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Table S4 from A Prospective Study Exploring the Safety and Efficacy of Lenvatinib for Patients with Advanced Hepatocellular Carcinoma and High Tumor Burden: The LAUNCH Study

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posted on 2023-12-01, 09:00 authored by Kazufumi Kobayashi, Sadahisa Ogasawara, Susumu Maruta, Tomomi Okubo, Norio Itokawa, Yuki Haga, Yuya Seko, Michihisa Moriguchi, Shunji Watanabe, Yuki Shiko, Hirokazu Takatsuka, Hiroaki Kanzaki, Keisuke Koroki, Masanori Inoue, Masato Nakamura, Soichiro Kiyono, Naoya Kanogawa, Takayuki Kondo, Eiichiro Suzuki, Yoshihiko Ooka, Shingo Nakamoto, Yosuke Inaba, Masafumi Ikeda, Shinichiro Okabe, Naoki Morimoto, Yoshito Itoh, Kazuyoshi Nakamura, Kenji Ito, Ryosaku Azemoto, Masanori Atsukawa, Ei Itobayashi, Naoya Kato

Radiological assessments according to RECIST 1.1 (evaluation by each investigator)

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ARTICLE ABSTRACT

This study aimed to investigate the safety and efficacy of lenvatinib in real-world settings, including patients excluded from the REFLECT trial, a phase III trial that compared lenvatinib with sorafenib. This multicenter, nonrandomized, open-label prospective study was conducted at 10 medical facilities in Japan (jRCTs031190017). Eligible patients had advanced hepatocellular carcinoma (HCC) and were suitable for lenvatinib therapy. The study included patients with high tumor burden (with >50% intrahepatic tumor volume, main portal vein invasion, or bile duct invasion), Child-Pugh B status, and receiving lenvatinib as second-line therapy following atezolizumab plus bevacizumab. From December 2019 to September 2021, 59 patients were analyzed (47 and 12 patients with Child-Pugh A and B, respectively). In patients with Child-Pugh A, the frequency of aspartate aminotransferase elevation was high (72.7%) in the high-burden group. No other significant ad verse events (AE) were observed even in second-line treatment. However, patients with Child-Pugh B had high incidence of grade ≥3 AE (100.0%) and high discontinuation rates caused by AE (33.3%) compared with patients with Child-Pugh A (80.9% and 17.0%, respectively). Median progression-free survival was 6.4 and 2.5 months and median overall survival was 19.7 and 4.1 months in Child-Pugh A and B, respectively. Lenvatinib plasma concentration was higher in patients with Child-Pugh B on days 8 and 15 and correlated with dose modifications and lower relative dose intensity. Lenvatinib is safe and effective for advanced HCC in patients with Child-Pugh A, even with high tumor burden. However, it carries a higher risk of AE and may not provide adequate efficacy for patients with Child-Pugh B status.

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