■为在中国应用达克替尼一线治疗表皮生长因子受体(EGFR)21L858R突变非小细胞肺癌(NSCLC)患者提供真实证据,并探讨影响疗效和安全性的因素。
■纵向,连续的案例系列,采用混合前瞻性和回顾性数据的多中心研究.主要终点是无进展生存期(PFS),次要终点包括治疗持续时间(DOT),总生存期(OS),客观反应率(ORR),疾病控制率(DCR)和安全性。
■共纳入155例接受一线达克替尼治疗的EGFR21L858R突变患者。这些患者的中位随访时间为20.4个月。在134例具有可评估病变的患者中,ORR为70.9%,DCR为96.3%.中位PFS为16.3[95%置信区间(95%CI),13.7-18.9]个月。多因素Cox回归分析提示基线脑转移(BM)状态[与没有BM:危险比(HR),1.331;95%CI,0.720-2.458;P=0.361]和初始剂量(45mgvs.30mg:HR,0.837;95%CI,0.427-1.641;P=0.604)对中位PFS没有显著影响。中位DOT为21.0个月(95%CI,17.5-24.6),未达到中位OS。64例患者进展后进行基因检测,其中29例(45.3%)患者发生了EGFR20T790M突变.此外,在进展后停止达科替尼治疗的46例患者中,31例(67.4%)患者随后接受了第三代EGFR-酪氨酸激酶抑制剂。最常见的3-4级不良事件是皮疹(10.4%),腹泻(9.1%),口腔炎(7.1%)和甲沟炎(4.5%)。45mg组3-4级皮疹的发生率明显高于30mg组(21.9%vs.7.5%,P=0.042)。
■在中国的EGFR21L858R突变NSCLC患者中,一线达科替尼治疗显示出有希望的疗效和可耐受的不良事件。
UNASSIGNED: To provide real-world evidence for the application of first-line dacomitinib treatment for epidermal growth factor receptor (EGFR) 21L858R mutant non-small cell lung cancer (NSCLC) patients in China and to explore the factors influencing the efficacy and safety.
UNASSIGNED: A longitudinal, consecutive case-series, multicenter study with mixed prospective and retrospective data was conducted. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included duration of treatment (DOT), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and safety.
UNASSIGNED: A total of 155 EGFR 21L858R mutant patients treated with first-line dacomitinib were included. The median follow-up time for these patients was 20.4 months. Among 134 patients with evaluable lesions, the ORR was 70.9% and the DCR was 96.3%. The median PFS was 16.3 [95% confidence interval (95% CI), 13.7-18.9] months. Multivariate Cox regression analysis suggested that the baseline brain metastasis (BM) status [with vs. without BM: hazard ratio (HR), 1.331; 95% CI, 0.720-2.458; P=0.361] and initial doses (45 mg vs. 30 mg: HR, 0.837; 95% CI, 0.427-1.641; P=0.604) did not significantly affect the median PFS. The median DOT was 21.0 (95% CI, 17.5-24.6) months and the median OS was not reached. Genetic tests were performed in 64 patients after progression, among whom 29 (45.3%) patients developed the EGFR 20T790M mutation. In addition, among the 46 patients who discontinued dacomitinib treatment after progression, 31 (67.4%) patients received subsequent third-generation EGFR-tyrosine kinase inhibitors. The most common grade 3-4 adverse events were rash (10.4%), diarrhea (9.1%), stomatitis (7.1%) and paronychia (4.5%). The incidence of grade 3-4 rash was significantly higher in the 45 mg group than that in the 30 mg group (21.9% vs. 7.5%, P=0.042).
UNASSIGNED: First-line dacomitinib treatment demonstrated promising efficacy and tolerable adverse events among EGFR 21L858R mutant NSCLC patients in China.