Real-world safety and effectiveness of lenvatinib in unresectable hepatocellular carcinoma in Korea: post-marketing study
Creators: name: Kang, Wonseok
name: Kim, Yoon Jun
name: Kim, Seung Up
name: Seo, Yeon Seok
name: Kim, Jin-Wook
name: Kim, Ji Hoon
name: Park, Soo Young
name: Baek, Yang-Hyun
name: Kim, Kang Mo
name: Lee, Hae Lim
name: Yoon, Ki Tae
name: Kim, Hyeyeong
name: Cheong, Jae Youn
name: Hwang, Jae Seok
name: Kim, Ju Hyun
name: Kim, Kwang Min
name: Sung, Pil Soo
name: Kim, Jieun
name: Kim, Do Young
Publisher: name: Taylor & Francis
Year: 2024
Subjects: subject: Medicine
subject: Genetics
subject: FOS: Biological sciences
subject: Pharmacology
subject: Immunology
subject: FOS: Clinical medicine
subject: Cancer
subject: Science Policy
subject: Plant Biology

description: <b>Aim:</b> This post-marketing surveillance study evaluated the safety and effectiveness of lenvatinib as first-line treatment for unresectable hepatocellular carcinoma in Korea. <b>Materials &amp; methods:</b> Adverse drug reactions (ADRs) and other safety and effectiveness end points were assessed in patients who initiated lenvatinib according to the approved label in republic of Korea. <b>Results:</b> Among 658 lenvatinib-treated patients, ADRs were reported in 57.8%; ADRs grade ≥3 in 13.5%. The most common grade ≥3 ADRs were asthenia (1.2%) and hepatic encephalopathy (1.2%). Physician-reported tumor responses (n = 511) were complete (1.0%) or partial (12.9%) response and stable (45.2%) or progressive disease (40.9%); objective response rates were higher with longer lenvatinib treatment duration (<i>p</i> &lt; 0.001). <b>Conclusion:</b> Lenvatinib was generally well tolerated and effective in real-world clinical practice in Korea. <b>Clinical trial registration:</b>ClinicalTrials.govNCT05225207 Since 2018, lenvatinib has been available in several countries as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). This was a prospective, multicenter, observational, post-marketing surveillance of the safety and effectiveness of lenvatinib as first-line treatment for uHCC in routine clinical practice in republic of Korea. Among 700 case report forms of patients who initiated lenvatinib according to the approved label in republic of Korea at 29 institutions, 658 were included in the safety analysis and 511 in the effectiveness analysis. None of the safety population (median age 64 years, 85% male) had received prior chemotherapy, 64.1% had received non-chemotherapy treatment, and 42.1% had a history of hypertension treatment. Among 658 lenvatinib-treated patients, the incidence of adverse drug reactions (ADRs) was 57.8% and the incidence of ADRs grade ≥3 was 13.5%. The most common ADRs were hypertension (14.4%) diarrhea (10.5%), palmar-plantar erythrodysesthesia syndrome (10.0%) and decreased appetite (7.6%); the most common grade ≥3 ADRs were asthenia (1.2%) and hepatic encephalopathy (1.2%). Factors significantly associated with adverse events were history of non-chemotherapy treatment, hypertension treatment; and the average daily dose of lenvatinib (12 mg/day compared with &lt;8 mg/day and 8 – &lt;10 mg/day). Physician-reported tumor responses evaluated by RECIST v1.1 or mRECIST criteria were: complete response (1.0%); partial response (12.9%); stable disease (45.2%); and progressive disease (40.9%). Objective response rates were significantly higher with longer (≥3 months to &gt;9 months) lenvatinib treatment duration compared with &lt;3 months. This PMS study shows that lenvatinib has a manageable tolerability profile and provides clinically meaningful effectiveness as first-line treatment for patients with uHCC in the real-world clinical setting in Korea.