{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,11]],"date-time":"2026-09-11T12:52:03Z","timestamp":1789131123383,"version":"build-2803163510"},"reference-count":44,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T00:00:00Z","timestamp":1740355200000},"content-version":"vor","delay-in-days":23,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,2,1]],"date-time":"2025-02-01T00:00:00Z","timestamp":1738368000000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Cancer cachexia presents a significant challenge, but the ghrelin agonist anamorelin shows promise as a potential treatment. This study examined whether the baseline systemic inflammatory response (SIR) (measured by the modified Glasgow Prognostic Score [mGPS]), low BMI or greater weight loss, was associated with a differential treatment effect of anamorelin in people with cachexia and non\u2013small\u2010cell lung cancer (NSCLC).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      ROMANA 1 and ROMANA 2 were double\u2010blind, placebo\u2010controlled, randomised Phase 3 trials that enrolled people with inoperable stage III\/IV NSCLC with cachexia (\u2265\u20095% weight loss within 6\u2009months or body mass index [BMI]\u2009&lt;\u200920\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      ). Patients were randomised 2:1 to anamorelin 100\u2009mg once daily or placebo, for 12\u2009weeks. This is a post hoc analysis of efficacy endpoints (body weight and body composition: lean body mass [LBM] and fat mass [FM]), stratified by baseline mGPS, BMI and weight loss and measured in the modified intent\u2010to\u2010treat pooled population.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Seven hundred ninety\u2010five patients had available data. Anamorelin improved body weight (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) and body composition parameters (LBM and FM,\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.01) in all mGPS groups. In patients with mGPS\u2009=\u20092, anamorelin increased weight &gt;\u20095% and improved hand grip strength (HGS) and the Functional Assessment of Anorexia\/Cachexia Therapy Anorexia\/Cachexia Subscale (FAACT A\/CS). In patients with BMI\u2009&lt;\u200920\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      at baseline or weight loss \u2265\u200910% in the prior 6\u2009months, anamorelin led to significant increases in body weight from baseline (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001) versus placebo. Patients with weight loss \u2265\u200910% in the prior 6\u2009months showed the highest improvements in LBM (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001). Patients with BMI\u2009&lt;\u200920\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      at baseline showed the highest improvements in FM (\n                      <jats:italic>p<\/jats:italic>\n                      \u2009&lt;\u20090.001).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI\u2009&lt;\u200920\u2009kg\/m\n                      <jats:sup>2<\/jats:sup>\n                      and weight loss \u2265\u200910%. These results highlight that the anabolic mechanisms of anamorelin are more effective in high\u2010risk groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>NCT identifiers: ROMANA 1: NCT01387269; ROMANA 2: NCT01387282.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/jcsm.13732","type":"journal-article","created":{"date-parts":[[2025,2,26]],"date-time":"2025-02-26T04:06:00Z","timestamp":1740542760000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Anamorelin Efficacy in Non\u2013Small\u2010Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2"],"prefix":"10.1002","volume":"16","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2807-6192","authenticated-orcid":false,"given":"Barry\u00a0J.\u00a0A.","family":"Laird","sequence":"first","affiliation":[{"name":"Institute of Genetics and Cancer University of Edinburgh, Western General Hospital  Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Skipworth","sequence":"additional","affiliation":[{"name":"Clinical Surgery Royal Infirmary of Edinburgh University of Edinburgh  Edinburgh UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip\u00a0D.","family":"Bonomi","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Rush University Medical Center  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marie","family":"Fallon","sequence":"additional","affiliation":[{"name":"Institute of Genetics and Cancer University of Edinburgh, Western General Hospital  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