A phase II study of gemcitabine plus cisplatin chemotherapy in advanced bilharzial bladder carcinoma

Bilharzial bladder cancer represents a distinct clinicopathological entity. To investigate whether gemcitabine-cisplatin is also active against bladde r cancer of bilharzial origin, we performed a phase II study of previously untreated patients with stage III/IV disease. Standard eligibility criteria were used. Patients received gemcitabine (1000 mg/m(2)) on days 1, 8 and 1 5 and cisplatin (70 mg/m(2)) on day 2 of every 28-day cycle. The 32 males a nd 5 females had a median age of 59 years (range: 29-81 years). Of 33 evalu able patients, 8 (24%) achieved complete responses, and 10 (30%) partial re sponses, for an overall response rate of 55%. 3 patients had minor response s. Responses were observed at all disease sites including lung and liver le sions. Myelosuppression was significant but manageable. Non-haematological toxicity was limited mainly to nausea and vomiting and raised liver enzymes . Thus, these data suggest that gemcitabine plus cisplatin induces high res ponse rates in patients with bilharzial bladder cancer with a moderate toxi city profile. (C) 2000 Published by Elsevier Science Ltd. All rights reserv ed.