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免疫治疗时代转移性非小细胞肺癌患者的真实世界治疗模式、生物标志物检测及临床结局

Real-world treatment patterns, biomarker testing, and clinical outcomes of metastatic non-small cell lung cancer patients in the immunotherapy era.

作者信息

Apter Lior, Sharman Moser Sarah, Arunachalam Ashwini, Gazit Sivan, Hoshen Moshe, Chodick Gabriel, Siegelmann-Danieli Nava

机构信息

Health Division, Maccabi Healthcare Services, Tel Aviv, Israel.

Department of Health Policy and Management, School of Public Health, Faculty of Health Sciences, Ben-Gurion University of the Negev, Be'er-Sheva, Israel.

出版信息

Front Oncol. 2024 Oct 25;14:1442909. doi: 10.3389/fonc.2024.1442909. eCollection 2024.

Abstract

BACKGROUND

Treatment for first-line (1L) metastatic non-small cell cancer (mNSCLC) changed with the introduction of immunotherapy. We describe treatment utilization and clinical outcomes in a real-world mNSCLC cohort in a 2.7-million-member state-mandated health provider.

METHODS

Newly diagnosed mNSCLC patients initiating systemic anti-cancer treatment (January 2017-December 2020) were identified from the National Cancer Registry. Real-world time on treatment (rwToT) was defined as the length of time between the first and last administration date of treatment. Real-world overall survival (rwOS) was estimated using Kaplan-Meier analysis. Outcomes were assessed at a minimum of 6 months' follow-up (cutoff: 30 June 2021).

RESULTS

Among 843 patients, 85% had adenocarcinoma (NSQ) and 15% had squamous cell carcinoma (SQ) histology: of these, 43% and 26% were women, median age was 67 and 69 years, and 55% and 48% had 0-1 ECOG performance status, respectively (missing: 27% and 30%, respectively). Median follow-up for the entire cohort was 27.1 months (95% CI: 24.7-29.6). NSQ patients with no known EGFR/ALK/ROS1 aberrations received PD-1 inhibitor monotherapy (PDM) ( = 147) or combination (PDC) ( = 194) or platinum-based chemotherapy (PBC, = 133). Median rwToT was 4.5 (95% CI: 3.5-7.6), 5.2 (95% CI: 4.6-7.6), and 2.3 (95% CI: 2.1-3.0) months, respectively; for the subgroup of patients with ECOG PS 0-1, rwToT was 9.4 (95% CI: 5.0-20.8), 7.1 (95% CI: 5.0-10.1), and 2.9 (95% CI: 2.2-4.1) months, respectively. Median rwOS from 1L was 12.5 (95% CI: 9.9-17.9), 14.8 (95% CI: 10.5-19.4), and 9.1 (95% CI: 7.1-11.5) months; for the subgroup of patients with ECOG PS 0-1, median rwOS was 25.1 [95% CI: 14.9-not reached (NR)], 17.6 (95% CI: 14.3-NR), and 11.3 (95% CI: 9.2-21.3) months, respectively. For ECOG PS 0-1 and PD-L1 ≥50% patients, median rwOS was 25.1 months (95% CI: 13.9-NR) and NR for PDM and PDC, respectively. For ECOG PS 0-1 and PD-L1 <50% patients, median rwOS was 14.3 (95% CI: 10.1-NR) and 11.2 (95% CI: 9.1-21.3) months for PDC and PBC, respectively.

CONCLUSION

Our real-world data support the benefit of single-agent PD-1 inhibitor monotherapy for patients with PD-L1 high expression or PD-1 inhibitor combination for all patients diagnosed with mNSCLC with no known EGFR/ALK/ROS1 aberrations, initiating 1L treatment.

摘要

背景

随着免疫疗法的引入,一线(1L)转移性非小细胞癌(mNSCLC)的治疗发生了变化。我们描述了在一个拥有270万成员的州立医疗服务机构中,真实世界mNSCLC队列的治疗使用情况和临床结果。

方法

从国家癌症登记处识别出2017年1月至2020年12月开始进行全身抗癌治疗的新诊断mNSCLC患者。真实世界治疗时间(rwToT)定义为首次和最后一次治疗给药日期之间的时间长度。使用Kaplan-Meier分析估计真实世界总生存期(rwOS)。在至少6个月的随访(截止日期:2021年6月30日)时评估结果。

结果

在843例患者中,85%为腺癌(NSQ)组织学,15%为鳞状细胞癌(SQ)组织学:其中,43%和26%为女性,中位年龄分别为67岁和69岁,55%和48%的ECOG体能状态为0 - 1(缺失值分别为27%和30%)。整个队列的中位随访时间为27.1个月(95%CI:24.7 - 29.6)。无已知EGFR/ALK/ROS1变异的NSQ患者接受PD - 1抑制剂单药治疗(PDM,n = 147)或联合治疗(PDC,n = 194)或铂类化疗(PBC,n = 133)。中位rwToT分别为4.5(95%CI:3.5 - 7.6)、5.2(95%CI:4.6 - 7.6)和2.3(95%CI:2.1 - 3.0)个月;对于ECOG PS 0 - 1的患者亚组,rwToT分别为9.4(95%CI:5.0 - 20.8)、7.1(95%CI:5.0 - 10.1)和2.9(95%CI:2.2 - 4.1)个月。1L治疗后的中位rwOS分别为12.5(95%CI:9.9 - 17.9)、14.8(95%CI:10.5 - 19.4)和9.1(95%CI:7.1 - 11.5)个月;对于ECOG PS 0 - 1的患者亚组,中位rwOS分别为25.1[95%CI:14.9 - 未达到(NR)]、17.6(95%CI:14.3 - NR)和11.3(95%CI:9.2 - 21.3)个月。对于ECOG PS 0 - 1且PD - L1≥50%的患者,PDM和PDC的中位rwOS分别为25.1个月(95%CI:13.9 - NR)和NR。对于ECOG PS 0 - 1且PD - L1<50%的患者,PDC和PBC的中位rwOS分别为14.3(95%CI:10.1 - NR)和11.2(95%CI:9.1 - 21.3)个月。

结论

我们的真实世界数据支持对于所有诊断为无已知EGFR/ALK/ROS1变异且开始1L治疗的mNSCLC患者,PD - L1高表达患者使用单药PD - 1抑制剂治疗有益,或所有患者使用PD - 1抑制剂联合治疗有益。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd19/11543355/84124b9239ee/fonc-14-1442909-g001.jpg

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