Cited 8 times in
Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT
DC Field | Value | Language |
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dc.contributor.author | 한광협 | - |
dc.date.accessioned | 2022-09-14T01:22:32Z | - |
dc.date.available | 2022-09-14T01:22:32Z | - |
dc.date.issued | 2021-06 | - |
dc.identifier.issn | 0944-1174 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190430 | - |
dc.description.abstract | Background: REFLECT was an open-label, phase 3 study comparing the efficacy and safety of lenvatinib versus sorafenib in patients with unresectable hepatocellular carcinoma (uHCC). Based on phase 2 study (Study 202) results, body weight-based dosing for lenvatinib was used in REFLECT to minimize dose disruptions and modifications needed to address dose-related adverse events. This post hoc analysis of REFLECT data assessed lenvatinib efficacy and safety by body weight group. Methods: The study randomly administered lenvatinib (n = 476) or sorafenib (n = 475) to patients with untreated (no prior systemic therapy) uHCC. Lenvatinib starting-dose data were stratified by body weight: patients weighing < 60 kg received 8 mg/day; patients weighing ≥ 60 kg received 12 mg/day. Overall survival (OS), progression-free survival (PFS), objective response rate, and safety were assessed. Results: Survival outcomes and safety profiles appeared similar between the two body-weight-based lenvatinib starting-dose groups. Median OS for patients in the < 60 kg body weight group (n = 153) was 13.4 months [95% confidence interval (CI) 10.5-15.7] compared to 13.7 months (95% CI 12.0-15.6) in the ≥ 60 kg body weight group (n = 325). In both lenvatinib groups, PFS was 7.4 months (< 60 kg group: 95% CI 5.4-9.2; ≥ 60 kg group: 95% CI 6.9-9.0). Treatment-emergent adverse events (TEAEs) required dose modifications in 43.0% in the < 60 kg body weight group and 57.5% in the ≥ 60 kg body weight group. Conclusions: This exploratory analysis of data from REFLECT indicated that body weight-based lenvatinib dosing in patients with uHCC was successful in maintaining efficacy, with comparable rates of TEAEs and dose modifications in the two body weight groups. Clinincal trial: Trial registration ID: ClinicalTrials.gov # NCT01761266. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Springer International | - |
dc.relation.isPartOf | JOURNAL OF GASTROENTEROLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Antineoplastic Agents / adverse effects | - |
dc.subject.MESH | Antineoplastic Agents / pharmacology | - |
dc.subject.MESH | Antineoplastic Agents / therapeutic use | - |
dc.subject.MESH | Body Weight / drug effects* | - |
dc.subject.MESH | Carcinoma, Hepatocellular / drug therapy* | - |
dc.subject.MESH | Dose-Response Relationship, Drug* | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Liver Neoplasms / complications | - |
dc.subject.MESH | Liver Neoplasms / drug therapy | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Phenylurea Compounds / adverse effects | - |
dc.subject.MESH | Phenylurea Compounds / pharmacology* | - |
dc.subject.MESH | Phenylurea Compounds / therapeutic use | - |
dc.subject.MESH | Quinolines / adverse effects | - |
dc.subject.MESH | Quinolines / pharmacology* | - |
dc.subject.MESH | Quinolines / therapeutic use | - |
dc.subject.MESH | Sorafenib / adverse effects | - |
dc.subject.MESH | Sorafenib / pharmacology | - |
dc.subject.MESH | Sorafenib / therapeutic use | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Safety and efficacy of lenvatinib by starting dose based on body weight in patients with unresectable hepatocellular carcinoma in REFLECT | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Takuji Okusaka | - |
dc.contributor.googleauthor | Kenji Ikeda | - |
dc.contributor.googleauthor | Masatoshi Kudo | - |
dc.contributor.googleauthor | Richard Finn | - |
dc.contributor.googleauthor | Shukui Qin | - |
dc.contributor.googleauthor | Kwang-Hyub Han | - |
dc.contributor.googleauthor | Ann-Lii Cheng | - |
dc.contributor.googleauthor | Fabio Piscaglia | - |
dc.contributor.googleauthor | Masahiro Kobayashi | - |
dc.contributor.googleauthor | Max Sung | - |
dc.contributor.googleauthor | Minshan Chen | - |
dc.contributor.googleauthor | Lucjan Wyrwicz | - |
dc.contributor.googleauthor | Jung-Hwan Yoon | - |
dc.contributor.googleauthor | Zhenggang Ren | - |
dc.contributor.googleauthor | Kalgi Mody | - |
dc.contributor.googleauthor | Corina Dutcus | - |
dc.contributor.googleauthor | Toshiyuki Tamai | - |
dc.contributor.googleauthor | Min Ren | - |
dc.contributor.googleauthor | Seiichi Hayato | - |
dc.contributor.googleauthor | Hiromitsu Kumada | - |
dc.identifier.doi | 10.1007/s00535-021-01785-0 | - |
dc.contributor.localId | A04268 | - |
dc.relation.journalcode | J01416 | - |
dc.identifier.eissn | 1435-5922 | - |
dc.identifier.pmid | 33948712 | - |
dc.subject.keyword | Body weight | - |
dc.subject.keyword | Dosing | - |
dc.subject.keyword | Hepatocellular carcinoma | - |
dc.subject.keyword | Lenvatinib | - |
dc.subject.keyword | REFLECT | - |
dc.contributor.alternativeName | Han, Kwang Hyup | - |
dc.contributor.affiliatedAuthor | 한광협 | - |
dc.citation.volume | 56 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 570 | - |
dc.citation.endPage | 580 | - |
dc.identifier.bibliographicCitation | JOURNAL OF GASTROENTEROLOGY, Vol.56(6) : 570-580, 2021-06 | - |
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