Long-term survival in phase II trials of gemcitabine plus cisplatin for advanced transitional cell cancer

Purpose: To assess long-term survival and prognostic indicators of survival in patients with advanced urothelial cancer treated with gemcitabine and cisplatin. Materials and methods: Survival data from three previously published phase 11 trials of gemcitabine/cisplatin were updated. Baseline hemoglobin. performance status, and presence of visceral metastases, which are known prognostic factors with other regimens, were examined. Survival curves were constructed by the Kaplan-Meier method and significance assessed using the log-rank statistic. Cox's Proportional Hazards Model was used to construct univariate and multivariate survival models. Results and conclusions: Overall median survival of 121 included patients was 13.2 (11.0 to 14.9) months and estimated 4 year Survival was 13 +/- 6%. In a univariate analysis. the presence of visceral metastases and a hemoglobin <12.5 mg/dl had significant adverse prognostic implications (P<0.001 and P=0.02, respectively). Performance status was not a significant predictor of survival, perhaps due to the fact that only 14% of patients had a performance status of 2. In a multivariate analysis, only the absence of visceral metastases retained its prognostic importance with all estimated 24% 4-year Survival ill Such patients. These results lend further evidence for the clinical benefit of this regimen in advanced transitional cell cancer. (C) 2002 Elsevier Science Inc. All rights reserved.