厄洛替尼治疗晚期非小细胞肺癌的临床研究

Clinical study on the efficacy and safety of erlotinib in treatment of advanced non-small cell lung cancer

目的：探讨厄洛替尼单药二线或三线治疗晚期非小细胞肺癌的疗效与不良反应。方法：研究对象为2005年10月-2006年9月曾经接受过1～2个化疗方案治疗失败或复发的ⅢB／Ⅳ期的非小细胞肺癌患者，给予厄洛替尼口服150mg／d，直至疾病进展；观察疗效和不良反应，并进行随访。应用Kaplan—Meier法进行生存分析。结果：共有50例患者入组，随访至2007年9月20日，中位随访时间为17个月，随访率为100％。50例患者中有3例不可评价疗效，其余患者中完全缓解占0％（0／47）、部分缓解占38．3％（18／47）、疾病稳定占44．7％（21／47）、疾病进展占17．0％（8／47）；疾病控制率为83．0％；中位疾病进展时间和中位生存时间分别为7．0和13．7个月；1年无肿瘤进展生存率和1年生存率分别为30％和56％。Ⅱ-Ⅲ度皮疹患者的肿瘤缓解率与疾病控制率要显著高于0-Ⅰ度的皮疹患者，部分缓解和疾病稳定患者的生存受益要明显优于疾病进展患者。Ⅲ度以上皮疹的发生率为4％（2／50）。结论：给予既往化疗失败的晚期非小细胞肺癌患者单药厄洛替尼治疗是有效的，且耐受性良好。患者的生存期不受性别、吸烟状态和病理组织类型的影响，皮疹严重度为Ⅱ度或以上的患者的疗效似乎更佳。

Objective： To investigate the efficacy and adverse reaction of erlotinib as a single agent in 2nd and 3rd treatment of advanced non-small cell lung cancer （NSCLC） patients. Methods： Patients with advanced NSCLC （ Ⅲ B/Ⅳ stage） were recruited in this study. They had recurrence after receiving at least one or two regimens of platinum-based chemotherapy from October 2005 to September 2006. Erlotinib was given orally to the patients at 150 mg/d, once daily until disease progression. The clinical outcome and adverse reaction were observed. Patients were followed up. Kaplan-Meier method was used to perform survival analysis. Results： Fifty NSCLC patients were enrolled into the study and followed up until September 20, 2007. The median follow-up period was 17 months and the follow-up ratio was 100%. The clinical outcome could not be evaluated in 3 patients. There was no patient with complete response （0%, 0/47 ）, 38.3% patients with partial response （ 18/47）, 44.7% patients with stable disease （21/47） and 17.0% patients with progressive disease （ 8/47 ）. Disease control rate was 83.0% （59/47）. Median time to progression and median overall survival period were 7.0 and 13.7 months, respectively. One year progression-free survival rate and 1-year overall survival rate were 30% and 56%, respectively. Patients with Ⅱ to Ⅲ grade skin rash had higher response rate and disease control rate than those with 0 to Ⅰ grade. The patients with partial response and stable disease obtained superior survival benefit than those with progressed disease. The occurence rate of skin rash over grade m was 4% （2/50） Conclusion： Erlotinib as a single agent is effective in the treatment of advanced NSCLC patients after failure of chemotherapy. The tolerance is well. The survival time is not dependent on gender, smoking status, and pathological classification. The patients with severe skin rash （ 〉 grade Ⅱ） achieves better.