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中国临床研究:2025,38(1):28-32
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阿帕替尼在晚期胃癌二线治疗中的疗效和安全性
(1. 南京医科大学附属肿瘤医院 江苏省肿瘤医院肿瘤科,江苏 南京 210009;2. 江苏省肿瘤医院 江苏省肿瘤防治研究所肿瘤科,江苏 南京 210009)
Efficacy and safety of apatinib in the second-line treatment of advanced gastric cancer
摘要
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投稿时间:2024-03-19   网络发布日期:2025-01-20
中文摘要: 目的 探讨阿帕替尼在晚期胃癌二线治疗中的疗效和安全性,为不能耐受化疗的晚期胃癌患者的治疗提供参考。 方法 选取2017年8月至2022年6月在江苏省肿瘤医院一线治疗失败后使用阿帕替尼的晚期胃癌患者45例为研究对象。所有患者均因一线治疗失败行二线治疗,二线治疗方案包括阿帕替尼分别联合免疫治疗、化疗、免疫治疗加化疗、抗体偶联药物加化疗等四类联合方案,以及帕替尼单药治疗。采用Kaplan-Meier法和log-rank检验进行生存分析,Cox模型分析影响中位无进展生存期(PFS)的因素。分层因素包括性别、年龄、是否手术、DNA错配修复(MMR)状态、人类表皮生长因子受体2(HER-2)表达和程序性死亡受体1/配体1(PD-1/PD-L1)表达。 结果 随访截至2023-12-31,45例患者中,阿帕替尼的疾病控制率(DCR)为48.9%,中位PFS 为5.0个月,阿帕替尼联合免疫治疗加化疗的效果最佳,PFS达到7.6个月,但各治疗方案的PFS差异无统计学意义(P>0.05)。分层分析显示,不同性别、年龄、是否手术、HER-2表达、PD-1/PD-L1表达、MMR状态组间PFS差异亦无统计学意义(P>0.05)。最常见的不良反应是消化道反应(8.9%)和白细胞减少(8.9%),但不良反应均可控。 结论 阿帕替尼在晚期胃癌的二线治疗中有一定获益,特别是免疫治疗加化疗联合阿帕替尼三种治疗联合方案可能为患者带来生存上的优势。
Abstract:Objective To explore the efficacy and safety of apatinib in the second-line treatment of advanced gastric cancer, providing a reference to guide treatment decisions for patients with advanced gastric cancer who are unable to endure chemotherapy. Methods A total of 45 patients with advanced gastric cancer, who underwent apatinib treatment after failure of first-line treatment at Jiangsu Cancer Hospital from August 2017 to June 2022, were selected as the subjects for this study. All patients underwent second-line therapy due to failure of first-line therapy. The second-line treatment regimens included four types of combination regimens: apatinib combined with immunotherapy, chemotherapy, immunotherapy plus chemotherapy, antibody-drug conjugate plus chemotherapy, respectively, and patinib monotherapy meanwhile. Survival analysis was performed using the Kaplan-Meier method and log-rank test, while factors influencing median progression-free survival (PFS) were analyzed using the Cox regression model. Stratification factors included gender, age, taking operation or not, microsatellite instability (MMR) status, human epidermal growth factor receptor 2 (HER-2) expression, and programmed cell death receptor 1 (PD-1) / ligand 1 (PD-L1) expression. Results Follow-up untill 2023-12-31, among the 45 patients, the disease control rate (DCR) of apatinib was 48.9%, with a median PFS of 5.0 months. The combination of apatinib with immunotherapy and chemotherapy produced the optimal outcomes, with a median PFS reaching 7.6 months. There was no statistically significant difference in PFS among the various treatment regimens (P>0.05). Furthermore, the PFS differences among various groups stratified by gender, age, taking operation or not, HER-2 expression, PD-1/PD-L1 expression, and MMR status were also not statistically significant (P>0.05). The most common adverse reactions were gastrointestinal disturbances (8.9%) and leukopenia (8.9%), but all adverse reactions were manageable. Conclusion Apatinib has some advantages in the second-line treatment of advanced gastric cancer, especially the combination regimen of immunotherapy, chemotherapy and apatinib may bring survival advantages to patients.
文章编号:     中图分类号:R735.2    文献标志码:A
基金项目:江苏省卫健委科研项目重点项目(ZD2021019)
附件
引用文本:
郭梦雅,陈越,彭炜惟,等.阿帕替尼在晚期胃癌二线治疗中的疗效和安全性[J].中国临床研究,2025,38(1):28-32.

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