5-YEAR FOLLOW-UP OF A PROSPECTIVE TRIAL OF RADICAL CYSTECTOMY AND NEOADJUVANT CHEMOTHERAPY - NORDIC CYSTECTOMY TRIAL-I

Purpose: Chemotherapy is widely used in patients with locally advanced bladder cancer but until now there has been no conclusive evidence th at this therapy improves survival. The Nordic Cooperative Bladder Canc er Study Group conducted a randomized phase III study to assess the po ssible benefit of neoadjuvant chemotherapy in patients with bladder ca ncer undergoing radical cystectomy after short-term radiotherapy. Mate rials and Methods: Our trial included 325 patients with locally advanc ed stage T1 grade 3 or stages T2 to T4aNXMO bladder cancer allocated r andomly into a chemotherapy or no chemotherapy group (control). The ch emotherapy schedule consisted of 2 cycles of 70 mg./m.(2) cisplatin an d 30 mg./m.(2) doxorubicin with a 3-week interval between the cycles. Results: After 5 years the overall survival rate was 59% in the chemot herapy group and 51% in the control group (p = 0.1). The corresponding cancer specific survival rate was 64 and 54%, respectively. In regard to treatment, no difference was observed for stages T1 and T2 disease , while there was a 15% difference in overall survival for patients wi th stages T3 to T4a disease (p = 0.03). In a multivariate analysis onl y chemotherapy and T category emerged as independent prognostic factor s. The relative death risk for patients who received chemotherapy was 0.69 (95% confidence interval 0.49 to 0.98) compared to the control gr oup after adjustment for the other tested factors. Conclusions: Neoadj uvant chemotherapy seems to improve long-term survival after cystectom y in patients with stages T3 to T4a bladder carcinoma, while no surviv al benefit was found for stages T1 to T2 disease.