吉非替尼与多西紫杉醇二线治疗晚期非小细胞肺癌

Gefitinib and Docetaxol as Second-line Therapy for Patients with Advanced Non-small Cell Lung Cancer

[目的]分析比较吉非替尼与多西紫杉醇单药,在一线治疗失败的晚期非小细胞肺癌(NSCLC)患者中的有效性和安全性。[方法]回顾性分析北京协和医院2002年4月1日～2006年6月1日期间标准一线化疗失败的78例晚期NSCLC患者的临床资料,患者接受吉非替尼口服或多西紫杉醇单药治疗,其中吉非替尼组44例,多西紫杉醇组34例。采用Kaplan-Meier方法和Log-Rank分析比较两组患者无疾病进展生存时间(PFS)和中位生存时间(MS)。[结果]吉非替尼组客观有效率明显高于多西紫杉醇组,分别为29.5%和2.9%;疾病控制率相近,分别为72.7%和70.6%。吉非替尼组和多西紫杉醇组患者的MS分别为17.5个月(95%CI:9.3～25.7)和26.8个月(95%CI:15.1～38.5)(χ2=3.35,P=0.0672);中位PFS分别为9.8个月(95%CI:6.2～13.4)和4.4个月(95%CI:2.5～6.3)(χ2=11.33,P=0.0008)。吉非替尼组和多西紫杉醇组1年生存率分别为56%和74%。多西紫杉醇组3/4级血液学毒性反应高达58.8%,吉非替尼组未观察到3/4级血液学毒性。[结论]吉非替尼作为晚期NSCLC患者的二线治疗药物,客观有效率及PFS明显高于多西紫杉醇组,且有更高的安全性。

[Purpose] To compare the efficacy and safety of gefitinib and docetaxol as second-line therapy for patients with advanced non-small cell lung cancer （NSCLC） in Peking Union Medical College Hospital. [Methods ] From 2002-4-1 to 2006-6-1, 78 cases with advanced NSCLC patients, who failed to standard first-line chemotherapy, received oral gefitinib（n=44） or docetaxol single agent chemotherapy（n=34）. Median survival （MS） was analysed with Kaplan-Meier and Log-Rank method. [Results] Partial remission （PR） （29.5%） in gefitinib group was significantly higher than that in docetaxol group （2.9%）; while disease control rate was similar, 72.7% and 70.6% respectively. MS was 17.5 months （95%CI：9.3-25.7） in gefitinib group and 26.8 months （95% CI：15.1- 38.5） in docetaxol group without significant difference（Х^2=3.35,P=0.0672）. PFS in gefitinib group and in docetaxol group was 9.8 months （95% CI： 6.2-13.4） and 4.4 months （95%CI： 2.5-6.3） respectively, with significant difference （Х^2=11.33, P=0.0008）. One-year survival rate in gefitinib group and in docetaxol group was 56% and 74% respectively. Severe toxicity was not found in gefitinib group, while grade 3/4 hematologic toxicity was 58.8% in docetaxol group. [Conclusion] Gefitinib as second-line treatment for NSCLC may be well tolerated and has better PR and PFS.