Multicenter Phase II Study of Intraoperative Radiotherapy of Early Breast Cancer: Ipsilateral Tumor Recurrence.

ABSTRACT

BACKGROUND: We performed a multicenter phase II study on the efficacy and safety of intraoperative radiotherapy (IORT) as partial breast irradiation using multiple devices. METHODS: The primary endpoint was ipsilateral breast tumor recurrence (IBTR). Key inclusion criteria were T < 2.5 cm, age > 50 years, surgical margin > 1 cm, intraoperative pathologically free margins, and sentinel node negative. After resection of the tumor, radiation at 21 Gy was delivered directly to the mammary gland employing an electron linear accelerator in the operating room, otherwise the patient was transported from the surgical suite to the radiation room. RESULTS: Overall, 142 patients were enrolled in this study and 129 underwent IORT. Stage 0 n = 4 (3.1%); stage I n = 98 (76.0%); and stage IIA n = 27 (20.9%). Luminal type n = 116 (89.9%); triple-negative n = 9 (7.0%); and human epidermal growth factor receptor 2 n = 4 (3.1%). Median follow-up time was 59.5 months (range 27.5-99.0), and the rate of IBTR was 3.1% (95% confidence interval 0.9-7.8). The toxicities included fibrosis in deep-connective tissue grade 1, 78.1%; wound infection grade 3, 1.6% and grade 2, 1.6%; and soft tissue necrosis grade 3, 0.8% and grade 2, 0.8%. Recurrence in the breast occurred in four cases; the site of recurrence was just under the skin near the primary tumor site, with similar histology and subtype. CONCLUSIONS: In this multicenter phase II study, the rate of IBTR was low and IORT at 21 Gy was feasible in properly selected patients. It is important to use a careful surgical technique to reduce local recurrence because the skin is not included in the radiation field of IORT.