Evidence map›Paper›PMID 42411631›Full record

Observational studyJournal of cachexia, sarcopenia and muscle2026

A Prospective Observational Study of Anamorelin During Chemoimmunotherapy in Non-Small Cell Lung Cancer With Cachexia (SPIRAL-ANA).

Kenji Morimoto, Junji Uchino, Makoto Hibino, Yuki Takeyasu, Ken Yamamoto, Yoshie Morimoto, Yusuke Chihara, Takayuki Nakano, Hiroyasu Kaneda, Shunya Tanaka and 12 more

Erratum issuedAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Journal of cachexia, sarcopenia and muscle, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Kenji MorimotoDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0003-3394-1838
Junji UchinoDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Makoto HibinoDepartment of Respiratory Medicine, Shonan Oiso Hospital, Kanagawa, Japan.
Yuki TakeyasuDepartment of Thoracic Oncology, Kansai Medical University, Osaka, Japan.
Ken YamamotoDivision of Thoracic Oncology, Kobe Minimally Invasive Cancer Center, Hyogo, Japan.
Yoshie MorimotoDepartment of Pulmonary Medicine, Kyoto Kuramaguchi Medical Center, Kyoto, Japan.
Yusuke ChiharaDepartment of Respiratory Medicine, Uji-Tokushukai Medical Center, Kyoto, Japan.
Takayuki NakanoDepartment of Respiratory Medicine, Fukuchiyama City Hospital, Kyoto, Japan.
Hiroyasu KanedaDepartment of Clinical Oncology, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
Shunya TanakaDepartment of Respiratory Medicine, Japanese Red Cross Society Kyoto Daiichi Hospital, Kyoto, Japan.
Shinsuke OgusuDivision of Hematology, Respiratory Medicine and Oncology, Department of Internal Medicine, Faculty of Medicine, Saga University, Saga, Japan.
Yasuhiro GotoDepartment of Respiratory Medicine, Fujita Health University School of Medicine, Aichi, Japan.
Takashi NomizoDepartment of Respiratory Medicine, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Takayo OtaDepartment of Breast Medical Oncology, Izumi City General Hospital, Osaka, Japan.
Hiroaki TsukamotoDepartment of Respiratory Medicine, National Hospital Organization Himeji Medical Center, Hyogo, Japan.
Yoshizumi TakemuraDepartment of Pulmonary Medicine, Otsu City Hospital, Shiga, Japan.
Katsumi NakatomiDepartment of Respiratory Medicine, National Hospital Organization Ureshino Medical Center, Saga, Japan.
Hayato KobaDepartment of Respiratory Medicine, Kanazawa University Hospital, Kanazawa, Japan.
Kohei YoshimineDepartment of Respiratory Medicine, Iizuka Hospital, Fukuoka, Japan.
Takayuki ShimoseStatistics and Data Center, Clinical Research Support Center Kyushu, Fukuoka, Japan.
Tadaaki YamadaDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Koichi TakayamaDepartment of Pulmonary Medicine, Kyoto Prefectural University of Medicine, Kyoto, Japan.ORCID https://orcid.org/0000-0002-7723-8960

Funding

Ono Pharmaceutical Co. Ltd
6 · The paper itself

Abstract

backgroundThe prognosis of patients with advanced non-small cell lung cancer (NSCLC) complicated by cancer cachexia remains poor. Anamorelin, a ghrelin receptor agonist, has been approved only in Japan for the treatment of cancer cachexia.

methodsThis prospective multicentre observational study was conducted to evaluate the impact of anamorelin administration on the efficacy and safety of chemoimmunotherapy in patients with NSCLC and cancer cachexia. The primary endpoint was progression-free survival (PFS), evaluated against a predefined threshold derived from a previous retrospective cohort of patients with cachectic NSCLC treated with chemoimmunotherapy alone. This study was registered in the Japan Registry of Clinical Trials (jRCT1071210053).

resultsBetween August 2021 and January 2024, 123 patients were enrolled from 29 institutions in Japan, with 114 included in the full analysis set. The median age was 73 years; 28 (24.6%) were female and 20 patients (17.5%) had a performance status of 2. The objective response rate was 57.9% (95% confidence interval [CI]: 48.7%-66.6%). Median PFS and overall survival (OS) were 6.2 months (95% CI: 4.6-7.7) and 18.5 months (95% CI: 13.1-28.6), respectively. The lower limit of the 95% CI for PFS did not exceed the predefined threshold of 5 months. At week 12, 61 of 85 patients (71.8%) had transitioned from cancer cachexia to a non-cachectic state. Landmark survival analyses at week 12 showed that patients who achieved this transition had significantly longer OS compared with those who remained cachectic (19.9 vs. 7.1 months; hazard ratio for cachexia vs. transition, 2.19; 95% CI: 1.19-4.02; p = 0.0098). Grade ≥ 3 hyperglycemia was observed in six patients (5.1%), but no new safety signals were identified.

conclusionsAnamorelin combined with chemoimmunotherapy did not prolong PFS in advanced NSCLC with cancer cachexia, but achieved a high rate of cachexia reversal. Transition to a non-cachectic state was associated with improved OS, suggesting that cachexia reversal may serve as a surrogate for survival benefit.

trial registrationjRCT1071210053 (jRCT).

Indexed as

CachexiaCarcinoma, Non-Small-Cell LungHydrazinesImmunotherapyLung NeoplasmsOligopeptidesAgedAged, 80 and overFemaleHumansMaleMiddle AgedProspective StudiesTreatment OutcomeanamorelinHydrazinesOligopeptidesanamorelincancer cachexiachemoimmunotherapynon‐small cell lung cancer

Identifiers

PMID42411631
PMCPMC13339061

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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.