Résumé
Very promising results have been obtained by vinorelbine-doxorubicin combination in the treatment of advanced breast cancer. However previous experience with schedules in which the doxorubicin dose was administered on day 1 alone were associated with a high level of cardiac toxicity. There is evidence that fractionating the dose of doxorubicin and administering it at weekly intervals may reduce the cardiac toxicity without substantially impairing the efficacy. To asses the efficacy and tolerability of vinorelbine and fractionated dose doxorubicin [the total dose was divided into two administrations on days 1 and 8] in patients with advanced breast cancer. Fifty-two patients with locally advanced or metastatic breast cancer who had received no prior chemotherapy except in an adjuvant setting were entered into the study. They were treated vinorelbine 25 mg/m[2] plus doxorubicin 25 mg/m[2] both administered in day 1 and 8 every three weeks. Objective responses were observed in 30 patients [71, 4%]. There were 7 [16.6%] complete responses [CR] and 23 [54.8%] partial responses [PR]. In addition 10 patients [23.8%] had stable disease [SD] and 2 [4.8%] progressed while on treatment. Twenty of 28 patients with visceral disease responded to treatment [71.4%]. The median duration of response was 11.5 months [range, 2 to > 24+] and the median overall survival was 21.5 months [range 2 to > 36+]. Hematological toxicity was predominantly related to neutropenia with Grade 3-4 reported in 18.1% of the cycles. Alopecia was reported in 66.7% of the patients. Grade 3 nausea/vomiting in 3.6% of the cycles. No clinically significant cases of cardiac dysfunction were seen. The fractionated schedule of vinorelbine and doxorubicin is associated with excellent tolerability [especially cardiac], coupled with high levels of activity comparable to those observed using the un-fractionated regimen