Abstract

ABSTRACT Background Prognostic factors for overall survival (OS) in patients receiving second-line chemotherapy for advanced platinum-pretreated urothelial carcinoma (UC) include ECOG performance status (PS) >0, hemoglobin (Hb) Methods Of 12 available phase II trials evaluating second-line therapy for advanced UC (n = 748), 7 trials with available baseline TFPC, Hb, PS and LM were utilized (n = 559). These trials evaluated vinflunine (2 trials), docetaxel alone or with vandetanib, paclitaxel-gemcitabine, nanoparticle-albumin-bound paclitaxel, cetuximab alone or with paclitaxel, and volasertib. The Kaplan-Meier method was used to estimate OS from date of starting second-line therapy. Cox proportional hazards regression stratified for trial was used to evaluate the prognostic effect of factors on OS. External validation was conducted in a second-line phase III trial comparing best supportive care (BSC) vs. vinflunine plus BSC (n = 352). Results Median OS was 5.2, 7.1, 8.3, 7.6 and 10.6 months respectively for patients having TFPC 12 months. ECOG-PS >0 (HR = 1.66), LM (HR = 1.49), Hb 0, Hb Conclusions A shorter duration of TFPC exhibited a significant negative prognostic impact on OS independent of ECOG-PS >0, Hb Disclosure T.K. Choueiri: Research support to institution from Astrazeneca. R. Fougeray: Employee of Pierre Fabre. Y. Wong: Research support to institution from Imclone. S.S. Sridhar: Research support to institution from Celgene. J. Bellmunt: Research support to institution from Pierre Fabre. All other authors have declared no conflicts of interest.

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