Vinorelbine (navelbine) as a salvage treatment for advanced breast cancer.

BACKGROUND

Vinorelbine (Navelbine), a new vinca alkaloid, is an effective drug in breast cancer. Our study was undertaken to assess the efficacy and tolerance of Navelbine in refractory advanced and/or metastatic breast cancer (AMBC).

METHODS

One hundred heavily pretreated patients with AMBC entered the study and were scheduled to receive 30 mg/m2 of Navelbine weekly by a 20 min i.v. infusion with dose adjustments according to tolerance. All patients had previously received at least one chemotherapy regimen including an anthracycline for advanced disease.

RESULTS

Sixteen of the 100 assessable patients responded (1 complete response and 15 partial responses), for an overall response rate of 16% (IC 95: 8%-23%). The median duration of response was 5 months (3-18). Responses were seen in lymph nodes (13/27), breast (11/34), soft tissue and skin (13/36), lung (3/14) and liver (2/25), but not in bone metastases. The main toxicities (WHO grade > or = 3) were granulocytopenia and anemia in, respectively, 51% and 9% of all 100 eligible patients. Thrombocytopenia and other non-haematological toxicities consisting of peripheral neuropathy, constipation, nausea/vomiting, alopecia and phlebitis were rare and mild.

CONCLUSIONS

Vinorelbine is an active drug in AMBC, particularly in breast, lymph nodes and skin/soft tissue sites, with an excellent tolerance. Since the mean dose intensity was 19.7 mg/m2/week, a dose of 20 mg/m2/week is recommended for heavily pretreated patients (radiotherapy and chemotherapy).