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

Kazufumi Kobayashi, Sadahisa Ogasawara, Ei Itobayashi, Tomomi Okubo, Norio Itokawa, Kazuyoshi Nakamura, Michihisa Moriguchi, Shunji Watanabe, Masafumi Ikeda, Hidekatsu Kuroda, Tomokazu Kawaoka, Atsushi Hiraoka, Yutaka Yasui, Teiji Kuzuya, Rui Sato, Hiroaki Kanzaki, Keisuke Koroki, Masanori Inoue, Masato Nakamura, Soichiro KiyonoNaoya Kanogawa, Takayuki Kondo, Shingo Nakamoto, Yoshihito Ozawa, Kaoru Tsuchiya, Masanori Atsukawa, Hiroshi Aikata, Takeshi Aramaki, Shiro Oka, Naoki Morimoto, Masayuki Kurosaki, Yoshito Itoh, Namiki Izumi, Naoya Kato

研究成果: ジャーナルへの寄稿学術論文査読

抄録

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.

本文言語英語
ページ(範囲)394-404
ページ数11
ジャーナルInvestigational New Drugs
42
4
DOI
出版ステータス出版済み - 08-2024

All Science Journal Classification (ASJC) codes

  • 腫瘍学
  • 薬理学
  • 薬理学(医学)

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