Real‐World Data on Prognostic Factors for Overall Survival in EGFR Mutation‐Positive Advanced Non‐Small Cell Lung Cancer Patients Treated with First‐Line Gefitinib

AbstractBackground.This study aimed to identify independent prognostic factors for overall survival (OS) of patients with advanced non‐small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation and receiving gefitinib as first‐line treatment in real‐world practice.Materials and Methods.We enrolled 226 patients from June 2011 to May 2013. During this period, gefitinib was the only EGFR‐tyrosine kinase inhibitor reimbursed by the Bureau of National Health Insurance of Taiwan.Results.The median progression‐free survival and median OS were 11.9 months (95% confidence interval [CI]: 9.7–14.2) and 26.9 months (21.2–32.5), respectively. The Cox proportional hazards regression model revealed that postoperative recurrence, performance status (Eastern Cooperative Oncology Grade [ECOG] ≥2), smoking index (≥20 pack‐years), liver metastasis at initial diagnosis, and chronic hepatitis C virus (HCV) infection were independent prognostic factors for OS (hazard ratio [95% CI] 0.3 [0.11–0.83], p = .02; 2.69 [1.60–4.51], p < .001; 1.92 [1.24–2.97], p = .003; 2.26 [1.34–3.82], p = .002; 3.38 [1.85–7.78], p < .001, respectively). However, brain metastasis (BM) at initial diagnosis or intracranial progression during gefitinib treatment had no impact on OS (1.266 [0.83–1.93], p = .275 and 0.75 [0.48–1.19], p = .211, respectively).Conclusion.HCV infection, performance status (ECOG ≥2), newly diagnosed advanced NSCLC without prior operation, and liver metastasis predicted poor OS in EGFR mutation‐positive advanced NSCLC patients treated with first‐line gefitinib; however, neither BM at initial diagnosis nor intracranial progression during gefitinib treatment had an impact on OS.Implications for Practice.The finding that chronic hepatitis C virus (HCV) infection might predict poor overall survival (OS) in epidermal growth factor receptor mutation‐positive advanced non‐small cell lung cancer (NSCLC) patients treated with first‐line gefitinib may raise awareness of benefit from anti‐HCV treatment in this patient population. Brain metastasis in the initial diagnosis or intracranial progression during gefitinib treatment is not a prognostic factor for OS. This study, which enrolled a real‐world population of NSCLC patients, including sicker patients who were not eligible for a clinical trial, may have impact on guiding usual clinical practice.

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