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.

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.

• Authors: Hongge Liang, Xia Song, Yuhui Zhang, Shucai Zhang, Fang Li, Jian Fang, Junling Li, Li Liang, Ligong Nie, Kewei Ma, Liangming Zhang, Xiaohong Wang, Junjun Xu, Yanxia Wei, Jinghui Wang, Qi Song, Guangming Tian, Yuxin Mu, Yangchun Gu, Lei Yang, Ping Sun, Wei Zhong, Jing Zhao, Yan Xu, Minjiang Chen, Mengzhao Wang
• Journal: Thoracic cancer (Thorac Cancer) Vol. 10 Issue 7 Pg. 1521-1532 (07 2019) ISSN: 1759-7714 [Electronic] Singapore
• PMID: 31144459 (Publication Type: Journal Article, Multicenter Study, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2019 The Authors. Thoracic Cancer published by China Lung Oncology Group and John Wiley & Sons Australia, Ltd.

Chemical References

• Protein Kinase Inhibitors
• ALK protein, human
• Anaplastic Lymphoma Kinase
• EGFR protein, human
• ErbB Receptors

Topics

• Adult
• Aged
• Aged, 80 and over
• Anaplastic Lymphoma Kinase (genetics, metabolism)
• Carcinoma, Non-Small-Cell Lung (drug therapy, genetics, pathology)
• ErbB Receptors (genetics)
• Female
• Gene Rearrangement
• Humans
• Lung Neoplasms (drug therapy, genetics, pathology)
• Male
• Middle Aged
• Molecular Targeted Therapy
• Mutation
• Neoplasm Staging
• Prospective Studies
• Protein Kinase Inhibitors (therapeutic use)
• Young Adult