Background: Vinorelbine (Navelbine), a new vinca alkaloid, is an effec
tive drug in breast cancer. Our study was undertaken to assess the eff
icacy and tolerance of Navelbine in refractory advanced and/or metasta
tic breast cancer (AMBC). Patients and methods: One hundred heavily pr
etreated patients with AMBC entered the study and were scheduled to re
ceive 30 mg/m2 of Navelbine weekly by a 20 min i.v. infusion with dose
adjustments according to tolerance. All patients had previously recei
ved at least one chemotherapy regimen including an anthracycline for a
dvanced disease. Results: Sixteen of the 100 assessable patients respo
nded (1 complete response and 15 partial responses), for an overall re
sponse rate of 16% (IC 95: 8%-23%). The median duration of response wa
s 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), b
ut not in bone metastases. The main toxicities (WHO grade greater-than
-or-equal-to 3) were granulocytopenia and anemia in, respectively, 51%
and 9% of all 100 eligible patients. Thrombocytopenia and other non-h
aematological toxicities consisting of peripheral neuropathy, constipa
tion, nausea/vomiting, alopecia and phlebitis were rare and mild. Conc
lusion: 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).