REACH and REACH-2 investigated ramucirumab versus placebo in patients with advanced hepatocellular carcinoma (HCC). Ascites is common in HCC and associated with poorer outcomes. This exploratory, pooled meta-analysis of patients with baseline alpha-fetoprotein (AFP) ≥400 ng/mL investigated outcomes by treatment-emergent (TE) ascites in REACH and REACH-2.
A pooled meta-analysis of independent patient data for participants (N=542) with baseline AFP ≥400 ng/mL (stratified by study) from REACH and REACH-2 was performed. Overall survival (OS) and progression-free survival (PFS) were evaluated by Kaplan-Meier estimator, and OS further assessed by Cox models. The effect of TE ascites on OS was evaluated by multivariate Cox models.
TE ascites developed in 66 patients (20.9%) in the ramucirumab group and 33 patients (14.8%) in the placebo group. When adjusted for treatment duration, the incidence rates per 100 patient-years of any grade TE ascites were 59.1 and 71.9 for the ramucirumab and placebo groups, respectively, and the incidence of grade ≥3 TE ascites were 13.4 and 19.6, respectively. TE ascites was associated with TE hypoalbuminemia (odds ratio 4.9, 95% CI 2.5-9.3), but not TE proteinuria or hypertension. One patient discontinued ramucirumab treatment due to TE ascites. Ramucirumab treatment improved OS and PFS compared with placebo, irrespective of TE ascites.
When adjusted for treatment duration, the incidence of TE ascites was no higher in patients who received ramucirumab than in those who received placebo. Ramucirumab was well tolerated and provided a survival benefit irrespective of the development of TE ascites. This article is protected by copyright. All rights reserved.

This article is protected by copyright. All rights reserved.

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