1. Ramucirumab for advanced hepatocellular carcinoma in the current real world: a Japanese single-arm study post-REACH-2 (The R-evolution study).
- Author
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Kobayashi K, Ogasawara S, Itobayashi E, Okubo T, Itokawa N, Nakamura K, Moriguchi M, Watanabe S, Ikeda M, Kuroda H, Kawaoka T, Hiraoka A, Yasui Y, Kuzuya T, Sato R, Kanzaki H, Koroki K, Inoue M, Nakamura M, Kiyono S, Kanogawa N, Kondo T, Nakamoto S, Ozawa Y, Tsuchiya K, Atsukawa M, Aikata H, Aramaki T, Oka S, Morimoto N, Kurosaki M, Itoh Y, Izumi N, and Kato N
- Subjects
- Humans, Male, Female, Aged, Middle Aged, Prospective Studies, Japan, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Quinolines therapeutic use, Quinolines adverse effects, Progression-Free Survival, Aged, 80 and over, Adult, Phenylurea Compounds therapeutic use, Phenylurea Compounds adverse effects, Phenylurea Compounds administration & dosage, Antineoplastic Agents therapeutic use, Antineoplastic Agents adverse effects, Bevacizumab therapeutic use, Bevacizumab adverse effects, Bevacizumab administration & dosage, East Asian People, Ramucirumab, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular pathology, Liver Neoplasms drug therapy, Liver Neoplasms pathology, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized adverse effects
- 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., (© 2024. The Author(s).)
- Published
- 2024
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