Gemcitabine plus cisplatin therapy, a safety regimen in advanced bladder cancer

Abstract

4799 Background: We evaluated the efficacy and toxicity of gemcitabine plus cisplatin (GC) therapy compared with methotrexate, vinblastin, doxorubicin puls cisplastin (MVAC) therapy in patients with advanced bladder cancer. Methods: Thirty-eight patients with measurable bladder cancer who had received no prior chemotherapy for metastatic disease were scheduled to receive gemcitabine 1,000mg/m2 intravenously over 30 minutes on days 1, 8, and 15 and cisplatin 75mg/m2 over 1 hour on day 2 of a 28-day cycle. Patients were treated with six cycles, unless disease progression or severe toxicity. Primary end point was overall survival. All toxicities were compared with previous our MVAC therapy results. Thirty-five patients were scheduled to receive MVAC therapy (methotrexate 30mg/m2, vinblastin 3mg/m2, doxorubicin 30mg/m2 puls cisplastin 70mg/m2). Results: There were six complete responses and 17 partial responses in 38 assessable patients, for an overall response rate of 23 of 38 (60.5%). The median survival was similar on both threatment group and 26 patients who had received GC therapy still alive at this time. Toxicity was primarily hematologic, with 3 of 38 patients (7.9%) having grade 3 anemia, with 6 of 38 patients (15.7%) having grade 3 granulocytopenia and 2 of 38 (5.2%) having grade 3 thrombocytopenia. Three patients had severe gastro-intestinal symptom and one patient had severe low performance status. More GC than MVAC had high grade granulocytopenia(15.7% v 33.3%, p<0.05). All patients required a dose modification of gemcitabine at some point in their therapy; the primary reason was thrombocytopenia and/or neutropenia. Conclusions: Gemcitabine plus cisplatin therapy is an active regimen for the treatment of advanced bladder cancer and better safety profile and tolerability than MVAC therapy. No significant financial relationships to disclose.