Complete long‐term survival data from a trial of adjuvant chemotherapy vs control after radical cystectomy for locally advanced bladder cancer

摘要: OBJECTIVES To report the long-term follow-up of patients with locally advanced bladder cancer treated either adjuvant combined chemotherapy methotrexate, vinblastine, doxorubicin/epirubicin, and cisplatin (MVAC/MVEC) or no additional treatment after radical cystectomy, to examine various survival endpoints factors associated survival. PATIENTS AND METHODS Between May 1987 December 1990, 49 undergoing cystectomy for were randomized observation only systemic three cycles MVAC/MVEC (methotrexate 30 mg/m2 on day 1, 15 22; vinblastine 3 mg/m2 on 2, doxorubicin 30 mg/m2 epirubicin 45 mg/m2 on 2; 70 mg/m2 on 2 a 28-day cycle). Data obtained progression-free, overall tumour-specific survival. RESULTS In all, 23 control arm 26 chemotherapy. The trial intended accrue 100 but was stopped an interim analysis showed marked difference in progression free-survival when these first had been randomized. intent-to-treat analysis, including hazard ratios (HR) 95% confidence intervals point estimates at 10 years vs chemotherapy, as follows: progression-free HR 2.84 (1.46–5.54; P= 0.002), 13.0% 43.7%; 1.75 (0.95–3.23; 0.069), 17.4% 26.9%; 2.52 (1.28–4.99; 0.007), 41.7%, respectively. CONCLUSIONS The results further support use adjuvant-combined cisplatin-based regimens cancer, this significantly improves survival.