【摘要】 目的 评估新辅助程序性死亡受体1(PD-1)/程序性死亡配体1(PD-L1)单抗+化疗±其他疗法治疗可切除局部进展期胃癌（GC）或胃食管结合部癌（GEJC）患者的疗效和安全性。方法 检索了建库至2023年7月28日的Pubmed、Embase、Cochrane Library和Web of Science数据库中的相关研究，提取疾病控制率（DCR）、客观缓解率（ORR）、1年总生存率、1年无病生存率、3年总生存率、3年无病生存率、病理学完全缓解（pCR）率、主要病理学缓解（MPR）率、R0切除率等疗效数据，以及1～2级治疗相关不良反应（TRAE）发生率、≥3级TRAE发生率和免疫相关不良反应（irAE）发生率等安全性数据。通过纽卡斯尔-渥太华量表（NOS）和亚乔安娜布里格斯研究所（JBI）关键评价清单评估纳入研究的质量。结果 共纳入10项研究，10项研究均发表于2022—2023年，共纳入353例患者，中位年龄为57.9～65.5岁。NOS和JBI关键评价清单评价结果显示，纳入文献质量较好。在疗效方面，汇总后的DCR、ORR、1年总生存率、1年无病生存率、3年总生存率、3年无病生存率、pCR率、MPR率、R0切除率分别为92%(95%CI:85%～99%)、61%(95%CI:50%～72%)、95%(95%CI:91%～98%)、93%(95%CI:89%～97%)、 90%(95%CI:83%～97%)、 83%(95%CI:74%～92%)、 22%(95%CI:18%～27%)、44%(95%CI:33%～55%)和95%(95%CI:92%～98%)。在安全性方面，大多数患者出现了1～2级TRAE。最常见的血液系统1～2级TRAE为白细胞减少（47%,95%CI:38%～56%），最常见的消化系统1～2级TRAE为呕吐（20%,95%CI:10%～30%）。≥3级TRAE发生率低，均<10%。irAE发生率也均<10%，其中发生率较高的有甲状腺功能减低、甲状腺功能亢进和皮炎，发生率分别为6%(95%CI:1%～11%)、7%(95%CI:0～14%)和7%(95%CI:2%～12%)。结论 疗效和安全性数据的汇总结果显示，新辅助PD-1/PD-L1单抗+化疗±阿帕替尼对可切除局部进展期GC或GEJC患者的疗效确切，不良反应可耐受。更多还原

【Abstract】 Objective To evaluate efficacy and safety of the combination neoadjuvant therapy of programmed cell death protein 1(PD-1)/programmed death ligand 1(PD-L1) monoclonal antibody and chemotherapy with or without other therapy in patients with locally advanced resectable gastric cancer(GC) or gastroesophageal junction cancer(GEJC). Methods Searching relative studies in the Pub Med, Embase, Cochrane Library, and Web of Science. Efficacy data including disease control rate(DCR), objective response rate(ORR), 1-year overall survival rate, 1-year disease-free survival rate, 3-year overall survival rate, 3-year disease-free survival rate, pathological complete response(p CR) rate, major pathological response(MPR) rate and R0 resection rate were extracted. Safety data including grade 1-2 treatment-related adverse event(TRAE) rate, ≥ grade 3 TRAE rate and immune-related adverse event(ir AE) rate were extracted. The quality of enrolled studies was evaluated by the Newcastle-Ottawa Scale(NOS) and the Joanna Briggs Institute(JBI) critical appraisal checklist. Results This meta-analysis enrolled 10 studies which were published between 2022 and 2023. A total of 353 patients were in these 10 studies and the median age of these patients was 57.9-65.5 years. The results of NOS and JBI critical appraisal checklist showed that all 10 studies were with relative high quality. In terms of efficacy, the merged DCR, ORR, 1-year overall survival rate, 1-year disease-free survival rate, 3-year overall survival rate, 3-year disease-free survival rate, p CR rate, MPR rate and R0 resection rate was 92%(95%CI: 85%-99%), 61%(95%CI: 50%-72%), 95%(95%CI: 91%-98%), 93%(95%CI: 89%-97%), 90%(95%CI: 83%-97%), 83%(95%CI: 74%-92%), 22%(95%CI: 18%-27%), 44%(95%CI: 33%-55%) and 95%(95%CI: 92%-98%), respectively. In terms of safety, most of these patients suffered grade 1-2 TRAE. The most common hematological grade 1-2 TRAE was leukopenia(47%, 95%CI: 38%-56%). The most common gastrointestinal grade 1-2 TRAE was vomiting(20%, 95%CI: 10%-30%). Both ≥ grade 3 TRAE rate and ir AE rate were lower than 10%. The most common ir AE including hypothyroidism(6%, 95%CI: 1%-11%), hyperthyroidism(7%, 95%CI: 0-14%) and dermatitis(7%, 95%CI: 2%-12%). Conclusion The merged efficacy and safety data revealed that the combination neoadjuvant therapy of PD-1/PD-L1 monoclonal antibody and chemotherapy with or without apatinib showed high efficacy and tolerable adverse event in patients with locally advanced resectable GC or GEJC.更多还原