Immediate postoperative instillation of gemcitabine after transurethral resection of bladder tumors

Abstract

4685 Background: Based on the results of our monocenter phase I study of intravesical administration of gemcitabine (Gemzar) immediately after transurethral resection of superficial bladder cancer (TUR-BT) we performed an extended feasibility study as an amended study procedure at four different sites in Germany. Methods: From July to October 2003, 24 patients (pts.) with cystoscopic diagnosis of superficial bladder cancer (SBC) and the need for TUR-BT were enrolled into the study. 23 pts. were eligible for TUR-BT and drug-instillation (17 male, median age 67.9 years [range 53.7 years –79.8 years]; 6 female, median age 74.6 years [range 64.7 years –75.6 years]); one pt. was finally not operated on due to serious comorbidities. The eligible 23 pts. underwent TUR-BT with complete resection of all visible tumors. Immediately (within the first 1h) after TUR-BT, pts. received 2000 mg gemcitabine in 100 mL unbuffered saline with a dwell time of approx. 30 min (Buettner et al Proc. ASCO (2003) 22:1785). After the instillation, the bladder was evacuated and irrigated with saline until gross haematuria resolved. Pts. were questioned about potential side effects 24 h after the instillation and at 12 weeks at the time of follow-up cystoscopy. Repeated resection without instillation was performed in two pts. with extensive stage pT1 G2 and pT1 G3 tumors, respectively Results: The instillation was well tolerated in all pts. and side effects were transient and did not exceede CTC grade 2 (bleeding grade 1: 1 pt.; haematuria grade 1: 1 pt., grade 2: 3 pts.; dysuria grade 1: 4 pts., incontincence grade 2: 1 pt., sweat grade 1: 1 pt.). Pts. with muscle-invasive tumor (n=1) or no tumor (n=9) were excluded from efficacy analyis, which is not finished. Full efficacy data will be presented at the meeting. Conclusions: The immediate application of gemcitabine after TUR-BT can be safely given into the bladder in a muticenter setting. A double-blind, placebo-controlled randomized phase III study is in progress to evaluate the effect of intravesical gemcitabine on the relapse-free survival rate of SBC. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly Deutschland GmbH Lilly Deutschland GmbH Lilly Deutschland GmbH