厄洛替尼治疗晚期非小细胞肺癌156例临床观察

Clinical Observation of Erlotinib in the Treatment for 156 Cases with Advanced Non-small Cell Lung Cancer

目的观察厄洛替尼治疗晚期非小细胞肺癌(NSCLC)的疗效及安全性。方法对156例晚期非小细胞肺癌使用厄洛替尼每次150 mg/d,直到病变进展或出现不可耐受的不良反应,观察治疗疗效及安全性。结果可评价疗效156例,完全缓解(CR)1例(0.6%),部分缓解(PR)38例(24.4%),稳定(SD)86例(55.1%),进展(PD)31例(19.9%)。客观有效率为25.0%(39/156),疾病控制率为80.1%(125/156),中位无进展生存期(PFS)为3.5个月,其中腺癌患者中位无进展生存期3.6个月,非腺癌患者为2.7个月。非腺癌患者有效率、疾病控制率及中位PFS显著低于腺癌患者(P<0.05)。男性患者疗效低于女性患者(P=0.028),无皮疹患者疗效低于有皮疹患者(P<0.05),非吸烟患者疗效高于吸烟患者(P=0.032)。最常见的副反应为腹泻(60例,38.5%)及皮疹(129例,82.7%)。结论厄洛替尼治疗晚期非小细胞肺癌具有很好的安全、有效性,不良反应可耐受。

Objective To evaluate the efficacy and safety of Erlotinib in the treatment for advanced non-small cell lung cancer（NSCLC）. Methods A total of 156 cases of NSCLC patients received 150 mg oral doses of erlotinib once daily continuously until disease progression or developing unacceptable toxicity. And the efficacy and safety of Erlotinib for the advanced NSCLC patients were analyzed. Results The efficacy of all the 156 NSCLC patients were evaluated. One cases（0.6%） achieved complete response（CR）,38 cases（24.4%） achieved partial response（PR）,86 cases（55.1%） achieved stable disease（SD）,and 31 cases（19.9%） exhibited progress disease（PD）. The overall response rate（RR） and the disease control rate（DCR） of Erlotinib were 25.0%（39/156） and 80.1%（125/156） respectively. The median progression-free survival（m PFS） was 3.5 months. The median PFS of adenocarcinoma and non-adenocarcinoma was 3.6 months vs 2.7 months. The RR,DCR and m PFS were significantly higher in adenocarcinoma patients than those in non-adenocarcinoma patients（P〈0.05）. The effectivity of erlotinib were significantly higher in rash than no rash. The effectivity of erlotinib was significantly higher in female and non-smokers than male and smokers（P〈0.05）. The common toxicities were rash（129 cases,82.7%） and diarrhea（60 cases,38.5%）. Conclusion Erlotinib is effective and safe in the treatment for advanced NSCLC patients with tolerable toxitity.