A PHASE-II STUDY OF GEMCITABINE IN PATIENTS WITH TRANSITIONAL-CELL CARCINOMA OF THE URINARY-TRACT PREVIOUSLY TREATED WITH PLATINUM

The aim of this study was to evaluate the efficacy and safety of gemci tabine, a pyrimidine antimetabolite, in the treatment of advanced tran sitional cell carcinoma of the urinary tract. 35 patients with unresec table or metastatic transitional cell carcinoma of the urinary tract p reviously treated with a platinum-based regimen were studied. Gemcitab ine was administered at a dosage of 1200 mg/m(2) as a 30-min intraveno us infusion on days 1, 8 and 15, repeated every 28 days. 31 patients w ere evaluable for efficacy. 4 patients achieved a complete response (1 2.9%), 3 a partial response (9.6%) and 13 (42%) were stable for at lea st 4 weeks (overall response 22.5%; 95% confidence interval 8-37%). Th e median response duration was 11.8 months (range 3.6-17.7+ months) an d median survival for all patients entered was 5 months (range 2-21+ m onths). 2 patients with complete response are still alive with no evid ence of disease after 14 and 21 months. Gemcitabine also provided subj ective symptomatic relief from pain, cystitis, dysuria, haematuria and peripheral oedema. Patients experienced little WHO grade 3-4 toxicity , with anaemia in 8 patients (23%), thrombocytopenia in 5 (14.2%), leu copenia in 4 (11.4%) and neutropenia in 7 (20%). WHO grade 3-4 hepatic toxicity occurred in 4 patients (11.4%) and transient elevations of t ransaminase was noted in 3 (8.6%). No patient had WHO grade 3-4 elevat ion of serum creatinine level. There was no WHO grade 4 symptomatic to xicity and no alopecia was noted. Transient influenza symptoms with ge mcitabine occurred in 18 patients (51.4%) with 13 patients (37.1%) exp eriencing fever (2.9% WHO grade 3). In conclusion, gemcitabine is an n ew active agent for the treatment of transitional cell carcinoma of th e urinary bladder with a mild toxicity profile; it warrants further in vestigation in combination with cisplatin in chemotherapy naive patien ts. (C) 1998 Published by Elsevier Science Ltd. All rights reserved.