Evidence map›Paper›PMID 27549242›Full record

Trial reportJournal of gastroenterology2017

Ramucirumab as second-line treatment in patients with advanced hepatocellular carcinoma: Japanese subgroup analysis of the REACH trial.

Masatoshi Kudo, Etsuro Hatano, Shinichi Ohkawa, Hirofumi Fujii, Akihide Masumoto, Junji Furuse, Yoshiyuki Wada, Hiroshi Ishii, Shuntaro Obi, Shuichi Kaneko and 15 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01140347 (A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab), which is not on this map. Cited by 28 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 3 pooled it
3.0field-weighted citation impact, top 8% 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.

NCT01140347 phase3completednot on this map

A Multicenter, Randomized, Double-Blind, Phase 3 Study of Ramucirumab (IMC-1121B) Drug Product and Best Supportive Care (BSC) Versus Placebo and BSC as Second-Line Treatment in Patients With Hepatocellular Carcinoma Following First-Line Therapy With Sorafenib (REACH)

TypeinterventionalSponsorEli Lilly and CompanyRan2010 to 2015Enrolled565ConditionsHepatocellular CarcinomaArmsPlacebo, Ramucirumab DP (IMC-1121B), BSC
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 3 syntheses or guidelines pooled it, 40 citations in OpenAlex.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Trial
  5. Review
  6. Review
  7. Article
  8. Review
  9. Article
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  11. Article
  12. Review
  13. Review
  14. Article
  15. Targeted therapy for hepatocellular carcinoma.Signal transduction and targeted therapy · 2020
    Review
  16. Article
  17. Article
  18. Article
  19. Article
  20. Review
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

25 authors at 20 institutions in 2 countries.

Masatoshi KudoKindai University Faculty of Medicine, Osaka-Sayama, Osaka, Japan. m-kudo@med.kinki.ac.jp.
Etsuro HatanoKyoto University Hospital, Kyoto, Japan.
Shinichi OhkawaKanagawa Cancer Center, Yokohama, Kanagawa, Japan.
Hirofumi FujiiJichi Medical University, Shimotsuke, Tochigi, Japan.
Akihide MasumotoAso Iizuka Hospital, Fukuoka, Japan.
Junji FuruseKyorin University School of Medicine Hospital, Tokyo, Japan.
Yoshiyuki WadaNational Hospital Organization Kyushu Medical Center, Fukuoka, Japan.
Hiroshi IshiiThe Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.
Shuntaro ObiKyoundo Hospital, Sasaki Institute, Tokyo, Japan.
Shuichi KanekoKanazawa University Hospital, Ishikawa, Japan.
Seiji KawazoeSaga-Ken Medical Centre Koseikan, Saga, Japan.
Osamu YokosukaChiba University Hospital, Chiba, Japan.
Masafumi IkedaNational Cancer Center Hospital East, Chiba, Japan.
Katsuaki UkaiSendai Medical Center, Sendai, Miyagi, Japan.
Sojiro MoritaKochi Health Sciences Center, Kochi, Japan.
Akihito TsujiKagawa University Hospital, Takamatsu, Kagawa, Japan.
Toshihiro KudoOsaka University Hospital, Osaka, Japan.
Mitsuo ShimadaTokushima University Hospital, Tokushima, Japan.
Yukio OsakiOsaka Red Cross Hospital, Osaka, Japan.
Ryosuke TateishiThe University of Tokyo Hospital, Tokyo, Japan.
Gen SugiyamaKurume University Medical Center, Fukuoka, Japan.
Paolo Benjamin AbadaEli Lilly and Company, Indianapolis, IN, USA.
Ling YangEli Lilly and Company, Bridgewater, NJ, USA.
Takuji OkusakaNational Cancer Center Hospital, Tokyo, Japan.
Andrew Xiuxuan ZhuMassachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA, USA.
Eli Lilly (United States) · USAso Iizuka Hospital · JPChiba University Hospital · JPHarvard University · USJichi Medical University · JPKagawa University Hospital · JPKanagawa Prefectural Hospital Organization · JPKanazawa University Hospital · JPKindai University · JPKurume University Medical Center · JPKyorin University Hospital · JPKyoto University Hospital · JPNational Cancer Center Hospital East · JPNational Kyushu Medical Center · JPOsaka Red Cross Hospital · JPOsaka University Hospital · JPSaga-Ken Medical Centre Koseikan · JPSasaki Institute · JPSendai Medical Center · JPThe Cancer Institute Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundREACH evaluated ramucirumab in the second-line treatment of patients with advanced hepatocellular carcinoma. In the intent-to-treat population (n = 565), a significant improvement in overall survival (OS) was not observed. In patients with an elevated baseline α-fetoprotein (AFP) level (400 ng/mL or greater), an improvement in OS was demonstrated. An analysis of the Japanese patients in REACH was performed.

methodsAn analysis was performed with the subset of the intent-to-treat population enrolled in Japan (n = 93).

resultsThe median OS was 12.9 months for the ramucirumab arm (n = 45) and 8.0 months for the placebo arm (n = 48) [hazard ratio (HR) 0.621 (95 % confidence interval (CI) 0.391-0.986); P = 0.0416]. The median progression-free survival was 4.1 months for the ramucirumab arm and 1.7 months for the placebo arm [HR 0.449 (95 % CI 0.285-0.706); P = 0.0004]. The objective response rates were 11 % for the ramucirumab arm and 2 % for the placebo arm (P = 0.0817). The grade 3 or higher treatment-emergent adverse events occurring in more than 5 % of patients with a higher incidence for the ramucirumab arm (n = 44) than for the placebo arm (n = 47) were ascites (7% vs 2 %), hypertension (7 % vs 2 %), and cholangitis (7 % vs 0 %). In patients with a baseline AFP level of 400 ng/mL or greater, the median OS was 12.9 months for the ramucirumab arm (n = 20) and 4.3 months for the placebo arm (n = 22) [HR 0.464 (95 % CI 0.232-0.926); P = 0.0263].

conclusionsIn the Japanese patients in REACH, ramucirumab treatment improved OS, including in patients with a baseline AFP level of 400 ng/mL or greater; improvements in progression-free survival and objective response rate were also demonstrated. The safety profile of ramucirumab was acceptable and well tolerated in Japanese patients. ClinicalTrials.gov identifier NCT01140347.

Indexed as

AdultAgedAged, 80 and overalpha-FetoproteinsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, HepatocellularDouble-Blind MethodDrug Administration ScheduleFemaleHumansKaplan-Meier EstimateLiver NeoplasmsMaleMiddle Agedalpha-FetoproteinsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedNiacinamidePhenylurea CompoundsRamucirumabSorafenibClinical trialJapanLiver neoplasmsVascular endothelial growth factor receptor 2α-Fetoprotein

Identifiers

PMID27549242
OpenAlexW2517657717

What OpenQuestion holds

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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.