SAN FRANCISCO—Baseline α-fetoprotein (AFP) levels may be a predictive marker for patients with advanced hepatocellular carcinoma receiving ramucirumab as second-line treatment, a study (Abstract 232) presented this week at the 2015 Gastrointestinal Cancers Symposium has shown.
The REACH study was a phase 3 study that evaluated the safety and efficacy of ramucirumab alone for the treatment of patients with advanced hepatocellular carcinoma who had previously received sorafenib. In this pre-specified subgroup analysis, researchers looked at the effect of baseline AFP levels ≥400ng/mL on ramucirumab efficacy.
Results showed that among the 250 patients with baseline AFP ≥400ng/mL treated with ramucirumab or placebo, the overall survival hazard ratio was 0.67 (95% CI: 0.51 – 0.90; P = 0.0059). The median overall survival was 7.8 and 4.2 months for the ramucirumab and placebo groups, respectively.
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Among the 417 patients with baselines AFP ≥1.5 x ULN, the median overall survival was 8.6 and 5.7 months for the ramucirumab and placebo groups, respectively (HR = 0.749; 95% CI: 0.603 – 0.930; P = 0.0088).
Analyses of the significance of the interaction between baseline AFP cutoffs, ≥400ng/mL and ≥1.5 x ULN, and ramucirumab treatment effect showed P-values of 0.0272 and 0.0372, respectively.
In regard to safety, patients in these subgroups had a similar safety profile as those in the overall safety population.
- Zhu AX, Ryoo B-Y, Yen C-J, et al. Ramucirumab (RAM) as second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): Analysis of patients with elevated α-fetoprotein (AFP) from the randomized phase III REACH study. J Clin Oncol. 2015;33:(suppl 3; abstr 232).