Gemcitabine-cisplatin versus methotrexate, vinblastine, doxorubicin and cisplatin in locally advanced or metastatic transitional cell carcinoma of the bladder

ABSTRACT

To compare the efficacy and toxicity of the combination of gemcitabine plus cisplatin [GC] and methotrexate, vinblastine, doxorubicin plus cisplatin [MVAC] in the treatment of patients with locally advanced or metastatic transitional cell carcinoma [TCC] of the bladder. Forty five patients with locally advanced or metastatic TCC of the bladder were r and omized to GC [gemcitabine 1000mg/m[2] days 1, 8 and 15; cisplatin 70mg/m[2] day 2] or st and ard MVAC [methotrexate 30mg/m[2] days 1, 15 and 22; vinblastine 3mg/m2 on days 2, 15 and 22; doxorubicin 30mg/m[2] on day 2; and cisplatin 70mg/m[2] on day 2]. The cycles were repeated every 28 days for a maximum of six cycles. Forty five patients were r and omized [GC, n=23; MVAC, n=22]. Overall response rates were similar on both. arms [GC, 47.8%; MVAC, 45.5%, p=0.934]. Overall survival and progression free-survival were similar on both arms [HR, 1.067; 95% CI, 0.595 to 1.915, p=0.828, and HR, 0.861; 95% Cl, 0.461 to 1.610, p=0.640, respectively]. Patients on the [GC arm received a median of six cycles compared with a median of 4 cycles for patients on the MVAC arm. Dose adjustments occurred in only 40% of the cycles with GC and in 64.7% with MVAC. Grades 3 and 4 anemia and thrombocytopenia were seen more often on GC arm than on MVAC arm [26% vs 18.1%, p=0.776 and 43.5% vs 22.7%, p=0.265 respectively]. However, the RBC and platelet transfusion rates were similar on both arms. More MVAC treated-patients compared with GC treated-patients had grade 3 and 4neutropenia [81.8% vs 60.8% respectively, p=0.043], neutropenic fever [18.2% vs 0% respectively p=0.049], neutropenic sepsis [13.6% vs 0% respectively, p=0.089], grade 3 and 4 mucositis [27.2% vs 0% respectively, p=0.027] and alopecia [54.5% vs 8.7% respectively, p=0.001]. More patients on GC had better results than MVAC patients as regard weight and performance status. Combination chemotherapy of gemcitabine plus cisplatin provides similar outcomes to that of st and ard MVAC in treatment of patients with locally advanced or metastatic TCC of the bladder with a better safety profile and tolerability