腹腔镜胃癌根治术后新辅助免疫化疗的安全性和有效性：一项多中心真实世界临床研究。

BACKGROUND: The safety and efficacy of neoadjuvant immunochemotherapy (nICT) for locally advanced gastric cancer (LAGC) remain controversial. METHODS: Patients with LAGC who received either nICT or neoadjuvant chemotherapy (nCT) at 3 tertiary referral teaching hospitals in China between January 2016 and October 2022 were analyzed. After propensity-score matching (PSM), comparing the radiological response, pathological response rate, perioperative outcomes, and early recurrence between the two groups. RESULTS: After PSM, 585 patients were included, with 195 and 390 patients comprising the nICT and nCT groups, respectively. The nICT group exhibited a higher objective response rate (79.5% vs. 59.0%; P <0.001), pathological complete response rate (14.36% vs. 6.41%; P =0.002) and major pathological response rate (39.49% vs. 26.15%; P =0.001) compared with the nCT group. The incidence of surgical complications (17.44% vs. 16.15%, P =0.694) and the proportion of perioperative textbook outcomes (80.0% vs. 81.0%; P =0.767) were similar in both groups. The nICT group had a significantly lower proportion of early recurrence than the nCT group (29.7% vs. 40.8%; P =0.047). Furthermore, the multivariable logistic analysis revealed that immunotherapy was an independent protective factor against early recurrence [odds ratio 0.62 (95% CI 0.41-0.92); P =0.018]. No significant difference was found in neoadjuvant therapy drug toxicity between the two groups (51.79% vs. 45.38%; P =0.143). CONCLUSIONS: Compared with nCT, nICT is safe and effective, which significantly enhanced objective and pathological response rates and reduced the risk for early recurrence among patients with LAGC. TRIAL REGISTRATION: Clinical Trials.gov.

背景：新辅助免疫化疗（nICT）治疗局部进展期胃癌（LAGC）的安全性和有效性仍存在争议。

方法：分析了 2016 年 1 月至 2022 年 10 月在中国 3 家三级转诊教学医院接受 nICT 或新辅助化疗（nCT）的 LAGC 患者。经过倾向评分匹配（PSM）后，比较两组患者的影像学反应、病理缓解率、围手术期结局和早期复发情况。

结果：PSM 后，共纳入 585 例患者，其中 nICT 组和 nCT 组各 195 例和 390 例。nICT 组客观缓解率（79.5% vs. 59.0%；P <0.001）、病理完全缓解率（14.36% vs. 6.41%；P =0.002）和主要病理缓解率（39.49% vs. 26.15%；P =0.001）均高于 nCT 组。两组患者的手术并发症发生率（17.44% vs. 16.15%，P =0.694）和围手术期达到标准结局的比例（80.0% vs. 81.0%；P =0.767）相似。nICT 组早期复发率明显低于 nCT 组（29.7% vs. 40.8%；P =0.047）。此外，多变量逻辑分析显示，免疫治疗是早期复发的独立保护因素[比值比 0.62（95%可信区间 0.41-0.92）；P =0.018]。两组患者新辅助治疗药物毒性无显著差异（51.79% vs. 45.38%；P =0.143）。

结论：与 nCT 相比，nICT 安全有效，可显著提高 LAGC 患者的客观缓解率和病理缓解率，降低早期复发风险。

试验注册：ClinicalTrials.gov。