替莫唑胺联合全脑放疗治疗脑转移瘤的疗效评价

Efficacy evaluation of radiotherapy and temozolomide in patients with brain metastases

目的:评价替莫唑胺联合全脑放疗治疗脑转移瘤患者的疗效及安全性。方法:将55例脑转移瘤患者(转移灶>3个)随机分为替莫唑胺联合放疗组及放疗组。替莫唑胺联合放疗组予以常规分割行全脑放疗,DT:40 Gy(2 Gy.d-1,每周5 d),于放疗d1开始给予替莫唑胺口服治疗(75 mg.m-2.d-1),放疗结束后每28 d予以替莫唑胺口服5 d(200 mg.m-2.d-1)化疗,共6周期。放疗组全脑放疗,DT:40 Gy(2 Gy.d-1,每周5 d)。使用Kaplan-Meier方法计算生存率、无进展生存率及生存曲线,组间生存率比较应用Log-rank检验。结果:替莫唑胺联合放疗组与放疗组的客观缓解率分别为76.9%和48.0%(P=0.033);中位生存期分别为8.0和5.5个月,差异达统计学显著性(P=0.025);中位无进展生存期为分别为5.0和3.1个月,差异达统计学显著性(P=0.020)。替莫唑胺联合放疗组发生恶心、呕吐的患者显著高于单纯放疗组,但大部分患者可耐受。结论:替莫唑胺联合全脑放疗有可能提高脑转移瘤患者的局部控制及远期生存,且耐受性良好。

Objective： To assess the efficacy and safety of temozolomide combined with radiotherapy in patients with brain metastases.Methods： Fifty-five patients with more than three brain metastases were randomized to oral temozolomide（75mg·m-2·d-1） combined with 40-Gy fractionated conventional external-beam radiotherapy（2Gy·d-1,5 days per week） for 4 weeks versus 40-Gy radiotherapy alone.In the group receiving combined therapy,patients took temozolomide（200mg·m-2·d-1） for 5 days for six cycles of 28 days after radiotherapy.Overall and progression-free survival curves were estimated by Kaplan-Meier technique and compared by two-sided log-rank test.Results： The objective response rate was significantly improved in patients receiving temozolomide＋radiotherapy versus radiotherapy alone（76.9% vs 48.0%,P=0.033）.The median overall survival and median progression-free survival were 5.5 vs 8.0 months（P=0.025） and 3.1 vs 5.0 months（P=0.020） for the radiotherapy-alone and the combined groups,respectively.Daily temozolomide combined with radiotherapy was generally well tolerated;however,nausea and vomiting were significantly increased in combined group.Conclusion： Temozolomide is safe,and shows significant improvements in response rate,progression-free survival and overall survival when administered in combination with radiotherapy in patients with brain metastases.