Real-world data of anamorelin in advanced gastrointestinal cancer patients with cancer cachexia.

IF 2.5 2区医学 Q2 HEALTH CARE SCIENCES & SERVICES

BMC Palliative Care Pub Date : 2024-08-24 DOI:10.1186/s12904-024-01538-9

Ari Nishimura, Satoshi Hamauchi, Akifumi Notsu, Kunihiro Fushiki, Kotoe Oshima, Takahiro Tsushima, Takeshi Kawakami, Akiko Todaka, Tomoya Yokota, Hirofumi Yasui, Yusuke Onozawa, Kentaro Yamazaki

{"title":"Real-world data of anamorelin in advanced gastrointestinal cancer patients with cancer cachexia.","authors":"Ari Nishimura, Satoshi Hamauchi, Akifumi Notsu, Kunihiro Fushiki, Kotoe Oshima, Takahiro Tsushima, Takeshi Kawakami, Akiko Todaka, Tomoya Yokota, Hirofumi Yasui, Yusuke Onozawa, Kentaro Yamazaki","doi":"10.1186/s12904-024-01538-9","DOIUrl":null,"url":null,"abstract":"Background: Cancer cachexia is characterized by the loss of body weight (BW) and anorexia. Anamorelin (ANAM) is a selective ghrelin receptor agonist with appetite-enhancing anabolic action. The ONO-7643-05 trial demonstrated that ANAM increased lean body mass and improved anorexia in a Japanese population. However, the clinical outcomes of patients on ANAM have not yet been reported.Patients and methods: We investigated the clinical outcomes of patients with unresectable, advanced, or recurrent gastrointestinal cancer (colorectal, gastric, or pancreatic cancer) who were treated with ANAM between April 2017 and August 2022. Cachexia was defined as the presence of anorexia and a loss of ≥ 5% of BW within 6 months. To evaluate the response to ANAM, the patients who had discontinued ANAM within 3 weeks were excluded. Response to ANAM was defined as maintenance of or increase in BW and improved appetite from baseline at every 3-week evaluation. We also collected data on the reasons for the discontinuation of ANAM and the correlation between clinical factors and ANAM response. Safety analysis of ANAM was performed for all patients who received ANAM.Results: Seventy-four patients were included in this study (49 males and 25 females), with a median age of 67.1 years (range, 36-83). The primary tumors were colorectal cancer in 27 (36.5%), gastric cancer in 20 (27.0%), and pancreatic cancer in 27 (36.5%). The Eastern Cooperative Oncology Group performance status was 0 in 10 (13.5%), 1 in 44 (59.5%), and ≥ 2 in 20 (27.0%). The number of previous chemotherapy regimens was 0 in 20 (27.0%), 1 in 22 (29.7%), and ≥ 2 in 32 (43.2%). ANAM was discontinued within 3 weeks in 28 patients for the following reasons: low-grade (grade 1 or 2) adverse events in 15 patients, ileus in three, grade 3 fatigue in one, progressive disease in one, censored follow-up in six, and unknown reasons in three. The proportion of ANAM responders was 63.6% (95% confidence interval, 47.8-77.6%). Among baseline characteristics, age ≥ 75 attenuated the ANAM response (p = 0.03). ANAM responders showed better disease control with chemotherapy than non-responders (75.0% vs. 37.5%, p = 0.02).Conclusions: ANAM may improve the outcomes of patients with gastrointestinal cancer cachexia in clinical practice.","PeriodicalId":48945,"journal":{"name":"BMC Palliative Care","volume":null,"pages":null},"PeriodicalIF":2.5000,"publicationDate":"2024-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11344333/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"BMC Palliative Care","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s12904-024-01538-9","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"HEALTH CARE SCIENCES & SERVICES","Score":null,"Total":0}

引用次数: 0

Abstract

Background: Cancer cachexia is characterized by the loss of body weight (BW) and anorexia. Anamorelin (ANAM) is a selective ghrelin receptor agonist with appetite-enhancing anabolic action. The ONO-7643-05 trial demonstrated that ANAM increased lean body mass and improved anorexia in a Japanese population. However, the clinical outcomes of patients on ANAM have not yet been reported.

