Phase I study of gemcitabine-cisplatin versus pemetrexed cisplatin for patients with advanced or metastatic bladder cancer.

Purpose: The present study aimed to compare the chemotherapeutic regimens of gemcitabine plus cisplatin (GC) vs pemetrexed plus cisplatin (PC) in bladder cancer (BC) with vascular invasion and/or distant metastasis.
Methods: From January 2010 to January 2017, 53 patients with advanced or metastatic BC were included and randomly divided into two groups. Patients in the GC group were administered 1,000 mg/m ² gemcitabine on day 1 and 15 and 70 mg/m ² cisplatin on day 1 as an IV infusion. Patients in the PC group were administered 500 mg/m ² pemetrexed on day 1 and 15 and 70 mg/m2 cisplatin on day 1 as an IV infusion. The two regimens were repeated every 28 days. Patients were treated for about 4-6 cycles until the occurrence of severe toxicity or patient refusal.
Results: The median overall survival (OS) and the median progression-free survival (PFS) in the GC group were significantly higher than that in the PC group (OS: p=0.033 and PFS: p=0.039, respectively). Besides, the response rates and disease control were obviously higher in the GC group (68% and 86%, respectively) compared to the PC group (44% and 56%, respectively), although without statistical significance. Regarding toxicity, higher rates of neutropenia and nausea in the PC group were noted, while thrombocytopenia was more frequent in the GC group.
Conclusions: The gemcitabine plus cisplatin combination was more effective and well tolerated in patients with advanced or metastatic BC compared to the pemetrexed plus cisplatin regimen.