Evidence map›Paper›PMID 38693813›Full record

Observational studyCancer medicine2024

Real-world safety and effectiveness of anamorelin for cancer cachexia: Interim analysis of post-marketing surveillance in Japan.

Koichi Takayama, Ai Kojima, Chikara Honda, Masahiro Nakayama, Satomi Kanemata, Toshimitsu Endo, Kei Muro

Abstract readObservational Study
In one paragraph

Observational study in Cancer medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
–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

15 citing papers in PubMed.

  1. Trial
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  4. Predictors of the early discontinuation of anamorelin hydrochloride in gastrointestinal cancer-related cachexia: a multicenter retrospective cohort study (HGCSG2201).Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  5. Review
  6. Article
  7. Article
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  9. Effect of anamorelin on body weight in patients with gastric cancer-associated cachexia: an observational study.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Observational
  10. Article
  11. Article
  12. Observational
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  15. 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

7 authors.

Koichi TakayamaDepartment of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID 0000-0002-7723-8960
Ai KojimaPharmacovigilance, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Chikara HondaPharmacovigilance, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Masahiro NakayamaPharmacovigilance, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Satomi KanemataMedical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Toshimitsu EndoMedical Affairs, Ono Pharmaceutical Co., Ltd., Osaka, Japan.
Kei MuroDepartment of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.ORCID 0000-0002-5572-743X

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAnamorelin was approved in Japan in 2021 to treat cancer cachexia associated with non-small cell lung, gastric, pancreatic, or colorectal cancers. Post-marketing surveillance is being conducted to evaluate the real-world safety and effectiveness of anamorelin.

methodsThis prospective, observational surveillance registered all patients who started treatment with anamorelin after April 21, 2021. Hyperglycemia, hepatic impairment, conduction disorders, and their associated adverse events related to treatment were defined as main safety specifications. Body weight (BW) and appetite were assessed as effectiveness specifications.

resultsThis analysis was based on data as of January 21, 2023. The safety and effectiveness analysis sets included 6016 and 4511 patients, respectively. Treatment-related adverse events in ≥1% of patients were hyperglycemia (3.9%) and nausea (2.6%). The incidences of hyperglycemia, hepatic impairment, conduction disorders, and their associated adverse events related to treatment were 4.8%, 1.2%, and 1.1%, respectively. The mean changes (standard error [SE]) in BW from baseline to weeks 3, 12, 24, and 52 were 0.64 (0.05) kg, 1.19 (0.12) kg, 1.40 (0.21) kg, and 1.42 (0.39) kg, respectively. The mean changes (SE) in Functional Assessment of Anorexia/Cachexia Treatment 5-item Anorexia Symptom Scale total scores from baseline to weeks 3, 12, 24, and 52 were 3.2 (0.09), 4.8 (0.18), 5.2 (0.30), and 5.3 (0.47), respectively, exceeding the clinically meaningful improvement score (2.0 points).

conclusionThe overall safety of anamorelin raised no new safety concerns, although continued caution may be required for hyperglycemia and nausea. Improvements in BW and appetite were also observed in real-world clinical settings.

Indexed as

CachexiaHydrazinesNeoplasmsProduct Surveillance, PostmarketingAdultAgedAppetiteFemaleHumansHyperglycemiaJapanMaleMiddle AgedOligopeptidesProspective StudiesTreatment OutcomeanamorelinHydrazinesOligopeptidesanamorelinappetitebody weightcancer cachexiaclinical practicepost‐marketing surveillance

Identifiers

PMID38693813
PMCPMC11063721

What OpenQuestion holds

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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.