Phase II study of vinorelbine (alternating intravenous and oral) in combination with docetaxel as first-line chemotherapy in metastatic breast cancer

摘要: Combination of intravenous (i.v.) vinorelbine and docetaxel was shown to be feasible effective in metastatic breast cancer (MBC). In an effort improve patient convenience, we investigated first-line treatment a regimen alternating i.v. oral combination with docetaxel. Forty-nine patients (median age, 53 years) MBC received maximum 6 cycles consisting 20 mg/m² plus 60 mg/m² given on day 1, 15 every 3 weeks open-label, multicentre phase II study (recommended dose established I [1]). Sixty-three percent the had prior adjuvant chemotherapy 78% presented visceral involvement. Twenty-four responses were documented validated by independent panel review, yielding response rates 49% (95% CI: 34–64) 49 enrolled 55.8% 40–71) 43 evaluable patients. Median duration 9.4 months. progression-free survival median overall 5.5 33.2 months, respectively. Neutropenia main dose-limiting toxicity but complications uncommon, four having experienced febrile neutropenia one developed neutropenic infection. Other frequently reported adverse events included alopecia, fatigue, stomatitis, constipation, diarrhoea nausea, which rarely severe. This is manageable. Vinorelbine per 1 15-docetaxel represents convenient option combine for palliative MBC.