中国药物警戒 ›› 2023, Vol. 20 ›› Issue (3): 301-305.
DOI: 10.19803/j.1672-8629.20220594

• 基础与临床研究 • 上一篇    下一篇

PD-1抑制剂联合化疗一线新辅助治疗局部进展期胃腺癌的近期疗效及安全性评估

焦福智1, 陈雅蕊1, 姬薇1, 郝建朋2, 关泉林2,3,*   

  1. 1兰州大学第一临床医学院,甘肃 兰州 730000;
    2兰州大学第一医院肿瘤外科,甘肃 兰州 730000;
    3甘肃省胃肠病重点实验室,甘肃 兰州 730000
  • 收稿日期:2022-10-11 出版日期:2023-03-15 发布日期:2023-03-17
  • 通讯作者: * 关泉林,男,博士,教授,消化道及甲状腺肿瘤的基础与临床研究。E-mail: guanql@lzu.edu.cn
  • 作者简介:焦福智,男,在读硕士,胃肠道肿瘤的临床研究。
  • 基金资助:
    国家重点研发计划（2017YFC0908302）

Short-term efficacy and safety evaluation of PD-1 inhibitor combined with chemotherapy as a first-line neoadjuvant therapy for locally advanced gastric adenocarcinoma

JIAO Fuzhi1, CHEN Yarui1, JI Wei1, HAO Jianpeng2, GUAN Quanlin2,3,*   

  1. 1The First Clinical Medical College, Lanzhou University, Lanzhou Gansu 730000, China;
    2Department of Oncology Surgery, the First Hospital of Lanzhou University, Lanzhou Gansu 730000, China;
    3Key Laboratory for Gastrointestinal Disease of Gansu Province, Lanzhou Gansu 730000, China
  • Received:2022-10-11 Online:2023-03-15 Published:2023-03-17

PDF (PC)

102

摘要： 目的 评估程序性死亡受体-1（PD-1）抑制剂联合奥沙利铂和替吉奥（SOX）方案在局部进展期胃腺癌患者新辅助治疗中的近期疗效和安全性。方法 回顾性分析2020年1月1日至2022年1月31日于兰州大学第一医院收治的114例局部进展期胃腺癌患者的临床资料,根据治疗方案将患者分为PD-1抑制剂联合SOX组（联合组,35例）和SOX组（化疗组,79例）,治疗后评估2组患者的近期疗效和不良反应。结果 近期疗效方面,联合组与化疗组治疗后评估为完全缓解（CR）、主要病理缓解（MPR）、病理完全缓解（pCR）的患者比例相比分别为17.14% vs 3.79%（χ2=4.247, P=0.039）、28.57% vs 12.66%（χ2=4.246, P=0.039）、20.00% vs 6.33%（χ2=4.813, P=0.028）,差异均有统计学意义;2组之间客观缓解率（ORR）分别为71.43%和50.63%,差异有统计学意义（χ2=4.280, P=0.039）,疾病控制率（DCR）分别为100%和97.47%,差异无统计学意义;临床N分期的降期率分别为91.43%和56.96%,差异有统计学意义（χ2=13.143,P<0.001）。不良反应方面,联合组和化疗组总不良反应及3级不良反应的发生率差异无统计学意义;在1~2级不良反应中,联合组转氨酶升高的发生率较高,差异有统计学意义;2组均未观察到4级不良反应及治疗相关死亡事件的发生。结论 PD-1抑制剂联合SOX方案在局部进展期胃腺癌新辅助治疗中显示出显著的疗效和良好的安全性,可尝试作为其一线治疗的一种选择。

关键词: 程序性死亡受体-1抑制剂, 信迪利单抗, 奥沙利铂, 替吉奥, 胃癌, 新辅助化疗, 免疫治疗, 药品不良反应

Abstract: Objective To evaluate the short-term efficacy and safety of programmed death receptor-1 (PD-1) inhibitor combined with oxaliplatin plus S-1 (SOX) regimen in neoadjuvant therapy of locally advanced gastric adenocarcinoma. Methods The clinical data on 114 patients with locally advanced gastric adenocarcinoma admitted to the First Hospital of Lanzhou University between 2020 and 2022 was analyzed retrospectively. According to treatment regimens, these patients were divided into the PD-1 inhibitor combined with SOX group (35 cases) and SOX group (79 cases). The short-term efficacy and adverse reactions in the two groups were assessed after treatment. Results In terms of short-term efficacy, the percentages of patients evaluated as CR, MPR and pCR after treatment in the combined group and chemotherapy group were 17.14% vs 3.79% (χ2=4.247, P=0.039), 28.57% vs 12.66% (χ2=4.246, P=0.039) and 20.00% vs 6.33%(χ2=4.813,P=0.028) respectively, so the difference was statistically significant. The ORR between the two groups was 71.43% and 50.63% respectively, suggesting that the difference was of statistical significance (χ2=4.280, P=0.039). The DCR was 100% and 97.47% respectively, with no statistically significant difference. The descending rate of N stage was 91.43% and 56.96% respectively in the two groups, and the difference was also statistically significant (χ2=13.143, P<0.001). In terms of adverse reactions, there was no significant difference between the two groups. As for 1~2 grade adverse reactions, the incidence of transaminase elevation in the combination group was higher, and the difference was statistically significant. No grade 4 adverse reactions or treatment related deaths were observed in either group. Conclusion PD-1 inhibitor combined with SOX regimen showed significant efficacy and good safety in neoadjuvant therapy of locally advanced gastric adenocarcinoma, which can be used as a first-line treatment option.

Key words: programmed death receptor-1 inhibitor(PP-1), sintilimab, oxaliplatin, S-1(SOX), gastric cancer, neoadjuvant chemotherapy, immunotherapy, drug adverse reactions

中图分类号: