(HealthDay News) – For patients with urothelial cancer who are ineligible for cisplatin therapy, treatment with gemcitabine/carboplatin (GC) or methotrexate/carboplatin/vinblastine (M-CAVI) regimens show similar efficacy, according to a study published online December 12 in the Journal of Clinical Oncology.
Maria De Santis, MD, from the Kaiser Franz Josef Hospital in Vienna, Austria, and colleagues compared the efficacy of two carboplatin-based chemotherapy regimens in 238 patients with urothelial cancer who were ineligible for cisplatin chemotherapy (chemotherapy-naive patients with measurable disease, an impaired renal function [glomerular filtration rate <60 but >30 mL/min] and/or performance score of 2). In a phase II/III trial, participants were randomized to receive either GC or M-CAVI, and followed up for a median 4.5 years. The primary objective was to compare the overall survival (OS) between the GC and M-CAVI groups. Secondary end points included overall response rate (ORR), progression-free survival (PFS), toxicity, and quality of life.
The investigators found that the best ORRs achieved were 41.2 and 30.3% for patients receiving GC and M-CAVI, respectively (confirmed response in 36.1 and 21% patients, respectively; P=0.8). Median OS was 9.3 and 8.1 months in the GC and M-CAVI groups, respectively (P=0.64). The two treatment groups did not differ in PFS (P=0.78). Severe acute toxicity was observed in 9.3 and 21.2% of patients in the GC and M-CAVI groups, respectively (death, grade 4 thrombocytopenia with bleeding, grade 3 or 4 renal toxicity, neutropenic fever, or mucositis).
“There were no significant differences between the GC and M-CAVI arms in OS or for the secondary end points of response and PFS,” the authors write.
Several authors disclosed financial ties to Eli Lilly, which partially funded the study.