{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T16:13:17Z","timestamp":1777479197375,"version":"3.51.4"},"reference-count":32,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T00:00:00Z","timestamp":1645574400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2022,5,15]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Cancer cachexia is a syndrome characterized by anorexia and decreased body weight. This study evaluated the efficacy and safety of anamorelin, an orally active, selective ghrelin receptor agonist, in patients with cancer cachexia and a low body mass index (BMI).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, open\u2010label, single\u2010arm study enrolled Japanese patients with non\u2013small cell lung cancer or gastrointestinal cancer with cancer cachexia (BMI\u00a0&lt;\u00a020\u00a0kg\/m<jats:sup>2<\/jats:sup>, involuntary weight loss &gt; 2% in the last 6\u00a0months, and anorexia). Patients were administered 100\u00a0mg of anamorelin once daily for up to 24\u00a0weeks. The primary end point was a composite clinical response (CCR) at 9\u00a0weeks, which was defined as an increase in body weight of \u22655% from the baseline, an increase of \u22652 points in the score of the 5\u2010item Anorexia Symptom Scale of the Functional Assessment of Anorexia\/Cachexia Therapy, and being alive.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>One hundred two patients were eligible and enrolled. The means and standard deviations for age and BMI were 71.0\u00a0\u00b1\u00a08.2\u00a0years and 17.47\u00a0\u00b1\u00a01.48\u00a0kg\/m<jats:sup>2<\/jats:sup>, respectively. The CCR rate at 9\u00a0weeks was 25.9% (95% confidence interval [CI], 18.3%\u201035.3%), which met the primary end point with a lower 95% CI exceeding the prespecified minimum of 8%. Improvements in body weight and anorexia were durable and were accompanied by improvements in patients' global impression of change for appetite\/eating\u2010related symptoms and overall condition. Adverse drug reactions occurred in 37 of 101 treated patients (36.6%), with the most common being glycosylated hemoglobin increases, constipation, and peripheral edema.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Anamorelin improved body weight and anorexia\u2010related symptoms in patients with cancer cachexia and a low BMI with durable efficacy and favorable safety and tolerability.<\/jats:p><\/jats:sec><jats:sec><jats:title>Lay Summary<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n\n<jats:list-item><jats:p>Anamorelin is a drug that stimulates appetite and promotes weight gain.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>This clinical trial was aimed at determining its efficacy and safety in Japanese cancer patients with a low body mass index and cachexia, a syndrome associated with anorexia and weight loss.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>Anamorelin was found to improve body weight and anorexia\u2010related symptoms in these patients, and these effects were durable for up to 24\u00a0weeks. Moreover, anamorelin was generally well tolerated.<\/jats:p><\/jats:list-item>\n\n<jats:list-item><jats:p>These findings suggest that anamorelin is a valuable treatment option for patients with cancer cachexia and a low body mass index.<\/jats:p><\/jats:list-item>\n<\/jats:list>\n<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.34154","type":"journal-article","created":{"date-parts":[[2022,2,23]],"date-time":"2022-02-23T08:22:31Z","timestamp":1645604551000},"page":"2025-2035","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":43,"title":["A multicenter, open\u2010label, single\u2010arm study of anamorelin (ONO\u20107643) in patients with cancer cachexia and low body mass index"],"prefix":"10.1002","volume":"128","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4047-2929","authenticated-orcid":false,"given":"Tateaki","family":"Naito","sequence":"first","affiliation":[{"name":"Division of Thoracic Oncology Shizuoka Cancer Center Shizuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0651-7767","authenticated-orcid":false,"given":"Junji","family":"Uchino","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine Graduate School of Medical Science Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Toru","family":"Kojima","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Fukui Prefectural Hospital Fukui Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yutaka","family":"Matano","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Komatsu Municipal Hospital Komatsu Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koichi","family":"Minato","sequence":"additional","affiliation":[{"name":"Division of Respiratory Medicine Gunma Prefectural Cancer Center Ota Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kentaro","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Research Institute for Diseases of the Chest Graduate School of Medical Sciences Kyushu University Fukuoka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takuro","family":"Mizukami","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology St. Marianna University Kawasaki Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shinji","family":"Atagi","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Hospital Organization Kinki\u2010Chuo Chest Medical Center Sakai Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Higashiguchi","sequence":"additional","affiliation":[{"name":"Yonaha Okanoue Hospital Kuwana Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5572-743X","authenticated-orcid":false,"given":"Kei","family":"Muro","sequence":"additional","affiliation":[{"name":"Department of Clinical Oncology Aichi Cancer Center Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7723-8960","authenticated-orcid":false,"given":"Koichi","family":"Takayama","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine Graduate School of Medical Science Kyoto Prefectural University of Medicine Kyoto Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junji","family":"Furuse","sequence":"additional","affiliation":[{"name":"Department of Medical Oncology Kyorin University Faculty of Medicine Mitaka Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eiichiro","family":"Morishima","sequence":"additional","affiliation":[{"name":"Department 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manufacturing and marketing approval of Adlumiz\u00ae (anamorelin) a ghrelin receptor agonist for the treatment of cancer cachexia in Japan. ONO Pharmaceutical Co. Ltd. Published January 22 2021. Accessed August 5 2021. (Japanese version athttps:\/\/www.ono\u2010pharma.com\/news\/20210122.htmlhttps:\/\/www.ono.co.jp\/news\/20210122.html"},{"key":"e_1_2_9_18_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2014.56.1894"},{"key":"e_1_2_9_19_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jamda.2019.12.012"},{"key":"e_1_2_9_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(15)00558-6"},{"key":"e_1_2_9_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(14)71154-4"},{"key":"e_1_2_9_22_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-012-1500-1"},{"key":"e_1_2_9_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12083"},{"key":"e_1_2_9_24_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-015-2606-z"},{"key":"e_1_2_9_25_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-019-02135-7"},{"key":"e_1_2_9_26_1","doi-asserted-by":"publisher","DOI":"10.1080\/00031305.2018.1473796"},{"key":"e_1_2_9_27_1","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdx192"},{"key":"e_1_2_9_28_1","unstructured":"A study to evaluate the efficacy and safety of anamorelin HCl for the treatment of malignancy associated weight loss and anorexia in adult patients with advanced non\u2013small cell lung cancer (NSCLC) (NCT03743064). 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