A Phase II Trial of Oral Vinorelbine and Capecitabine in Anthracycline Pretreated Patients with Metastatic Breast Cancer

Background: Optimal chemotherapy (CT) for advanced breast treatment should be effective, well tolerated and convenient. In this study the efficacy and safety of the fully oral combination of oral vinorelbine (Navelbine Oral) plus capecitabine (Xeloda) in metastatic breast cancer (MBC) patients pretreated with anthracycline, was evaluated. Patients and Methods: In this phase II multicenter study, this combination CT was given as a first- or second-line therapy for MBC. The treatment schedule was: oral vinorelbine 60 mg/m 2 day 1 and day 8 plus capecitabine 1,000 mg/m 2 twice daily from day 1 to day 14, every 21 days. Results: One hundred and fifteen patients were included in this trial. The median age was 58 years (range: 40-75). All the patients had received prior anthracycline-based chemotherapy. The combination was well tolerated, with, in particular, only 0.8% of patients presenting with febrile neutropenia. In the intention-to-treat (ITT) population, an objective response was achieved in 65 patients (56.5% ). A complete response was achieved in 22 patients (19.1% ); partial response in 43 patients (37.4% ); stable disease in 36 patients (31.3% ), and progressive disease was observed in 14 patients (12.2% ). After a median follow-up of 10.0 months, the median progression-free survival (PFS) was 10.5 months and the median survival was 17.5 months. Conclusion: Oral vinorelbine-capecitabine shows very promising activity and low toxicity in MBC treatment, with high compliance of the patients. Metastatic breast cancer (MBC) is a highly heterogeneous disease where particular criteria must be considered, taking into account not only the clinical and biological parameters but also patient expectations and preferences. The objectives of an optimal chemotherapy (CT) for MBC are to prolong survival and to enhance the quality of life with minimal toxicity. The therapeutic strategy may include sequential single agents or combination CT (1, 2). In this setting, tolerability and acceptability are also of paramount importance for the compliance of patients. In current practice, anthracycline-based regimens are given as a standard in the adjuvant setting. Due to the risk of cumulative cardiac toxicity of these agents, there is a need to develop non-anthracycline-containing alternatives in the metastatic relapse setting. Similarly, taxanes tend to be more and more used in the early-stage setting. Hence, their neurological and haematological toxicity profile even when albumin-bound nanoparticle agent is used, makes them a questionable option in certain patients at metastatic relapse.