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Abstract：
BACKGROUND: Anamorelin is expected to improve cancer cachexia by increasing lean body mass (LBM) due to increased appetite and protein synthesis. However, the effect of anamorelin on cancer cachexia in real-world practice is unclear. The purpose of this study was to evaluate the efficacy and safety of anamorelin and to identify predictors of efficacy on treatment with anamorelin.
METHODS: We retrospectively analyzed data from patients with cancer cachexia treated with chemotherapy between May 2021 and August 2022. Efficacy of anamorelin was evaluated using LBM, with \"12-week sustained effective response\" to anamorelin treatment defined as maintenance or an increase in LBM for 12 weeks. We examined factors associated with \"12-week sustained effective response\" to anamorelin treatment using a multivariable logistic model that included controlling nutritional status (CONUT) score, an objective assessment of nutritional disorders, and the modified Glasgow prognostic score (mGPS), which scores the cachexia status of cancer patients. To assess patient subjective quality of life (QOL) changes related to eating after starting anamorelin treatment, we used a questionnaire (QOL-ACD appetite-related items: Q8, 9, 11). Adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
RESULTS: On analysis of data from 40 patients, 23 patients showed a 12-week sustained effective response to anamorelin (57.5%). At 12 weeks, LBM significantly increased by 1.63 ± 3.73 kg (mean ± SD). Multivariable logistic analysis revealed that a low CONUT score was significantly associated with \"12-week sustained effective response\" to anamorelin treatment (adjusted odds ratio: 13.5, 95% confidence intervals: 2.2-84.2, P = 0.004). QOL assessment showed a trend toward increased appetite and enjoyment of meals after anamorelin initiation. Five patients (12.5%) had an increase in HbA1c of more than 1.0% during the 12 weeks after the start of anamorelin. No patient had QT interval prolongation or grade 3 or higher hepatic transaminase elevation.
CONCLUSIONS: Anamorelin may maintain or increase LBM with tolerable safety in patients with cancer cachexia undergoing chemotherapy. A low CONUT score, despite meeting criteria for cancer cachexia, is suggested as a predictor for the efficacy of anamorelin, indicating that patients with a low CONUT score may benefit from early introduction of anamorelin.
METHODS: We retrospectively analyzed data from patients with cancer cachexia treated with chemotherapy between May 2021 and August 2022. Efficacy of anamorelin was evaluated using LBM, with \"12-week sustained effective response\" to anamorelin treatment defined as maintenance or an increase in LBM for 12 weeks. We examined factors associated with \"12-week sustained effective response\" to anamorelin treatment using a multivariable logistic model that included controlling nutritional status (CONUT) score, an objective assessment of nutritional disorders, and the modified Glasgow prognostic score (mGPS), which scores the cachexia status of cancer patients. To assess patient subjective quality of life (QOL) changes related to eating after starting anamorelin treatment, we used a questionnaire (QOL-ACD appetite-related items: Q8, 9, 11). Adverse events were evaluated in accordance with the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0.
RESULTS: On analysis of data from 40 patients, 23 patients showed a 12-week sustained effective response to anamorelin (57.5%). At 12 weeks, LBM significantly increased by 1.63 ± 3.73 kg (mean ± SD). Multivariable logistic analysis revealed that a low CONUT score was significantly associated with \"12-week sustained effective response\" to anamorelin treatment (adjusted odds ratio: 13.5, 95% confidence intervals: 2.2-84.2, P = 0.004). QOL assessment showed a trend toward increased appetite and enjoyment of meals after anamorelin initiation. Five patients (12.5%) had an increase in HbA1c of more than 1.0% during the 12 weeks after the start of anamorelin. No patient had QT interval prolongation or grade 3 or higher hepatic transaminase elevation.
CONCLUSIONS: Anamorelin may maintain or increase LBM with tolerable safety in patients with cancer cachexia undergoing chemotherapy. A low CONUT score, despite meeting criteria for cancer cachexia, is suggested as a predictor for the efficacy of anamorelin, indicating that patients with a low CONUT score may benefit from early introduction of anamorelin.
