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Efficacy and safety of regorafenib compared to placebo and to post-cross-over regorafenib in advanced non-adipocytic soft tissue sarcoma

European Journal of Cancer Jul 08, 2018

Brodowicz T, et al. - In the placebo-controlled phase-2 REGOSARC trial, researchers provided evidence for the effectiveness of regorafenib in leiomyosarcoma, synovial sarcoma and other non-adipocytic sarcoma but not in liposarcoma. Then, those who received placebo were given regorafenib post-progression, and researchers assessed efficacy in patients post-cross-over with regorafenib in advanced non-adipocytic soft tissue sarcoma. One hundred thirty-nine subjects were recruited in the non-adipocytic sarcoma cohorts from June 2013 to December 2014. Results revealed a progression-free survival (PFS) benefit with regorafenib vs placebo in this longer follow-up. As compared to early treatment, delayed start of regorafenib was correlated with a statistically non-significant shorter PFS without impact on overall survival. In refractory non-adipocytic sarcomas, observed PFS confirmed that regorafenib warrants further clinical investigation.

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