P5-19-01: Final Results of a Three-Arm Randomised Phase II Study of Oral Vinorelbine Plus Capecitabine Versus Oral Vinorelbine and Capecitabine in Sequence Versus Docetaxel Plus Capecitabine in Patients with Metastatic Breast Cancer Previously Treated with Anthracyclines.

Purpose: Owing to the increasing number of patients treated with anthracycline-based adjuvant chemotherapy, there is a need for new effective and tolerable non-anthracycline based regimens in metastatic breast cancer. Patients and methods: Patients with HER2−negative metastatic breast cancer previously treated with anthracyclines in (neo) adjuvant setting were randomised to fully oral 3-weekly cycles of the combination of oral vinorelbine with capecitabine (V+C), to the same drugs alternating every 3 cycles (V ⇔ C), 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 V ⇔ C 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 endpoint was disease control rate (CR+PR+NC ≥ 3 months). Results: A total of 139 patients were randomly assigned to V+C (44 patients), V ⇔ C (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, V ⇔ 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]. The response rate was 31.8% [18.6−47.6], 8.7% [2.4−20.8] and 35.4% [22.2−50.5], respectively. The median duration of progression-free survival in the V+C, V ⇔ C and D+C arms [95% CI] was 7.2 months [5.3−8.9], 3.4 months [2.6−5.6] and 8.9 months [7.2−12.0]; the median overall survival [95% CI] was 22.2 [18.8; 29.9], 19.4 [12.5; 35.4] and 24.2 [14.2; 38.5] months, respectively. Lower efficacy observed in the sequential arm could be due to higher prevalence of patients with visceral disease in this arm (91.3% in comparison to 65.9% in V+C and 64.6% in D+C arm). 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. Conclusions: 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. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P5-19-01.