Pazopanib vs pazopanib + gemcitabine in refractory soft tissue sarcoma: A randomized phase II trial of the AIO.

11004Background: There is a need for active chemotherapy combinations in anthracycline-refractory soft tissue sarcoma. Pazopanib, a TK-inhibitor of VEGF, PDGF and c-kit, significantly improves PFS (PALETTE-Trial, v. d. Graaf, Proc. ASCO 2011). Gemcitabine has shown single agent activity in anthracycline refractory patients (pts), and pazopanib/gemcitabine has shown to be (Plummer R., Cancer Chemother and Pharmacol 2013). This combination (arm A) was investigated against single agent pazopanib (arm B) in anthracycline refractory patients. Methods: From 9/11 - 7/14 90 patients with relapsed or refractory soft tissue sarcoma after at least 1 anthracycline based chemotherapy have been randomize, with life expectancy > 3 months, ECOG-PS 0-2, adequate organ function and at least 1 measurable lesion (RECIST). Primary endpoint (PE): rate of progression @ 3 months (PFS-R), with an anticipated PFS-R of 40 % (arm B) (PALETTE-trial) vs. =/> 60% (arm A), with 90 pts to demonstrate a significant difference (p < 0.05, 1...