Abstract
BackgroundTyrosine 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.MethodsWe conducted a prospective study including 1134 patients with cytologically or histologically confirmed advanced NSCLC (stage IIIb–IV) at 12 Chinese hospitals.ResultsThe 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).ConclusionSquamous 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.
Highlights
Lung cancer has become one of the most common cancers worldwide, with high morbidity and mortality rates as most patients are not eligible for radical surgery at the time of diagnosis
The first-line targeted therapy rate remains low in Chinese patients with non-small cell lung cancer (NSCLC)
Fu et al.[16] recruited 487 lung cancer patients who underwent testing for anaplastic lymphoma kinase (ALK) rearrangement at Sun Yat-sen University Cancer Center, and found that the ALK rearrangement rate was 9.0% (44/487), and that ALK-rearranged NSCLC tended to occur in younger individuals who were either non-smokers or light smokers with adenocarcinoma
Summary
Lung cancer has become one of the most common cancers worldwide, with high morbidity and mortality rates as most patients are not eligible for radical surgery at the time of diagnosis. Pan et al.[13] analyzed 176 NSCLC patients treated at the First Affiliated Hospital of Wenzhou Medical College, and observed that the total mutation rate of the EGFR gene in exons 19, 20, and 21 was 48.3% (85/176) They further identified several factors, including female gender, adenocarcinoma, distant metastasis, and the chemotherapy, that may increase the probability of EGFR gene mutations. Zhou et al.[15] analyzed EGFR mutations of 261 patients with pathologically confirmed NSCLC from West China Hospital, and observed that the EGFR mutation rate was 48.7%, with smoking status and pathological types as independent predictors. 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.
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