Phase II study of gemcitabine plus cisplatin in patients with anthracycline- and taxane- pretreated metastatic breast cancer.

PURPOSE Metastatic breast cancer patients are usually exposed to taxane and anthracycline as neoadjuvant, adjuvant and palliative chemotherapeutic agents. This study was designed to determine the efficacy and safety of the use of a gemcitabine and cisplatin (GP) combination treatment in patients with metastatic breast cancer that were pretreated with anthracycline and taxane. MATERIALS AND METHODS We evaluated the use of a GP regimen (1,000 mg/m(2) gemcitabine administered on days 1 and 8 plus 60 mg/m(2) cisplatin administered on day 1 every 3 weeks) in 38 breast cancer patients who had received prior chemotherapy with anthracycline and taxane as an adjuvant or neoadjuvant therapy, or as a palliative therapy. RESULTS The median patient age was 49 years (age range, 35 approximately 69 years). The overall response rate was 28.9% in 11 patients (95% confidence interval [CI], 14 approximately 44%). The median time to progression was 5.2 months (95% CI, 3.6 approximately 6.8 months). Median survival was 19.5 months (95% CI, 11.2 approximately 27.8 months). Major grade 3/4 hematological toxicity was due to leukopenia (36 of 157 cycles, 23.1%). Non-hematological toxicity was rarely severe; grade 1/2 nausea and vomiting were observed in 37.8% of the patients. There were no treatment related deaths. CONCLUSIONS Our results suggest that the use of gemcitabine plus cisplatin appears to be effective and has an acceptable toxicity profile in patients with advanced breast cancer that have been pretreated with anthracycline and taxane.