Gemcitabine and cisplatin combination chemotherapy as a first-line treatment in patients with metastatic breast cancer.

PURPOSE: The objectives of this phase II prospective study were to evaluate the efficacy and toxicity of Gemcitabine plus cisplatin as a first line chemotherapy in female patients with metastatic breast cancer who previously received anthracyclin-based regimen as adjuvant chemotherapy. PATIENTS AND METHODS: Twenty five patients with metastatic and at least one bi-dimensionally measurable lesion were included in this study. Adequate bone marrow reserve, adequate hepatic and renal functions and performance status of < or = 2 were required. Patients have previously received anthracyclin based-chemotherapy as adjuvant. Treatment consisted of Gemcitabine 1250 mg/m2 on days 1 and 8 and cisplatin 75 mg/m2 on day 1, cycles were repeated at 3-week intervals.
RESULTS: 25 patients were evaluable for toxicity and 22 patients for response. Overall response was 54.5%. Complete response was reported in 13.6% of patients and partial response was reported in 40.9% of patients. Six patients (27.2%) had stable disease and disease progression was reported in 18.2% of patients. Response was reported in all metastatic sites. Toxicities included grade 3, 4 vomiting in 32% and grade 3, 4 neutropenia in 12%, grade 3, 4 thrombocytopenia in 32%. Only one case of neutropenic fever was reported. Renal and neurotoxicity was encountered in 12% and alopecia grade 1, 2 in 8% of patients. No treatment related death was reported. The median overall survival was 14.8 months (range: 2 to 18.5).
CONCLUSION: Gemcitabine and cisplatin combination chemotherapy is active and well tolerated regimen for patients with metastatic breast cancer. This regimen represents a therapeutic option for patients receiving front line therapy for their metastatic breast cancer. Phase III randomized trial is needed for comparison with other 2nd line regimens to define the exact role of this combination.