Adjuvant chemotherapy (AC) with cisplatin + gemcitabine (CG) versus chemotherapy (CT) at relapse (CR) in patients (pts) with muscle-invasive bladder cancer (MIBC) submitted to radical cystectomy (RC). An Italian multicenter randomised phase III trial

Abstract

5023 Background: Fifty-percent of pts with MIBC develops metastases after RC. The role of AC in muscle invasive bladder cancer is under debate as data from 6 randomised trials, moreover with serious biases, gave not univocal results and there is no evidence so far to support its routine use. This randomized study was designed to evaluate the benefit of AC versus CR in patients with MIBC submitted to RC. Methods: Between September 2001 and July 2007, 194 pts with pT2G3, pT3–4, N0–2 transitional cell bladder carcinoma submitted to radical cystectomy were randomised to control and CT at relapse (Arm A: 92 pts) or to 4 courses of AC (Arm B: 102 pts). These latter pts were further randomized in 2 subgroups with G 1,000 mg/m2 day 1,8 and 15 + C 70 mg/m2 day 2 (Arm B2: 50 pts) or G as above + C 70 mg/m2 day 15(Arm B15: 52 pts). Cycles were repeated every 4 weeks. Pts were stratified according to site and pN status (pN0 vs pN1–2). The primary endpoint was overall survival (OS) while disease-free survival (DFS), toxicity, dose-intensity and quality of life were the secondary endpoints. Results: Baseline characteristics, similar in the 2 arms, were as follows: median age 64 yrs, pT1–2 28%, pT3–4 72%; pN0 53%, pN1 21%, pN2 26%. In Arm B the 64% of pts received 4 courses and 77% at least 3. There was no CT-related death. Main toxicities were also similar in the two CT arms except for thrombocytopenia Gr 3–4 25 vs 5.% (p = 0.01) for arm B2 and B15 respectively. At a median follow up of 32.5 months (range 25.5–39) no significant difference in OS and DFS between arm A and B were found. The 3-year OS is 67% (± 6% SE) for arm A and 48% (± 6% SE) for arm B and the 3-year DFS is 47% (± 6% SE) for arm A and 35% (± 6% SE) for arm B. Conclusions: These preliminary results seem to indicate that AC did not improve OS and DFS in these pts. More detailed results will be presented at the meeting. No significant financial relationships to disclose.