Regorafenib fell short of improving progression-free survival in patients with treatment-refractory liposarcomas, Richard Reidel, MD, of Duke University Medical Center, Durham, N.C., reported at the annual meeting of the American Society of Clinical Oncology.
In a 48-patient study, the median progression-free survival was not significantly different for regorafenib-treated patients, 1.9 months, and for placebo-treated patients, 2.1 months. None of the regorafenib-treated patients had responses. Median overall survival was not reached for either group of patients.
The most common grade 3-4 adverse events observed with regorafenib included: grade 3 abdominal pain (13%), hypertension (13%), rash (13%), anemia (8%), anorexia (8%), generalized weakness (8%), and elevated lipase (8%). Grade 5 events occurred in one patient on regorafenib and 3 on placebo.
For the study, patients with advanced or metastatic, treatment-refractory liposarcoma were randomized 1:1 to receive either regorafenib 160 mg daily or placebo (3 weeks on, 1 week off). The study was powered to detect a difference of at least 3 months in median progression-free survival. Secondary objectives included adverse event assessments, overall response rate, time to tumor progression, progression-free survival at 8 and 16 weeks, overall survival, and disease-specific survival. Follow up information was available for 47 patients, with a median follow up of 3.8 months (0.2-15.3). The analyses included 33 dedifferentiated, 12 myxoid/round cell and 2 pleomorphic liposarcomas.
Dr. Riedel, and some of his co-authors, disclosed financial relationships with several drug companies including Bayer, the maker of regorafenib (Stivarga). Clinical trial information: NCT02048371
SOURCE: Riedel R et al. ASCO 2018 (annual meeting of the American Society of Clinical Oncology), Abstract 11505.