摘要：
背景：由于食欲和蛋白质合成的增加，预计Anamorelin通过增加瘦体重（LBM）来改善癌症恶病质。然而,在现实世界的实践中,阿纳瑞林对癌症恶病质的影响尚不清楚.这项研究的目的是评估anamorelin的疗效和安全性，并确定anamorelin治疗疗效的预测因子。
方法：我们回顾性分析了2021年5月至2022年8月期间接受化疗的癌症恶病质患者的数据。使用LBM评估anamorelin的疗效，对Anamorelin治疗的“12周持续有效反应”定义为LBM维持或增加12周。我们使用多变量逻辑模型，包括控制营养状况（CONUT）评分，研究了与Anamorelin治疗的“12周持续有效反应”相关的因素，对营养障碍的客观评估，和改良的格拉斯哥预后评分(mGPS)，对癌症患者的恶病质状况进行评分。评估患者在开始阿纳瑞林治疗后与进食相关的主观生活质量（QOL）变化，我们使用问卷（QOL-ACD食欲相关项目：Q8，9，11）。根据不良事件通用术语标准(CTCAE)5.0版评价不良事件。
结果：对40例患者的数据进行分析，23例患者对anamorelin表现出12周的持续有效反应（57.5％）。12周时,LBM显著增加1.63±3.73kg(平均值±SD)。多变量逻辑分析显示，CONUT得分较低与anamorelin治疗的“12周持续有效反应”显着相关（调整比值比：13.5，95％置信区间：2.2-84.2，P=0.004）。QOL评估显示，开始服用anamorelin后，食欲和进餐的趋势增加。5名患者（12.5％）在开始使用anamorelin后的12周内HbA1c升高超过1.0％。没有患者出现QT间期延长或3级或更高的肝转氨酶升高。
结论：Anamorelin在接受化疗的癌性恶病质患者中可以维持或增加LBM，安全性可耐受。CONUT得分低,尽管符合癌症恶病质的标准，被建议作为阿纳瑞林疗效的预测因子，这表明CONUT评分较低的患者可能会从早期引入阿纳瑞林中获益。
方法：我们回顾性分析了2021年5月至2022年8月期间接受化疗的癌症恶病质患者的数据。使用LBM评估anamorelin的疗效，对Anamorelin治疗的“12周持续有效反应”定义为LBM维持或增加12周。我们使用多变量逻辑模型，包括控制营养状况（CONUT）评分，研究了与Anamorelin治疗的“12周持续有效反应”相关的因素，对营养障碍的客观评估，和改良的格拉斯哥预后评分(mGPS)，对癌症患者的恶病质状况进行评分。评估患者在开始阿纳瑞林治疗后与进食相关的主观生活质量（QOL）变化，我们使用问卷（QOL-ACD食欲相关项目：Q8，9，11）。根据不良事件通用术语标准(CTCAE)5.0版评价不良事件。
结果：对40例患者的数据进行分析，23例患者对anamorelin表现出12周的持续有效反应（57.5％）。12周时,LBM显著增加1.63±3.73kg(平均值±SD)。多变量逻辑分析显示，CONUT得分较低与anamorelin治疗的“12周持续有效反应”显着相关（调整比值比：13.5，95％置信区间：2.2-84.2，P=0.004）。QOL评估显示，开始服用anamorelin后，食欲和进餐的趋势增加。5名患者（12.5％）在开始使用anamorelin后的12周内HbA1c升高超过1.0％。没有患者出现QT间期延长或3级或更高的肝转氨酶升高。
结论：Anamorelin在接受化疗的癌性恶病质患者中可以维持或增加LBM，安全性可耐受。CONUT得分低,尽管符合癌症恶病质的标准，被建议作为阿纳瑞林疗效的预测因子，这表明CONUT评分较低的患者可能会从早期引入阿纳瑞林中获益。
