{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,7]],"date-time":"2026-10-07T11:39:03Z","timestamp":1791373143425,"version":"4.3.1"},"reference-count":37,"publisher":"Wiley","issue":"5","license":[{"start":{"date-parts":[[2018,7,27]],"date-time":"2018-07-27T00:00:00Z","timestamp":1532649600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004312","name":"Eli Lilly and Company","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004312","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J cachexia sarcopenia muscle"],"published-print":{"date-parts":[[2018,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Cachexia is a formidable clinical challenge in pancreatic cancer. We assessed LY2495655 (antimyostatin antibody) plus standard\u2010of\u2010care chemotherapy in pancreatic cancer using cachexia status as a stratifier.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this randomized, phase 2 trial, patients with stage II\u2013IV pancreatic cancer were randomized to 300\u00a0mg LY2495655, 100\u00a0mg LY2495655, or placebo, plus physician\u2010choice chemotherapy from a prespecified list of standard\u2010of\u2010care regimens for first and later lines of care. Investigational treatment was continued during second\u2010line treatment. The primary endpoint was overall survival.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 125 patients were randomized. In August 2014, 300\u00a0mg LY2495655 was terminated due to imbalance in death rates between the treatment arms; in January 2015, 100\u00a0mg LY2495655 treatment was terminated due to futility. LY2495655 did not improve overall survival: the hazard ratio was 1.70 (90% confidence interval, 1.1\u20132.7) for 300\u00a0mg vs. placebo and 1.3 (0.82\u20132.1) for 100\u00a0mg vs. placebo (recommended doses). Progression\u2010free survival results were consistent with the overall survival results. A numerically higher hazard ratio was observed in patients with weight loss (WL) of \u22655% (cachexia) than with &lt;5% WL within 6\u00a0months before randomization. Subgroup analyses for patients stratified by WL in the 6\u00a0months preceding enrollment suggested that functional responses to LY2495655 (either dose) may have been superior in patients with &lt;5% WL vs. patients with \u22655% WL. Among possibly drug\u2010related adverse events, fatigue, diarrhoea, and anorexia were more common in LY2495655\u2010treated than in placebo\u2010treated patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>In the intention\u2010to\u2010treat analysis, LY2495655 did not confer clinical benefit in pancreatic cancer. Our data highlight the importance of assessing survival when investigating therapeutic management of cachexia and support the use of WL as a stratifier (independent of performance status).<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcsm.12331","type":"journal-article","created":{"date-parts":[[2018,7,27]],"date-time":"2018-07-27T10:30:03Z","timestamp":1532687403000},"page":"871-879","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":107,"title":["LY2495655, an antimyostatin antibody, in pancreatic cancer: a randomized, phase 2 trial"],"prefix":"10.1002","volume":"9","author":[{"given":"Talia","family":"Golan","sequence":"first","affiliation":[{"name":"Sheba Medical Center Ramat Gan Israel"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ravit","family":"Geva","sequence":"additional","affiliation":[{"name":"Sackler Faculty of Medicine Tel Aviv University Tel Aviv Israel"},{"name":"Tel Aviv Sourasky Medical Center Tel 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