PMID- 33708639
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220421
IS  - 2235-1795 (Print)
IS  - 1664-5553 (Electronic)
IS  - 1664-5553 (Linking)
VI  - 10
IP  - 1
DP  - 2021 Feb
TI  - Efficacy and Safety of Lenvatinib Therapy for Unresectable Hepatocellular 
      Carcinoma in a Real-World Practice in Korea.
PG  - 52-62
LID - 10.1159/000512239 [doi]
AB  - BACKGROUND: Lenvatinib has been recently approved as a first-line treatment 
      option for patients with unresectable hepatocellular carcinoma (HCC) in Korea. We 
      aimed to study the efficacy and safety of lenvatinib therapy in a real-world 
      practice and to find prognostic factors related to survival and disease 
      progression. METHODS: A hospital-based retrospective study was conducted on 111 
      consecutive patients who had unresectable HCC and were treated with lenvatinib at 
      Samsung Medical Center from October 2018 to March 2020. Efficacy was determined 
      using the modified Response Evaluation Criteria in Solid Tumors (mRECIST) 
      criteria in 111 patients who completed 1st tumor assessment. Safety was evaluated 
      in 116 HCC patients including 5 patients who discontinued lenvatinib due to 
      adverse events (AEs) before 1st tumor assessment using Common Terminology 
      Criteria for AEs version 5.0. RESULTS: A total of 111 patients with a median age 
      of 59 years were analyzed during a median follow-up duration of 6.2 (4.4-9.0) 
      months. The Kaplan-Meier estimate of overall survival was 10.5 months, and the 
      median progression-free survival was 6.2 months. Based on mRECIST criteria, the 
      objective response rate was 18.9% and disease control rate was 75.7%. AEs 
      developed in 86/116 (74.1%) patients, and grade >/=3 AEs developed in 16/116 
      (13.8%) patients. Diarrhea, hand-foot skin rash, abdominal pain, hypertension, 
      and anorexia were identified as the AEs with the highest frequencies of any 
      grade. REFLECT eligibility criteria including tumor extent >/=50% liver occupation 
      or inadequate bone marrow function and occurrence of anorexia were prognostic 
      factors for survival, and occurrence of diarrhea was a favorable factor for 
      disease progression. CONCLUSION: Lenvatinib therapy showed a favorable efficacy 
      and safety in a real-world practice. The REFLECT eligibility criteria and 
      specific AEs could be one of the prognostic markers.
CI  - Copyright (c) 2021 by S. Karger AG, Basel.
FAU - Goh, Myung Ji
AU  - Goh MJ
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Oh, Joo Hyun
AU  - Oh JH
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Park, Yewan
AU  - Park Y
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Kim, Jihye
AU  - Kim J
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Kang, Wonseok
AU  - Kang W
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Sinn, Dong Hyun
AU  - Sinn DH
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Gwak, Geum-Youn
AU  - Gwak GY
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Paik, Yong-Han
AU  - Paik YH
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Choi, Moon Seok
AU  - Choi MS
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Lee, Joon Hyeok
AU  - Lee JH
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Koh, Kwang Cheol
AU  - Koh KC
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
FAU - Paik, Seung Woon
AU  - Paik SW
AD  - Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of 
      Medicine, Seoul, Republic of Korea.
LA  - eng
PT  - Journal Article
DEP - 20210108
PL  - Switzerland
TA  - Liver Cancer
JT  - Liver cancer
JID - 101597993
PMC - PMC7923940
OTO - NOTNLM
OT  - Efficacy
OT  - Hepatocellular carcinoma
OT  - Lenvatinib
OT  - Real-world practice
OT  - Safety
COIS- The authors have no conflicts of interest to declare.
EDAT- 2021/03/13 06:00
MHDA- 2021/03/13 06:01
PMCR- 2021/01/08
CRDT- 2021/03/12 07:18
PHST- 2020/04/16 00:00 [received]
PHST- 2020/10/10 00:00 [accepted]
PHST- 2021/03/12 07:18 [entrez]
PHST- 2021/03/13 06:00 [pubmed]
PHST- 2021/03/13 06:01 [medline]
PHST- 2021/01/08 00:00 [pmc-release]
AID - lic-0010-0052 [pii]
AID - 10.1159/000512239 [doi]
PST - ppublish
SO  - Liver Cancer. 2021 Feb;10(1):52-62. doi: 10.1159/000512239. Epub 2021 Jan 8.