Back to Search
Start Over
Ramucirumab for advanced hepatocellular carcinoma in the current real world: a Japanese single-arm study post-REACH-2 (The R-evolution study).
- Source :
-
Investigational new drugs [Invest New Drugs] 2024 Aug; Vol. 42 (4), pp. 394-404. Date of Electronic Publication: 2024 Jun 06. - Publication Year :
- 2024
-
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.<br /> (© 2024. The Author(s).)
- 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
Subjects
Details
- Language :
- English
- ISSN :
- 1573-0646
- Volume :
- 42
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Investigational new drugs
- Publication Type :
- Academic Journal
- Accession number :
- 38842657
- Full Text :
- https://doi.org/10.1007/s10637-024-01441-3