Evidence map›Paper›PMID 27005463›Full record

Trial reportSupportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer2016

Anamorelin (ONO-7643) in Japanese patients with non-small cell lung cancer and cachexia: results of a randomized phase 2 trial.

Koichi Takayama, Nobuyuki Katakami, Takuma Yokoyama, Shinji Atagi, Kozo Yoshimori, Hiroshi Kagamu, Hiroshi Saito, Yuichi Takiguchi, Keisuke Aoe, Akira Koyama and 2 more

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 91 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
91citing papers in PubMed, 9 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

91 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  8. Anamorelin for cancer anorexia-cachexia syndrome: a systematic review and meta-analysis.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2017
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31 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

12 authors.

Koichi TakayamaDepartment of Respirology, Kyoto Prefectural University of Medicine, Kyoto, Japan. takayama@koto.kpu-m.ac.jp.
Nobuyuki KatakamiDivision of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe, Japan.
Takuma YokoyamaDepartment of Respiratory Medicine, Kyorin University Hospital, Mitaka, Japan.
Shinji AtagiDepartment of Thoracic Oncology, National Hospital Organization Kinki-chuo Chest Medical Center, Sakai, Japan.
Kozo YoshimoriDepartment of Clinical Oncology, Japan Anti-Tuberculosis Association, Fukujuji Hospital, Kiyose, Japan.
Hiroshi KagamuDivision of Respiratory Medicine, Graduate School of Medical and Dental Sciences, Niigata University, Niigata, Japan.
Hiroshi SaitoDepartment of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Aichi, Japan.
Yuichi TakiguchiDepartment of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba, Japan.
Keisuke AoeDepartment of Medical Oncology, National Hospital Organization Yamaguchi - Ube Medical Center, Ube, Japan.
Akira KoyamaOno Pharmaceutical Co. Ltd, Osaka, Japan.
Naoyuki KomuraOno Pharmaceutical Co. Ltd, Osaka, Japan.
Kenji EguchiHealth Science on Supportive Medicine for Intractable Diseases, Teikyo University School of Medicine, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeCancer cachexia is characterized by decreased body weight (mainly lean body mass [LBM]) and negatively impacts quality of life (QOL) and prognosis. Anamorelin (ONO-7643) is a novel selective ghrelin receptor agonist under development for treating cancer cachexia.

methodsIn this double-blind, exploratory phase 2 trial, we examined the efficacy and safety of anamorelin in Japanese patients (n = 181) with non-small cell lung cancer (NSCLC) and cancer cachexia (≥5 % weight loss within the previous 6 months). The participants were randomized into three groups and were administered 50 or 100 mg anamorelin, or placebo, orally every day for 12 weeks. The co-primary endpoints were the changes from baseline over 12 weeks in LBM and handgrip strength (HGS). Secondary endpoints included body weight, QOL, Karnofsky Performance Scale (KPS), and serum biomarkers.

resultsThe change in LBM over 12 weeks was 0.55 and 1.15 kg in the placebo and 100-mg anamorelin groups, respectively, but the efficacy of anamorelin in HGS was not detected. The changes in body weight were -0.93, 0.54, and 1.77 kg in the placebo, 50-mg anamorelin, and 100-mg anamorelin groups, respectively. Anamorelin (100 mg) significantly improved KPS and QOL-ACD compared with placebo. Administration of anamorelin for 12 weeks was well tolerated.

conclusionsThis phase 2 study showed that 100 mg anamorelin has promising results in improving lean body mass, performance status, and especially, QOL in patients with cancer cachexia.

Indexed as

AgedCachexiaCarcinoma, Non-Small-Cell LungDouble-Blind MethodFemaleHumansHydrazinesLung NeoplasmsMaleMiddle AgedOligopeptidesPrognosisQuality of LifeanamorelinHydrazinesOligopeptidesAnamorelin (ONO-7643)CachexiaLean body massNon-small cell lung cancerRandomized controlled trial

Identifiers

PMID27005463
PMCPMC4917578

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Registered trials

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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.