KEYNOTE-585：帕博利珠单抗联合或不联合围手术期化疗用于胃癌的 III 期研究。
KEYNOTE-585: Phase III study of perioperative chemotherapy with or without pembrolizumab for gastric cancer.
机构信息
Seoul National University College of Medicine, 101 Daehak-ro, Ihwa-Dong, Seoul, Republic of Korea.
University Hospitals Gasthuisberg Leuven & KU Leuven, 49 Herestraat, Leuven 3001, Belgium.
出版信息
Future Oncol. 2019 Mar;15(9):943-952. doi: 10.2217/fon-2018-0581. Epub 2019 Feb 19.
BACKGROUND
Surgical resection is the only curative treatment option for gastric cancer. Despite widespread adoption of multimodality perioperative treatment strategies, 5-year overall survival rates remain low. In patients with advanced gastric or gastroesophageal junction adenocarcinoma, pembrolizumab has demonstrated promising efficacy and manageable safety as monotherapy in previously treated patients and as first-line therapy in combination with cisplatin and 5-fluorouracil. Combining chemotherapy with pembrolizumab in the neoadjuvant/adjuvant setting may benefit patients with locally advanced, resectable disease.
AIM
To describe the design and rationale for the global, multicenter, randomized, double-blind, Phase III KEYNOTE-585 study to evaluate the efficacy and safety of pembrolizumab plus chemotherapy compared with placebo plus chemotherapy as neoadjuvant/adjuvant treatment for localized gastric or gastroesophageal junction adenocarcinoma. ClinicalTrials.gov : NCT03221426.
背景
手术切除是胃癌唯一的治愈性治疗选择。尽管多模式围手术期治疗策略已广泛应用，但 5 年总生存率仍然较低。在晚期胃或胃食管交界处腺癌患者中，帕博利珠单抗作为单药在先前治疗的患者中以及联合顺铂和 5-氟尿嘧啶作为一线治疗已显示出有前景的疗效和可管理的安全性。在新辅助/辅助治疗中将化疗与帕博利珠单抗联合使用可能使局部晚期可切除疾病患者受益。
目的
描述全球多中心、随机、双盲、III 期 KEYNOTE-585 研究的设计和原理，以评估帕博利珠单抗联合化疗与安慰剂联合化疗作为局限性胃或胃食管交界处腺癌新辅助/辅助治疗的疗效和安全性。ClinicalTrials.gov：NCT03221426。
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