摘要
目的评价吉非替尼作为二线和二线以上方案治疗晚期非小细胞肺癌（NSCLC）的临床价值。方法符合入组条件的156例患者采用吉非替尼治疗，口服，每天1次，每次250mg，持续服用直到疾病进展或出现不可耐受的毒副反应。结果154例患者可评价疗效，总有效率（RR）为28．6％（44／154），95％口为21．6％～31．6％；临床受益率为89．6％（138／154），95％a为84．8％～94．4％。有效患者的中位缓解时间为7．5个月（95％CI为3．9～12．1个月），中位肿瘤进展时间（TTP）为5．1个月（95％CI为3．4～6．6个月），中位总生存期（OS）为10个月（95％CI为7．9～12．1个月），1年生存率为41．0％（95％CI为33．3％～48．7％）。腺癌患者的有效率显著高于鳞癌患者（P=0．026）。其中，鳞癌患者肿瘤进展的风险是腺癌的1．7倍（95％CI为1．1～2．6，P=0．011）；男性死亡的风险是女性的2．0倍（95％CI为1．0～2．6，P=0．002）。154例患者中，63例（40．9％）患者至少出现了一种药物相关毒副反应，但多数较轻，且可逆，发生率最高的是皮疹（26．3％），多伴发皮肤干燥和瘙痒。结论吉非替尼作为二线及二线以上方案治疗晚期NSCLC有较好的疗效和安全性。
Objective To evaluate the safety and efficacy of gofitinib as second-line or even thirdline treatment for previously treated patients with locally advanced or metastatic non-small cell lung cancer （NSCLC）. Methods 156 patients with locally advanced NSCLC which were about to undergo progression after previous chemotherapy were eligible for this study. The regimen was oral intake of gofitinib 250 mg once daily in the morning or afternoon until the disease progression or toxicity has become intolerable. The drug was provided by AstroZeneca Company by its Expanded Access Program. Results 154 such patients were evaluable for response and toxicity assessment. The overall rate of objective response and disease control was 28.6% （44/154） and 89.6% （138/154）. The median duration of response was 7.5 months. The median time to disease progression （TTP） was 5.1 months and the median overall survival time （OS） 10.0 months. The actuarial 1-year survival was 41.0%. The response rate in adenocarcinoma was significantly higher than that in squamous carcinoma （ P = 0. 026 ）. The risk of disease progression in patients with squamous carcinoma was 1.7 times as much as that of adenocarcinoma patients （ P = 0.011 ）, and the risk of death in male was 2.0 times as much as that in female （P = 0. 002）. At least one of these adverse events would be observed in 40. 9% （63/154） of these patients, which, however was mild and reversible. Conclusion Gefitinib is effective and safe as a second-line or third-line treatment for previously treated patients with locally advanced or metastatic non-small cell lung cancer.
出处
《中华肿瘤杂志》
CAS
CSCD
北大核心
2007年第1期66-69,共4页
Chinese Journal of Oncology
