3 weeks). This study was designed with a noninferiority margin of 10%, assuming a 2-year reconstruction complication rate of 25% with conventional PMRT. Randomization was stratified by immediate versus delayed and autologous versus implant-only reconstruction. RESULTS: Between 2018 and 2021, 898 patients enrolled with a median follow-up of 3.9 years; 825 patients were evaluable for the primary end point. The 24-month reconstruction complication rates were 12.3% (52/422) with hypofractionated PMRT and 10.2% (41/403) with conventional PMRT, corresponding to an estimated difference of -2.1% (95% CI, -6.5 to 2.2). The complication rate was higher (regardless of arm) with implant-only versus autologous reconstruction (odds ratio = 1.65). There was no statistically significant difference in 36-month locoregional recurrence rates: 1.5% (95% CI, 0.7 to 3.2) with hypofractionated and 2.2% (95% CI, 1.1 to 4.3) with conventional PMRT. Acute and late toxicity rates were not statistically different. CONCLUSION: A 16-fraction course of hypofractionated PMRT is safe and noninferior to conventional PMRT in women undergoing breast reconstruction after mastectomy.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.