Ou Sai-Hong Ignatius, Lin Huamao M, Hong Jin-Liern, Yin Yu, Jin Shu, Lin Jianchang, Mehta Minal, Nguyen Danny, Neal Joel W
Division of Hematology-Medical Oncology, Department of Internal Medicine, Chao Family Comprehensive Cancer Center, University of California Irvine School of Medicine, Orange, California.
Global Evidence and Outcomes Oncology, Takeda Development Center Americas, Inc., Lexington, Massachusetts.
JTO Clin Res Rep. 2023 Aug 16;4(10):100558. doi: 10.1016/j.jtocrr.2023.100558. eCollection 2023 Oct.
This study describes treatment patterns and outcomes in patients with NSCLC with EGFR exon 20 insertions () in the United States.
The Flatiron Health electronic health record database was used to select three cohorts among patients diagnosed with NSCLC with (January 1, 2011-February 29, 2020): (1) first-line (1L) or patients receiving 1L therapy after documented ; (2) second or later-line (≥2L) or patients receiving ≥2L therapy after documented ; and (3) ≥2L postplatinum trial-aligned, or ≥2L patients previously treated with platinum chemotherapy whose baseline characteristics aligned with key eligibility criteria (initiating new treatment after documented and ≥1 previous treatment excluding mobocertinib or amivantamab) of the mobocertinib trial NCT02716116. Real-world end points were confirmed overall response rate, overall survival, and progression-free survival.
Of 237 patients with -mutated NSCLC, 129 and 114 patients were included in the 1L and ≥2L cohorts, respectively. In 1L patients, platinum chemotherapy plus nonplatinum chemotherapy (31.0%) and EGFR tyrosine kinase inhibitors (28.7%) were the most common regimens. In ≥2L patients, immuno-oncology monotherapy (28.1%) and EGFR tyrosine kinase inhibitors (17.5%) were the most common index treatments. For any 1L, ≥2L, and ≥2L postplatinum trial-aligned patients, the confirmed overall response rate was 18.6%, 9.6%, and 14.0%, respectively; the median overall survival was 17.0, 13.6, and 11.5 months; the median progression-free survival was 5.2, 3.7, and 3.3 months, respectively.
The outcomes for patients with NSCLC with were poor. This real-world study provides a benchmark on treatment outcomes in this patient population and highlights the unmet need for improved therapeutic options.
本研究描述了美国表皮生长因子受体(EGFR)外显子20插入突变的非小细胞肺癌(NSCLC)患者的治疗模式和结局。
利用Flatiron Health电子健康记录数据库,在2011年1月1日至2020年2月29日期间被诊断为EGFR外显子20插入突变的NSCLC患者中选择三组队列:(1)一线(1L)或在记录到EGFR外显子20插入突变后接受1L治疗的患者;(2)二线或更后线(≥2L)或在记录到EGFR外显子20插入突变后接受≥2L治疗的患者;(3)≥2L铂类治疗后试验匹配组,即先前接受过铂类化疗且基线特征符合莫博替尼试验NCT02716116关键入选标准(在记录到EGFR外显子20插入突变后开始新治疗且既往至少接受过1次除莫博替尼或阿美替尼以外的治疗)的≥2L患者。真实世界终点为确认的总缓解率、总生存期和无进展生存期。
在237例EGFR外显子20插入突变的NSCLC患者中,1L队列和≥2L队列分别纳入了129例和114例患者。在1L患者中,铂类化疗加非铂类化疗(31.0%)和EGFR酪氨酸激酶抑制剂(28.7%)是最常见的治疗方案。在≥2L患者中,免疫肿瘤学单药治疗(28.1%)和EGFR酪氨酸激酶抑制剂(17.5%)是最常见的初始治疗。对于任何1L、≥2L和≥2L铂类治疗后试验匹配组患者,确认的总缓解率分别为18.6%、9.6%和14.0%;中位总生存期分别为17.0个月、13.6个月和11.5个月;中位无进展生存期分别为5.2个月、3.7个月和3.3个月。
EGFR外显子20插入突变的NSCLC患者结局较差。这项真实世界研究为该患者群体的治疗结局提供了一个基准,并突出了对改善治疗选择的未满足需求。