Outcomes to first-line pembrolizumab in patients with PD-L1-high (≥50%) non-small cell lung cancer and a poor performance status
Outcomes to first-line pembrolizumab in patients with PD-L1-high (≥50%) non-small cell lung cancer and a poor performance status
复制标题
DOI：
10.1136/jitc-2020-001007
复制
发表时间：
2020-01-01
影响因子：
10.9
通讯作者：
Awad, Mark
中科院分区：
文献类型：
--
作者：
Alessi, Joao, V;Ricciuti, Biagio;Awad, Mark
背景患有非小细胞肺癌（NSCLC）且东部肿瘤协作组体能状态（ECOG PS）较差的患者已被排除在III期免疫治疗临床试验之外。我们试图评估一线pembrolizumab治疗PD-L1肿瘤比例评分（TPS）>= 50%且ECOG PS为2的晚期NSCLC患者的临床结局。方法我们对接受一线pembrolizumab治疗的转移性NSCLC患者进行了多中心回顾性分析，PD-L1 TPS>= 50%（EGFRandALK基因组改变阴性）。根据ECOG PS比较患者的临床结局。结果234例患者中，83.3%（n=195）的ECOG PS为0或1，16.7%（n=39）的ECOG PS为2。在年龄、性别、烟草使用、组织学、KRAS突变状态、是否存在其他潜在靶向驱动突变（BRAF、MET、HER 2、RET）、是否存在脑转移和PD-L1 TPS分布方面，ECOG PS 0-1组与2组之间的基线临床病理学特征平衡。与ECOG PS为0或1的患者相比，ECOG PS为2的患者的客观缓解率显著较低（43.1% vs 25.6%; p=0.04），中位无进展生存期在数值上较短（6.6个月vs 4.0个月; HR 0.70（95% CI 0.47 - 1.06）; p=0.09），中位总生存期显著缩短（20.3个月vs 7.4个月; HR 0.42（95% CI 0.26至0.68）; p
Background Patients with non-small cell lung cancer (NSCLC) and a poor Eastern Cooperative Oncology Group Performance Status (ECOG PS) have been excluded from phase III immunotherapy clinical trials. We sought to evaluate clinical outcomes to first-line pembrolizumab in patients with advanced NSCLC, a PD-L1 Tumor Proportion Score (TPS) of >= 50%, and an ECOG PS of 2. Methods We performed a multicenter retrospective analysis of patients with metastatic NSCLC and a PD-L1 TPS of >= 50% (negative for genomic alterations inEGFRandALK) who received treatment with first-line pembrolizumab. Clinical outcomes were compared in patients based on ECOG PS. Results Among the 234 patients, 83.3% (n=195) had an ECOG PS of 0 or 1, and 16.7% (n=39) had an ECOG PS of 2. The baseline clinicopathological characteristics were balanced between the ECOG PS 0-1 vs 2 groups in terms of age, sex, tobacco use, histology,KRASmutation status, presence of other potentially targetable driver mutations (BRAF, MET, HER2, RET), presence of brain metastases, and PD-L1 TPS distribution. Compared with patients with an ECOG PS of 0 or 1, patients with an ECOG PS of 2 had a significantly lower objective response rate (43.1% vs 25.6%; p=0.04), a numerically shorter median progression-free survival (6.6 months vs 4.0 months; HR 0.70 (95% CI 0.47 to 1.06); p=0.09), and a significantly shorter median overall survival (20.3 months vs 7.4 months; HR 0.42 (95% CI 0.26 to 0.68); p