Randomized Trial of Hypofractionated Postmastectomy Radiation Therapy in Women With Breast Reconstruction (RT CHARM, Alliance A221505).
Matthew M Poppe, Jennifer J Le-Rademacher, Bruce G Haffty et al.
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In 30 seconds
RT CHARM (Alliance A221505) was a randomized noninferiority trial comparing hypofractionated with conventional postmastectomy radiation therapy in women with unilateral invasive breast cancer undergoing immediate or delayed reconstruction. Among 825 patients evaluable for the primary outcome, 24-month reconstruction complication rates were 12.3% (52/422) with 16 fractions and 10.2% (41/403) with 25 fractions; the estimated difference was -2.1% (95% CI, -6.5 to 2.2). The authors concluded that hypofractionated treatment was safe and noninferior. Locoregional recurrence and acute and late toxicity did not differ significantly between groups.
Key findings
- At 24 months, reconstruction complications occurred in 12.3% (52/422) with hypofractionated PMRT and 10.2% (41/403) with conventional PMRT.
- The estimated complication-rate difference was -2.1% (95% CI, -6.5 to 2.2), supporting noninferiority of the 16-fraction regimen.
- Implant-only reconstruction was associated with higher complication rates than autologous reconstruction (odds ratio = 1.65), regardless of treatment arm.
- At 36 months, locoregional recurrence rates were 1.5% (95% CI, 0.7 to 3.2) and 2.2% (95% CI, 1.1 to 4.3) with hypofractionated and conventional PMRT, respectively; the difference was not statistically significant.
Why it matters
For patients undergoing reconstruction after mastectomy, radiation schedule may affect treatment burden as well as reconstruction outcomes. This randomized comparison found that a shorter course did not increase the primary complication outcome beyond the trial’s noninferiority threshold, while recurrence and toxicity outcomes were also not significantly different. The findings help address concerns about using hypofractionated PMRT in this population.
What to keep in mind
The primary endpoint was evaluable in 825 of 898 enrolled patients. Follow-up was a median of 3.9 years, limiting assessment of longer-term outcomes.