Neoadjuvant chemotherapy in bladder cancer: a randomized study. Nordic Cystectomy Trial I.

An analysis by the Nordic Cooperative Bladder Cancer Study Group concerned the possible benefit of neoadjuvant chemotherapy--given before scheduled low-dose irradiation and cystectomy. In the trial, started in 1985, 311 patients with locally advanced bladder cancer, T1 grade 3, T2-T4a NXMO, were randomly allocated to a 'chemotherapy' or a 'no chemotherapy' group. Chemotherapy consisted of two cycles comprising cisplatin 70 mg/m2 and doxorubicin 30 mg/m2, with a 3-week interval between cycles 1 and 2. All patients were locally irradiated with 4 Gy daily for 5 consecutive days. The follow-up included 266 cystectomized patients. In May 1992 the mean observation time was 18 months for all patients and 47 months for those still alive. The results suggest that a significant downstaging in the group randomized to chemotherapy was found only in T1, grade 3 tumours (56 patients, p = 0.002). The overall survival rate in all 311 patients was significantly higher in the chemotherapy group (p = 0.03) and likewise among the 253 patients with T2-T4a tumour (p = 0.018). For the 210 patients who underwent cystectomy for T2-T4a tumour, there was a trend towards longer survival when chemotherapy was given (p = 0.057). Patients with initially muscle-invasive tumour who responded to neoadjuvant treatment survived longer than non responders (p = 0.0005). The results suggest that neoadjuvant chemotherapy improve the outcome of radical surgery for muscle-invasive bladder cancer, though the effect on long-term survival is inconclusive. Further studies on the effect of neoadjuvant chemotherapy is initiated.