Evidence map›Paper›PMID 31615466›Full record

Trial reportBMC cancer2019

Randomized, phase II trial of sequential hepatic arterial infusion chemotherapy and sorafenib versus sorafenib alone as initial therapy for advanced hepatocellular carcinoma: SCOOP-2 trial.

Masaaki Kondo, Manabu Morimoto, Satoshi Kobayashi, Shinichi Ohkawa, Hisashi Hidaka, Takahide Nakazawa, Hiroshi Aikata, Takeshi Hatanaka, Daichi Takizawa, Kotaro Matsunaga and 7 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 53 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
53citing papers in PubMed, 13 pooled it
5.1field-weighted citation impact, top 4% 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

53 citing papers in PubMed, 13 syntheses or guidelines pooled it, 74 citations in OpenAlex.

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  8. Sorafenib Plus Hepatic Arterial Infusion Chemotherapy in Advanced Hepatocellular Carcinoma: A Systematic Review and Meta-analysis.The Turkish journal of gastroenterology : the official journal of Turkish Society of Gastroenterology · 2023
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  12. Objective Response Predicts Survival in Advanced Hepatocellular Carcinoma Treated with Systemic Therapies.Clinical cancer research : an official journal of the American Association for Cancer Research · 2022
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 9 institutions in 3 countries.

Masaaki KondoGastroenterological Center, Yokohama City University Medical Center 4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan. mkondou@yokohama-cu.ac.jp.ORCID http://orcid.org/0000-0002-6063-4561
Manabu MorimotoGastroenterological Center, Yokohama City University Medical Center 4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.
Satoshi KobayashiHepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center Hospital; 1-1-2, Nakao, Asahi-ku, Yokohama, Kanagawa, 241-0815, Japan.
Shinichi OhkawaHepatobiliary and Pancreatic Medical Oncology, Kanagawa Cancer Center Hospital; 1-1-2, Nakao, Asahi-ku, Yokohama, Kanagawa, 241-0815, Japan.
Hisashi HidakaGastroenterology Division of Internal Medicine, Kitasato University Hospital; 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0329, Japan.
Takahide NakazawaGastroenterology Division of Internal Medicine, Kitasato University Hospital; 1-15-1, Kitasato, Minami-ku, Sagamihara, Kanagawa, 252-0329, Japan.
Hiroshi AikataDepartment of Gastroenterology and Metabolism, Applied Life Sciences, Institute of Biomedical and Health Sciences, Hiroshima University; 1-2-3, Kasumi, Minami-ku, Hiroshima, Hiroshima, 734-8551, Japan.
Takeshi HatanakaDepartment of Internal Medicine, Isesaki Municipal Hospital; 12-1, Tsunatorihonmachi, Isesaki, Gunma, 372-0817, Japan.
Daichi TakizawaDepartment of Internal Medicine, Isesaki Municipal Hospital; 12-1, Tsunatorihonmachi, Isesaki, Gunma, 372-0817, Japan.
Kotaro MatsunagaDivision of Gastroenterology and Hepatology, Department of Internal Medicine, St Marianna University School of Medicine; 2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, 216-8511, Japan.
Chiaki OkuseDivision of Gastroenterology and Hepatology, Kawasaki Municipal Tama Hospital; 1-30-37, Shukugawara, Tama-ku, Kawasaki, Kanagawa, 214-8525, Japan.
Michihiro SuzukiDivision of Gastroenterology and Hepatology, Kawasaki Municipal Tama Hospital; 1-30-37, Shukugawara, Tama-ku, Kawasaki, Kanagawa, 214-8525, Japan.
Masataka TaguriDepartment of Data Science, Yokohama City University School of Data Science; 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.
Takako IshibashiYokohama City University Center for Novel and Exploratory Clinical trials; 1-1-1, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.
Kazushi NumataGastroenterological Center, Yokohama City University Medical Center 4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.
Shin MaedaDepartment of Gastroenterology, Yokohama City University Hospital; 3-9, Fukuura, Kanazawa-ku, Yokohama, Kanagawa, 236-0004, Japan.
Katsuaki TanakaGastroenterological Center, Yokohama City University Medical Center 4-57, Urafune-cho, Minami-ku, Yokohama, Kanagawa, 232-0024, Japan.
Yokohama City University Medical Center · JPIsesaki Fukushima Hospital · JPKanagawa Prefectural Hospital Organization · JPKitasato University Hospital · JPTamagawa University · JPYokohama City University Hospital · JPFukuda Denshi (Japan) · JPHiroshima University · JPSt. Marianna University School of Medicine · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe efficacy of hepatic arterial infusion chemotherapy (HAIC) for advanced hepatocellular carcinoma (HCC) remains unclear. We conducted a multi-center randomized phase II study comparing a sequential HAIC-sorafenib regimen versus sorafenib alone as an initial therapy for HCC.

methodsPatients were randomly assigned (ratio, 1:1) to receive sequential HAIC with cisplatin followed by sorafenib (HAIC group, n = 35) or sorafenib alone (sorafenib group, n = 33) as an initial therapy. The primary endpoint was the one-year survival rate. Secondary endpoint included overall survival (OS), the 2-year survival rate, the time-to-progression (TTP), the objective response rate (ORR), the disease control rate (DCR), and safety.

resultsFor the primary endpoint, the one-year survival rates were 46% in the HAIC group and 58% in the sorafenib group. The median OS period was 10.0 months (95% CI, 7.0-18.8) in the HAIC group and 15.2 months (95% CI, 8.2-19.7) in the sorafenib group (hazard ratio [HR], 1.08; 95% CI, 0.63 to 1.86, P = 0.78). The median TTP, ORR and DCR in the HAIC group were 2.8 months (95% CI, 1.7-5.5), 14.3, and 45.7%, respectively, while those in the sorafenib group were 3.9 months (95% CI, 2.3-6.8), 9.1, and 45.5%, respectively. No unexpected adverse events related to HAIC or sorafenib were observed in either group.

conclusionsSequential HAIC with cisplatin and sorafenib does not improve the survival benefit, compared with sorafenib alone, when used as an initial therapy for advanced HCC. However, this study was underpowered in regard to its primary and secondary endpoints, so the results should be interpreted with caution.

trial registrationUMIN ID 000006147 , registration data: August 11, 2011.

Indexed as

Infusions, Intra-ArterialAgedAged, 80 and overAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularCisplatinFemaleFollow-Up StudiesHepatic ArteryHumansLiver NeoplasmsMaleMiddle AgedSorafenibSurvival RateAntineoplastic AgentsCisplatinSorafenibCisplatinHepatic arterial infusion chemotherapyHepatocellular carcinomaSequential treatmentSorafenib

Identifiers

PMID31615466
PMCPMC6794885
OpenAlexW2981257152

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.