All-oral combination of oral vinorelbine and capecitabine as first-line chemotherapy in HER2-negative metastatic breast cancer: an International Phase II Trial

Abstract

BACKGROUND: This multicentre, international phase II trial evaluated the efficacy and safety profile of a first-line combination of oral vinorelbine plus capecitabine for women with metastatic breast cancer (MBC). METHODS: Patients with measurable, HER2-negative disease received, as a first line in metastatic setting, 3-weekly cycles of oral vinorelbine 80 mg m À2 (after a first cycle at 60) on day 1 and day 8, plus capecitabine 1000 mg m À2 (750 if X65 years of age) twice daily, on days 1 -14. Treatment was continued until progression or unacceptable toxicity. RESULTS: A total of 55 patients were enrolled and 54 were treated (median age: 58.5 years). Most (78%) had visceral involvement and 63% had received earlier (neo)adjuvant chemotherapy. The objective response rate (RECIST) in 49 evaluable patients was 51% (95% confidence interval (CI), 36 -66), including complete response in 4%. The clinical benefit rate (response or stable disease for X6 months) was 63% (95% CI, 48 -77). The median duration of response was 7.2 months (95% CI, 6.4 -10.2). After a median follow-up of 41 months, median progression-free survival was 8.4 months (95% CI, 5.8 -9.7) and median overall survival was 29.2 months (95% CI, 18.2 -40.1). Treatment-related adverse events were manageable, the main grade 3 -4 toxicity was neutropaenia (49%); two patients experienced febrile neutropaenia and three patients had a neutropaenic infection (including one septic death). A particularly low rate of alopaecia was observed. CONCLUSION: These results show that the all-oral combination of oral vinorelbine and capecitabine is an effective and well-tolerated first-line regimen for MBC.

Second-Line Combination Chemotherapy with Vinorelbine and Capecitabine in Patients with Advanced Breast Cancer Previously Treated with Anthracyclines and/or Taxanes

“…Overall, the adverse events were both predictable and manageable; toxicities overlapping between both drugs were minor. Safety data reported in the present phase II study are consistent with those previously reported in clinical studies [17,30,31]. …”

“…Recently, oral VRL has been investigated in the treatment of patients with advanced/metastatic breast cancer [23,31]. Several surveys have shown that, provided efficacy and tolerability are not compromised, most patients prefer oral to intravenous chemotherapy [32,33].…”

Combination of capecitabine and mitomycin C as first-line treatment in patients with metastatic breast cancer

“…Therefore, in this population of patients with chemo-naïve MBC, the combination of capecitabine and MMC afforded clinical benefit to the vast majority (96%) of patients. Furthermore, with a median TTP of 8.5 months, and a median OS of 29.8 months, the clinical efficacy of capecitabine-MMC is comparable to that afforded by combinations of capecitabine with taxanes or vinorelbine in this setting [9,37,38]. It is also notable that the efficacy of capecitabine-MMC was preserved in patients who had received (neo) adjuvant chemotherapy.…”

Biweekly vinorelbine and tegafur/uracil in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: GEICAM 2000–02 phase II study

“…Other studies report the administration of oral vinorelbine in combination with another oral drug, capecitabine, to patients with advanced breast cancer [34][35][36]. In them, patients received 80 mg/m 2 of oral vinorelbine (except the fi rst cycle at 60 mg/m 2 ) on days 1 and 8 plus 1000 mg/m 2 of capecitabine, twice daily on days 1-14.…”