摘要
目的:评价晚期非小细胞肺癌(NSCLC)诱导化疗后给予吉非替尼单药维持治疗的临床价值。方法:2002年5月～2005年2月,晚期NSCLC患者根据最后一个化疗方案疗效分为两组,疗效为部分缓解(PR)或稳定(SD)的为吉非替尼维持治疗组,疗效为进展(PD)的为吉非替尼解救治疗组。入组后给予口服吉非替尼治疗,每日1次,每次250mg,持续服用到疾病进展。结果:共有119例患者入组,其中吉非替尼维持治疗组为79例,解救治疗组为40例。维持治疗组总有效率(RR)31.6%(25/77),其中3例CR,解救治疗组RR为27.5%(11/40),两组之间无统计学差异(P=0.645)。吉非替尼维持治疗组的进展时间(TTP)为6.0个月,显著长于解救治疗组的4.0个月(P=0.03)。维持治疗中位生存期(OS)为11.0个月,而解救治疗组的中位OS为7.0个月,二者差异具有统计学意义(P=0.019)。维持治疗组中腺癌患者的有效率显著高于鳞癌患者(39.7%vs.12.5%,P=0.041),TTP也显著长于鳞癌患者(7.5个月vs.3.0个月,P=0.02);女性患者的中位OS显著长于男性患者(18.5个月vs.9.0个月,P=0.002)。毒副作用多数较轻,且可逆,以1、2级为主。结论:吉非替尼作为晚期NSCLC诱导化疗后的维持治疗,有较好的疗效和安全性。与化疗进展后再使用吉非替尼方案相比,化疗未进展时使用能更好地发挥该药的优势,给予患者更大的生存获益。
Objective：To evaluate the efficacy of using gefitinib as maintenance therapy after chemotherapy. Methods：Patients with stage ⅢB/Ⅳ NSCLC were devided into maintenance group achieved partial response or disease stabilization following the last chemotherapy and treatment group achieved progressive disease. Cefitinib was administered at the dose of 250 mg/d. Results： From May 2002 to February 2005, we enrolled 119 patients. Response rate to gefitinib was 31.6% （25/77）in maintenance group and 27.5% （11/40）in treatment group （P = 0. 645 ）. In comparison with patients in treatment group, patients of maintenance group had better time to progression（ median, 6. 0 vs. 4. 0 months ; P = 0. 03 ） and overall survival（ median, 11.0 vs. 7.0 months ; P = 0. 019）. The toxicity profile was mild and there was no significant difference between two groups. Conclusion： Maintenance therapy with gefitinib after chemotherapy was feasible and safe, which produced significantly longer TTP and OS compared to using gefitinib after failure to chemotherapy.
出处
《临床肿瘤学杂志》
CAS
2009年第2期118-122,共5页
Chinese Clinical Oncology
关键词
吉非替尼
非小细胞肺癌
维持治疗
Gefitinib
Non-small cell lung cancer
Sequential administration
