e11547 Background: Metronomic chemotherapy regimens have shown efficacy in patients with metastatic breast cancer through antiangiogenic mechanisms. We present preliminary data of a phase II trial of metronomic capecitabine (CAP) in combination with oral vinorelbine (VIN) as treatment of metastatic breast cancer (MBC). Methods: Patients with advanced breast cancer, pretreated or not for metastatic disease, were treated with VIN (60 mg/m2, on days 1 and day 8 of a 21-day cycle) combined with metronomic CAP (1500 mg daily). Primary end-point was overall response rate (ORR), secondary end-point time to progression (TTP), clinical benefit rate (CBR; PR+ CR + prolonged SD for ≥ 24 weeks) and tolerability. Results: A total of 31 patients with histologically confirmed, Her2 negative MBC, have been enrolled, 22 actually valuable for response and toxicity. Median age was 62 years (range 34-75), visceral metastases were present in 18 patients (58%), 11 patients (35%) were pretreated with chemotherapy, most of them with anthracycline and taxanes. Triple negative tumors were 5 (16%). Median number of cycles was 12 (range 4-34). The ORR was 54.5 % (95% CI, 44-63%), with two CR (9 %) and 10 PR (45%). Seven patients had SD, 5 prolonged (23%). The CBR was 77% (95% CI , 71%-84%). Three progressions of disease were observed (14%). Median TTP was 8 months (range 3- 24 +). Median overall survival was 32 months (range, 6-39 + ). The most frequent toxicities were WHO diarrhea grade 1 and neutropenia grade 2. Grade 3 skin toxicity was observed in two patients subsequently found to have DPD enzyme deficiency. No grade 2 alopecia was reported. Conclusions: In this phase II study, the all oral combination of low dose metronomic CAP combined with VIN seems to be very active, confirming data with standard doses, and allows a very long duration of response and treatment. The observed toxicity was mild and manageable. Thus, patients accrual is ongoing to the pre-set target of 66 patients.
Beta-interferon, retinoids and tamoxifen in metastatic breast cancer: Long-term follow-up of a phase II study
