(ChemotherapyAdvisor) – Adding paclitaxel to gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic urothelial cancer demonstrated a higher response rate and a 3.1 month survival benefit vs. gemcitabine/cisplatin; however, this difference was not significant, a study in the Journal of Clinical Oncology published online February 27 has found.

Previously, a Phase I/II study had suggested that the three-drug regimen had greater antitumor activity and might improve survival. The Phase III EORTC Intergroup Study 30987 randomized patients without prior systemic therapy from 2001 to 2004 to paclitaxel/gemcitabine/cisplatin (n=312) or gemcitabine/cisplatin (n=314).

After a median follow-up of 4.6 years, median overall survival (OS), the primary outcome, was 15.8 months for paclitaxel/gemcitabine/cisplatin vs. 12.7 months for gemcitabine/cisplatin (HR=85; P=0.075). A subgroup of all eligible patients, including those with bladder primary tumors, had significantly longer OS with the 3-drug regimen, 3.2 months.

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Progression-free survival was not significantly longer in the paclitaxel/gemcitabine/cisplatin arm (HR=0.87; P=0.11). Overall response rate was 55.5% in the paclitaxel/gemcitabine/cisplatin arm and 43.6% in the gemcitabine/cisplatin arm (P=0.0031). Both treatments were well tolerated; more thrombocytopenia and bleeding occurred with gemcitabine/cisplatin (11.4%) than with paclitaxel/gemcitabine/cisplatin (6.8%; P=0.05). Febrile neutropenia occurred more frequently in the paclitaxel/gemcitabine/cisplatin arm (13.2%) than in the gemcitabine/cisplatin arm (4.3%; P<0.001).

“Novel approaches will be required to obtain major improvements in survival of incurable urothelial cancer,” the investigators concluded.