A RANDOMIZED TRIAL COMPARING METHOTREXATE AND VINBLASTINE (MV) WITH CISPLATIN, METHOTREXATE AND VINBLASTINE (CMV) IN ADVANCED TRANSITIONAL-CELL CARCINOMA - RESULTS AND A REPORT ON PROGNOSTIC FACTORS IN A MEDICAL-RESEARCH-COUNCIL STUDY

Transitional cell carcinomas may arise at any site within the urinary tract and are a source of considerable morbidity and mortality. In par ticular, patients with metastatic disease have a poor prognosis, with less than 5% alive at 5 years. A multicentre randomized trial comparin g methotrexate and vinblastine (MV) with cisplatin, methotrexate and v inblastine (CMV) in advanced or metastatic transitional cell carcinoma was conducted in the UK. From April 1991 to June 1995, 214 patients w ere entered by 16 centres, 108 randomized to CMV and 106 to MV. A tota l of 204 patients have died. The hazard ratio (relative risk of dying) was 0.68 (95% CI 0.51-0.90, P-value = 0.0065) in favour of CMV. This translates to an absolute improvement in 1-year survival of 13%, 16% i n MV and 29% in CMV. The median survival for CMV and MV was 7 months a nd 4.5 months respectively. Two hundred and eight patients objectively progressed or died. The hazard ratio was 0.55 (95% CI 0.41-0.73, P-va lue = 0.0001) in favour of CMV. Two hundred and nine patients symptoma tically progressed or died. The hazard ratio was 0.48 (95% CI 0.36-0.6 4, P-value = 0.0001) in favour of CMV. The most important pretreatment factors influencing overall survival were WHO performance status and extent of disease. These two factors were used to derive a prognostic index which could be used to categorize patients into three prognostic groups. We conclude that the addition of cisplatin to methotrexate an d vinblastine should be considered in patients with transitional cell carcinoma, taking into account the increased toxicity.