吉非替尼联合择期放疗治疗晚期非小细胞肺癌的临床研究

Clinical study of gefitinib combined with selected radiotherapy in advanced non-small cell ：lung cancer

目的观察吉非替尼联合择期放疗治疗晚期非小细胞肺癌（NSCLC）的疗效和不良反应。方法13例晚期NSCLC，应用吉非替尼治疗，对10例吉非替尼治疗获益的患者，根据患者及家属意愿分为联合组和对照组，每组5例，联合组联合放疗，对照组继续单独应用吉非替尼治疗直至病情进展。结果到随访截止日期，全部患者1年生存率达53．8％（7，13），2年生存率达46．2％（6／13）。联合组和对照组的中位无进展生存期（PFS）分别为24个月和8个月（P=0．0019），中位总生存期（OS）分别为32个月和10个月（P=0．0062）。不良反应主要为皮疹和腹泻。无症状性肺纤维化3例。结论吉非替尼联合择期放疗治疗晚期NSCLC可以显著延长PFS和OS，不良反应可以耐受，是NSCLC规范化治疗和个体化治疗的合理选择。

Objective To study the effect and toxicity of gefitinib combined with selected racljotherapy in the treatment of patients with advanced non-small-cell lung cancer （NSCLC）. Methods From March 2006 to February 2009,10 of 13 advanced NSCLC patients who got benefit from gefitinib were enrolled to treatment group （gefitinib concurrent selected radiotherapy） and control group （gefitinib only）, with 5 cases, in each group. The response was evaluated as progression free survival （PFS） and overall survival （OS）. Results No patient got complete remission （CR）. Ten of 13 patients got partial remission （PR） and stable disease （SD）. The 1 year and 2 years survival rate was 53.8%（7/13） and 46.2%（6/13） respectively. The median PFS in treatment group and control group was 24 months and 8 months respectively（P = 0.0019）. The median OS was 32 months and 10 months respectively （P = 0.0062）. The main toxicities were reversible skin rash and diarrhea,and 3 patients developed asymptomatic radiation pulmonary fibrosis. Conclusions Gefitinib combining with selected radiotherapy is effective and tolerated in patients with advanced NSCLC. It may prolong PFS and OS. It may be a rational choice for the standard and individualized treatment of NSCLC.