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Ramucirumab for advanced hepatocellular carcinoma in the current real world: a Japanese single-arm study post-REACH-2 (The R-evolution study). | LitMetric

AI Article Synopsis

  • This study assessed the safety and effectiveness of ramucirumab as a second- and third-line treatment for advanced hepatocellular carcinoma (HCC) in a real-world setting, complementing findings from the REACH-2 trial.
  • Conducted in Japan with 19 enrolled patients, the study found a 6-month progression-free survival rate of 14.3%, with median progression-free survival and overall survival of 3.7 and 12.0 months, respectively.
  • The most common severe adverse events included hypertension (23.5%), proteinuria (17.6%), and neutropenia (11.8%), with 29.4% of patients discontinuing treatment due to these adverse effects.

Article Abstract

This study aimed to complement the results of the REACH-2 study by prospectively evaluating the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma (HCC) in a real-world setting. This was an open-label, nonrandomized, multicenter, prospective study conducted at 13 institutions in Japan (jRCTs031190236). The study included Child-Pugh Class A patients with advanced HCC who had received pretreatment with atezolizumab plus bevacizumab (Atez/Bev) or lenvatinib. Ramucirumab was introduced as a second-line treatment after Atez/Bev or lenvatinib and as a third-line treatment after Atez/Bev and lenvatinib. Between May 2020 and July 2022, we enrolled 19 patients, including 17 who received ramucirumab. Additionally, seven patients received lenvatinib, another seven patients received Atez/Bev, and three patients received Atez/Bev followed by lenvatinib as prior treatment. The primary endpoint was a 6-month progression-free survival (PFS) rate, which was 14.3%. The median PFS and overall survival were 3.7 and 12.0 months, respectively. The most common grade ≥ 3 adverse events (AEs) were hypertension (23.5%), proteinuria (17.6%), and neutropenia (11.8%). The discontinuation rate due to AEs was 29.4%. Six patients progressed from Child-Pugh A to B after treatment with ramucirumab. Thirteen patients were eligible for post-ramucirumab treatment, including systemic therapy. Despite the limited number of patients, the efficacy of ramucirumab was comparable to that observed in the REACH-2 study when used after lenvatinib and Atez/Bev. However, the incidence of AEs was higher than that in the REACH-2 study.

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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11327193PMC
http://dx.doi.org/10.1007/s10637-024-01441-3DOI Listing

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