Biweekly administration of gemcitabine and vinorelbine as first line therapy in elderly advanced breast cancer.

Background: Gemcitabine and Vinorelbine both as a single agent or associated are active in advanced breast cancer patients as second line therapy, with low toxicity. In the elderly patients polichemotherapy is difficult for co-morbidity, but results with monotherapy are fewer. The use of this association as first line could be of help.

Patients And Methods: Thirty-four patients over 65 were treated with 1000 mg/m2 of gemcitabine and 25 mg/m2 of vinorelbine on days 1 and 8 every 21 days. An analysis of toxicities, TTP and OS were performed.

Results: The ORR was 53%: a CR was obtained in five patients (15%) and a PR in 13 patients (38%). Moreover, seven patients (21%) had a stable disease maintained for 6 months. The mean duration of CR and PR were, respectively, of 10 (range 7-19) and 7 (range: 4-14), months. Toxicity was low, mainly haematological: grade 3-4 neutropenia occurred only in 7 (20%) cases without febrile neutropenia.

Conclusions: The gemcitabine and vinorelbine combination shows significant activity in elderly metastatic breast cancer patients. The treatment is well tolerated and has an acceptable toxicity profile.