O-011 Characteristics and outcomes of patients enrolled in the CORRECT and CONCUR phase 3 trials of regorafenib for metastatic colorectal cancer (mCRC)

Abstract

Introduction: The international CORRECT trial (NCT01103323) showed that regorafenib improves overall survival (OS) vs placebo in patients with previously treated mCRC. The CONCUR trial (NCT01584830) confirmed the survival benefit for regorafenib in Asian patients. We examined the characteristics of patients in the two trials. Methods: The designs of both phase 3 trials were similar, except that CONCUR included only Asian patients and prior use of biologic targeted therapy was not mandatory. Patients were randomly assigned 2:1 to regorafenib 160 mg or placebo for the first 3 weeks of every 4-week cycle. The primary endpoint was OS. Results: CORRECT involved 760 patients from North America, Europe, Australia, and Asia (n = 4 Chinese; n = 100 Japanese), whereas CONCUR included 204 patients from Asian countries (n = 172 Chinese; n = 0 Japanese). In CONCUR, patients had fewer treatment lines for metastatic disease, a higher proportion of patients were PS1, and overall 40% had no prior biologic targeted therapy (Table). The most frequent drug-related grade ≥3 adverse events in CORRECT were hand-foot skin reaction (HFSR, 17%), fatigue (10%), diarrhea and hypertension (7% each). In CONCUR, the most frequent drug-related grade ≥3 adverse events were HFSR (16%), hypertension (11%), hyperbilirubinemia, hypophosphatemia, and alanine aminotransferase increase (7%, each). Conclusion: CONCUR and CORRECT confirm the clinical benefit of regorafenib in patients with previously treated mCRC and a statistically significant improvement in OS in Asian and non-Asian patients. Adverse events were mostly similar across both trials and consistent with the known safety profile of regorafenib. (Table Presented).