Evidence map›Paper›PMID 29205286›Full record

Trial reportCancer2018

Anamorelin (ONO-7643) for the treatment of patients with non-small cell lung cancer and cachexia: Results from a randomized, double-blind, placebo-controlled, multicenter study of Japanese patients (ONO-7643-04).

Nobuyuki Katakami, Junji Uchino, Takuma Yokoyama, Tateaki Naito, Masashi Kondo, Kouzo Yamada, Hiromoto Kitajima, Kozo Yoshimori, Kazuhiro Sato, Hiroshi Saito and 7 more

Open access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 147 papers, 8 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
147citing papers in PubMed, 8 pooled it
6.7field-weighted citation impact, top 3% 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

147 citing papers in PubMed, 8 syntheses or guidelines pooled it, 235 citations in OpenAlex.

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

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 16 institutions in 2 countries.

Nobuyuki KatakamiDivision of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan.
Junji UchinoDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Takuma YokoyamaDepartment of Respiratory Medicine, Kyorin University Hospital, Mitaka, Japan.
Tateaki NaitoDivision of Thoracic Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Masashi KondoDepartment of Respiratory Medicine Graduate School of Medicine, Nagoya University, Nagoya, Japan.
Kouzo YamadaDepartment of Thoracic Oncology, Kanagawa Cancer Center, Yokohama, Japan.
Hiromoto KitajimaDepartment of Respiratory Medicine, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.
Kozo YoshimoriDepartment of Clinical Oncology, Japan Anti-Tuberculosis Association, Fukujuji Hospital, Kiyose, Japan.
Kazuhiro SatoDepartment of Respiratory Medicine, Nagaoka Red Cross Hospital, Nagaoka, Japan.
Hiroshi SaitoDepartment of Respiratory Medicine, Aichi Cancer Center Aichi Hopital, Aichi, Japan.
Keisuke AoeDepartment of Medical Oncology, National Hospital Organization Yamaguchi-Ube Medical Center, Ube, Japan.
Tetsuya TsujiDepartment of Rehabilitation Medicine, Keio University School of Medicine, Tokyo, Japan.
Yuichi TakiguchiDepartment of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Koichi TakayamaDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Naoyuki KomuraOno Pharmaceutical Co, Ltd, Osaka, Japan.
Toru TakiguchiOno Pharmaceutical Co, Ltd, Osaka, Japan.ORCID 0000-0001-6118-2977
Kenji EguchiHealth Science on Supportive Medicine for Intractable Diseases, Teikyo University School of Medicine, Tokyo, Japan.
Ono Pharmaceutical (Japan) · JPAichi Cancer Center · JPChiba University · JPFujita Health University · JPFukuoka University · JPIntegrated Oncology (United States) · USJapan Anti Tuberculosis Association · JPKanagawa Prefectural Hospital Organization · JPKeio University · JPKyorin University Hospital · JPKyoto Prefectural University of Medicine · JPNagaoka Red Cross Hospital · JPNational Sanyo Hospital · JPShikoku Cancer Center · JPShizuoka Cancer Center · JPTeikyo University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCachexia, described as weight loss (mainly in lean body mass [LBM]) and anorexia, is common in patients with advanced cancer. This study examined the efficacy and safety of anamorelin (ONO-7643), a novel selective ghrelin receptor agonist, in Japanese cancer patients with cachexia.

methodsThis double-blind clinical trial (ONO-7643-04) enrolled 174 patients with unresectable stage III/IV non-small cell lung cancer (NSCLC) and cachexia in Japan. Patients were randomized to daily oral anamorelin (100 mg) or a placebo for 12 weeks. The primary endpoint was the change from the baseline LBM (measured with dual-energy x-ray absorptiometry) over 12 weeks. The secondary endpoints were changes in appetite, body weight, quality of life, handgrip strength (HGS), and 6-minute walk test (6MWT) results.

resultsThe least squares mean change (plus or minus the standard error) in LBM from the baseline over 12 weeks was 1.38 ± 0.18 and -0.17 ± 0.17 kg in the anamorelin and placebo groups, respectively (P < .0001). Changes from the baseline in LBM, body weight, and anorexia symptoms showed significant differences between the 2 treatment groups at all time points. Anamorelin increased prealbumin at weeks 3 and 9. No changes in HGS or 6MWT were detected between the groups. Twelve weeks' treatment with anamorelin was safe and well tolerated in NSCLC patients.

conclusionsAnamorelin significantly increased LBM and improved anorexia symptoms and the nutritional state, but not motor function, in Japanese patients with advanced NSCLC. Because no effective treatment for cancer cachexia is currently available, anamorelin can be a beneficial treatment option. Cancer 2018;124:606-16. © 2017 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.

Indexed as

AgedBody CompositionCachexiaCarcinoma, Non-Small-Cell LungDouble-Blind MethodFemaleHumansHydrazinesLung NeoplasmsMaleMiddle AgedOligopeptidesanamorelinHydrazinesOligopeptidesanamorelin (ONO-7643)cachexialean body massnon-small cell lung cancerrandomized controlled trial

Identifiers

PMID29205286
PMCPMC5814824
OpenAlexW2774323119

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.