| 沈绮雯,王 乐,朱 骥.纳武单抗联合化疗与单纯化疗一线治疗晚期胃腺癌、胃食管结合部腺癌、食管腺癌患者的疗效对比——CheckMate 649研究的解读[J].肿瘤学杂志,2022,28(1):74-80. |
| 纳武单抗联合化疗与单纯化疗一线治疗晚期胃腺癌、胃食管结合部腺癌、食管腺癌患者的疗效对比——CheckMate 649研究的解读 |
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| 投稿时间：2021-12-27 |
| DOI：10.11735/j.issn.1671-170X.2022.01.B015 |
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| 中文关键词: 纳武单抗 联合化疗 胃腺癌 胃食管结合部腺癌 食管腺癌 临床研究 |
| 英文关键词:nivolumab combined chemotherapy gastric adenocarcinoma gastro-oesophageal junction adenocarcinoma oesophageal adenocarcinoma clinical trial |
| 基金项目:The Summary of a Phase 3 Trial (CheckMate 649) of the First-line Nivolumab in Advanced Gastric, Gastro-oesophageal Junction and Oesophageal Adenocarcinoma |
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| 中文摘要: |
| 摘 要：CheckMate 649研究是一项立足于非HER2阳性晚期胃癌一线治疗的Ⅲ期临床研究。研究设计上，该研究基于不断更新的医学认知与同期获悉的临床数据进行了多次设计方案的修正，并通过统计学方法，确保了检验效能的同时，也控制住了多重性问题中的Ⅰ类错误膨胀。研究结果上，纳武单抗联合化疗组对比单纯化疗组，达到了研究的主要双终点及次要多终点；联合治疗组的优势随着PD-L1联合阳性分数观察集中截断值的提高而提高。分层分析显示，中国亚组的疾病控制和生存获益更加显著。CheckMate 649研究的结果有亮点，也有争议，值得进一步讨论与思考。 |
| 英文摘要: |
| Abstract： The CheckMate 649 study is a phase Ⅲ clinical study based on the first-line treatment of non-HER2 positive advanced gastric cancer. In terms of study design， the study carried out several revisions on the design plan based on the continuously updated medical cognition and the clinical data obtained simultaneously. Statistical methods were used to ensure the efficacy of the test and to control the type Ⅰ error in multiplicity problems. In terms of the results of the study， compared with the chemotherapy alone group， the nivolumab combined chemotherapy group reached the primary dual endpoints and multiple secondary endpoints of the study； the advantage of the combined treatment group increased with the increase in the cutoff value of the CPS observation focus. The stratified analysis showed that the disease control and survival benefits of the Chinese subgroup were more significant. The results of CheckMate 649 have highlights but also controversy， which deserves further discussion and reflection. |
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