A clinical trial involving 828 patients found that three weeks of radiation following mastectomy did not increase reconstruction complications compared with the standard five-week course.
A shorter, three-week radiation schedule following mastectomy is as safe and effective as the standard five-week course for women undergoing breast reconstruction, according to results from a national clinical trial published in the Journal of Clinical Oncology.
The RT CHARM trial (Alliance A221505), led by the Alliance for Clinical Trials in Oncology in conjunction with NRG Oncology and the Canadian Cancer Trials Group, provides evidence that hypofractionated radiation therapy does not compromise cancer control or reconstruction outcomes in this patient population.
Hypofractionated radiation, which delivers slightly higher daily doses over fewer total visits, has long been used after lumpectomy. However, its adoption after mastectomy with reconstruction has been limited due to concerns that higher daily doses could increase complications and jeopardize reconstruction success.
“Patients undergoing mastectomy and reconstruction already face a challenging medical journey. Having the evidence to allow women to confidently shorten their radiation treatment from five weeks down to three will save patients time, reduce their financial stress, and let them get back to their daily lives sooner—all without increasing complications, lowering their chances of cure, or sacrificing cosmetic results,” says Matthew M. Poppe, MD, lead author of the study, a radiation oncologist at the Huntsman Cancer Institute at the University of Utah, and vice chair of the Alliance Breast Committee, in a release. “These results give us the data to safely change practice.”
Key Trial Findings
The trial evaluated 828 patients at 209 academic and community medical centers across the United States and Canada. Half received standard radiation (25 treatments over five to six weeks), while the other half received the shorter schedule (16 treatments over three to four weeks).
- Reconstruction safety: Two years after treatment, surgical complication rates were 12.3% for the shorter schedule and 10.2% for the standard schedule. Statistical analysis confirmed the shorter course was non-inferior to standard therapy.
- Cancer control: After nearly four years of follow-up, cancer recurrence rates in the treated area were 1.5% for the shorter schedule versus 2.2% for the standard schedule.
- Reconstruction type: The trial included patients receiving implant-based reconstructions as well as autologous reconstruction using the patient’s own tissue (flaps), and findings support the shorter schedule for both approaches.
Implications for Plastic Surgeons
The findings are expected to influence coordination between radiation oncologists, breast surgeons, and plastic surgeons when planning reconstruction timelines for post-mastectomy patients.
“RT CHARM provides the clearest picture to date on how shorter radiation therapy schedules interact with modern breast reconstruction techniques,” says Poppe in a release. “It gives radiation oncologists, breast surgeons, and plastic surgeons the reliable information they need to help patients make the most informed choices for their care.”
