Clinical impact of gemcitabine mono-maintenance versus best supportive care after first-line gemcitabine with platinum in patients with metastatic urothelial carcinoma.

Abstract

404 Background: To evaluate the clinical impact of gemcitabine (GEM) monotherapy after 1st line GEM with platinum in patients with metastatic urothelial carcinoma. Methods: We retrospectively reviewed the medical records of 113 patients who showed with radiological response or stabilization after 4-6 cycles of GEM with platinum.61 patients received maintenance of GEM-mono (GEM group) as 1000 mg/m2 on day 1 and 8 every three weeks until progression or development of unacceptable toxicity. And 52 patients received best supportive care (BSC) with regular radiologic evaluation (BSC group). Progression free survival (PFS) and overall survival (OS) from start date of GEM-mono or BSC was examined. Results: After a median follow-up of all population of 8.21 months, 43 (70%) patients had progressed and 32 (52%) died in the GEM-mono arm, compared to 45 (86%) and 39 (76%) in the BSC arm, respectively. Maintenance of GEM-mono was for a median 6 cycles (2-19). Median PFS was 7–12 months (range 1.5-13.0) in the GEM-mono arm and 4–8 months (range 1.4-8.6) in the BSC arm (Hazard Ratio 0.580, 95%CI 0.38-0.95, p=0.032). Most common grade 3/4 adverse events in the GEM arm were neutropenia (n=11; 18%) and fatigue (n=13; 21%). After progression, 42 (68%) patients received treatment at the GEM and 30 (58%) at the BSC arm. Conclusions: Our data suggest that maintenance of GEM-mono therapy in patients who responded to 1st line GEM with platinum provides a significant prolongation of PFS, and with a manageable toxicity profile.