| 王 谨,莫 淼,季永领.帕博利珠单抗联合同步放化疗治疗不可切除的Ⅲ期NSCLC的疗效和安全性：KEYNOTE-799研究及2年随访数据解读[J].肿瘤学杂志,2022,28(11):972-981. |
| 帕博利珠单抗联合同步放化疗治疗不可切除的Ⅲ期NSCLC的疗效和安全性：KEYNOTE-799研究及2年随访数据解读 |
| The Summary of KEYNOTE-799 Study： Pembrolizumab Plus Concurrent Chemoradiation Therapy in Patients with Unresectable， Locally Advanced， Stage Ⅲ Non-small Cell Lung Cancer |
| 投稿时间：2022-11-25 |
| DOI：10.11735/j.issn.1671-170X.2022.11.B015 |
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| 中文关键词: 帕博利珠单抗 同步放化疗 非小细胞肺癌 客观缓解率 肺炎 |
| 英文关键词:pembrolizumab concurrent chemoradiation therapy non-small cell lung cancer objective response rate pneumonits |
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| 中文摘要: |
| 摘 要：KEYNOTE-799研究近期更新了2年生存结果。这是一个由10个国家52个研究中心参与的非随机Ⅱ期研究，旨在研究帕博利珠单抗联合同步放化疗治疗不可切除的Ⅲ期NSCLC的疗效，其主要研究终点为客观缓解率（ORR）和3级及以上肺炎的发生率。研究共纳入216例不可切除的局部晚期非小细胞肺癌（NSCLC）患者，其中112例患者进入A队列（鳞癌和非鳞NSCLC），104例患者进入B队列（非鳞NSCLC）（2022ASCO更新时变为102例）。两组在给予帕博利珠单抗+化疗诱导治疗1个周期后行帕博利珠单抗联合同步放化疗，接着行帕博利珠单抗巩固治疗。结果显示，A队列ORR为71.4%，疾病控制率（DCR）达到88.4%；B队列ORR为75.5%，DCR达到93.1%。A队列中位PFS为 30.6 个月，2年PFS率55.3%；B队列中位PFS未达到，2年PFS率为60.6%。两队列的中位OS和缓解持续时间都未达到。KEYNOTE-799进行了免疫联合同步放化疗的尝试，有望使更多不可切除的局部晚期NSCLC患者接受免疫治疗。 |
| 英文摘要: |
| Abstract： The results of KEYNOTE-799 was recently updated. It was a non-randomizcd stageⅡ study that 52 centres in 10 countries participated in and investigated pembrolizumab plus concurrent chemoradiation therapy(CCRT) in patients with unresectable stage Ⅲ non-small cell lung cancer(NSCLC). The primary endpoint was the objective response rate(ORR) and the incidence of grade ≥3 pneumonitis. KEYNOTE-799 enrolled a significantly larger cohort with 216 patients. Cohort A enrolled 112 patients(squamous and non-squamous histology). Cohort B enrolled 102 patients(non-squamous). Both cohorts were given pembrolizumab plus CCRT after 1 cycle of pembrolizumab plus chemotherapy， then pembrolizumab was performed for the further therapy. ORR and disease control rate(DCR) were 71.4% and 88.4% in cohort A and 75.5% and 93.1% in cohort B， respectively. Median duration of response and OS were not reached(NR) in both cohorts；median PFS was 30.6 months in cohort A， and NR in cohort B and 2-years PFS rate was 55.3% in cohort A and NR in cohort B. The result of KEYNOTE-799 might imply the advent of trimodal therapy by introducing pembrolizumab to CCRT in unresectable， locally advanced， stage Ⅲ NSCLC. |
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