PMID- 35525913
OWN - NLM
STAT- MEDLINE
DCOM- 20220510
LR  - 20220716
IS  - 1471-2407 (Electronic)
IS  - 1471-2407 (Linking)
VI  - 22
IP  - 1
DP  - 2022 May 7
TI  - A prospective observational cohort study of lenvatinib as initial treatment in 
      patients with BCLC-defined stage B hepatocellular carcinoma.
PG  - 517
LID - 10.1186/s12885-022-09625-x [doi]
LID - 517
AB  - BACKGROUND: Transarterial chemoembolization (TACE) is the standard treatment for 
      intermediate stage hepatocellular carcinoma (HCC) (Barcelona Clinic Liver Cancer 
      [BCLC] B). However, it often leads to a poor prognosis and decreased hepatic 
      function especially in patients with BCLC substage B2. Lenvatinib (LEN) was 
      demonstrated to be efficacious in these patients in the REFLECT phase 3 trial. We 
      therefore aimed to evaluate the efficacy and safety of LEN as a first-line 
      treatment for the patients with HCC at BCLC substage B2. METHODS: This 
      prospective observational study used LEN in TACE-naive patients with HCC at BCLC 
      substage B2 and preserved hepatic function. The primary endpoint was overall 
      survival. A one-year survival rate threshold of 60% and an expected survival rate 
      of 78%, based on previous reports of TACE, was assumed for setting the sample 
      size. With a one-sided alpha-type error of 5% and 70% detection power, 25 patients 
      were required over a 2-year enrollment period and 10-month follow-up period. 
      RESULTS: Thirty-one patients were enrolled in this study from June 2018 to June 
      2020. The 1-year survival rate was 71.0% (90% confidence interval, 68.4-73.6%). 
      Median overall and progression-free survival periods were 17.0 and 10.4 months, 
      and the objective response rates according to Response Evaluation Criteria in 
      Solid Tumor (RECIST) version 1.1 and modified RECIST criteria were 22.6% and 
      70.0%, respectively. Common adverse events (AEs) were fatigue (68%), hypertension 
      (65%), anorexia (61%), palmar-plantar erythrodysesthesia (39%), and 
      thrombocytopenia (32%) of any grade; aspartate aminotransferase increased (23%), 
      alanine aminotransferase increased (16%), and grade >/= 3 proteinuria (13%). 
      Treatment interruption and dose reduction were required in 61% and 81% of 
      patients, respectively. LEN was discontinued in 29 patients due to disease 
      progression (n = 17), AEs (n = 9), conversion to curative treatments (n = 2), and 
      sudden death (n = 1), whereas post-LEN treatments were administered in 18 
      patients, including systemic chemotherapy (n = 11), TACE (n = 6), transarterial 
      infusion (n = 1) and clinical trial (n = 1). CONCLUSIONS: The results suggest 
      that LEN provides treatment benefits as an initial therapeutic in patients with 
      BCLC substage B2 HCC with a safety profile comparable to that previously 
      reported.
CI  - (c) 2022. The Author(s).
FAU - Kobayashi, Satoshi
AU  - Kobayashi S
AD  - Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology 
      Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 
      241-8515, Japan. kobayashis@kcch.jp.
FAU - Fukushima, Taito
AU  - Fukushima T
AD  - Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology 
      Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 
      241-8515, Japan.
FAU - Ueno, Makoto
AU  - Ueno M
AD  - Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology 
      Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 
      241-8515, Japan.
FAU - Moriya, Satoshi
AU  - Moriya S
AD  - Gastroenterological Center, Yokohama City University Medical Center, Yokohama, 
      Kanagawa, Japan.
FAU - Chuma, Makoto
AU  - Chuma M
AD  - Gastroenterological Center, Yokohama City University Medical Center, Yokohama, 
      Kanagawa, Japan.
FAU - Numata, Kazushi
AU  - Numata K
AD  - Gastroenterological Center, Yokohama City University Medical Center, Yokohama, 
      Kanagawa, Japan.
FAU - Tsuruya, Kota
AU  - Tsuruya K
AD  - Department of Gastroenterology, Tokai University School of Medicine, Isehara, 
      Kanagawa, Japan.
