Hr. Khaled et al., A phase II study of gemcitabine plus cisplatin chemotherapy in advanced bilharzial bladder carcinoma, EUR J CANC, 36, 2000, pp. S34-S37
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.