Patients and methods: We investigated the clinical outcomes of patients with unresectable, advanced, or recurrent gastrointestinal cancer (colorectal, gastric, or pancreatic cancer) who were treated with ANAM between April 2017 and August 2022. Cachexia was defined as the presence of anorexia and a loss of ≥ 5% of BW within 6 months. To evaluate the response to ANAM, the patients who had discontinued ANAM within 3 weeks were excluded. Response to ANAM was defined as maintenance of or increase in BW and improved appetite from baseline at every 3-week evaluation. We also collected data on the reasons for the discontinuation of ANAM and the correlation between clinical factors and ANAM response. Safety analysis of ANAM was performed for all patients who received ANAM.

Results: Seventy-four patients were included in this study (49 males and 25 females), with a median age of 67.1 years (range, 36-83). The primary tumors were colorectal cancer in 27 (36.5%), gastric cancer in 20 (27.0%), and pancreatic cancer in 27 (36.5%). The Eastern Cooperative Oncology Group performance status was 0 in 10 (13.5%), 1 in 44 (59.5%), and ≥ 2 in 20 (27.0%). The number of previous chemotherapy regimens was 0 in 20 (27.0%), 1 in 22 (29.7%), and ≥ 2 in 32 (43.2%). ANAM was discontinued within 3 weeks in 28 patients for the following reasons: low-grade (grade 1 or 2) adverse events in 15 patients, ileus in three, grade 3 fatigue in one, progressive disease in one, censored follow-up in six, and unknown reasons in three. The proportion of ANAM responders was 63.6% (95% confidence interval, 47.8-77.6%). Among baseline characteristics, age ≥ 75 attenuated the ANAM response (p = 0.03). ANAM responders showed better disease control with chemotherapy than non-responders (75.0% vs. 37.5%, p = 0.02).

Conclusions: ANAM may improve the outcomes of patients with gastrointestinal cancer cachexia in clinical practice.

查看原文本刊更多论文

阿那莫瑞林治疗癌症恶病质晚期消化道癌症患者的真实世界数据。

背景：癌症恶病质的特点是体重（BW）下降和厌食。阿那莫瑞林（ANAM）是一种选择性胃泌素受体激动剂，具有增进食欲的合成代谢作用。ONO-7643-05 试验表明，在日本人群中，ANAM 可增加瘦体重并改善厌食症。然而，尚未报道使用 ANAM 患者的临床疗效：我们调查了2017年4月至2022年8月期间接受ANAM治疗的不可切除、晚期或复发性胃肠道癌症（结直肠癌、胃癌或胰腺癌）患者的临床结果。厌食症的定义是在6个月内出现厌食且体重下降≥5%。为评估对 ANAM 的反应，排除了在 3 周内停用 ANAM 的患者。对 ANAM 的反应定义为：在每 3 周进行一次评估时，体重与基线相比保持不变或有所增加，食欲有所改善。我们还收集了有关停用 ANAM 的原因以及临床因素与 ANAM 反应之间相关性的数据。我们对所有接受 ANAM 治疗的患者进行了 ANAM 安全性分析：本研究共纳入74名患者（49名男性，25名女性），中位年龄为67.1岁（36-83岁）。原发肿瘤为结直肠癌的有27例（36.5%），胃癌20例（27.0%），胰腺癌27例（36.5%）。东部合作肿瘤学组（Eastern Cooperative Oncology Group）表现状态为 0 的有 10 例（13.5%），1 的有 44 例（59.5%），≥2 的有 20 例（27.0%）。既往化疗次数为 0 次的有 20 例（27.0%），1 次的有 22 例（29.7%），≥2 次的有 32 例（43.2%）。28名患者在3周内因以下原因停用了ANAM：15名患者出现低度（1级或2级）不良反应，3名患者出现回肠梗阻，1名患者出现3级乏力，1名患者病情进展，6名患者随访中断，3名患者原因不明。ANAM应答者比例为63.6%（95%置信区间，47.8-77.6%）。在基线特征中，年龄≥ 75 岁会降低 ANAM 反应（p = 0.03）。与无应答者相比，ANAM应答者的化疗疾病控制率更高（75.0% vs. 37.5%，p = 0.02）：结论：在临床实践中，ANAM 可改善胃肠道癌症恶病质患者的预后。

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

BMC Palliative Care HEALTH CARE SCIENCES & SERVICES-

CiteScore

4.60

自引率

9.70%

发文量

201

审稿时长

21 weeks

期刊介绍： BMC Palliative Care is an open access journal publishing original peer-reviewed research articles in the clinical, scientific, ethical and policy issues, local and international, regarding all aspects of hospice and palliative care for the dying and for those with profound suffering related to chronic illness.

文献相关原料

公司名称	产品信息	采购帮参考价格