{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T12:51:59Z","timestamp":1789131119878,"version":"build-2803163510"},"reference-count":22,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2024,5,1]],"date-time":"2024-05-01T00:00:00Z","timestamp":1714521600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2024,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Anamorelin was approved in Japan in 2021 to treat cancer cachexia associated with non\u2010small cell lung, gastric, pancreatic, or colorectal cancers. Post\u2010marketing surveillance is being conducted to evaluate the real\u2010world safety and effectiveness of anamorelin.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>This analysis was based on data as of January 21, 2023. The safety and effectiveness analysis sets included 6016 and 4511 patients, respectively. Treatment\u2010related adverse events in \u22651% 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\u2010item 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).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>The 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\u2010world clinical settings.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.7170","type":"journal-article","created":{"date-parts":[[2024,5,2]],"date-time":"2024-05-02T02:54:25Z","timestamp":1714618465000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Real\u2010world safety and effectiveness of anamorelin for cancer cachexia: Interim analysis of post\u2010marketing surveillance in Japan"],"prefix":"10.1002","volume":"13","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-7723-8960","authenticated-orcid":false,"given":"Koichi","family":"Takayama","sequence":"first","affiliation":[{"name":"Department of Pulmonary Medicine, Graduate School of Medical Science Kyoto Prefectural University of Medicine  Kyoto Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ai","family":"Kojima","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chikara","family":"Honda","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Nakayama","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satomi","family":"Kanemata","sequence":"additional","affiliation":[{"name":"Medical Affairs, Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshimitsu","family":"Endo","sequence":"additional","affiliation":[{"name":"Medical Affairs, Ono Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"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 Hospital  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,5]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms22168491"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.21037\/apm.2018.08.04"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1470-2045(10)70218-7"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s13539-014-0159-5"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/jcsm.12675"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.31128"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32406"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1023\/A:1015614505929"},{"key":"e_1_2_14_10_1","unstructured":"Functional Assessment of Chronic Illness Therapy (FACIT) Group.Scoring of the FACIT measures. Available at:https:\/\/www.facit.org\/scoring2023."},{"key":"e_1_2_14_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-015-2606-z"},{"key":"e_1_2_14_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-019-02135-7"},{"key":"e_1_2_14_13_1","doi-asserted-by":"publisher","DOI":"10.2169\/internalmedicine.0730-22"},{"key":"e_1_2_14_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-023-07576-y"},{"issue":"3","key":"e_1_2_14_15_1","first-page":"235","article-title":"Endocrinological changes after anamorelin administration in patients with gastrointestinal cancer","volume":"77","author":"Kuraoka S","year":"2023","journal-title":"Acta Med Okayama"},{"key":"e_1_2_14_16_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2023.09.702"},{"key":"e_1_2_14_17_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-020-05346-8"},{"key":"e_1_2_14_18_1","doi-asserted-by":"publisher","DOI":"10.1159\/000533539"},{"key":"e_1_2_14_19_1","unstructured":"jRCT1071210053.A prospective observational study of the effect of ANamorelin Administration on combined immunochemotherapy in patients with non\u2010small cell lung cancer (SPIRAL\u2010ANA study). Available from:https:\/\/jrct.niph.go.jp\/en\u2010latest\u2010detail\/jRCT10712100532024."},{"key":"e_1_2_14_20_1","unstructured":"UMIN000050878.Prospective observational study to evaluate the efficacy of anamorelin on the course of first line chemotherapy in patients with previously\u2010untreated advanced non\u2010small cell lung cancer and cachexia (NEJ050B). Available from:https:\/\/center6.umin.ac.jp\/cgi\u2010open\u2010bin\/ctr_e\/ctr_view.cgi?recptno=R0000579832024."},{"key":"e_1_2_14_21_1","unstructured":"UMIN000045611.Impact of anamorelin with unresectable pancreatic gastric and colorectal cancer patients for a quality of life skeletal muscle index and malnutrition. Available from:https:\/\/center6.umin.ac.jp\/cgi\u2010open\u2010bin\/ctr_e\/ctr_view.cgi?recptno=R0000512852024."},{"key":"e_1_2_14_22_1","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.34154"},{"key":"e_1_2_14_23_1","doi-asserted-by":"publisher","DOI":"10.1002\/cam4.5206"}],"container-title":["Cancer Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cam4.7170","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,10,10]],"date-time":"2024-10-10T10:56:09Z","timestamp":1728557769000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cam4.7170"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,5]]},"references-count":22,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2024,5]]}},"alternative-id":["10.1002\/cam4.7170"],"URL":"https:\/\/doi.org\/10.1002\/cam4.7170","archive":["Portico"],"relation":{},"ISSN":["2045-7634","2045-7634"],"issn-type":[{"value":"2045-7634","type":"print"},{"value":"2045-7634","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,5]]},"assertion":[{"value":"2023-11-29","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-27","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-05-01","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e7170"}}