Shi Yuankai, Zhang Xin, Wu Gang, Xu Jianping, He Yong, Wang Dong, Huang Cheng, Chen Mingwei, Yu Ping, Yu Yan, Li Wei, Li Qi, Hu Xiaohua, Xia Jinjing, Bu Lilian, Yin Angela, Zhou Yigong
Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 17 Panjiayuan Nanli, Chaoyang District, Beijing 100021, China.
Respiratory Diseases Department, Zhongshan Hospital Fudan University, Shanghai, China.
Lancet Reg Health West Pac. 2022 Apr 11;23:100452. doi: 10.1016/j.lanwpc.2022.100452. eCollection 2022 Jun.
There are limited studies on treatment and survival analysis among patients with unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC) in routine practice in China. To address this gap, we conducted a prospective observational study in a cohort of patients treated at 11 hospitals in China.
This was a multicentre, prospective cohort study including patients with newly diagnosed unresectable Stage IIIB or IV NSCLC from June 26th, 2015 to April 28th, 2017. Patient baseline characteristics, disease characteristics, and anti-cancer treatments were obtained by medical chart review. The overall survival (OS) from the initiation of first-line treatment was analysed by the Kaplan-Meier method. Factors associated with survival were analysed by univariate and multivariate Cox regression models.
Among 1324 patients enrolled with median follow-up duration of 15·0 (range: 0·0-42·1) months, 83·5% (1105/1324) of them received first-line chemotherapy of which platinum-based compounds were the dominated agents. Overall, 30·9% (409/1324) of patients received targeted therapy as 1st-line treatment including 65·0% (266/409) EGFR-TKIs and 5·1% (21/409) ALK-TKIs. Of all eligible patients, gene testing rates were 44·0% (583/1324) for mutations, 17·0% (225/1324) for gene fusions, and 8·3% (110/1324) for gene fusions. The EGFR-TKIs were administered to 63·9% (179/280) of mutated patients as first-line treatment. The overall median OS was 23·2 (95%CI 19·5-25·5) months, and patients treated at tier 1 cities had better OS than that of tier 2 cities. Also, the OS in patients with mutation was longer than those with wild type. Multivariate Cox regression models suggested that male, education below high school, tier 2 cities, smoking history, and multiple metastases were associated with poor survival.
The gene test coverage was relatively low among the studied population, and over half of mutated patients received EGFR-TKIs, suggesting that the result of genetic tests in real-world settings may not always indicate the selection of treatment. The OS benefit observed from patients treated in tier 1 cities and those with mutation may indicate a need for broader gene test coverage, providing NSCLC patients with personalized treatment according to the results of genetic tests.
Roche Holding AG.TRANSLATED ABSTRACT: This translation in Chinese was submitted by the authors and we reproduce it as supplied. It has not been peer reviewed. Our editorial processes have only been applied to the original abstract in English, which should serve as reference for this manuscript.:IIIBIV(NSCLC)., ,, 11.:,, 20156262017428IIIBIVNSCLC.,.Kaplan-Meier(OS), Cox.:1324, 15.0(:0.0-42.1), 83.5%(1105/1324), ., 30.9%(409/1324), 65.0%(266/409)EGFR-TKI5.1%(21/409)ALK-TKI., EGFR,EML4-ALKROS144.0%(583/1324),17.0%(225/1324)8.3%(110/1324).63.9%(179/280)EGFREGFR-TKI.23.2 (95% 19·5-25·5) , ., EGFREGFR.Cox, ,,,.:, EGFREGFR-TKI, , .EGFR, , NSCLC.
在中国的常规医疗实践中，关于不可切除的IIIB期或IV期非小细胞肺癌（NSCLC）患者的治疗及生存分析的研究有限。为填补这一空白，我们在中国11家医院治疗的一组患者中开展了一项前瞻性观察性研究。
这是一项多中心前瞻性队列研究，纳入了2015年6月26日至2017年4月28日新诊断的不可切除IIIB期或IV期NSCLC患者。通过病历审查获取患者的基线特征、疾病特征和抗癌治疗情况。采用Kaplan-Meier法分析一线治疗开始后的总生存期（OS）。通过单因素和多因素Cox回归模型分析与生存相关的因素。
在1324例入组患者中，中位随访时间为15.0（范围：0.0 - 42.1）个月，其中83.5%（1105/1324）接受了一线化疗，以铂类化合物为主。总体而言，30.9%（409/1324）的患者接受了靶向治疗作为一线治疗，其中65.0%（266/409）为表皮生长因子受体酪氨酸激酶抑制剂（EGFR-TKIs），5.1%（21/409）为间变性淋巴瘤激酶酪氨酸激酶抑制剂（ALK-TKIs）。在所有符合条件的患者中，表皮生长因子受体（EGFR）突变检测率为44.0%（583/1324），棘皮动物微管相关蛋白样4-间变性淋巴瘤激酶（EML4-ALK）基因融合检测率为17.0%（225/1324），ROS1基因融合检测率为8.3%（110/1324）。63.9%（179/280）的EGFR突变患者接受了EGFR-TKIs作为一线治疗。总体中位OS为23.2（95%CI 19.5 - 25.5）个月，在一线城市治疗的患者OS优于二线城市的患者。此外，EGFR突变患者的OS长于EGFR野生型患者。多因素Cox回归模型表明，男性、高中以下学历、二线城市、吸烟史和多发转移与生存不良相关。
在研究人群中基因检测覆盖率相对较低，超过一半的EGFR突变患者接受了EGFR-TKIs治疗，这表明在现实环境中基因检测结果可能并不总是能指导治疗选择。在一线城市治疗的患者和EGFR突变患者观察到的OS获益可能表明需要扩大基因检测覆盖率，根据基因检测结果为NSCLC患者提供个性化治疗。
罗氏控股公司。
本中文翻译由作者提交，我们按提供内容原样转载。未经同行评审。我们的编辑流程仅适用于英文原文摘要，该英文摘要应作为本稿件的参考。：IIIB期或IV期（NSCLC）。……，在中国11家医院。……，2015年6月26日至2017年4月28日，IIIB期或IV期NSCLC患者。采用Kaplan-Meier法（OS），Cox法。1324例，15.0（范围：0.0 - 42.1），83.5%（1105/1324），……，30.9%（409/1324），65.0%（266/409）EGFR-TKI，5.1%（21/409）ALK-TKI。EGFR、EML4-ALK、ROS1，44.0%（583/1324），17.0%（225/1324），8.3%（110/1324）。63.9%（179/280）EGFR突变患者接受EGFR-TKI。23.2（95%CI 19·5 - 25·5）个月，……，EGFR突变患者。Cox法，……，……。：EGFR突变患者，EGFR-TKI，……。EGFR突变患者，……，NSCLC。
