ABSTRACT
Owing to the increased number of patients treated with anthracycline-based adjuvant chemotherapy, there is a need for new effective and tolerable nonanthracycline regimens in metastatic breast cancer. Patients with HER2-negative metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting were randomized to fully oral 3 weekly cycles of the combination of oral vinorelbine with capecitabine (V + C), to the same drugs alternating every three cycles (VâC), or to the combination of docetaxel and capecitabine (D + C). V was given at 80 mg/m(2) (after the first cycle at 60 mg/m(2)) on days 1 and 8 in the V + C arm and weekly in the VâC arm, C at 1,000 mg/m(2) bid from days 1 to 14, and D on day 1 at 75 mg/m(2). The primary end point was disease control rate (CR + PR + NC ≥ 3 months). A total of 139 patients were randomly assigned to V + C (44 patients), VâC (47 patients), and D + C (48 patients). After an independent review, the disease control rate in the intent-to-treat population in the V + C, VâC, and D + C arms [95% CI] was 70.5% [54.8-83.2], 37.0% [23.2-52.5], and 70.8% [55.9-83.1], and the median overall survival 22.2, 19.4, and 24.2 months, respectively. When taken into account the disease control rate, the alternating VâC regimen seems to be less effective compared with V + C or D + C combinations. Combinations of V + C or D + C showed similar efficacy and a different toxicity profile; V + C induced less neutropenia, infection, hand-foot syndrome, fatigue/asthenia, and alopecia, whereas D + C - less gastrointestinal toxicity. V + C combination constitutes a valuable fully oral alternative option to D + C in patients with metastatic breast cancer previously treated with anthracyclines in (neo)adjuvant setting, while offering the advantages of an all-oral treatment.
