Evidence map›Paper›PMID 35525913›Full record

Observational studyBMC cancer2022

A prospective observational cohort study of lenvatinib as initial treatment in patients with BCLC-defined stage B hepatocellular carcinoma.

Satoshi Kobayashi, Taito Fukushima, Makoto Ueno, Satoshi Moriya, Makoto Chuma, Kazushi Numata, Kota Tsuruya, Shunji Hirose, Tatehiro Kagawa, Nobuhiro Hattori and 8 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in BMC cancer, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 12 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

Satoshi KobayashiDepartment 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.
Taito FukushimaDepartment of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan.
Makoto UenoDepartment of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan.
Satoshi MoriyaGastroenterological Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.
Makoto ChumaGastroenterological Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.
Kazushi NumataGastroenterological Center, Yokohama City University Medical Center, Yokohama, Kanagawa, Japan.
Kota TsuruyaDepartment of Gastroenterology, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Shunji HiroseDepartment of Gastroenterology, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Tatehiro KagawaDepartment of Gastroenterology, Tokai University School of Medicine, Isehara, Kanagawa, Japan.
Nobuhiro HattoriDivision of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Tsunamasa WatanabeDivision of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Kotaro MatsunagaDivision of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Michihiro SuzukiDivision of Gastroenterology and Hepatology, St. Marianna University School of Medicine, Kawasaki, Kanagawa, Japan.
Haruki UojimaDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Hisashi HidakaDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Chika KusanoDepartment of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Kanagawa, Japan.
Motoko SuzukiDepartment of Data Science, National Cancer Center Hospital East, Kashiwa, Chiba, Japan.
Manabu MorimotoDepartment of Gastroenterology, Hepatobiliary and Pancreatic Medical Oncology Division, Kanagawa Cancer Center, Nakao 2-3-2, Asahi-ku, Yokohama, Kanagawa, 241-8515, Japan.
St. Marianna University School of Medicine · JPKitasato University · JPTokai University · JPKanagawa Cancer CenterKanagawa Prefectural Hospital Organization · JPYokohama City University · JPNational Cancer Center Hospital East · JPYokohama City University Medical Center · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTransarterial 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.

methodsThis prospective observational study used LEN in TACE-naïve 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 α-type error of 5% and 70% detection power, 25 patients were required over a 2-year enrollment period and 10-month follow-up period.

resultsThirty-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).

conclusionsThe 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.

Indexed as

Carcinoma, HepatocellularChemoembolization, TherapeuticLiver NeoplasmsHumansNeoplasm StagingPhenylurea CompoundsProspective StudiesQuinolinesRetrospective StudiesTreatment OutcomelenvatinibPhenylurea CompoundsQuinolinesHepatocellular carcinomaIntermediate stageLenvatinibSubstageTACE

Identifiers

PMID35525913
PMCPMC9080183
OpenAlexW4229003311

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.