In a single-center phase II trial reported in JAMA Network Open, Schaverien et al found that a strategy of premastectomy radiotherapy and immediate breast reconstruction was feasible in patients undergoing surgery for breast cancer.
Study Details
A total of 49 patients with cT0–T3, N0–N3b breast cancer and a recommendation for radiotherapy were enrolled in the feasibility trial at The University of Texas MD Anderson Cancer Center between August 2018 and August 2022. Patients were randomly assigned to receive either hypofractionated radiotherapy at 40.05 Gy in 15 fractions to the breast and regional node irradiation (including internal mammary nodes) at 37.5 Gy in 15 fractions (n = 25) or conventionally fractionated radiotherapy at 50 Gy in 25 fractions to the breast and regional node irradiation at 45 Gy in 25 fractions (n = 24). Patients then underwent surgery with immediate breast reconstruction. The primary outcome measure of the trial was reconstruction failure, defined as complete autologous flap loss.
Key Findings
Among the 49 patients (median age = 48 years, range = 31–72 years), 46 (94%) received neoadjuvant systemic therapy. One patient in the conventionally fractionated group underwent delayed breast reconstruction. A total of 48 patients underwent immediate breast reconstruction at a median of 23 days after radiotherapy.
Among the 48 patients, 41 had microvascular autologous flap reconstruction, 5 had latissimus dorsi pedicled flap reconstruction, and 2 had tissue expander placement.
No patients had complete autologous flap loss; one patient underwent tissue expander explantation. Mastectomy skin flap necrosis of the treated breast occurred in eight patients (17%), with one undergoing reoperation.
At a median follow-up of 29.7 months (range = 10.1–65.2 months), no patients had locoregional recurrence or distant metastasis.
The investigators concluded: “This randomized clinical trial found premastectomy radiotherapy and regional node irradiation followed by mastectomy and microvascular autologous flap immediate breast reconstruction to be feasible and safe. Based on these results, a larger randomized clinical trial of hypofractionated vs conventionally fractionated premastectomy radiotherapy has been started (TOPAz; ClinicalTrials.gov identifier NCT05774678).”
Mark V. Schaverien, MD, MSc, MEd, of the Division of Surgery, Department of Plastic Surgery, The University of Texas MD Anderson Cancer Center, is the corresponding author of the JAMA Network Open article.
Disclosure: The study was supported by the National Cancer Institute, Rising Tide Foundation for Clinical Cancer Research, and others. For full disclosures of the study authors, visit jamanetwork.com.
