| 关业兰,胡红林,金 莹.帕博利珠单抗对比多西他赛治疗PD-L1阳性的经治晚期非小细胞肺癌：KEYNOTE-010研究及5年生存更新数据解读[J].肿瘤学杂志,2022,28(5):428-438. |
| 帕博利珠单抗对比多西他赛治疗PD-L1阳性的经治晚期非小细胞肺癌：KEYNOTE-010研究及5年生存更新数据解读 |
| Interpretation of KEYNOTE-010 Study and 5-Year Survival Data： Pembrolizumab Versus Docetaxel in Treatment of Advanced Non-small Cell Lung Cancer Patient with PD-L1 Positive |
| 投稿时间：2022-05-05 |
| DOI：10.11735/j.issn.1671-170X.2022.05.B015 |
|
 |
| 中文关键词: 非小细胞肺癌 帕博利珠单抗 细胞程序性死亡配体1 肿瘤细胞阳性比例分数 疗效 |
| 英文关键词:non-small cell lung cancer pembrolizumab PD-L1 tumor cell proportion score efficacy |
| 基金项目: |
|
| 摘要点击次数: 738 |
| 全文下载次数: 235 |
| 中文摘要: |
| 摘 要：KEYNOTE-010研究是一项随机对照、开放标签、全球多中心、Ⅱ~Ⅲ期研究，比较帕博利珠单抗2 mg/kg、10 mg/kg与多西他赛在PD-L1阳性的经治晚期非小细胞肺癌（non-small cell lung cancer，NSCLC）患者中的疗效和安全性。该项研究的主要研究终点包括总人群和细胞程序性死亡配体1（PD-L1）肿瘤细胞阳性比例分数（tumor cell proportion score，TPS）≥50%患者的总生存期（overall survival，OS）及无进展生存期（progression-free survival，PFS）。在PD-L1 TPS≥50%的人群及总人群中，帕博利珠单抗不同剂量组的OS均显著性优于多西他赛组。在PD-L1 TPS≥50%的人群中，帕博利珠单抗不同剂量组的PFS均显著性优于多西他赛组。在总人群中，帕博利珠单抗不同剂量组与多西他赛组间的PFS均无显著性差异。在安全性方面，帕博利珠单抗不同剂量组的3~5级不良事件发生率均低于多西他赛组。在5年生存数据更新报告中，PD-L1 TPS≥1%的人群中，帕博利珠单抗组和多西他赛组的5年生存率分别为15.6%和6.5%；PD-L1 TPS≥50%的人群中，帕博利珠单抗组和多西他赛组的5年生存率分别为25.0%和8.2%。在79例完成了35个周期/2年帕博利珠单抗治疗的患者中，5年OS率达到83.0%。KEYNOTE-010研究结果奠定了帕博利珠单抗在PD-L1阳性晚期NSCLC患者二线及以上治疗的地位。 |
| 英文摘要: |
| Abstract： KEYNOTE-010 is a randomized， open-label， global multicenter， phaseⅡ~Ⅲ study to investigate the efficacy and safety of pembrolizumab 2 mg/kg or 10 mg/kg versus docetaxel in previously treated non-small cell lung cancer(NSCLC) patients with PD-L1 positive(tumor cell proportion score， TPS≥1%). The primary endpoints were overall survival(OS) and progression-free survival(PFS) in all patients and in those with PD-L1 expression(TPS)≥50%. In all patients and in those with PD-L1 expression(TPS)≥50%， the OS in patients treated with pembrolizumab 2 mg/kg or 10 mg/kg was prolonged than that in patients treated with docetaxel. In patients with PD-L1 TPS≥50%， PFS was significantly improved for pembrolizumab 2 mg/kg or 10 mg/kg compared to docetaxel. However， for all patients there was no significant difference in PFS between the different doses of pembrolizumab and docetaxel. In terms of safety， the incidence of grade 3~5 adverse events were lower for different doses of pembrolizumab and docetaxel. In patients with PD-L1 TPS≥1%， the 5-year OS rate was 15.6% for pembrolizumab and 6.5% for docetaxel， in patients with PD-L1 TPS≥50%， the 5-year OS rate was 25.0% for pembrolizumab and 8.2% for docetaxel， respectively. In 79 patients who completed 35 cycles /2 years of pembrolizumab treatment， the 5-year OS rate was 83.0%. The results of the KEYNOTE-010 study indicates that pembrolizumab can be a new standard of care in the second-line or later treatment for PD-L1 positive advanced NSCLC patients. |
|
在线阅读
查看全文 查看/发表评论 下载PDF阅读器 |