11 Feb STIVARGA (Regorafenib) For Patients with Unresectable Hepatocellular Carcinoma
MedicalResearch.com Interview with:
MedicalResearch.com: What is the background for this study? What are the main findings?
- Regorafenib is an oral multi-kinase inhibitor that potently blocks multiple protein kinases involved in tumor angiogenesis, oncogenesis, metastasis and tumor immunity. It is approved for the treatment of patients with hepatocellular carcinoma (HCC) who have previously been treated with sorafenib. The safety and effectiveness of regorafenib is being evaluated in patients with unresectable hepatocellular carcinoma (uHCC),a liver tumor not eligible for curative treatment approaches such as surgery, given the extent of disease.
- Following the Phase 3 RESORCE trial, which showed that regorafenib significantly improves overall survival versus placebo in patients with uHCC who progressed on prior sorafenib therapy, we conducted an interim analysis (the first 500 of 1000 patients) of the global REFINE observational trial to evaluate the safety and effectiveness of regorafenib in uHCC in the real-world setting.
- The REFINE study shows a more varied patient population than the Phase 3 RESORCE trial, including a higher proportion of patients with ECOG performance status ≥1, and a higher proportion with Child–Pugh B liver function.
- The incidence of regorafenib-related grade ≥3 treatment-emergent adverse events were lower than that reported in the RESORCE trial, possibly indicating improved adverse event management with the use of regorafenib in clinical practice.
- The median overall survival was longer than that reported in RESORCE, but the proportion of censored patients was high in this interim analysis; the median progression free survival was similar to that reported in RESORCE.
MedicalResearch.com: What should readers take away from your report?
Response: This is a real-life observational study of patients with unresectable hepatocellular carcinoma for whom physicians decided to treat with regorafenib. In this interim analysis, differences were observed in the characteristics of patients treated with regorafenib from the Phase 3 RESORCE trial, reflecting less stringent inclusion criteria in a real-world study.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
- As this is an ongoing observational study, we look forward to seeing the characteristics of the second 500 patients in the REFINE trial and reviewing the final safety and effectiveness results of regorafenib in patients with uHCC in clinical practice.
- This study brings valuable insights into the characteristics of the unresectable hepatocellular carcinoma patients that physicians are prescribing in routine clinical practice. As such, these results and continued research may help to inform dose modifications to improve patient outcomes while managing treatment-emergent adverse events.
ASCO GI January 2020 Abstract
Abstract: #542 Regorafenib in patients with unresectable hepatocellular carcinoma (uHCC) in routine clinical practice: Interim analysis of the prospective, observational REFINE trial
Ho Yeong Lim, Philippe Merle, Richard S. Finn, Catherine Frenette, Gianluca Masi, Masafumi Ikeda, Hong Zebger-Gong, Sabine Fiala-Buskies, Kirhan Ozgurdal, Masatoshi Kudo, and Shukui Qin
Journal of Clinical Oncology 2020 38:4_suppl, 542-542
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