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Stivarga improves OS for unresectable HCC
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Recent data from the RESORCE clinical trial presented at the European Society of Medical Oncology 18th World Congress on Gastrointestinal Cancer showed Stivarga was safe and improved overall survival for patients with unresectable hepatocellular carcinoma.
“The global incidence of liver cancer continues to increase and has more than tripled in the United States over the last three decades, and currently there are no proven or approved systemic second-line treatment options for patients with advanced HCC,” Jordi Bruix, MD, head of the Barcelona Liver Clinic Group, Hospital Clinic, University of Barcelona, Spain, and trial investigator, said in a press release. “The improvement in overall survival seen with [Stivarga] in the RESORCE study signals the addition of a potential option in this treatment setting.”
Jordi Bruix
Bruix and colleagues randomly assigned 573 patients with unresectable HCC whose disease progressed after treatment with Nexavar (sorafenib, Bayer HealthCare) to treatment with either 160 mg of Stivarga (regorafenib, Bayer; n = 379) for 3 weeks on and 1 week off, or placebo (n = 194) with 28 days constituting one full treatment cycle.
Results showed patients treated with regorafenib had a longer median overall survival (OS) of 10.6 months compared with 7.8 months for patients treated with placebo plus best supportive care (HR = 0.62; 95% CI, 0.5-0.78). The median progression-free survival was 3.1 months in the regorafenib-treated group compared with 1.5 months in the control group (HR = 0.46; 95% CI, 0.37‒0.56).
Disease control rate defined by mRECIST criteria was 65.2% in regorafenib-treated patients compared with the placebo group (36.1%; P < .001). The overall response rate (complete and partial) was 10.6% vs. 4.1% (P = .005).
More patients in the regorafenib-treated group experienced grade 3 adverse events (79.7%) compared with placebo (58.5%). Common grade 3 adverse events included hypertension, hand-foot skin reaction, fatigue and diarrhea. Approximately 68% of patients treated with regorafenib underwent dose modification due to adverse events compared with 31.1% of patients treated with placebo.
Patients treated with placebo had a higher mortality rate compared with regorafenib-treated patients after 30 days post-treatment (19.7% vs. 13.4%).
Bayer plans to submit data from the RESORCE study for marketing authorization of regorafenib for the treatment of unresectable HCC in the U.S. and worldwide later this year, according to the press release.
The researchers concluded: “Regorafenib significantly improved OS in patients with HCC who progressed during treatment with sorafenib. Adverse events were consistent with the known safety profile of regorafenib.” – by Melinda Stevens
Reference:
Bruix J, et al. Abstract #LBA-03. Presented at: European Society of Medical Oncology World Congress on Gastrointestinal Cancer; June 29-July 2, 2016; Barcelona, Spain.
Disclosure: Bruix reports consulting for AbbVie, Arqule, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, BTG, Gilead Sciences, Kowa, Novartis, Onxeo, OSI, Roche and Terumo.