1147 Gemcitabine in resistant stage IV bladder cancer: A phase II study

Abstract

Gemcitabine, a novel nucleoside analogue, has significant single-agent activity in a number of chemoresistant tumours such as ovary and non-small cell lung cancer. In an early phase I study with gemcitabine (dose: ≥875 mg/m 2 ; schedule: wk × 3 q4 wks), 1 complete and 2 partial responses were observed in 14 previously treated metastatic bladder cancer patients (overall response rate 21.4%). We report a phase II study of gemcitabine in patients with stage IV bladder cancer who had been treated unsuccessfully with one previous cisplatin-containing regimen. Characteristics of all 18 patients entered into the study were: 15 males; median age 65.1 years (range 39–75), Karnofsky PS 60 (3 pts), 70 (7), 80 (4), 90 (2), 100 (2). Gemcitabine 1250 mg/m 2 was given once a week for 3 weeks followed by one week of rest (one cycle). Of 14 patients eligible for efficacy analysis (4 patients too early), having received treatment for at least 2 cycles, there were 2 complete responses and 2 partial responses for an overall response rate of 29%. All 18 patients were evaluable for toxicity. There were no WHO grade 3 or 4 non-laboratory toxicities. The only WHO grade 4 laboratory toxicity was thrombocytopenia (1 pt). WHO grade 3 laboratory toxicities were: thrombocytopenia (1 pt), ALT (1), AST (1), creatinine (1), vomiting (2), anaemia (1). This study confirms that gemcitabine has single-agent activity in stage IV bladder cancer and has a mild to modest toxicity profile.