Efficacy and safety of anamorelin in patients with metastatic urothelial carcinoma receiving systemic chemotherapy: a randomized controlled study.

IF 4.8 2区医学 Q1 ONCOLOGY

Oncologist Pub Date : 2025-07-02 DOI:10.1093/oncolo/oyaf167

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

{"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":"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.","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}

引用次数: 0

Abstract

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.

查看原文本刊更多论文

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。

背景：恶性恶病质降低转移性尿路上皮癌（mUC）患者化疗效果。Anamorelin通过增加血清胰岛素样生长因子1 （IGF-1）改善癌症恶病质。本研究的目的是评估anamorelin对mUC患者的疗效和安全性。方法：对38例接受铂类化疗的mUC患者进行介入前瞻性研究。患者被随机分配到anamorelin (Ana；N =20)或对照组（N =18）。主要终点是前白蛋白的变化。次要终点是白蛋白、IGF-1、体重、骨骼肌质量指数（SMI）、白细胞介素-6 （IL-6）和中位总生存期（mOS）的变化。结果：两组间白蛋白前、白蛋白、体重、重度精神障碍指数变化相似。与对照组相比，Anamorelin治疗组1周后血清IGF-1水平较高(结论：Anamorelin在mUC患者中耐受性良好。较高的血清IGF-1水平可能与anamorelin的疗效有关；然而，需要更大规模的研究来证实这一点。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Oncologist 医学-肿瘤学

CiteScore

10.40

自引率

3.40%

发文量

309

审稿时长

3-8 weeks

期刊介绍： 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.