Pembrolizumab Plus Chemotherapy Versus Chemotherapy as Perioperative Therapy in Locally Advanced Gastric and Gastroesophageal Junction Cancer: Final Analysis of the Randomized, Phase III KEYNOTE-585 Study.

Participants with previously untreated, locally advanced, resectable gastric and gastroesophageal junction (G/GEJ) cancer were enrolled into the main (n = 804) and fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT; n = 203) cohorts, and randomly assigned 1:1 to neoadjuvant and adjuvant pembrolizumab plus chemotherapy or placebo plus chemotherapy.

该研究招募了之前未经治疗、局部晚期、可切除的胃癌和胃食管交界处（G/GEJ）癌患者，纳入主要队列（n = 804）和氟尿嘧啶、亚叶酸钙、奥沙利铂和多西他赛（FLOT；n = 203）队列，并按1:1的比例随机分配接受新辅助和辅助的帕博利珠单抗加化疗或安慰剂加化疗。

The primary end points were pathologic complete response (pathCR) by central review, event-free survival (EFS) by investigator, OS, and safety.

主要终点是通过中心审查的病理完全缓解（pathCR）、通过研究者评估的无事件生存（EFS）、总生存（OS）和安全性。

Patient-reported outcomes was an exploratory end point.

患者报告的结果是一个探索性终点。

After a median follow-up of 59.9 months (range, 39-76), median OS was 71.8 versus 55.7 months (hazard ratio[HR], 0.86 [95% CI, 0.71 to 1.06]) with pembrolizumab plus chemotherapy versus placebo plus chemotherapy in the main cohort.

在中位随访59.9个月（范围，39-76个月）后，主要队列中，帕博利珠单抗联合化疗组与安慰剂联合化疗组的中位总生存期分别为71.8个月和55.7个月（风险比[HR]，0.86 [95%置信区间，0.71至1.06]）

The EFS HR was 0.81 (95% CI, 0.67 to 0.98).

无进展生存期（EFS）的风险比为0.81（95%置信区间，0.67至0.98）

Grade ≥3 drug-related adverse eventrates were 65% versus 63%.

3级或以上药物相关不良事件的发生率为65%对比63%。

Perioperative pembrolizumab plus chemotherapy did not worsen health-related quality of life versus placebo.

围手术期的帕博利珠单抗加化疗并未使健康相关的生活质量比安慰剂更差。

Pembrolizumab plus chemotherapy continued to show improved outcomes in pathCR and a trend toward longer EFS versus placebo in the main and main plus FLOT cohorts.

Pembrolizumab联合化疗在完全病理缓解(pathCR)中持续显示出改善的结果，并且在主要队列和主要加FLOT队列中，与安慰剂相比，无进展生存期(EFS)有延长的趋势。

Efficacy and safety outcomes with perioperative pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab in participants with untreated, locally advanced resectable G/GEJ cancer were consistent with previous analyses.

围手术期使用pembrolizumab联合化疗后进行辅助pembrolizumab治疗的疗效和安全性结果与之前的分析一致，适用于未接受治疗的局部晚期可切除的胃(G)或胃食管交界处(GEJ)癌患者。