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免疫疗法在KRAS突变的晚期非小细胞肺癌中的疗效:一项针对中国人群的真实世界研究。

Efficacy of immunotherapy in -mutant advanced NSCLC: A real-world study in a Chinese population.

作者信息

Peng Lixiu, Guo Jun, Kong Li, Huang Yong, Tang Ning, Zhang Juguang, Wang Minglei, He Xiaohan, Li Zhenzhen, Peng Yonggang, Wang Zhehai, Han Xiao

机构信息

Department of Medical Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.

Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China.

出版信息

Front Oncol. 2023 Jan 19;12:1070761. doi: 10.3389/fonc.2022.1070761. eCollection 2022.

Abstract

BACKGROUND

Immunotherapy has improved the clinical outcomes of patients with advanced non-small cell lung cancer (NSCLC). However, in patients with Kirsten rat sarcoma viral oncogene homolog () mutations, the superior efficacy of immunotherapy has not been elucidated and especially in real-world practice. Our study aimed to use real-world data to assess the efficacy of immunotherapy in -mutant NSCLC in a Chinese cohort.

METHODS

In this retrospective cohort study, we extracted the clinical, molecular, and pathologic data from the electronic health records of patients with advanced -mutant NSCLC at Shandong Cancer Hospital between January 2018 and May 2022. Furthermore, we evaluated the progression-free survival (PFS) and overall survival (OS) of the included patients.

RESULTS

Between January 2018 and November 2020, 793 patients were identified with stage IIIB-IV NSCLC and a total of 122 patients with mutations were included in the analysis. The majority of patients were diagnosed with stage IV (82.0%) adenocarcinoma (93.4%), along with a history of smoking (57.4%). Of these, 42% of patients received anti-PD-(L)1 with or without chemotherapy (Immunotherapy-based regimens), while 58.2% of patients received chemotherapy (Chemotherapy-based regimens). The median overall survival (mOS) in this cohort was 22.9 months (95% CI: 14.1-31.7), while the median-progression-free survival (mPFS) was 9.4 months (95% CI: 6.6-12.1). Patients receiving immunotherapy-based regimens displayed better mOS than those receiving chemotherapy-based regimens (45.2 vs. 11.3 months; =1.81E-05), with no statistical difference observed in the mPFS (10.5 vs. 8.2 months; =0.706). Patients receiving immunotherapy-based regimens either in the first line (=0.00038, =0.010, respectively) or second-line setting (=0.010, =0.026, respectively) showed benefits in both PFS and OS. Subgroup analysis indicated that in patients having G12C or non- G12C mutant types, immunotherapy showed benefits of better OS (=0.0037, =0.020, respectively) than chemotherapy. Moreover, in advanced NSCLCs patients with or without co-mutation the immunotherapy-based regimen achieved longer OS and PFS than chemotherapy-based regimens.

CONCLUSIONS

In the Chinese population of patients with -mutant advanced NSCLC, immunotherapy-based regimens achieved longer OS than chemotherapy-based regimens, which was independent of first or second-line setting, as well as mutational subtypes.

摘要

背景

免疫疗法改善了晚期非小细胞肺癌(NSCLC)患者的临床结局。然而,在携带 Kirsten 大鼠肉瘤病毒癌基因同源物()突变的患者中,免疫疗法的卓越疗效尚未得到阐明,尤其是在真实世界实践中。我们的研究旨在利用真实世界数据评估免疫疗法在中国队列携带 - 突变的 NSCLC 患者中的疗效。

方法

在这项回顾性队列研究中,我们从 2018 年 1 月至 2022 年 5 月期间山东肿瘤医院晚期 - 突变 NSCLC 患者的电子健康记录中提取了临床、分子和病理数据。此外,我们评估了纳入患者的无进展生存期(PFS)和总生存期(OS)。

结果

在 2018 年 1 月至 2020 年 11 月期间,共识别出 793 例 IIIB - IV 期 NSCLC 患者,其中 122 例携带 突变的患者纳入分析。大多数患者被诊断为 IV 期(82.0%)腺癌(93.4%),有吸烟史(57.4%)。其中,42%的患者接受了含或不含化疗的抗 PD - (L)1(基于免疫疗法的方案),而 58.2%的患者接受了化疗(基于化疗的方案)。该队列的中位总生存期(mOS)为 22.9 个月(95%CI:14.1 - 31.7),而中位无进展生存期(mPFS)为 9.4 个月(95%CI:6.6 - 12.1)。接受基于免疫疗法方案的患者显示出比接受基于化疗方案的患者更好的 mOS(45.2 个月对 11.3 个月; = 1.81E - 05),mPFS 无统计学差异(10.5 个月对 8.2 个月; = 0.706)。在一线(分别为 = 0.00038, = 0.010)或二线治疗(分别为 = 0.010, = 0.026)中接受基于免疫疗法方案的患者在 PFS 和 OS 方面均显示出获益。亚组分析表明,在携带 G12C 或非 G12C 突变类型的患者中,免疫疗法显示出比化疗更好的 OS(分别为 = 0.0037, = 0.020)。此外,在有或无 共突变的晚期 NSCLC 患者中,基于免疫疗法的方案比基于化疗的方案实现了更长的 OS 和 PFS。

结论

在中国携带 - 突变的晚期 NSCLC 患者群体中,基于免疫疗法的方案比基于化疗的方案实现了更长的 OS,这与一线或二线治疗以及 突变亚型无关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c413/9892536/2ca265ab08a3/fonc-12-1070761-g001.jpg

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