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帕博利珠单抗为基础的治疗方案在放化疗和巩固性度伐利尤单抗治疗后复发/难治性 NSCLC 的临床结局。

Clinical Outcomes With Pembrolizumab-Based Therapies in Recurrent/Refractory NSCLC After Chemoradiation and Consolidative Durvalumab.

机构信息

Department of Thoracic Oncology, The Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.

Department of Thoracic Oncology, The Cleveland Clinic Taussig Cancer Institute, Cleveland, OH.

出版信息

Clin Lung Cancer. 2023 Sep;24(6):e205-e213. doi: 10.1016/j.cllc.2023.04.008. Epub 2023 Apr 23.

Abstract

BACKGROUND

Often, patients with NSCLC experience recurrent/refractory (R/R) disease within 2 years of chemoradiation (CRT) and consolidative durvalumab. Despite prior immune checkpoint inhibitor exposure, immunotherapy with or without chemotherapy is typically initiated if a driver-oncogene is absent. However, there remains a paucity of data regarding the efficacy of immunotherapy in this patient population. Here, we present survival outcomes associated with pembrolizumab for R/R NSCLC.

MATERIALS AND METHODS

We retrospectively assessed adults with NSCLC who received pembrolizumab for R/R disease between January 2016 to January 2023. Primary objective was to estimate OS and PFS in this cohort compared to historical outcomes. Secondary objective was to compare OS and PFS among subgroups.

RESULTS

Fifty patients were evaluated. Median follow-up time was 11.3 months (2.9-38.2). OS was 10.6 months (95% CI, 8.8-19.2); 1-year OS rate 49% (95% CI, 36 - 67%). PFS was 6.1 months (95% CI, 4.7-9.0); 1-year PFS rate 25% (95% CI, 15%-42%). Current smokers had significantly better median OS/PFS as compared to former smokers (NA vs. 10.5 and 9.9 vs. 6.0 months, respectively). The addition of chemotherapy demonstrated an OS benefit (median OS 12.9 vs. 6.0 months) but was not statistically significant.

CONCLUSION

Patients with R/R NSCLC represent a distinct cohort with inferior survival outcomes when compared to those with de novo stage IV disease treated with pembrolizumab-based regimens. Based on our findings, we recommend oncologists exercise caution when considering checkpoint inhibitor monotherapy in the front-line setting for R/R NSCLC, regardless of PD-L1 expression.

摘要

背景

非小细胞肺癌(NSCLC)患者在接受放化疗(CRT)和巩固性 durvalumab 治疗后 2 年内常常出现复发/难治性(R/R)疾病。尽管存在驱动基因,但如果没有驱动基因,通常会在没有免疫检查点抑制剂的情况下开始使用免疫疗法或化疗。然而,对于该患者群体中免疫疗法的疗效,仍然缺乏数据。在这里,我们报告了 pembrolizumab 治疗 R/R NSCLC 的生存结果。

材料和方法

我们回顾性评估了 2016 年 1 月至 2023 年 1 月期间接受 pembrolizumab 治疗 R/R 疾病的 NSCLC 成人患者。主要目的是评估该队列的 OS 和 PFS,并与历史结果进行比较。次要目标是比较亚组之间的 OS 和 PFS。

结果

共评估了 50 例患者。中位随访时间为 11.3 个月(2.9-38.2)。OS 为 10.6 个月(95%CI,8.8-19.2);1 年 OS 率为 49%(95%CI,36%-67%)。PFS 为 6.1 个月(95%CI,4.7-9.0);1 年 PFS 率为 25%(95%CI,15%-42%)。与曾经吸烟者相比,目前吸烟者的中位 OS/PFS 显著改善(NA 与 10.5 和 9.9 与 6.0 个月)。添加化疗显示出 OS 益处(中位 OS 为 12.9 与 6.0 个月),但无统计学意义。

结论

与接受 pembrolizumab 为基础的方案治疗的初诊 IV 期疾病患者相比,R/R NSCLC 患者的生存结果明显较差。基于我们的发现,我们建议肿瘤学家在考虑将检查点抑制剂单药治疗用于 R/R NSCLC 的一线治疗时,无论 PD-L1 表达如何,都要谨慎行事。

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