靶向药物同步个体化放疗治疗晚期/转移性非小细胞肺癌的Ⅱ期临床研究  

Phase Ⅱ study of epidermal growth factor receptor tyrosine kinase inhibitors concurrent with tailored radiation therapy for patients with advanced or metastatic non-small cell lung cancer

作　　者：王竞[1] 夏廷毅[1] 王颖杰[1] 李宏奇[1] 李平[1] 王济东[1] 常冬姝[1] 刘丽媛[1] 邸玉鹏[1] 王轩[1] 吴伟章[1] 范乃斌[1] 王佐仁[1] 

机构地区：[1]全军肿瘤放疗中心/空军总医院肿瘤放疗科,北京100142

出　　处：《癌症进展》2011年第1期94-101,共8页Oncology Progress

摘　　要：目的探索靶向药物吉非替尼或厄洛替尼同步个体化放疗治疗晚期/转移性非小细胞肺癌(NSCLC)的安全性和有效性,探索肿瘤综合治疗的新模式。方法 21例经病理组织学确诊的Ⅳ期NSCLC接受表皮生长因子受体酪氨酸激酶抑制剂(EGFR-TKIs)吉非替尼或厄洛替尼同步胸部放疗。胸部放疗采用根治性为目的的适形放疗(CRT)和/或伽马射线立体定向放疗(γ-SBRT)。不良反应依据美国国立癌症研究院常见不良反应标准(NCI-CTCAE3.0)评价。主要研究终点为安全性,总生存(OS)和中位生存时间(MST)。次要研究终点为肿瘤局部控制率、肿瘤进展时间(TTP)、无进展生存(PFS)。结果吉非替尼或厄洛替尼同步个体化放疗的皮肤不良反应、消化道反应和血液学不良反应可控,没有导致严重的肺部不良反应。接受胸部放疗计划的患者中位肿瘤靶区容积(GTV)是55 cm^3(范围,5～420 cm^3),GTV边缘中位剂量是70Gy(范围,42～70Gy),中位生物等效剂量(BED)是105Gy(范围,60～119Gy)。EGFR-TKIs中位维持治疗时间是8.1个月(范围,1.9～29.0个月),EGFR-TKIs同步放疗没有发生治疗相关性死亡。中位随访10.0个月(范围,1.1～38.3个月),胸部肿瘤局部控制率为95%,中位TTP为5.8个月(范围,1.2～18.6个月),中位PFS为7.8个月(95%的可信区间,1.7～13.9个月),MST为21.8个月(95%的可信区间,5.3～38.4个月),1年PFS为39%,1年、2年和3年的OS分别为41%、24%和24%。结论靶向药物同步放疗安全有效,可以作为晚期/转移性NSCLC的治疗选择。Objective Phase Ⅱ study of epidermal growth factor receptor tyrosine kinase inhibitors （EGFR-TKIs） concurrent with individualized radiation therapy in patients with stage Ⅳ non-small cell lung eanee （NSCLC）. Methods Patients with histologically or cytologically confirmed advanced or metastatic （ stage Ⅳ ） NSCLC were administrated withEGFR-TKIs （gefitinib or erlotinib） concurrent with the definitive involved-field radiotherapy. Radiotherapy multi-technol- ogies including three-dimensional conformal radiatoion therapy （3D-CRT）, intensity-modified radiation therapy （IMRT）, and gamma ray stereotaetic body radiation therapy （y-SBRT） were comprehensively considered. The dose of synchronous boost to GTV was required to achieve optimal local control and minimal toxicity. The primary endpoints were acute toxicity, overall survival （OS）, and median survival time （MST）. The secondary endpoints included local control rate （LCR）, time to progression （TTP）, and progression-free survival （PFS）. Results Between June 2007 and January 2010, 21 patients with stage IV NSCLC assessable for toxicity and 20 patients were available for efficacy were enrolled. The study demonstrated that the toxicities of skin, digest tract and haematology were manageable. There was no death related to treatment. The median maintenance time of EGFR-TKIs was 0. 1 months （range, 1.9 -29. 0 months）. The median gross target volume （GTV） was 55 cm3 （range, 5 -420cm3）. The median dose at the margin of GTV was 70 Gy （range, 42-70 Gy） and the median biological equivolent dose （BED） was 105 Gy （range, 60 -119 Gy）. With a median fnllnw-up of 10. 0 months, the LCR for thoracic tumor was 95% , and the median TTP was 5.8 months. The median PFS and MST were 7.8 months and 21.8 months, respectively. The 1-year PFS were 39%, and 1-year, 2-year, and 3-year OS were 41% , 24% , and 24% , respectively. Conclusion Gefitinib or erlotinib concurrent with tailored thoracic radiation therapy is safe a

关 键 词：靶向药物 同步放疗 非小细胞肺癌 

分 类 号：R734.2[医药卫生—肿瘤]