Department of Medical Oncology, Jilin Provincial Cancer Hospital, Changchun, China.
Department of Internal Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, China.
Thorac Cancer. 2018 Nov;9(11):1461-1469. doi: 10.1111/1759-7714.12859. Epub 2018 Sep 25.
Before tyrosine kinase inhibitor (TKI) therapy can be administered in patients with advanced non-small cell lung cancer (NSCLC), EGFR mutation testing is required. However, few studies have evaluated the extent of EGFR testing in real-world practice in China.
A multicenter, observational study of EGFR testing in NSCLC patients in North China was conducted. Treatment-naïve patients or those with postoperative recurrent stage IIIB/IV NSCLC were enrolled. The primary objective was EGFR testing rate. Secondary objectives included EGFR mutation status, EGFR testing methods and specimens, factors associated with EGFR testing, and overall survival with or without EGFR testing.
Overall, 2809 patients with stage IIIB/IV NSCLC were enrolled; 90.78% had adenocarcinoma. The EGFR screening rate was 42.54%. EGFR testing rates were higher in tumor samples obtained by lymph node puncture, and in patients with urban medical insurance, adenocarcinoma, non-smokers, or those located in developed cities (all P < 0.001). The EGFR mutation rate was 46.44%. The most commonly used specimens for EGFR testing were biopsy tumor samples (67.53%). PCR-based methods (72.05%), Sanger sequencing (5.36%), and Luminex liquid chip (5.10%) were the most frequently used testing platforms. Similar positive EGFR mutation rates were achieved with different platforms. TKI therapy was the first-line treatment administered to most EGFR-positive patients (56.22%), and chemotherapy in EGFR-negative patients (84.88%). Overall survival was higher in EGFR-tested than in untested patients (27.50 vs. 19.73 months; P = 0.007).
Real-world EGFR testing rates for NSCLC in North China were relatively low because of clinical and social factors, including medical insurance coverage.
在为晚期非小细胞肺癌(NSCLC)患者使用酪氨酸激酶抑制剂(TKI)治疗之前,需要进行 EGFR 突变检测。然而,在中国,很少有研究评估真实世界实践中 EGFR 检测的程度。
在中国华北地区进行了一项多中心、观察性 NSCLC 患者 EGFR 检测研究。纳入未经治疗的患者或术后复发的 IIIB/IV 期 NSCLC 患者。主要目标是 EGFR 检测率。次要目标包括 EGFR 突变状态、EGFR 检测方法和标本、与 EGFR 检测相关的因素以及有无 EGFR 检测的总生存率。
共有 2809 例 IIIB/IV 期 NSCLC 患者入组;90.78%为腺癌。EGFR 筛查率为 42.54%。在经淋巴结穿刺获得的肿瘤标本中以及在具有城市医疗保险、腺癌、不吸烟者或位于发达城市的患者中,EGFR 检测率更高(均 P<0.001)。EGFR 突变率为 46.44%。最常用于 EGFR 检测的标本是活检肿瘤标本(67.53%)。基于 PCR 的方法(72.05%)、Sanger 测序(5.36%)和 Luminex 液体芯片(5.10%)是最常用的检测平台。不同平台的 EGFR 阳性突变率相似。大多数 EGFR 阳性患者(56.22%)接受 TKI 治疗作为一线治疗,而 EGFR 阴性患者(84.88%)接受化疗。EGFR 检测患者的总生存率高于未检测患者(27.50 与 19.73 个月;P=0.007)。
由于包括医疗保险覆盖范围在内的临床和社会因素,华北地区 NSCLC 的真实世界 EGFR 检测率相对较低。