FAU - Hirose, Shunji
AU  - Hirose S
AD  - Department of Gastroenterology, Tokai University School of Medicine, Isehara, 
      Kanagawa, Japan.
FAU - Kagawa, Tatehiro
AU  - Kagawa T
AD  - Department of Gastroenterology, Tokai University School of Medicine, Isehara, 
      Kanagawa, Japan.
FAU - Hattori, Nobuhiro
AU  - Hattori N
AD  - Division of Gastroenterology and Hepatology, St. Marianna University School of 
      Medicine, Kawasaki, Kanagawa, Japan.
FAU - Watanabe, Tsunamasa
AU  - Watanabe T
AD  - Division of Gastroenterology and Hepatology, St. Marianna University School of 
      Medicine, Kawasaki, Kanagawa, Japan.
FAU - Matsunaga, Kotaro
AU  - Matsunaga K
AD  - Division of Gastroenterology and Hepatology, St. Marianna University School of 
      Medicine, Kawasaki, Kanagawa, Japan.
FAU - Suzuki, Michihiro
AU  - Suzuki M
AD  - Division of Gastroenterology and Hepatology, St. Marianna University School of 
      Medicine, Kawasaki, Kanagawa, Japan.
FAU - Uojima, Haruki
AU  - Uojima H
AD  - Department of Gastroenterology, Kitasato University School of Medicine, 
      Sagamihara, Kanagawa, Japan.
FAU - Hidaka, Hisashi
AU  - Hidaka H
AD  - Department of Gastroenterology, Kitasato University School of Medicine, 
      Sagamihara, Kanagawa, Japan.
FAU - Kusano, Chika
AU  - Kusano C
AD  - Department of Gastroenterology, Kitasato University School of Medicine, 
      Sagamihara, Kanagawa, Japan.
FAU - Suzuki, Motoko
AU  - Suzuki M
AD  - Department of Data Science, National Cancer Center Hospital East, Kashiwa, Chiba, 
      Japan.
FAU - Morimoto, Manabu
AU  - Morimoto M
AD  - Department of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology 
      Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 
      241-8515, Japan.
LA  - eng
PT  - Journal Article
PT  - Observational Study
DEP - 20220507
PL  - England
TA  - BMC Cancer
JT  - BMC cancer
JID - 100967800
RN  - 0 (Phenylurea Compounds)
RN  - 0 (Quinolines)
RN  - EE083865G2 (lenvatinib)
SB  - IM
MH  - *Carcinoma, Hepatocellular/drug therapy
MH  - *Chemoembolization, Therapeutic/methods
MH  - Humans
MH  - *Liver Neoplasms/drug therapy
MH  - Neoplasm Staging
MH  - Phenylurea Compounds
MH  - Prospective Studies
MH  - Quinolines
MH  - Retrospective Studies
MH  - Treatment Outcome
PMC - PMC9080183
OTO - NOTNLM
OT  - Hepatocellular carcinoma
OT  - Intermediate stage
OT  - Lenvatinib
OT  - Substage
OT  - TACE
COIS- S. Kobayashi received honoraria for speakers' bureaus from Bayer Yakuhin, Chugai 
      Pharma, Eisai, Eli Lilly, and Co., Takeda Pharma; and M. Ueno received grants 
      from Chugai Pharma and speakers' bureaus from Chugai Pharma. The other authors 
      declare no conflicts of interest.
EDAT- 2022/05/08 06:00
MHDA- 2022/05/11 06:00
PMCR- 2022/05/07
CRDT- 2022/05/07 23:32
PHST- 2022/03/13 00:00 [received]
PHST- 2022/04/27 00:00 [accepted]
PHST- 2022/05/07 23:32 [entrez]
PHST- 2022/05/08 06:00 [pubmed]
PHST- 2022/05/11 06:00 [medline]
PHST- 2022/05/07 00:00 [pmc-release]
AID - 10.1186/s12885-022-09625-x [pii]
AID - 9625 [pii]
AID - 10.1186/s12885-022-09625-x [doi]
PST - epublish
SO  - BMC Cancer. 2022 May 7;22(1):517. doi: 10.1186/s12885-022-09625-x.