Evidence map›Paper›PMID 31720835›Full record

Trial reportJournal of gastroenterology2020

REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset.

Tatsuya Yamashita, Masatoshi Kudo, Kenji Ikeda, Namiki Izumi, Ryosuke Tateishi, Masafumi Ikeda, Hiroshi Aikata, Yasunori Kawaguchi, Yoshiyuki Wada, Kazushi Numata and 10 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIComparative StudyEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 148 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
148citing papers in PubMed, 7 pooled it
11.7field-weighted citation impact, top 1% 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.

NCT01761266 phase3completednot on this map

A Multicenter, Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Lenvatinib (E7080) Versus Sorafenib in First-Line Treatment of Subjects With Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorEisai LimitedRan2013 to 2021Enrolled954ConditionsHepatocellular Carcinoma (HCC)ArmsLenvatinib, Sorafenib
NCT07408804 narecruitingnot on this mapstarted 2025, after this paper: background citation

Comparison of Response Between Combination of Transarterial Chemoembolization and Lenvatinib Therapy Versus Lenvatinib Monotherapy in Patients With Unresectable Hepatocellular Carcinoma

TypeinterventionalSponsorBangladesh Medical UniversityRan2025 to 2026Enrolled40ConditionsUnresectable Hepatocellular Carcinoma (HCC)ArmsTACE (transarterial chemoembolization) combined with targeted therapy (Lenvatinib), Lenvatinib
3 · Its place in the literature

Who cites it

148 citing papers in PubMed, 7 syntheses or guidelines pooled it, 223 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review

88 more citing papers are in PubMed but not listed here.

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

20 authors at 13 institutions in 1 country.

Tatsuya YamashitaDepartment of Gastroenterology, Kanazawa University, Kanazawa, Japan. ytatsuya@m-kanazawa.jp.
Masatoshi KudoDepartment of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Kenji IkedaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Namiki IzumiDepartment of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan.
Ryosuke TateishiDepartment of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Masafumi IkedaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Hiroshi AikataDepartment of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.
Yasunori KawaguchiDepartment of Hepatobiliary and Pancreatology, Saga-Ken Medical Center Koseikan, Saga, Japan.
Yoshiyuki WadaDepartment of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Kazushi NumataGastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.
Yoshitaka InabaDepartment of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.
Ryoko KuromatsuDivision of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.
Masahiro KobayashiDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Takuji OkusakaDepartment of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Toshiyuki TamaiEisai Co., Ltd., Tokyo, Japan.
Chifumi KitamuraEisai Co., Ltd., Tokyo, Japan.
Kenichi SaitoEisai Co., Ltd., Tokyo, Japan.
Katsuya HarunaEisai Co., Ltd., Tokyo, Japan.
Kiwamu OkitaDepartment of Hepatology, Shunan Memorial Hospital, Kudamatsu, Japan.
Hiromitsu KumadaDepartment of Hepatology, Toranomon Hospital, Tokyo, Japan.
Eisai (Japan) · JPToranomon Hospital · JPAichi Cancer Center · JPHiroshima University · JPJapan Hospital Association · JPKanazawa University · JPKindai University · JPKurume University · JPMusashino Red Cross Hospital · JPNational Cancer Center Hospital East · JPNational Kyushu Medical Center · JPThe University of Tokyo · JPYokohama City University · JP

Funding

Eisai N/AEisai Inc. N/AMerck Sharp & Dohme Corp. N/A
6 · The paper itself

Abstract

backgroundA phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79-1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported.

methodsThe intent-to-treat population enrolled in Japan was analyzed.

resultsOf 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62-1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm.

conclusionsThe efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. TRIAL REGISTRATION ID: ClinicalTrials.gov. No. NCT01761266.

Indexed as

AdultAgedAged, 80 and overAntineoplastic AgentsCarcinoma, HepatocellularFemaleHumansIntention to Treat AnalysisJapanLiver NeoplasmsMaleMiddle AgedPhenylurea CompoundsQuinolinesSorafenibSurvival AnalysisAntineoplastic AgentslenvatinibPhenylurea CompoundsQuinolinesSorafenibHepatocellular carcinomaJapanese populationLenvatinibREFLECT trialSorafenib

Identifiers

PMID31720835
PMCPMC6942573
OpenAlexW2985556259

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.