Shah Riyaz, Girard Nicolas, Nagar Saurabh P, Griesinger Frank, Roeper Julia, Davis Keith L, Karimi Parisa, Sawyer William, Yu Ning, Taylor Aliki, Feliciano Josephine
Kent Oncology Centre, Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Hermitage Lane, Maidstone, ME16 9QQ, UK.
Thorax Institute Curie Montsouris, Institute Curie, Paris, France.
Drugs Real World Outcomes. 2021 Dec;8(4):537-545. doi: 10.1007/s40801-021-00261-8. Epub 2021 Sep 17.
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) are the preferred first-line (1L) therapy for EGFR mutation-positive (EGFRm) advanced/metastatic non-small cell lung cancer (NSCLC).
Our objective was to describe real-world treatment patterns and T790M testing practices in patients with 1L disease progression (Europe/USA) following treatment with first- or second-generation EGFR-TKIs.
This was a retrospective, non-interventional medical record review of patients with EGFRm locally advanced/metastatic NSCLC from routine clinical practice (EGFR-TKI initiation: 1 January 2015 to 31 December 2017; follow-up: last available medical record). Endpoints were demographic/clinical characteristics, incidence of central nervous system (CNS) metastases/leptomeningeal disease, second-line (2L) treatment, T790M mutation testing, and osimertinib treatment prevalence.
Among 469 patients, 73% (n = 341/469) progressed on 1L EGFR-TKI treatment. Of those who progressed, 74% (n = 252/341) were tested for T790M, with 50% (n = 126/252) testing positive; 75% (n = 94/126) of T790M-positive patients received osimertinib (mostly 2L). Of the patients with progression, 24% (n = 83/341) did not receive 2L treatment, and 88% (n = 73/83) of these patients died. At diagnosis of advanced disease, 9% of patients (n = 41) had CNS metastases; at EGFR-TKI initiation, 14% of patients (n = 68) had CNS metastases. Over the study period, 11% of patients (n = 42) developed CNS metastases not detected at NSCLC diagnosis.
Rates of resistance mutation testing and subsequent utilization of recommended 2L therapies could be improved. As more targeted therapies are developed, it will be crucial to improve the molecular testing rates to ensure patients receive appropriate, effective, and timely treatment.
表皮生长因子受体（EGFR）酪氨酸激酶抑制剂（TKIs）是EGFR突变阳性（EGFRm）的晚期/转移性非小细胞肺癌（NSCLC）的首选一线治疗方案。
我们的目的是描述在接受第一代或第二代EGFR-TKIs治疗后出现一线疾病进展（欧洲/美国）的患者的真实世界治疗模式和T790M检测情况。
这是一项对来自常规临床实践的EGFRm局部晚期/转移性NSCLC患者的回顾性、非干预性病历审查（EGFR-TKI起始时间：2015年1月1日至2017年12月31日；随访：最后可获得的病历）。终点指标包括人口统计学/临床特征、中枢神经系统（CNS）转移/软脑膜疾病的发生率、二线治疗、T790M突变检测以及奥希替尼治疗的普及率。
在469例患者中，73%（n = 341/469）在一线EGFR-TKI治疗中出现进展。在出现进展的患者中，74%（n = 252/341）接受了T790M检测，其中50%（n = 126/252）检测呈阳性；T790M阳性患者中有75%（n = 94/126）接受了奥希替尼治疗（大多为二线治疗）。在出现进展的患者中，24%（n = 83/341）未接受二线治疗，这些患者中有88%（n = 73/83）死亡。在晚期疾病诊断时，9%的患者（n = 41）有CNS转移；在开始使用EGFR-TKI时，14%的患者（n = 68）有CNS转移。在研究期间，11%的患者（n = 42）出现了在NSCLC诊断时未检测到的CNS转移。
耐药突变检测率以及推荐的二线治疗的后续使用率有待提高。随着更多靶向治疗药物的研发，提高分子检测率对于确保患者获得适当、有效和及时的治疗至关重要。
