Phase 2 study of lenvatinib in patients with advanced hepatocellular carcinoma View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-04

AUTHORS

Kenji Ikeda, Masatoshi Kudo, Seiji Kawazoe, Yukio Osaki, Masafumi Ikeda, Takuji Okusaka, Toshiyuki Tamai, Takuya Suzuki, Takashi Hisai, Seiichi Hayato, Kiwamu Okita, Hiromitsu Kumada

ABSTRACT

BACKGROUND: Lenvatinib is an oral inhibitor of vascular endothelial growth factor receptor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor alpha, RET, and KIT. This phase 2, single-arm, open-label multicenter study evaluated lenvatinib in advanced hepatocellular carcinoma (HCC). METHODS: Patients with histologically/clinically confirmed advanced HCC who did not qualify for surgical resection or local therapies received lenvatinib at a dosage of 12 mg once daily (QD) in 28-day cycles. The primary efficacy endpoint was time to progression (TTP) per modified Response Evaluation Criteria in Solid Tumors v1.1; secondary efficacy endpoints included objective response rate (ORR), disease control rate (DCR), and overall survival (OS). RESULTS: Between July 2010 and June 2011, 46 patients received lenvatinib at sites across Japan and Korea. The median TTP, as determined by independent radiological review, was 7.4 months [95 % confidence interval (CI): 5.5-9.4]. Seventeen patients (37 %) had partial response and 19 patients (41 %) had stable disease (ORR: 37 %; DCR: 78 %). Median OS was 18.7 months (95 % CI: 12.7-25.1). The most common any-grade adverse events (AEs) were hypertension (76 %), palmar-plantar erythrodysesthesia syndrome (65 %), decreased appetite (61 %), and proteinuria (61 %). Dose reductions and discontinuations due to AEs occurred in 34 (74 %) and 10 patients (22 %), respectively. Median body weight was lower in patients with an early (<30 days) dose withdrawal or reduction than in those without. CONCLUSIONS: Lenvatinib 12-mg QD showed clinical activity and acceptable toxicity profiles in patients with advanced HCC, but early dose modification was necessary in patients with lower body weight. Further development of lenvatinib in HCC should consider dose modification by body weight. TRIAL REGISTRATION ID: www.ClinicalTrials.gov NCT00946153. More... »

PAGES

512-519

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s00535-016-1263-4

DOI

http://dx.doi.org/10.1007/s00535-016-1263-4

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1022330529

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/27704266


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Download the RDF metadata as:  json-ld nt turtle xml License info

HOW TO GET THIS DATA PROGRAMMATICALLY:

JSON-LD is a popular format for linked data which is fully compatible with JSON.

curl -H 'Accept: application/ld+json' 'https://scigraph.springernature.com/pub.10.1007/s00535-016-1263-4'

N-Triples is a line-based linked data format ideal for batch operations.

curl -H 'Accept: application/n-triples' 'https://scigraph.springernature.com/pub.10.1007/s00535-016-1263-4'

Turtle is a human-readable linked data format.

curl -H 'Accept: text/turtle' 'https://scigraph.springernature.com/pub.10.1007/s00535-016-1263-4'

RDF/XML is a standard XML format for linked data.

curl -H 'Accept: application/rdf+xml' 'https://scigraph.springernature.com/pub.10.1007/s00535-016-1263-4'


 

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317 https://www.grid.ac/institutes/grid.410813.f schema:alternateName Toranomon Hospital
318 schema:name Department of Hepatology, Toranomon Hospital, Toranomon 2-2-2, Minato-ku, 105-8470, Tokyo, Japan
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320 https://www.grid.ac/institutes/grid.416533.6 schema:alternateName Saga-Ken Medical Centre Koseikan
321 schema:name Department of Hepatobiliary and Pancreatology, Saga-Ken Medical Centre KOSEIKAN, Saga, Japan
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323 https://www.grid.ac/institutes/grid.417000.2 schema:alternateName Osaka Red Cross Hospital
324 schema:name Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan
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326 https://www.grid.ac/institutes/grid.418765.9 schema:alternateName Eisai (Japan)
327 schema:name Eisai Co., Ltd.,, Tokyo, Japan
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329 https://www.grid.ac/institutes/grid.497282.2 schema:alternateName National Cancer Center Hospital East
330 schema:name Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan
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