在外科手术期间使用 pembrolizumab 治疗早期非小细胞肺癌
Heather Wakelee1, Moishe Liberman1, Terufumi Kato1
1From Stanford University School of Medicine, Stanford Cancer Institute, Stanford, CA (H.W.); Centre Hospitalier de l'Université de Montréal (M.L.) and McGill University Health Centre (J.D.S.) - both in Montreal; Kanagawa Cancer Center, Yokohama (T.K.), and National Cancer Center Hospital East, Kashiwa (M.T.) - both in Japan; Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea (S.-H.L.); the National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College (S.G.), and Beijing Cancer Hospital, Peking University (K.-N.C.) - both in Beijing; University Hospitals Leuven, Leuven, Belgium (C.D.); Hospital de la Santa Creu i Sant Pau, Barcelona (M.M.), and Hospital Universitario Insular de Gran Canaria, Universidad de Las Palmas de Gran Canaria, Las Palmas (D.R.-A.) - both in Spain; Zentralklinik Bad Berka, Bad Berka, Germany (E.E.); Sanatorio Parque, Cordoba, Argentina (G.L.M.); Hôpital d'Instruction des Armées Sainte-Anne, Toulon, France (O.B.); Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York (J.E.C.); the Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi Gonzaga di Orbassano, Turin, Italy (S.N.); and Merck, Rahway, NJ (J.Y., S.M.K., A.S.).
术后 pembrolizumab 显著改善了早期非小细胞肺癌 (NSCLC) 患者的无事件生存率和病理反应. 在这项试验中,总体存活率没有显著差异.
科学领域:
- 在瘤学瘤学.
- 临床试验 临床试验
- 免疫治疗是一种免疫疗法.
背景情况:
- 早期非小细胞肺癌 (NSCLC) 对外科手术期间的治疗策略提出了挑战.
- 研究结合新辅助剂和辅助剂免疫检查点抑制的疗效对于改善患者的治疗结果至关重要.
研究的目的:
- 为了评估外科手术期间 pembrolizumab 在可切除早期NSCLC 的患者的疗效.
- 为了比较接受 pembrolizumab 和安慰剂的患者之间的无事件生存率和整体生存率.
主要方法:
- 进行了一项随机,双盲,第三期试验,涉及可切除II期,IIIA期或IIIB期NSCLC的患者.
- 参与者接受了新辅助 pembrolizumab 或安慰剂与化疗,随后是手术和辅助 pembrolizumab 或安慰剂.
主要成果:
- 24个月的无事件存活率在布罗利祖马布组 (62.4%) 与安慰剂 (40.6%) 相比显著更高.
- 主要病理反应和病理完整反应率在使用 pembrolizumab 时显著改善.
- 在分析时,总体存活率在两组之间没有显著差异.
结论:
- 在外科手术期间, pembrolizumab 在可切除的早期NSCLC中显著改善了无事件生存率和病理反应.
- 虽然整体存活率没有显著差异,但观察到的改善表明这种新辅助和辅助方法的潜在益处.
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