Barry J. A. Laird, Richard Skipworth, Philip D. Bonomi, Marie Fallon, Stein Kaasa, Ruben Giorgino, Donald C. McMillan, David C. Currow
{"title":"Anamorelin在非小细胞肺癌恶病质患者中的疗效：来自ROMANA 1和ROMANA 2的见解","authors":"Barry J. A. Laird, Richard Skipworth, Philip D. Bonomi, Marie Fallon, Stein Kaasa, Ruben Giorgino, Donald C. McMillan, David C. Currow","doi":"10.1002/jcsm.13732","DOIUrl":null,"url":null,"abstract":"<div>\n \n \n <section>\n \n <h3> Background</h3>\n \n <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–small-cell lung cancer (NSCLC).</p>\n </section>\n \n <section>\n \n <h3> Methods</h3>\n \n <p>ROMANA 1 and ROMANA 2 were double-blind, placebo-controlled, randomised Phase 3 trials that enrolled people with inoperable stage III/IV NSCLC with cachexia (≥ 5% weight loss within 6 months or body mass index [BMI] < 20 kg/m<sup>2</sup>). Patients were randomised 2:1 to anamorelin 100 mg once daily or placebo, for 12 weeks. 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-to-treat pooled population.</p>\n </section>\n \n <section>\n \n <h3> Results</h3>\n \n <p>Seven hundred ninety-five patients had available data. Anamorelin improved body weight (<i>p</i> < 0.001) and body composition parameters (LBM and FM, <i>p</i> < 0.01) in all mGPS groups. In patients with mGPS = 2, anamorelin increased weight > 5% and improved hand grip strength (HGS) and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS). In patients with BMI < 20 kg/m<sup>2</sup> at baseline or weight loss ≥ 10% in the prior 6 months, anamorelin led to significant increases in body weight from baseline (<i>p</i> < 0.001) versus placebo. Patients with weight loss ≥ 10% in the prior 6 months showed the highest improvements in LBM (<i>p</i> < 0.001). Patients with BMI < 20 kg/m<sup>2</sup> at baseline showed the highest improvements in FM (<i>p</i> < 0.001).</p>\n </section>\n \n <section>\n \n <h3> Conclusion</h3>\n \n <p>Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI < 20 kg/m<sup>2</sup> and weight loss ≥ 10%. These results highlight that the anabolic mechanisms of anamorelin are more effective in high-risk groups.</p>\n </section>\n \n <section>\n \n <h3> Trial Registration</h3>\n \n <p>NCT identifiers: ROMANA 1: NCT01387269; ROMANA 2: NCT01387282.</p>\n </section>\n </div>","PeriodicalId":48911,"journal":{"name":"Journal of Cachexia Sarcopenia and Muscle","volume":"16 1","pages":""},"PeriodicalIF":9.4000,"publicationDate":"2025-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcsm.13732","citationCount":"0","resultStr":"{\"title\":\"Anamorelin Efficacy in Non–Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2\",\"authors\":\"Barry J. A. Laird, Richard Skipworth, Philip D. Bonomi, Marie Fallon, Stein Kaasa, Ruben Giorgino, Donald C. McMillan, David C. Currow\",\"doi\":\"10.1002/jcsm.13732\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div>\\n \\n \\n <section>\\n \\n <h3> Background</h3>\\n \\n <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–small-cell lung cancer (NSCLC).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Methods</h3>\\n \\n <p>ROMANA 1 and ROMANA 2 were double-blind, placebo-controlled, randomised Phase 3 trials that enrolled people with inoperable stage III/IV NSCLC with cachexia (≥ 5% weight loss within 6 months or body mass index [BMI] < 20 kg/m<sup>2</sup>). Patients were randomised 2:1 to anamorelin 100 mg once daily or placebo, for 12 weeks. 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-to-treat pooled population.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Results</h3>\\n \\n <p>Seven hundred ninety-five patients had available data. Anamorelin improved body weight (<i>p</i> < 0.001) and body composition parameters (LBM and FM, <i>p</i> < 0.01) in all mGPS groups. In patients with mGPS = 2, anamorelin increased weight > 5% and improved hand grip strength (HGS) and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS). In patients with BMI < 20 kg/m<sup>2</sup> at baseline or weight loss ≥ 10% in the prior 6 months, anamorelin led to significant increases in body weight from baseline (<i>p</i> < 0.001) versus placebo. Patients with weight loss ≥ 10% in the prior 6 months showed the highest improvements in LBM (<i>p</i> < 0.001). Patients with BMI < 20 kg/m<sup>2</sup> at baseline showed the highest improvements in FM (<i>p</i> < 0.001).