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Safety and Effectiveness of Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice: An Observational Post-Marketing Study in Japan

Background Lenvatinib was approved for use in unresectable hepatocellular carcinoma (uHCC) in Japan in 2018. Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clin...

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Published in:Drugs - Real World Outcomes 2023-06, Vol.10 (2), p.195-205
Main Authors: Furuse, Junji, Izumi, Namiki, Motomura, Kenta, Inaba, Yoshitaka, Katamura, Yoshio, Kondo, Yasuteru, Yabushita, Kazuhisa, Motoyoshi, Katsuaki, Kudo, Masatoshi
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cited_by cdi_FETCH-LOGICAL-c608t-f9f8714089c8b1bae7bf4a94579145ed15a4ee8fdfbef7cfc31ea9b403464aa23
cites cdi_FETCH-LOGICAL-c608t-f9f8714089c8b1bae7bf4a94579145ed15a4ee8fdfbef7cfc31ea9b403464aa23
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container_issue 2
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container_title Drugs - Real World Outcomes
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creator Furuse, Junji
Izumi, Namiki
Motomura, Kenta
Inaba, Yoshitaka
Katamura, Yoshio
Kondo, Yasuteru
Yabushita, Kazuhisa
Motoyoshi, Katsuaki
Kudo, Masatoshi
description Background Lenvatinib was approved for use in unresectable hepatocellular carcinoma (uHCC) in Japan in 2018. Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clinical settings. Objective This study aimed to evaluate the real-world safety and effectiveness of lenvatinib for uHCC in clinical practice in Japan. Patients and Methods Between July 2018 and January 2019, patients with uHCC who were administered lenvatinib for the first time were enrolled in this prospective, multicenter, observational post-marketing study (NCT03663114). Patients were orally administered lenvatinib and followed up for 12 months. For safety, adverse drug reactions (ADRs) were evaluated. For effectiveness, the objective response rate (ORR) was calculated to evaluate tumor response. Overall survival (OS) was estimated using the Kaplan–Meier method. Results Data of 703 patients (median age, 73 years; 80.2% males) were analyzed. The median (range) treatment duration was 25.3 (0.3–68.9) weeks. The mean ± standard deviation initial dose was 7.37 ± 1.65 mg in patients with body weight  10%) were decreased appetite, fatigue, hypertension, proteinuria, palmar-plantar erythrodysesthesia, hypothyroidism, and diarrhea. The median OS of the 703 patients was 498.0 days. In 494 patients assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR was 39.5% (95% confidence interval: 35.1–43.9%). Patients with better liver or renal function at baseline achieved significantly higher ORR than those with worse liver or renal function. Conclusions In patients with uHCC in real-world clinical practice in Japan, treatment with lenvatinib was generally well tolerated, and no new safety concerns were identified. The ORR and median OS were similar to or better than the results of the Japanese subset of the global Phase III REFLECT trial. Our results demonstrated that clinically meaningful treatment responses were achieved with lenvatinib in real-world clinical practice.
