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AFP response may be predictive of survival in patients with HCC

Patients with hepatocellular carcinoma treated with sorafenib who experienced a reduction in alpha-fetoprotein levels had higher survival rates than those who did not in a recent retrospective analysis.

Researchers evaluated data from three clinical trials performed at Humanitas Cancer Center in Rozzano, Italy. The serum alpha-fetoprotein (AFP) levels were measured in 85 patients with hepatocellular carcinoma (HCC) treated with 400 mg sorafenib twice daily. Eighty-two patients also were assessed using Response Evaluation Criteria in Solid Tumors (RECIST). All participants had baseline AFP levels of more than 20 ng/mL, and response was defined as a decrease of more than 20% within 8 weeks of therapy initiation.

Disease control was achieved by 58 patients (70.7%) according to RECIST criteria, while 32 participants (37.6%) were considered AFP responders. The median overall survival rate was significantly higher in AFP responders (13.3 months) compared with nonresponders (8.2 months) (P=.022). This significance remained when researchers applied a 50% cut-off for response. The median overall survival rate among patients who achieved disease control according to RECIST was not significantly higher than those who did not (10.1 months compared with 7.5 months, P=.823).

The calculated HR for survival of 90 days or more (n=79) according to AFP response was 0.59 (95% CI, 0.36-0.98), and 1.03 (95% CI, 0.59-1.80) according to disease control. Multivariate analysis indicated that AFP response (HR=0.52; 95% CI, 0.31-0.85) was predictive of survival.

“This study suggests that AFP response is an independent surrogate endpoint for survival that should be considered in conjunction with radiologic response evaluation,” the researchers concluded. “In the era of targeted agents, which characteristically increase the rate of disease stabilization, the prognostic role of AFP response warrants further prospective validation in larger series.”