{"title":"anamorelin在接受全身化疗的转移性尿路上皮癌患者中的疗效和安全性：一项随机对照研究。","authors":"Kunihiro Odagiri, Yoshihisa Mimura, Taku Naiki, Yoshihiko Tasaki, Yosuke Sugiyama, Aya Naiki-Ito, Toshiki Etani, Takashi Nagai, Toshiharu Morikawa, Nobuhiko Shimizu, Maria Aoki, Masakazu Gonda, Takahiro Yasui, Yoko Furukawa-Hibi","doi":"10.1093/oncolo/oyaf167","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cancer cachexia reduces chemotherapy efficacy in patients with metastatic urothelial carcinoma (mUC). Anamorelin improves cancer cachexia by increasing serum insulin-like growth factor 1 (IGF-1). The aim of this study was to evaluate the efficacy and safety of anamorelin in patients with mUC.</p><p><strong>Methods: </strong>A total of 38 patients with mUC who received platinum-based chemotherapy were enrolled in an interventional prospective study. Patients were randomized to anamorelin (Ana; n=20) or control (n=18) groups. The primary endpoint was the change in prealbumin. Secondary endpoints were changes in albumin, IGF-1, body weight, skeletal muscle mass index (SMI), interleukin-6 (IL-6) and median overall survival (mOS).</p><p><strong>Results: </strong>Changes in prealbumin, albumin, body weight, and SMI were similar between groups. Compared to control, serum IGF-1 levels in the anamorelin-treated group were higher after 1-week (p<0.05). Changes in IGF-1 and SMI positively correlated in the anamorelin group (R=0.61, p<0.05). When the anamorelin group was divided into two groups by the median serum IGF-1 level after 1-week (Ana-IGF-1 high and Ana IGF-1 low groups), the SMI in the latter group showed a decreased tendency (p=0.14). The Ana-IGF-1 low group showed significantly higher IL-6 levels (p<0.05) at baseline and significantly shorter mOS compared to the Ana-IGF-1 high group (p<0.05). Treatment-related adverse events were comparable between the two groups (any grade: 100% vs. 100%; grade ≥3: 88.9% vs. 90.0%).</p><p><strong>Conclusion: </strong>Anamorelin was well tolerated in patients with mUC. A higher serum IGF-1 level might be associated with anamorelin efficacy; however, a larger study is needed to confirm this.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.8000,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study.\",\"authors\":\"Kunihiro Odagiri, Yoshihisa Mimura, Taku Naiki, Yoshihiko Tasaki, Yosuke Sugiyama, Aya Naiki-Ito, Toshiki Etani, Takashi Nagai, Toshiharu Morikawa, Nobuhiko Shimizu, Maria Aoki, Masakazu Gonda, Takahiro Yasui, Yoko Furukawa-Hibi\",\"doi\":\"10.1093/oncolo/oyaf167\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cancer cachexia reduces chemotherapy efficacy in patients with metastatic urothelial carcinoma (mUC). Anamorelin improves cancer cachexia by increasing serum insulin-like growth factor 1 (IGF-1). The aim of this study was to evaluate the efficacy and safety of anamorelin in patients with mUC.</p><p><strong>Methods: </strong>A total of 38 patients with mUC who received platinum-based chemotherapy were enrolled in an interventional prospective study. Patients were randomized to anamorelin (Ana; n=20) or control (n=18) groups. The primary endpoint was the change in prealbumin. Secondary endpoints were changes in albumin, IGF-1, body weight, skeletal muscle mass index (SMI), interleukin-6 (IL-6) and median overall survival (mOS).</p><p><strong>Results: </strong>Changes in prealbumin, albumin, body weight, and SMI were similar between groups. Compared to control, serum IGF-1 levels in the anamorelin-treated group were higher after 1-week (p<0.05). Changes in IGF-1 and SMI positively correlated in the anamorelin group (R=0.61, p<0.05). When the anamorelin group was divided into two groups by the median serum IGF-1 level after 1-week (Ana-IGF-1 high and Ana IGF-1 low groups), the SMI in the latter group showed a decreased tendency (p=0.14). The Ana-IGF-1 low group showed significantly higher IL-6 levels (p<0.05) at baseline and significantly shorter mOS compared to the Ana-IGF-1 high group (p<0.05). Treatment-related adverse events were comparable between the two groups (any grade: 100% vs. 100%; grade ≥3: 88.9% vs. 90.0%).</p><p><strong>Conclusion: </strong>Anamorelin was well tolerated in patients with mUC. A higher serum IGF-1 level might be associated with anamorelin efficacy; however, a larger study is needed to confirm this.</p>\",\"PeriodicalId\":54686,\"journal\":{\"name\":\"Oncologist\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":4.8000,\"publicationDate\":\"2025-07-02\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Oncologist\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/oncolo/oyaf167\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Oncologist","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/oncolo/oyaf167","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"ONCOLOGY","Score":null,"Total":0}
Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study.
Background: Cancer cachexia reduces chemotherapy efficacy in patients with metastatic urothelial carcinoma (mUC). Anamorelin improves cancer cachexia by increasing serum insulin-like growth factor 1 (IGF-1). The aim of this study was to evaluate the efficacy and safety of anamorelin in patients with mUC.
Methods: A total of 38 patients with mUC who received platinum-based chemotherapy were enrolled in an interventional prospective study. Patients were randomized to anamorelin (Ana; n=20) or control (n=18) groups. The primary endpoint was the change in prealbumin. Secondary endpoints were changes in albumin, IGF-1, body weight, skeletal muscle mass index (SMI), interleukin-6 (IL-6) and median overall survival (mOS).
Results: Changes in prealbumin, albumin, body weight, and SMI were similar between groups. Compared to control, serum IGF-1 levels in the anamorelin-treated group were higher after 1-week (p<0.05). Changes in IGF-1 and SMI positively correlated in the anamorelin group (R=0.61, p<0.05). When the anamorelin group was divided into two groups by the median serum IGF-1 level after 1-week (Ana-IGF-1 high and Ana IGF-1 low groups), the SMI in the latter group showed a decreased tendency (p=0.14). The Ana-IGF-1 low group showed significantly higher IL-6 levels (p<0.05) at baseline and significantly shorter mOS compared to the Ana-IGF-1 high group (p<0.05). Treatment-related adverse events were comparable between the two groups (any grade: 100% vs. 100%; grade ≥3: 88.9% vs. 90.0%).
Conclusion: Anamorelin was well tolerated in patients with mUC. A higher serum IGF-1 level might be associated with anamorelin efficacy; however, a larger study is needed to confirm this.
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The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.
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