doi_str_mv 10.1007/s40801-022-00348-w
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Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clinical settings. Objective This study aimed to evaluate the real-world safety and effectiveness of lenvatinib for uHCC in clinical practice in Japan. Patients and Methods Between July 2018 and January 2019, patients with uHCC who were administered lenvatinib for the first time were enrolled in this prospective, multicenter, observational post-marketing study (NCT03663114). Patients were orally administered lenvatinib and followed up for 12 months. For safety, adverse drug reactions (ADRs) were evaluated. For effectiveness, the objective response rate (ORR) was calculated to evaluate tumor response. Overall survival (OS) was estimated using the Kaplan–Meier method. Results Data of 703 patients (median age, 73 years; 80.2% males) were analyzed. The median (range) treatment duration was 25.3 (0.3–68.9) weeks. The mean ± standard deviation initial dose was 7.37 ± 1.65 mg in patients with body weight &lt; 60 kg and 10.43 ± 2.49 mg in those with body weight ≥ 60 kg. ADRs (any grade) were reported in 84.9% of the patients, with Grade ≥ 3 ADRs reported in 42.5% of the patients. The most common ADRs (&gt; 10%) were decreased appetite, fatigue, hypertension, proteinuria, palmar-plantar erythrodysesthesia, hypothyroidism, and diarrhea. The median OS of the 703 patients was 498.0 days. In 494 patients assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR was 39.5% (95% confidence interval: 35.1–43.9%). Patients with better liver or renal function at baseline achieved significantly higher ORR than those with worse liver or renal function. Conclusions In patients with uHCC in real-world clinical practice in Japan, treatment with lenvatinib was generally well tolerated, and no new safety concerns were identified. The ORR and median OS were similar to or better than the results of the Japanese subset of the global Phase III REFLECT trial. Our results demonstrated that clinically meaningful treatment responses were achieved with lenvatinib in real-world clinical practice.</description><identifier>ISSN: 2199-1154</identifier><identifier>EISSN: 2198-9788</identifier><identifier>DOI: 10.1007/s40801-022-00348-w</identifier><identifier>PMID: 36602748</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject>Cancer therapies ; Clinical medicine ; Clinical trials ; Disease control ; Drug dosages ; Drug therapy ; Growth factors ; Hepatoma ; Internal Medicine ; Liver cancer ; Marketing ; Medical equipment ; Medicine ; Medicine &amp; Public Health ; Original ; Original Research Article ; Patient outcomes ; Patients ; Pharmaceuticals ; Pharmacology/Toxicology ; Pharmacotherapy ; Response rates ; Tumors</subject><ispartof>Drugs - Real World Outcomes, 2023-06, Vol.10 (2), p.195-205</ispartof><rights>The Author(s) 2023</rights><rights>2023. The Author(s).</rights><rights>COPYRIGHT 2023 Springer</rights><rights>The Author(s) 2023. This work is published under http://creativecommons.org/licenses/by-nc/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c608t-f9f8714089c8b1bae7bf4a94579145ed15a4ee8fdfbef7cfc31ea9b403464aa23</citedby><cites>FETCH-LOGICAL-c608t-f9f8714089c8b1bae7bf4a94579145ed15a4ee8fdfbef7cfc31ea9b403464aa23</cites><orcidid>0000-0003-0663-6117</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.proquest.com/docview/2821239378/fulltextPDF?pq-origsite=primo$$EPDF$$P50$$Gproquest$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.proquest.com/docview/2821239378?pq-origsite=primo$$EHTML$$P50$$Gproquest$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,885,11688,25753,27924,27925,36060,37012,44363,44590,53791,53793,74895,75126</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36602748$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Furuse, Junji</creatorcontrib><creatorcontrib>Izumi, Namiki</creatorcontrib><creatorcontrib>Motomura, Kenta</creatorcontrib><creatorcontrib>Inaba, Yoshitaka</creatorcontrib><creatorcontrib>Katamura, Yoshio</creatorcontrib><creatorcontrib>Kondo, Yasuteru</creatorcontrib><creatorcontrib>Yabushita, Kazuhisa</creatorcontrib><creatorcontrib>Motoyoshi, Katsuaki</creatorcontrib><creatorcontrib>Kudo, Masatoshi</creatorcontrib><title>Safety and Effectiveness of Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice: An Observational Post-Marketing Study in Japan</title><title>Drugs - Real World Outcomes</title><addtitle>Drugs - Real World Outcomes</addtitle><addtitle>Drugs Real World Outcomes</addtitle><description>Background Lenvatinib was approved for use in unresectable hepatocellular carcinoma (uHCC) in Japan in 2018. Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clinical settings. Objective This study aimed to evaluate the real-world safety and effectiveness of lenvatinib for uHCC in clinical practice in Japan. Patients and Methods Between July 2018 and January 2019, patients with uHCC who were administered lenvatinib for the first time were enrolled in this prospective, multicenter, observational post-marketing study (NCT03663114). Patients were orally administered lenvatinib and followed up for 12 months. For safety, adverse drug reactions (ADRs) were evaluated. For effectiveness, the objective response rate (ORR) was calculated to evaluate tumor response. Overall survival (OS) was estimated using the Kaplan–Meier method. Results Data of 703 patients (median age, 73 years; 80.2% males) were analyzed. The median (range) treatment duration was 25.3 (0.3–68.9) weeks. The mean ± standard deviation initial dose was 7.37 ± 1.65 mg in patients with body weight &lt; 60 kg and 10.43 ± 2.49 mg in those with body weight ≥ 60 kg. ADRs (any grade) were reported in 84.9% of the patients, with Grade ≥ 3 ADRs reported in 42.5% of the patients. The most common ADRs (&gt; 10%) were decreased appetite, fatigue, hypertension, proteinuria, palmar-plantar erythrodysesthesia, hypothyroidism, and diarrhea. The median OS of the 703 patients was 498.0 days. In 494 patients assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR was 39.5% (95% confidence interval: 35.1–43.9%). Patients with better liver or renal function at baseline achieved significantly higher ORR than those with worse liver or renal function. Conclusions In patients with uHCC in real-world clinical practice in Japan, treatment with lenvatinib was generally well tolerated, and no new safety concerns were identified. The ORR and median OS were similar to or better than the results of the Japanese subset of the global Phase III REFLECT trial. 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Patients with diverse clinical characteristics receive lenvatinib treatment in clinical practice. Thus, it is crucial to evaluate the safety and effectiveness of lenvatinib in real-world clinical settings. Objective This study aimed to evaluate the real-world safety and effectiveness of lenvatinib for uHCC in clinical practice in Japan. Patients and Methods Between July 2018 and January 2019, patients with uHCC who were administered lenvatinib for the first time were enrolled in this prospective, multicenter, observational post-marketing study (NCT03663114). Patients were orally administered lenvatinib and followed up for 12 months. For safety, adverse drug reactions (ADRs) were evaluated. For effectiveness, the objective response rate (ORR) was calculated to evaluate tumor response. Overall survival (OS) was estimated using the Kaplan–Meier method. Results Data of 703 patients (median age, 73 years; 80.2% males) were analyzed. The median (range) treatment duration was 25.3 (0.3–68.9) weeks. The mean ± standard deviation initial dose was 7.37 ± 1.65 mg in patients with body weight &lt; 60 kg and 10.43 ± 2.49 mg in those with body weight ≥ 60 kg. ADRs (any grade) were reported in 84.9% of the patients, with Grade ≥ 3 ADRs reported in 42.5% of the patients. The most common ADRs (&gt; 10%) were decreased appetite, fatigue, hypertension, proteinuria, palmar-plantar erythrodysesthesia, hypothyroidism, and diarrhea. The median OS of the 703 patients was 498.0 days. In 494 patients assessed using the modified Response Evaluation Criteria in Solid Tumors (mRECIST), the ORR was 39.5% (95% confidence interval: 35.1–43.9%). Patients with better liver or renal function at baseline achieved significantly higher ORR than those with worse liver or renal function. Conclusions In patients with uHCC in real-world clinical practice in Japan, treatment with lenvatinib was generally well tolerated, and no new safety concerns were identified. The ORR and median OS were similar to or better than the results of the Japanese subset of the global Phase III REFLECT trial. Our results demonstrated that clinically meaningful treatment responses were achieved with lenvatinib in real-world clinical practice.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>36602748</pmid><doi>10.1007/s40801-022-00348-w</doi><tpages>11</tpages><orcidid>https://orcid.org/0000-0003-0663-6117</orcidid><oa>free_for_read</oa></addata></record>
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subjects Cancer therapies
Clinical medicine
Clinical trials
Disease control
Drug dosages
Drug therapy
Growth factors
Hepatoma
Internal Medicine
Liver cancer
Marketing
Medical equipment
Medicine
Medicine & Public Health
Original
Original Research Article
Patient outcomes
Patients
Pharmaceuticals
Pharmacology/Toxicology
Pharmacotherapy
Response rates
Tumors
title Safety and Effectiveness of Lenvatinib in Patients with Unresectable Hepatocellular Carcinoma in Real-World Clinical Practice: An Observational Post-Marketing Study in Japan
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