Background and objective: Erlotinib is a epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI). The standard dose is 150 mg/d. But some patients have to reduce the dose or stop treatment due to its side effects. The aim of this study is to evaluate the efficacy and safety of erlotinib 100 mg on patients with advanced aden carcinoma lung cancer previously failed to chemotherapy.
Methods: Forty adenocacinoma patients with histologically confirmed diagnosis were enrolled to be given erlotinib 100 mg/d until disease progression or occurrence of intolerable toxicity. Relationships between therapeutic effects of erlotinib, progression-free survival, side effects and the clinical characters were analyzed.
Results: Among 40 patients, 11 got partial response, 14 had a stable disease and 15 had a progressive disease. The total response rate was 27.5%, and the disease control rate was 62.5%. The median progression-free survival was 5.5 months. Fifteen patients were positive for EGFR mutation according to the result of peripheral blood test. The response rate and disease control rate in 15 EGFR-mutation-positive patients were 33.3% and 73.3%, respectively, and the PFS was 8.4 months for 15 patients. The patients with ECOG 0-1 had a significant better PFS than those with ECOG 2 (6.1 vs 3.1 months) (P=0.043). The most frequent toxicities of erlotinib were rash and diarrhea which were easily controlled.
Conclusion: Erlotinib 100 mg is effective and safe in treatment of patients with advanced aden carcinoma, especially for non-smoking patients, patients with good performance status and EGFR-mutation-positive patients.
背景与目的: 厄洛替尼是一种表皮生长因子受体酪氨酸激酶抑制剂，标准治疗剂量为150 mg/天。部分患者因毒副反应导致减量或终止治疗。本研究对厄洛替尼100 mg治疗晚期化疗失败的肺腺癌患者的疗效和安全性进行观察总结。
方法: 40例经病理组织学或细胞学确诊为腺癌的晚期非小细胞肺癌患者，无吸烟史，给予厄洛替尼100 mg/次/天，直至疾病进展或不良反应不能耐受为止，观察疗效、无疾病进展时间、不良反应及与临床特征之间的关系。
结果: 40例患者中，11例部分缓解，14例稳定，15例进展，总缓解率为27.5%，疾病控制率为62.5%。中位无疾病进展时间（progression free survival, PFS）为5.5个月。外周血检测EGFR突变共15例，占37.5%，总缓解率为33.3%，疾病控制率为73.3%，EGFR有突变者的PFS为8.4个月。ECOG评分0分-1分患者中位PFS为6.1个月，ECOG评分2分患者中位PFS为3.1个月，两组差异有统计学意义（P=0.043）。最常见的不良反应是皮疹和腹泻，对症处理后缓解。
结论: 厄洛替尼100 mg治疗晚期肺腺癌有一定的疗效，安全性高，对不吸烟的腺癌患者、体力状况好、伴EGFR突变的患者获益更多。