The authors included 16 studies: 3 phase III RCTs, one phase II RCT and 12 case series. One summary review was also included. The authors did not report the total number of participants. Data on treatment response were available from at least 436 women.
Single-agent vinorelbine.
One RCT with 179 women found that single-agent vinorelbine increased survival compared with melphalan: median survival was 35 weeks with vinorelbine versus 31 weeks with melphalan (P=0.03), while 1-year survival rates were 35.7% and 21.7%, respectively (P-value not reported). Another trial (n=98) found no survival benefit over 5-FU plus leucovorin, with or without mitoxantrone.
Data pooled from one phase III RCT and 8 phase II case series found that 24% of women responded to treatment using single-agent vinorelbine (95% CI: 20, 28). In anthracycline-resistant disease, the pooled response rate was 19% (95% CI: 14, 24).
Combined therapy.
One RCT in women treated with doxorubicin, with or without vinorelbine (n=303; 289 assessable), found no significant difference in median survival, response rate, or duration of response. Another RCT (n not reported) compared vinorelbine plus doxorubicin plus cyclophosphamide (FAC). Treatment response was 76% for the vinorelbine group versus 85% for the FAC group (P-value not reported). The duration of follow-up was too short for survival analysis.
Toxicity.
The authors found that vinorelbine had an acceptable toxicity profile. Most adverse events were haematological (neutropenia, febrile neutropenia and anaemia). Other adverse events included nausea, vomiting, diarrhoea, constipation, alopecia and peripheral neuropathy.