Evaluation of drug delivery and survival impact of dose-intense relative to conventional-dose methotrexate, vinblastine, doxorubicin, and cisplatin chemotherapy in urothelial cancer

The efficacy of dose-intense methotrexate, vinblastine, doxorubicin, and ci splatin (M-VAC) chemotherapy relative to conventional-dose M-VAC in patient s with advanced transitional cell carcinoma is unknown. The outcomes of 33 patients on two successive protocols using dose-intense M-VAC with granuloc yte colony-stimulating factor (G-CSF) support were compared with those of 1 29 patients treated with conventional-dose M-VAC to assess for an impact of dose-intense therapy on long-term survival. The mean relative dose intensi ty of chemotherapy delivered to the dose-intense cohort was 55% higher than that delivered to the conventional-dose cohort (p = 0.0001). However, no s ignificant differences were observed with regard to response proportion (72 % vs. 76%), median survival (13.3 vs. 16.7 months, p = 0.31), or 5-year sur vival (16% vs. 15%). Growth factor support enabled a statistically signific ant increase in the delivered dose intensity of M-VAC chemotherapy, but no survival advantage relative to conventional-dose M-VAC was observed.