Regorafenib may provide clinical benefit to patients with 1 of several types of sarcoma, according to a study presented at the 2016 American Society of Clinical Oncology (ASCO) meeting.1
In this double-blind, randomized, placebo-controlled phase 2 study, researchers enrolled 181 patients with metastatic sarcoma who had received at least 3 prior treatments. Sarcomas were grouped by type, which included liposarcoma, leiomyosarcoma, synovial sarcoma, and other types of soft-tissue sarcoma.
Eighty-nine patients were randomized to receive regorafenib; 92 were given a placebo. Only 4 partial responses were observed in the non-placebo cohort: 1 patient with synovial sarcoma, and 3 with “other types.” Aside from liposarcoma patients, those who received regorafenib had an average progression-free survival of 3.0 more months (hazard ratio, .36; P < .0001) than those who received a placebo; average overall survival was 4.4 more months (hazard ratio, .67; P = .06) in the non-placebo cohort.
Despite these results, the researchers concluded that regorafenib provides a statistically significant benefit for non-liposarcoma patients with pre-treated, metastatic sarcoma. Common adverse events in the non-placebo cohort included asthenia, diarrhea, mucositis, Hand-Foot syndrome, anorexia, and arterial hypertension.
1. Penel N, Mir O, Italiano A, Blay JY, Wallet J, Bertucci F, et al. Regorafenib (RE) in liposarcomas (LIPO), leiomyosarcomas (LMS), synovial sarcomas (SYN), and other types of soft-tissue sarcomas (OTS): Results of an international, double-blind, randomized, placebo (PL) controlled phase II trial. J Clin Oncol. 2016; 34 (suppl; abstr 11003).