Evidence map›Paper›PMID 24728665›Full record

Trial reportJournal of gastroenterology2015

Peretinoin after curative therapy of hepatitis C-related hepatocellular carcinoma: a randomized double-blind placebo-controlled study.

Kiwamu Okita, Namiki Izumi, Osamu Matsui, Katsuaki Tanaka, Shuichi Kaneko, Hisataka Moriwaki, Kenji Ikeda, Yukio Osaki, Kazushi Numata, Kohei Nakachi and 14 more

Abstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of gastroenterology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 56 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
56citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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

56 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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  6. Oncogenic function and transcriptional dynamics of MYCN in liver tumorigenesis.Proceedings of the National Academy of Sciences of the United States of America · 2026
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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

24 authors.

Kiwamu OkitaShimonoseki Kohsei Hospital, Kamishinchi-Machi 3-3-8, Shimonoseki, Yamaguchi, 750-0061, Japan, k.okita@kousei-h.jp.
Namiki Izumi
Osamu Matsui
Katsuaki Tanaka
Shuichi Kaneko
Hisataka Moriwaki
Kenji Ikeda
Yukio Osaki
Kazushi Numata
Kohei Nakachi
Norihiro Kokudo
Kazuho Imanaka
Shuhei Nishiguchi
Takuji Okusaka
Yoichi Nishigaki
Susumu Shiomi
Masatoshi Kudo
Kenichi Ido
Yoshiyasu Karino
Norio Hayashi
Yasuo Ohashi
Masatoshi Makuuchi
Hiromitsu Kumada
Peretinoin Study Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundEffective prophylactic therapies have not been established for hepatocellular carcinoma recurrence. Peretinoin represents one novel option for patients with hepatitis C virus-related hepatocellular carcinoma (HCV-HCC), and it was tested in a multicenter, randomized, double-blind, placebo-controlled study.

methodsPatients with curative therapy were assigned to one of the following regimens: peretinoin 600, 300 mg/day, or placebo for up to 96 weeks. The primary outcome was recurrence-free survival (RFS).

resultsOf the 401 patients initially enrolled, 377 patients were analyzed for efficacy. The RFS rates in the 600-mg group, the 300-mg group, and the placebo group were 71.9, 63.6, and 66.0 % at 1 year, and 43.7, 24.9, and 29.3 % at 3 years, respectively. The primary comparison of peretinoin (300 and 600-mg) with placebo was not significant (P = 0.434). The dose-response relationship based on the hypothesis that "efficacy begins to increase at 600 mg/day" was significant (P = 0.023, multiplicity-adjusted P = 0.048). The hazard ratios for RFS in the 600-mg group vs. the placebo group were 0.73 [95 % confidence interval (CI) 0.51-1.03] for the entire study period and 0.27 (95 % CI 0.07-0.96) after 2 years of the randomization. Common adverse events included ascites, increased blood pressure, headache, presence of urine albumin, and increased transaminases.

conclusionsAlthough the superiority of peretinoin to placebo could not be validated, 600 mg/day was shown to be the optimal dose, and treatment may possibly reduce the recurrence of HCV-HCC, particularly after 2 years. The efficacy and safety of peretinoin 600 mg/day should continue to be evaluated in further studies.

Indexed as

AgedAnticarcinogenic AgentsCarcinoma, HepatocellularDisease-Free SurvivalDose-Response Relationship, DrugDouble-Blind MethodFemaleHepatitis C, ChronicHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalRetinoidsTreatment Outcome(2E,4E,6E,10E)-3,7,11,15-tetramethyl-2,4,6,10,14-hexadecapentaenoic acidAnticarcinogenic AgentsRetinoids

Identifiers

PMID24728665
PMCPMC4318984

What OpenQuestion holds

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Registered trials

None linked

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.