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4505 Background: Nab-P has shown promising activity as second line treatment of advanced urothelial cancer post platinum (Ko YJ, Lancet Oncol 2013) and may be more active and less toxic compared to P. Methods: Canadian Cancer Trials Group led a multicentre randomized phase II trial comparing Nab-P 260mg/m2 IV q21 days to P 175mg/m2 IV q21 days in pts with advanced urothelial cancer progressing after one line of platinum-based therapy. The primary endpoint was progression free survival (PFS); secondary endpoints included overall survival (OS), response rate (RR), adverse events (AEs) using CTC AE V4.03 and QOL (EORTC-C15-PAL, FACT-Taxane). A sample size of 199 pts was selected to detect target PFS HR of 0.67 using a 1-sided 5% level test with 81% power. Stratification factors included ECOG, liver mets, LN only mets, Hb level and ≤6mo from last platinum regimen. Results: 199 pts from Canada and Australia were enrolled from 2014-2017 with median age 67y, including 72% males, 30% liver mets, 84% ECOG 0/1 and 55% ≤6mo from last platinum therapy. Relative dose intensity ≥90% was 78% for Nab-P vs 67% for P. With median follow up 16.4mo, median PFS for Nab-P was 3.4mo vs 3.0mo for P (HR 0.92, 90%CI 0.68-1.23, p = 0.31); median OS for Nab-P was 7.5mo vs 8.8mo for P (HR 0.95, 90%CI 0.70- 1.30, p = 0.40). RR were similar, Nab-P 21% vs P 23% (p = 0.97). Rate of Grade(Gr)3+ all causality AEs was 67% for Nab-P vs 46% for P (p = 0.009); peripheral sensory neuropathy was 74% (Gr3+ 7%) for Nab-P vs 66% (Gr3+ 3%) for P (p = 0.27 (all grades), 0.33(Grd3+)). There were no significant differences in mean scores in any domain of QOL between Nab-P and P. Conclusions: Nab-P has similar efficacy and QOL compared to P as second line therapy in advanced urothelial cancer. Gr3+ all causality AEs were higher in the Nab-P arm. Clinical trial information: NCT02033993.
Sridhar et al. (Sun,) studied this question.