PMID- 30671808
OWN - NLM
STAT- MEDLINE
DCOM- 20190717
LR  - 20200225
IS  - 1936-0541 (Electronic)
IS  - 1936-0533 (Linking)
VI  - 13
IP  - 2
DP  - 2019 Mar
TI  - The efficacy and safety of lenvatinib for advanced hepatocellular carcinoma in a 
      real-world setting.
PG  - 199-204
LID - 10.1007/s12072-019-09929-4 [doi]
AB  - BACKGROUND/PURPOSE: Lenvatinib (an inhibitor of vascular endothelial growth 
      factor (GF) receptors 1-3, fibroblast GF receptors 1-4, platelet-derived GF 
      receptor alpha, rearranged during transfection, and stem cell factor receptor) was 
      non-inferior to sorafenib in a phase 3 (REFLECT) trial of advanced hepatocellular 
      carcinoma. This study examined the efficacy and safety of lenvatinib in a 
      real-world setting. METHODS: This was a retrospective, multicenter, observational 
      study. Inclusion and exclusion criteria were based on the phase 3 trial, and 
      participants were observed for at least 12 weeks. Therapeutic effect was 
      determined using the modified Response Evaluation Criteria In Solid Tumors 
      (m-RECIST) at the 8th week. Patients received oral lenvatinib 12 mg/day (body 
      weight > 60 kg) or 8 mg/day (body weight < 60 kg). Dose interruptions followed by 
      reductions for lenvatinib-related toxicities were permitted. Grades of adverse 
      events (AEs) complied with the Common Terminology Criteria for Adverse Events 
      version 4.0. RESULTS: All 16 patients included in this study had prior treatment 
      history, and a median 3.9 years had passed since the first treatment. Fatigue, 
      hypertension, and proteinuria were the most frequent AEs, and were higher than 
      Grade 2. AEs could be controlled by appropriate dose reduction, interruption, and 
      symptomatic treatment according to the protocol. In the m-RECIST evaluation at 
      the 8th week, 0, 6, 8, and 1 patients had achieved complete response, partial 
      response, stable disease, and progressive disease, respectively. The objective 
      response rate was 40%. CONCLUSION: Lenvatinib treatment could be accomplished 
      with safety and good response in a real-world setting.
FAU - Obi, Shuntaro
AU  - Obi S
AUID- ORCID: 0000-0003-3525-4708
AD  - Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 
      Anesaki, Ichihara, 299-0111, Chiba, Japan. obis@med.teikyo-u.ac.jp.
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan. obis@med.teikyo-u.ac.jp.
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan. 
      obis@med.teikyo-u.ac.jp.
FAU - Sato, Takahisa
AU  - Sato T
AD  - Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 
      Anesaki, Ichihara, 299-0111, Chiba, Japan.
FAU - Sato, Shinpei
AU  - Sato S
AD  - Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 
      Anesaki, Ichihara, 299-0111, Chiba, Japan.
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan.
FAU - Kanda, Miho
AU  - Kanda M
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan.
FAU - Tokudome, Yuta
AU  - Tokudome Y
AD  - Department of Pharmacy, Kyoundo Hospital of Sasaki Institute, 1-8 Kandasurugadai, 
      Chiyoda, Tokyo, 101-0062, Japan.
FAU - Kojima, Yuichiro
AU  - Kojima Y
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Suzuki, Yoji
AU  - Suzuki Y
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Hosoda, Kenji
AU  - Hosoda K
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Kawai, Toshihiro
AU  - Kawai T
AD  - Internal Medicine, Chiba General Medical Center, Teikyo University, 3426-3 
      Anesaki, Ichihara, 299-0111, Chiba, Japan.
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan.
FAU - Kondo, Yuji
AU  - Kondo Y
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan.
FAU - Isomura, Yoshihiro
AU  - Isomura Y
AD  - Department of Gastroenterology and Hepatology, Kyoundo Hospital of Sasaki 
      Institute, 1-8 Kandasurugadai, Chiyoda, Tokyo, 101-0062, Japan.
FAU - Ohyama, Hiroshi
AU  - Ohyama H
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Nakagomi, Keiko
AU  - Nakagomi K
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Ashizawa, Hiroshi
AU  - Ashizawa H
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Miura, Yuko
AU  - Miura Y
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Amano, Hiroyuki
AU  - Amano H
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Mochizuki, Hitoshi
AU  - Mochizuki H
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
FAU - Omata, Masao
AU  - Omata M
AD  - Department of Gastroenterology, Yamanashi Prefectural Central Hospital, 1-1-1 
      Fujimi, Kofu, 400-8506, Yamanashi, Japan.
AD  - Department of Gastroenterology, Tokyo University, 7-3-1 Hongo, Bunkyo, Tokyo, 
      113-8655, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20190122
PL  - United States
TA  - Hepatol Int
JT  - Hepatology international
JID - 101304009
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Quinolines)
RN  - EE083865G2 (lenvatinib)
SB  - IM
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Agents/adverse effects/*therapeutic use
MH  - Carcinoma, Hepatocellular/*drug therapy
MH  - Fatigue/chemically induced
MH  - Female
MH  - Humans
MH  - Hypertension/chemically induced
MH  - Liver Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Phenylurea Compounds/adverse effects/*therapeutic use
MH  - Proteinuria/chemically induced
MH  - Quinolines/adverse effects/*therapeutic use
MH  - Response Evaluation Criteria in Solid Tumors
MH  - Retrospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Clinical practice
OT  - Efficacy
OT  - Hepatocellular carcinoma
OT  - Lenvatinib
EDAT- 2019/01/24 06:00
MHDA- 2019/07/18 06:00
CRDT- 2019/01/24 06:00
PHST- 2018/09/19 00:00 [received]
PHST- 2019/01/08 00:00 [accepted]
PHST- 2019/01/24 06:00 [pubmed]
PHST- 2019/07/18 06:00 [medline]
PHST- 2019/01/24 06:00 [entrez]
AID - 10.1007/s12072-019-09929-4 [pii]
AID - 10.1007/s12072-019-09929-4 [doi]
PST - ppublish
SO  - Hepatol Int. 2019 Mar;13(2):199-204. doi: 10.1007/s12072-019-09929-4. Epub 2019 
      Jan 22.