替莫唑胺与福莫司汀治疗恶性脑胶质瘤的临床观察

目的:比较替莫唑胺(TMZ)与福莫司汀(Fotemustine)治疗恶性脑胶质瘤的疗效、生存期及不良反应。方法:56例首次术后脑胶质瘤患者随机分为TMZ组和福莫司汀组各28例,两组患者均给予常规放疗,2Gy/d,5d/w,共持续6-7w,射线总剂量60-66Gy。放疗结束后1周开始化疗。TMZ组在放疗期间每日口服替莫唑胺75mg/m2,放疗结束后4周,继续口服TMZ(150-200)mg/(m2.d),5d/w,每5天为1个疗程,每疗程间隔23天,28天为1个治疗周期,根据患者耐受情况给药4-6个周期。福莫司汀组给予100mg/m2静脉滴注,每周1次连续3周,停药5周,维持期治疗每3周静脉注射1次,共4-6次。结果:TMZ组近期疗效(CR+PR)明显优于福莫司汀组(78.6%vs 50%,P<0.05);TMZ组1、2、3年生存率分别是71.4%(20/28)、39.3%(11/28)、28.6%(8/28),中位生存期22个月。Fotemustine组1、2、3年生存率分别是57.1%(16/28)、32.1%(9/28)、17.9%(5/28),中位生存期12个月。两组比较无显著差异(P>0.05),但有提高生存率的趋势。TMZ组恶心、呕吐及骨髓抑制程度明显低于福莫司汀组(P<0.001),而急慢性脑损伤无显著性差异(P>0.05)。结论:TMZ比福莫司汀可更明显地缩小肿瘤体积,提高近期疗效,有延长患者生存期的趋势,不良作用少,值得临床推广应用。

Clinical observation of temozolomide and fotemustine in treating patients with malignant gliomas

Objective:To compare the therapeutic effect,survival and safety of malignant gliomas patients treated with temozolomide(TMZ) and fotemustine.Methods: A total of 56 postoperative patients with malignant glioma were randomly divided into two groups: TMZ treatment and Fotemustine treatment group.All patients were performed conventional radiotherapy,2Gy/d,5d/W,6-7weeks as a treatment course,for a total of 60-66Gy.The patients of TMZ group were given daily oral temozolomide 75mg/m2 during radiotherapy.4 weeks after radiotherapy,all of the patients received 4-6 cycles of Temozolomide(150-200)mg/m2.The fotemustine group received fotemustine 100mg/m2 every week during the radiotherapy for 3 weeks.Then followed after a 5-week rest period by fotemustine 100mg/m2 every 3 weeks for 4-6 cycles.Results: The overall response rates(CR+PR) of the TMZ group and control group separately were 78.6% and 50%,there was significant difference between the two groups(P<0.05).The 1,2 and 3 year survival rates of patients in the TMZ group were 71.4%,39.3%,28.6%,and 57.1%,32.1%,17.9% in Fotemustine group.The median recurrent period in the TMZ group were 22 and 12 months in control group,and also with no singnificant difference(P=0.013).The happening rate of vomitting and myelotoxicity in TMZ group was lower than that in Fotemustine group(P<0.001).But the acute and late toxicity of brain was similar in 2 groups(P>0.05).Conclusion: TMZ can improve the local control rate and maybe hopeful to prolong the survival rate with less side effect compared to Fotemustine in patients with malignant gliomas.