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Title: 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.
Author: Yao ZH, Liao WY, Ho CC, Chen KY, Shih JY, Chen JS, Lin ZZ, Lin CC, Chih-Hsin Yang J, Yu CJ.
Journal: Oncologist; 2017 Sep; 22(9):1075-1083. PubMed ID: 28507206.
Abstract:
BACKGROUND: 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. 摘要 背景. 本研究使用携带有激活的表皮生长因子受体（EGFR）突变基因且在真实世界接受吉非替尼一线治疗的晚期非小细胞肺癌（NSCLC）患者确定总生存期（OS）的独立预后因素。 材料和方法. 本研究从2011年6月至2013年5月共招募226例患者。这期间, 吉非替尼是唯一一种可由台湾中央健康保险局报销的EGFR‐酪氨酸激酶抑制剂。 结果. 中位无进展生存期和中位OS分别为11.9 [95%置信区间（CI）：9.7‐14.2] 和26.9（21.2‐32.5）个月。Cox 比例风险回归模型显示术后复发、体力状态[东部肿瘤协作组评分（ECOG）≥2分]、吸烟指数（≥20包年）、首次诊断时肝转移和慢性丙型肝炎病毒（HCV）感染为OS的独立预后因素[风险比（95% CI）分别为0.3（0.11‐0.83）, p = 0.02；2.69（1.60‐4.51）, p<0.001；1.92（1.24‐2.97）, p = 0.003；2.26（1.34‐3.82）, p = 0.002；3.38 （1.85‐7.78）, p<0.001]。但首次诊断时为脑转移（BM）或吉非替尼治疗期间颅内进展不影响OS [风险比（95% CI）分别为1.266（0.83‐1.93）, p = 0.275；0.75（0.48‐1.19）, p = 0.211]。 结论. 在接受吉非替尼一线治疗的EGFR突变阳性的晚期NSCLC患者中, HCV感染、体力状态（ECOG ≥ 2分）、既往未接受过手术的首次诊断晚期NSCLC和肝转移预测OS不佳, 但首次诊断时BM和吉非替尼治疗期间颅内进展均不影响OS。 对临床实践的提示：慢性HCV感染可能预测接受吉非替尼一线治疗的EGFR突变阳性的晚期NSCLC患者OS不佳, 这将提高该人群通过抗HCV治疗获益的意识。首次诊断时为BM或吉非替尼治疗期间颅内进展不是OS的预后因素。本研究招募真实世界的NSCLC患者人群, 包括不符合临床试验要求的病情较重患者, 对指导常规临床实践可能会有一定影响。

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