Background: Accelerated partial breast irradiation (APBI) is generally limited to patients at extremely low risk of local recurrence. The significance of the risk factors, however, depends on the extent of surgery, radiation, and systemic therapy. In Japan, wide excision is generally supplemented by intraoperative margin-directed re-excision if the frozen section examination yields positive results. This approach combined with conventional radiotherapy achieved an excellent 10-year local control rate of 93%, and young age and ductal carcinoma in situ were not risk factors for local recurrence. To reduce the treatment duration, high-dose-rate interstitial brachytherapy (HDRIB) was employed. The first APBI phase I / II trial in Japan was conducted to determine if wider indications for early breast cancer patients were appropriate.
Methods: The subjects comprised 20 patients including those with extensive intraductal component (n=7), ductal carcinoma in situ (n=2), positive final margins (n=3), and of younger age (< or = 45 years; n=5). Breast-conserving surgery using an intraoperative re-excision approach was followed by intraoperative implantation of applicators. Sole HDRIB of a 36-42 Gy in 6-7 fractions was delivered postoperatively over 3-4 days. Tumors were staged as follows: cT1 (n=12), cT2 (n=8), cN0 (n=20). Systemic therapy was used in 16 patients (80%). The median follow-up period was 52 months (range, 26-86 months).
Results: Te five-year crude local, distant control, and Kaplan-Meier cause-specific survival rates were 95%, 95%, and 89%, respectively. Fat necrosis developed in 1 patient.
Conclusions: Sole HDRIB with intraoperative margin-directed re-excision was feasible under wider indications compared to other contemporary APBI series, and achieved acceptable and similar results to these series in terms of the local control rate and complications.