Addressing the need for immediate adjuvant chemotherapy, in the form of gemcitabine –cisplatin, after cystectomy and if this translates to a survival benefit was the main aim of this study. DFS and toxicity were secondary aims.
One hundred and six patients with pT2–pT4 disease or node positive (pN0–1) M0 disease transitional cell bladder carcinoma after radical cystectomy and bilateral lymphadenectomy, with no evidence of any microscopic residual disease, were randomly allocated within 90 days of surgery to control (50 patients) or to four courses of AC (56 patients).
At a median follow-up of 38 months (interquartile range 25-44.25), 51 patients had died (arm A, N = 25; arm B, N = 26). The 5-year OS of the whole series was 39 % (standard error 9%), with no significant difference between the two arms (p = 0.565). The median overall survival was 44 months, 42 in the control group and was 55 months in the AC arm (hazard ratio 1.2; 95% CI 0.69-2.1, p = 0.51).The only significant predictor of overall survival, independently of treatment arm, was nodal status via cox regression analysis after adjustment of tumour stage, grade, squamous differentiation and LVI (pN1 versus pN0: HR 2.8; 95% CI 1.46–5.47; p= 0.002). The 5 year overall survival pN0 was 57% (standard error 8 %); median 55 months, whilst for pN1 it was 30% (standard error 9 %); median36.4 months. The 5 year DFS for the entire study group was 46% (standard error 5%) with no significant difference between the two arms (p = 0.255): 43% Â± 7 in the control group and 50% Â±7 in the AC arm with a hazard ratio of 1.35; CI 0.79-2.3, p = 0.262. Median DFS was 37.1; 45 vs 28.75 months in the AC and control groups respectively. The only significant predictor of disease free survival, independently of treatment arm, was nodal status via cox regression analysis after adjustment of tumour stage, grade, squamous differentiation and LVI (pN1 versus pN0: HR 2.7; 95% CI 1.26–4.4;p= 0.007).No drug toxicity-related death was observed.
Both OS and DFS failed to show a significant improvement in with immediate versus deferred chemotherapy after radical cystectomy and bilateral lymphadenectomy for patients with muscle-invasive bladder cancer.
Clinical trial identification
NCT00028756 Sternberg first author EORTC trial
All authors have declared no conflicts of interest.