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真实世界数据:奥希替尼和铂类化疗治疗 EGFR 突变型 NSCLC 耐药患者的疗效。

Real-World Data About Treatment Outcomes for Patients with EGFR-Mutated NSCLC Resistance to Osimertinib and Platinum-Based Chemotherapy.

机构信息

Department of Medical Oncology, Faculty of Medicine, Kindai University, 377-2 Ohno-higashi, Osaka-Sayama, Osaka, 589-8511, Japan.

Department of Thoracic Medical Oncology, The Cancer Institute Hospital of JFCR, 3-8-31 Ariake, Koto-ku, Tokyo, 135-8550, Japan.

出版信息

Adv Ther. 2023 Oct;40(10):4545-4560. doi: 10.1007/s12325-023-02616-9. Epub 2023 Aug 12.

Abstract

INTRODUCTION

Docetaxel is an established standard therapy after osimertinib and platinum-based doublet chemotherapy (Pt-doublet) for locally advanced or metastatic non-small cell lung cancer (NSCLC) with an epidermal growth factor receptor gene (EGFR) mutation. To facilitate future therapeutic developments in these patients after treatment with osimertinib and Pt-doublet, we estimated the outcomes of currently used post-treatment therapies.

METHODS

Data of patients with NSCLC who received at least one medication after osimertinib and Pt-doublet between April 2008 and August 2021 were extracted from the Medical Data Vision claims database. The duration of treatment (DoT) (first treatment after osimertinib and Pt-doublet) and overall survival (OS) were estimated. The index date was the first day on which the medication was prescribed.

RESULTS

In total, 731 patients (mean age 64 years) were screened. The most frequent post-treatments were docetaxel-based chemotherapy (30.2%), immune checkpoint inhibitor (ICI) alone or in combination (17.2%), first-/second-generation EGFR-tyrosine kinase inhibitors (16.7%), osimertinib (16.3%), and Pt-doublet (5.2%). The median DoT and OS (95% confidence interval) of all post-treatments were 3.5 (3.27, 3.77) and 10.3 (9.3, 12.1) months, respectively, reflecting the median DoT (3.8 months) and OS (10.0 months) of docetaxel-based chemotherapy. Among all post-treatment regimens, ICIs resulted numerically the shortest [2.77 (2.33, 3.00) months] and osimertinib the longest [4.40 (3.47, 5.67) months] median DoT. The median OS was shortest in patients post-treated with ICIs [7.07 (5.40, 9.90) months] and longest in patients rechallenged with Pt-doublet (12.27 months), followed by patients post-treated with osimertinib (11.70 months). In a subset analysis of patients who received first-line osimertinib and second-line Pt-doublet as well as Pt-doublet immediately after osimertinib, those post-treated with ICIs had the shortest median DoT.

CONCLUSION

Given the limited real-world efficacy on EGFR-mutant NSCLC resistant to osimertinib and platinum-based chemotherapy, the development of more highly potent post-treatment therapies is warranted.

摘要

简介

对于表皮生长因子受体(EGFR)基因突变的局部晚期或转移性非小细胞肺癌(NSCLC)患者,在接受奥希替尼和铂类双联化疗(Pt-双联)后,多西他赛是一种既定的标准治疗方法。为了促进这些患者在接受奥希替尼和 Pt-双联治疗后的未来治疗发展,我们评估了目前使用的治疗后治疗的结果。

方法

从 Medical Data Vision 理赔数据库中提取了 2008 年 4 月至 2021 年 8 月期间接受奥希替尼和 Pt-双联治疗后至少接受一种药物治疗的 NSCLC 患者的数据。治疗持续时间(DoT)(奥希替尼和 Pt-双联治疗后的第一次治疗)和总生存期(OS)进行了估计。索引日期是处方药物的第一天。

结果

共筛选出 731 名患者(平均年龄 64 岁)。最常见的治疗后药物为多西他赛为基础的化疗(30.2%)、免疫检查点抑制剂(ICI)单独或联合治疗(17.2%)、第一代/第二代 EGFR 酪氨酸激酶抑制剂(16.7%)、奥希替尼(16.3%)和 Pt-双联(5.2%)。所有治疗后的中位 DoT 和 OS(95%置信区间)分别为 3.5(3.27,3.77)和 10.3(9.3,12.1)个月,反映了多西他赛为基础的化疗的中位 DoT(3.8 个月)和 OS(10.0 个月)。在所有治疗方案中,ICI 组的中位 DoT 最短[2.77(2.33,3.00)个月],奥希替尼组的中位 DoT 最长[4.40(3.47,5.67)个月]。接受 ICI 治疗的患者中位 OS 最短[7.07(5.40,9.90)个月],接受 Pt-双联治疗的患者中位 OS 最长[12.27 个月],其次是接受奥希替尼治疗的患者[11.70 个月]。在接受一线奥希替尼和二线 Pt-双联以及奥希替尼后立即接受 Pt-双联治疗的患者亚组分析中,接受 ICI 治疗的患者中位 DoT 最短。

结论

鉴于 EGFR 突变型 NSCLC 对奥希替尼和铂类化疗耐药的有限的真实世界疗效,需要开发更有效的治疗后治疗方法。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0c70/10499725/0cf49eb67891/12325_2023_2616_Fig1_HTML.jpg

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