Alpha-fetoprotein (aFP) levels of at least 400 ng/mL predict patients with hepatocellular carcinoma (HCC) likely to respond to second-line ramucirumab, according to a study published in JAMA Oncology.1
The REACH (Ramucirumab (IMC-1121B) Drug Product (DP) and Best Supportive Care (BSC) Versus Placebo and BSC as 2nd-Line Treatment in Participants With Hepatocellular Carcinoma After 1st-Line Therapy With Sorafenib; ClinicalTrials.gov Identifier: NCT01140347) study evaluated ramucirumab, an anti-vascular endothelial growth factor receptor-2 (VEGFR-2) monoclonal antibody, as a second-line treatment for HCC.
Patients were randomized to receive ramucirumab or placebo; analyses were conducted to determine drug safety and efficacy, and whether other factors, such as Child-Pugh score or aFP levels, affect outcome.
Five hundred and sixty-five Child-Pugh class A patients, for whom the prognosis is better than for patients classed B or C, were included in the final analyses; patients were assigned to 3 subgroups: Child-Pugh 5, Child-Pugh 6, and Child-Pugh 7 and 8.
Overall survival was best for patients with a Child-Pugh score of 5 and aFP levels of at least 400 ng/mL. There does not appear to be any survival benefit for patients with Child-Pugh scores of 6 or greater. Researchers will investigate the efficacy of ramucirumab among patients with elevated aFP levels.
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The authors refer to the safety profile of ramucirumab as “manageable,” though hypertension of at least grade 3 was noted in more than 10% of those who received the drug.
- Zhu AX, Baron AD, Malfertheiner P, et al. Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: analysis of REACH trial results by Child-Pugh score. JAMA Oncol. 2016 Sep 22. doi: 10.1001/jamaoncol.2016.4115 [Epub ahead of print]