</p>\\n </section>\\n \\n <section>\\n \\n <h3> Conclusion</h3>\\n \\n <p>Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI < 20 kg/m<sup>2</sup> and weight loss ≥ 10%. These results highlight that the anabolic mechanisms of anamorelin are more effective in high-risk groups.</p>\\n </section>\\n \\n <section>\\n \\n <h3> Trial Registration</h3>\\n \\n <p>NCT identifiers: ROMANA 1: NCT01387269; ROMANA 2: NCT01387282.</p>\\n </section>\\n </div>\",\"PeriodicalId\":48911,\"journal\":{\"name\":\"Journal of Cachexia Sarcopenia and Muscle\",\"volume\":\"16 1\",\"pages\":\"\"},\"PeriodicalIF\":9.4000,\"publicationDate\":\"2025-02-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://onlinelibrary.wiley.com/doi/epdf/10.1002/jcsm.13732\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Cachexia Sarcopenia and Muscle\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://onlinelibrary.wiley.com/doi/10.1002/jcsm.13732\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"GERIATRICS & GERONTOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Cachexia Sarcopenia and Muscle","FirstCategoryId":"3","ListUrlMain":"https://onlinelibrary.wiley.com/doi/10.1002/jcsm.13732","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"GERIATRICS & GERONTOLOGY","Score":null,"Total":0}
Anamorelin Efficacy in Non–Small-Cell Lung Cancer Patients With Cachexia: Insights From ROMANA 1 and ROMANA 2
Background
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–small-cell lung cancer (NSCLC).
Methods
ROMANA 1 and ROMANA 2 were double-blind, placebo-controlled, randomised Phase 3 trials that enrolled people with inoperable stage III/IV NSCLC with cachexia (≥ 5% weight loss within 6 months or body mass index [BMI] < 20 kg/m2). Patients were randomised 2:1 to anamorelin 100 mg once daily or placebo, for 12 weeks. 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-to-treat pooled population.
Results
Seven hundred ninety-five patients had available data. Anamorelin improved body weight (p < 0.001) and body composition parameters (LBM and FM, p < 0.01) in all mGPS groups. In patients with mGPS = 2, anamorelin increased weight > 5% and improved hand grip strength (HGS) and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale (FAACT A/CS). In patients with BMI < 20 kg/m2 at baseline or weight loss ≥ 10% in the prior 6 months, anamorelin led to significant increases in body weight from baseline (p < 0.001) versus placebo. Patients with weight loss ≥ 10% in the prior 6 months showed the highest improvements in LBM (p < 0.001). Patients with BMI < 20 kg/m2 at baseline showed the highest improvements in FM (p < 0.001).
Conclusion
Anamorelin improved body composition parameters in all patients, as well as physical function and symptom burden, particularly in patients with systemic inflammation, BMI < 20 kg/m2 and weight loss ≥ 10%. These results highlight that the anabolic mechanisms of anamorelin are more effective in high-risk groups.
Trial Registration
NCT identifiers: ROMANA 1: NCT01387269; ROMANA 2: NCT01387282.
期刊介绍：
The Journal of Cachexia, Sarcopenia and Muscle is a peer-reviewed international journal dedicated to publishing materials related to cachexia and sarcopenia, as well as body composition and its physiological and pathophysiological changes across the lifespan and in response to various illnesses from all fields of life sciences. The journal aims to provide a reliable resource for professionals interested in related research or involved in the clinical care of affected patients, such as those suffering from AIDS, cancer, chronic heart failure, chronic lung disease, liver cirrhosis, chronic kidney failure, rheumatoid arthritis, or sepsis.
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