1L-TKI 进展后 NSCLC 患者的临床结局：真实世界研究 'LUNGFUL' 的最终结果。

Clinical Outcomes Beyond 1L -TKI Progression in mNSCLC: Final Results of the Real-World Study 'LUNGFUL'.

机构信息

Fourth Oncology Department and Clinical Trials Unit, Henry Dunant Hospital Center, Athens, Greece;

Hematology-Oncology Unit, Fourth Department of Internal Medicine, Attikon University Hospital, National and Kapodistrian University of Athens, Athens, Greece.

出版信息

Anticancer Res. 2023 May;43(5):2243-2258. doi: 10.21873/anticanres.16388.

DOI:10.21873/anticanres.16388

PMID:37097667

Abstract

BACKGROUND/AIM: Real-world data on the EGFR mutational profile upon progression after first/second-generation EGFR-TKI treatment in patients with advanced non-small-cell lung cancer (NSCLC) and treatment strategies employed thereon are needed.

PATIENTS AND METHODS

This observational study was conducted in 23 hospital-based lung cancer Centers in Greece (protocol code: D133FR00126). Ninety-six eligible patients were consecutively enrolled between July-2017 and September-2019. Re-biopsy was performed in 18 of 79 patients who tested T790M-negative in liquid biopsy after progression in the first-line (1L) setting.

RESULTS

Of the study population, 21.9% tested T790M-positive, while 72.9% proceeded to 2L treatment, mainly comprising of a third-generation EGFR-TKI (48.6%), a switch to chemotherapy (30.0%), or chemo-immunotherapy (17.1%). The objective response rate (ORR) in 2L was 27.9% in T790M-negative and 50.0% in T790M-positive patients. Of evaluable patients, 67.2% experienced disease progression; median progression-free survival (PFS) was 5.7 and 10.0 months among T790M-negative and positive patients, respectively. Among T790M-negative patients, longer median PFS and post-progression survival were observed with third-generation EGFR-TKI treatment.

CONCLUSION

Mutational status and treatment strategy were identified as critical determinants of clinical outcomes in the 2L-setting of EGFR-mutated NSCLC patients in real-world settings in Greece, with early diagnosis, appropriate molecular testing and high-efficacy treatments at first lines positively affecting ORR and PFS.

摘要

背景/目的：需要真实世界的数据来了解在接受第一代/第二代 EGFR-TKI 治疗后进展的晚期非小细胞肺癌（NSCLC）患者的 EGFR 突变谱，并了解在此基础上采用的治疗策略。

患者和方法

本观察性研究在希腊的 23 家医院肺癌中心进行（方案编号：D133FR00126）。2017 年 7 月至 2019 年 9 月期间连续纳入了 96 名符合条件的患者。在一线（1L）治疗进展后液体活检中检测到 T790M 阴性的 79 名患者中有 18 名进行了再活检。

结果

研究人群中，21.9%的患者检测到 T790M 阳性，而 72.9%的患者接受了 2L 治疗，主要包括第三代 EGFR-TKI（48.6%）、化疗转换（30.0%）或化疗免疫治疗（17.1%）。在 2L 中，T790M 阴性患者的客观缓解率（ORR）为 27.9%，T790M 阳性患者为 50.0%。在可评估的患者中，67.2%的患者出现疾病进展；T790M 阴性和阳性患者的中位无进展生存期（PFS）分别为 5.7 个月和 10.0 个月。在 T790M 阴性患者中，第三代 EGFR-TKI 治疗观察到更长的中位 PFS 和进展后生存期。