Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma, a new study published online ahead of print in the journal The Lancet Oncology has shown.
For the international, placebo-controlled, double-blind, phase III REACH trial, researchers enrolled 565 patients with advanced hepatocellular carcinoma who were refractory or not amenable to locoregional therapy and had previously received sorafenib.
Patients were randomly assigned 1:1 to receive ramucirumab 8 mg/kg IV or placebo every 2 weeks plus best supportive care until disease progression, unacceptable toxicity, or death.
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Results showed that median overall survival in the ramucirumab group was 9.2 months (95% CI: 8.0, 10.6) compared with 7.6 months (95% CI: 6.0, 9.3) in the placebo group (HR = 0.87; 95% CI: 0.72, 1.05; P=0.14), indicating there was no significant difference in overall survival between the two groups.
In regard to safety, 12% of patients in the ramucirumab group experienced grade 3 or higher hypertension compared with 4% in the placebo group.
- Zhu AZ, Park JO, Ryoo B-Y, et al. Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)00050-9.