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Observational Study
. 2019 Jul;10(7):1521-1532.
doi: 10.1111/1759-7714.13090. Epub 2019 May 29.

Real-world data on EGFR/ALK gene status and first-line targeted therapy rate in newly diagnosed advanced non-small cell lung cancer patients in Northern China: A prospective observational study

Hongge Liang  1 , Xia Song  2 , Yuhui Zhang  3 , Shucai Zhang  4 , Fang Li  5 , Jian Fang  6 , Junling Li  7 , Li Liang  8 , Ligong Nie  9 , Kewei Ma  10 , Liangming Zhang  11 , Xiaohong Wang  12 , Junjun Xu  2 , Yanxia Wei  3 , Jinghui Wang  4 , Qi Song  5 , Guangming Tian  6 , Yuxin Mu  7 , Yangchun Gu  8 , Lei Yang  10 , Ping Sun  11 , Wei Zhong  1 , Jing Zhao  1 , Yan Xu  1 , Minjiang Chen  1 , Mengzhao Wang  1
Affiliations
Observational Study

Real-world data on EGFR/ALK gene status and first-line targeted therapy rate in newly diagnosed advanced non-small cell lung cancer patients in Northern China: A prospective observational study

Hongge Liang et al. Thorac Cancer. 2019 Jul.

Abstract

Background: Tyrosine kinase inhibitors (TKIs) can significantly prolong overall survival for patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR)-mutation or anaplastic lymphoma kinase (ALK)-rearrangement. However, the real-world evaluation status of ALK/EGFR in China remains unclear.

Methods: We conducted a prospective study including 1134 patients with cytologically or histologically confirmed advanced NSCLC (stage IIIb-IV) at 12 Chinese hospitals.

Results: The most common evaluation methods were amplification-refractory mutation system for EGFR status and immunohistochemistry targeting D5F3 for ALK status. Among patients with non-squamous, the EGFR mutation rate was 44.1% and the ALK rearrangement rate was 10.0%. Among patients with squamous cell carcinoma, the EGFR mutation rate was 8.3% and the ALK rearrangement rate was 3.7%. Among all patients, gender (HR = 1.7, 95%CI = 1.2-2.4, P = 0.006), smoking history (HR = 1.8, 95%CI = 1.3-2.7, P = 0.001), histology (HR = 5.0, 95%CI = 2.4-10.1, P < 0.001), and brain metastases (HR = 1.5, 95%CI = 1.1-2.2, P = 0.017) were independent predictors of EGFR mutation, while age (HR = 2.6, 95%CI = 1.7-4.1, P < 0.001) was an independent predictor of ALK rearrangement. The median time from tumor diagnosis to EGFR or ALK status confirmation was 7 and 5 days, respectively. Targeted therapy rate was 73.8% in EGFR-positive patients and 51.4% in ALK-positive patients. There was a negative correlation between the first-line targeted therapy rate and the EGFR mutation detection period (r = -0.152, P = 0.02), while no significant correlation among patients with ALK rearrangement (r = -0.179, P = 0.076).

Conclusion: Squamous NSCLC patients should also be routinely tested to determine their EGFR/ALK statuses. The first-line targeted therapy rate remains low in Chinese patients with NSCLC.

Keywords: ALK rearrangement; EGFR mutation; evaluation status; non-small cell lung cancer.

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