晚期胃肠癌恶液质患者安那莫林的真实世界数据。
Real-world data of anamorelin in advanced gastrointestinal cancer patients with cancer cachexia.
机构信息
Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi, Sunto-gun, Shizuoka, 411-8777, Japan.
Department of Biostatistics, Clinical Research Center, Shizuoka Cancer Center, Shizuoka, Japan.
出版信息
BMC Palliat Care. 2024 Aug 24;23(1):214. doi: 10.1186/s12904-024-01538-9.
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.
背景
癌症恶病质的特征是体重（BW）下降和厌食。阿那莫林（ANAM）是一种选择性的生长激素释放肽受体激动剂，具有增强食欲和促进合成代谢的作用。ONO-7643-05 试验表明，ANAM 可增加瘦体重并改善日本人群的厌食症。然而，尚未报道接受 ANAM 治疗的患者的临床结局。
患者和方法
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（结直肠癌、胃癌或胰腺癌）患者的临床结局。恶病质定义为存在厌食症和 6 个月内体重下降≥5%。为了评估 ANAM 的反应，排除了在 3 周内停止使用 ANAM 的患者。ANAM 的反应定义为每 3 周评估时 BW 保持或增加以及食欲改善。我们还收集了关于停止使用 ANAM 的原因以及临床因素与 ANAM 反应之间的相关性的数据。对所有接受 ANAM 治疗的患者进行了 ANAM 的安全性分析。
结果
本研究共纳入 74 例患者（男 49 例，女 25 例），中位年龄为 67.1 岁（范围 36-83 岁）。主要肿瘤为结直肠癌 27 例（36.5%）、胃癌 20 例（27.0%）和胰腺癌 27 例（36.5%）。东部肿瘤协作组体力状态为 0 级 10 例（13.5%）、1 级 44 例（59.5%）和≥2 级 20 例（27.0%）。化疗方案数为 0 个 20 例（27.0%）、1 个 22 例（29.7%）和≥2 个 32 例（43.2%）。28 例患者在 3 周内停止使用 ANAM，原因如下：15 例为低级别（1 级或 2 级）不良事件，3 例为肠梗阻，1 例为 3 级疲劳，1 例为进展性疾病，6 例为删失随访，3 例原因不明。ANAM 应答者的比例为 63.6%（95%置信区间，47.8-77.6%）。在基线特征中，年龄≥75 岁会减弱 ANAM 的反应（p=0.03）。ANAM 应答者的疾病控制情况优于无应答者（75.0%比 37.5%，p=0.02）。
结论
ANAM 可能改善胃肠道癌恶病质患者的临床结局。
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