Background and objective: Epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) has been widely used as the second- and third-line therapy in patients with advanced non-small cell lung cancer (NSCLC). However, its effect in the first-line treatment is unclear. The aim of this study was to evaluate the efficacy and safety of EGFR-TKI as first-line therapy.
Methods: The clinical characteristics, responses rate, disease control rate and overall survival were retrospectively analyzed in 77 chemonaive patients with advanced NSCLC. All of the patients received oral gefitinib (250 mg/d) or erlotinib (150 mg/d) until disease progression or unacceptable toxicity occurrence.
Results: The overall response rate was 33.8% and the disease control rate was 68.8%. The median progression-free survival and the median survival time were 6.0 months and 8.9 months, respectively. One-year survival rate was 61.4%. Responses correlated significantly with histology, PS score, smoking history, skin rash, EGFR mutations and serum CEA. Histology and skin rash were the independent predictors of survival. Common toxicities were skin rash and mild diarrhea. EGFR-TKI could improve the clinical symptoms and the quality of life.
Conclusion: EGFR-TKI is effective and well tolerated as first-line therapy in patients with advanced NSCLC.
背景与目的: 表皮生长因子受体酪氨酸激酶抑制剂（epidermal growth factor receptor tyrosine kinase inhibitor, EGFR-TKI）已广泛用于晚期非小细胞肺癌的二、三线治疗，但其在一线治疗中的作用尚未明确。本文旨在探讨EGFR-TKI一线治疗晚期非小细胞肺癌的疗效及安全性。
方法: 对77例一线使用EGFR-TKI吉非替尼或厄洛替尼治疗的晚期非小细胞肺癌患者的临床特征、治疗效果及生存时间进行回顾性分析，并对药物副作用与安全性进行评估。
结果: EGFR-TKI一线治疗总有效率为33.8%，疾病控制率为68.8%。中位无进展生存时间为6.0个月，中位生存时间为8.9个月，1年生存率为61.4%。统计学分析显示：病理类型、PS评分、皮疹情况、吸烟史、EGFR突变和血清CEA变化与疗效相关；病理类型和皮疹为影响生存的独立因素。药物不良反应主要表现为皮疹和轻度腹泻。患者服用EGFR-TKI后，疾病相关症状得到缓解，生活质量明显改善。
结论: EGFR-TKI一线治疗晚期非小细胞肺癌安全有效。