安罗替尼治疗老年晚期子宫内膜癌的疗效安全性及代谢综合征相关毒性管理策略研究

Study on the Efficacy, Safety and Management Strategies of Metabolic Syndrome-Related Toxicities of Anlotinib in the Treatment of Elderly Patients with Advanced Endometrial Cancer

摘要: 目的：本研究聚焦于老年晚期EC这一特殊且治疗选择有限的患者群体，具有明确的临床现实意义。老年患者常因合并症多、耐受性差而无法接受标准化疗，探索如安罗替尼这类口服、靶向药物的疗效与安全性，能为临床决策提供参考。方法：选取北华大学附属医院肿瘤内科2023年5月至2024年4月收治的符合以下标准的晚期EC患者，共28例。所有入组患者口服盐酸安罗替尼12 mg/d口服(用药2周/停药1周)，持续给药至疾病进展或不可耐受毒性。观察分析患者的临床疗效、无进展生存期及代谢综合征相关指标。结果：28例EC患者的平均DCR、ORR分别为89.29、60.71，PFS为12.0个月，较历史二线化疗数据(4~6个月)提升2倍。安全性方面需重点关注：① 89.29% (25/28)患者出现治疗相关高血压，39.29% (11/28)发生餐后2 h血糖异常；② 基于代谢综合征诊断标准(IDF, 2005)，32.14% (9/28)患者符合诊断；③ 所有不良事件均为1~2级，无3级以上毒性或治疗相关死亡。结论：安罗替尼可显著延长PFS，但需特别关注高血压的高发生率及其在合并心血管基础疾病老年患者中的风险管理。

Abstract: Objective: This study focuses on the special patient group of elderly patients with advanced EC who have limited treatment options, which has clear clinical practical significance. Elderly patients often cannot receive standard chemotherapy due to multiple comorbidities and poor tolerance. Exploring the efficacy and safety of oral targeted drugs such as anlotinib can provide a reference for clinical decision-making. Methods: Twenty-eight patients with advanced EC who met the following criteria and were admitted to the Department of Oncology of the Affiliated Hospital of Beihua University from May 2023 to April 2024 were selected. All enrolled patients were orally administered anlotinib hydrochloride at 12 mg/d (2 weeks of medication followed by 1 week of drug withdrawal), and the treatment was continued until disease progression or intolerable toxicity. The clinical efficacy, progression-free survival, and metabolic syndrome-related indicators of the patients were observed and analyzed. Results: The average DCR and ORR of 28 EC patients were 89.29 and 60.71, respectively, and PFS was 12.0 months, which was 2 times higher than the historical data of second-line chemotherapy (4~6 months). In terms of safety, the following points need to be emphasized: ① 89.29% (25/28) of the patients experienced treatment-related hypertension, and 39.29% (11/28) had abnormal blood glucose 2 hours after meals; ② Based on the diagnostic criteria for metabolic syndrome (IDF, 2005), 32.14% (9/28) of the patients met the diagnostic criteria; ③ All adverse events were grade 1~2, with no grade 3 or higher toxicity or treatment-related deaths. Conclusion: Enrotinib can significantly prolong PFS, but special attention should be paid to the high incidence of hypertension and its risk management in elderly patients with cardiovascular diseases.