Gemcitabine and Cisplatin Versus Methotrexate, Vinblastine, Doxorubicin, and Cisplatin In Advanced and or Metastatic Bilharzial Urothelial Carcinoma of the Bladder in Egypt.

Abstract

Purpose: Gemcitabine plus cisplatin (GC) and methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC)were compared in patients with locally advanced or metastatic bilharzial urothelial carcinoma.Patients and Methods: Patients with with locally advanced or metastatic bilharzial urothelial carcinoma (no prior systemic chemotherapy) were randomized to GC (gemcitabine 1,000 mg/m2 days 1, 8, 15, cisplatin 70 mg/m2 day 2) or standard MVAC every 28 days for a maximum of six cycles (Methotrexate = 30 mg/m2 on days 1, 15 and 22, Vinblastine = 3 mg/m2 on days 2, 15 and 22,Doxorubicin = 30 mg/m2 on day 2 and Cisplatin = 70 mg/m2 on day 2 (1-2 h infusion).Results: forty-one patients were randomized, twenty-one to the GC arm and twenty to the MVAC arm. Overall survival was similar(13 months) on both arms. Time to progressive disease was 7 months with GC group and 6 months with MVAC group and response rate (GC, 47.6% vs MVAC 45%). Significant prognostic factors correlating with better overall survival were Karnofsky performance status ≥ 70, TNM staging (Mo vs.M1) and the absence of visceral metastasis. Hematologic toxicities were significantly higher with GC therapy. More GC patients, compared with MVAC patients had grade 3/4 anemia (28.5% vs 15%) and thrombocytopenia(47.6% vs 25%). More MVAC patients, compared with GC patients had grade 3/4 neutropenia (80% vs 67.6%P = 0.001), grade 3/4 mucositis (20% v 9.5%) and alopecia (25% v 14.3%) Conclusion: GC provides a similar survival advantage to MVAC with a better tolerability. These results strengthen the role of GC as a standard of care in patients with locally advanced or metastatic bilharzial-related urothelial carcinoma.