PURPOSE: To evaluate the activity and tolerance of vinorelbine (VRL) in combination with gemcitabine (GEM) in pre-treated patients with refractory ovarian cancer. PATIENTS AND METHODS: Seventeen patients with ovarian cancer who had disease progression after a carboplatin and taxane front-line regimen were treated with VRL 30 mg/m(2) IV over 10 min followed by GEM 1,200 mg/m(2) IV over 30 min on days 1 and 15 of each 28 days cycle. Chemotherapy was given in a initial prospective plan of six cycles, unless disease progression or unacceptable toxicity was seen, giving more cycles as consolidation therapy in the case of CR, PR or SD. The median age of patients was 67 years old, and the performance status (WHO) was 1 for 13 and 2 for 4 patients. The treatment was second-line for 11 (65%) and >third-line for 6 (35%) patients. RESULTS: One complete and one partial response were observed (ORR:11%). Stable disease was seen in 4 (24%) patients and progressive disease in 11 (65%). The median time to tumor progression was 4 months (range 2-11), and the median survival has not yet been reached. Myelotoxicity was rare. Grade 1 neutropenia was observed just in one patient and grade 2/3 anemia in four patients (24%). Thrombocytopenia was absent. Non-hematologic toxicity was also predictable and easily manageable. CONCLUSION: The vinorelbine plus gemcitabine combination at the present doses and schedule is a safe but ineffective regimen, and therefore, is not recommended as second-line and beyond treatment in patients with refractory ovarian cancer.
PURPOSE: To evaluate the activity and tolerance of vinorelbine (VRL) in combination with gemcitabine (GEM) in pre-treated patients with refractory ovarian cancer. PATIENTS AND METHODS: Seventeen patients with ovarian cancer who had disease progression after a carboplatin and taxane front-line regimen were treated with VRL 30 mg/m(2) IV over 10 min followed by GEM 1,200 mg/m(2) IV over 30 min on days 1 and 15 of each 28 days cycle. Chemotherapy was given in a initial prospective plan of six cycles, unless disease progression or unacceptable toxicity was seen, giving more cycles as consolidation therapy in the case of CR, PR or SD. The median age of patients was 67 years old, and the performance status (WHO) was 1 for 13 and 2 for 4 patients. The treatment was second-line for 11 (65%) and >third-line for 6 (35%) patients. RESULTS: One complete and one partial response were observed (ORR:11%). Stable disease was seen in 4 (24%) patients and progressive disease in 11 (65%). The median time to tumor progression was 4 months (range 2-11), and the median survival has not yet been reached. Myelotoxicity was rare. Grade 1 neutropenia was observed just in one patient and grade 2/3 anemia in four patients (24%). Thrombocytopenia was absent. Non-hematologic toxicity was also predictable and easily manageable. CONCLUSION: The vinorelbine plus gemcitabine combination at the present doses and schedule is a safe but ineffective regimen, and therefore, is not recommended as second-line and beyond treatment in patients with refractory ovarian cancer.