摘要
目的比较替莫唑胺（TMZ）与司莫司汀（Me—CCNU）治疗复发的胶质母细胞瘤（GBM）和间变性星形细胞瘤（AA）的疗效和安全性。方法本研究为多中心、开放、随机、平行对照试验。入组151例复发GBM或AA患者中，纳入意向性治疗人群（ITT）分析共144例患者，被随机分入TMZ组（79例）和Me-CCNU组（65例）。给药计划：TMZ起始剂量150mg·m-2·d-1（曾接受过化疗者）或200mg·m-2·d-1（未接受过化疗者），连续5d口服给药，每28d为1个治疗周期；Me-CCNU起始剂量150mg·m-2·d-1，1次顿服，每隔28d给药1次；两种药物治疗期均为2～6个月，整个观察期6个月。在治疗完成2、3及6个月时采用MRI或增强CT检查，评估肿瘤缓解情况。评价两组患者无进展生存率（PFS）、总生存率（OS）和与药物相关的不良事件发生率。结果治疗6个月时TMZ组无进展生存率78．87％，Me-CCNU组55．88％，两组比较P〈0．05。总体存活率比较TMZ组96．89％，Me-CCNU组97．30％，两组比较P〉0．05。最终的肿瘤客观评估，TMZ组和Me-CCNU组完全缓解率分别为19．44％和6．38％，部分缓解率分别为26．39％和14．89％，病情稳定率分别为26．39％和34．03％，病情进展率分别为27．78％和44．68％（P〈0．01）。与药物相关的不良事件发生率TMZ、Me-CCNU组分别为29．11％和45．15％（P〈0．05）。结论TMZ在治疗复发性胶质母细胞瘤和间变性星形细胞瘤的疗效方面明显优于Me—CCNU，TMZ有较好的安全性，药物相关不良事件发生率低。
Objective To evaluate the efficacy and safety of temozolomide （TMZ） versus semustine （Me-CCNU） in the treatment of recurrent glioblastoma muhiforme （GBM） or anaplasfic astrocytoma （AA）. Methods A total of 151 patients with recurrent GBM or AA were enrolled into this randomized, muhicentre and open-label study. And 144 patients （intent-to-treat （ITT） population） were assigned randomly into 2 groups. TMZ was given orally at 200 or 150 mg·m-2·d-1 （prior chemotherapy） for 5 days, repeated every 28 days. Me-CCNU was given orally at 150 mg·m-2·d-1 once, repeated every 28 days. The treatment periods were within 2 -6 months and the follow-up period was 6 months. Gadopentetate dimeglumine-magnetic resonance imaging （GD-MRI） or contrast-enhanced computed tomography was performed at 2, 3 and 6 months after treatment to evaluate the image-based progression. Progression-free survival （PFS）, overall survival rates at the end of follow-up period and adverse events rates were evaluated. Results PFS at 6 months was 78.87% in TMZ group and 55.88% in Me-CCNU group （P 〈 0. 05 ）. Overall survival rates at the end of follow-up period were 96. 89% in TMZ group and 97.30% in Me- CCNU group （ P 〉 0. 05）. The objective response rate of TMZ and Me-CCNU groups were complete response （CR） （ 19.44% vs 6. 38% ）, partial response （PR） （ 26. 39% vs 14. 89% ）, stable disease （SD） （26. 39% vs 34. 03% ） and progressive disease （PD） （27. 78% vs 44. 68%, P 〈0. 01 ）. Adverse events rates of TMZ and Me-CCNU were 29. 11% and 45.15% respectively （P 〈 0. 05）. Condusion The efficacy of TMZ for patients with recurrent GBM or AA is better than that of Me-CCNU. And TMZ has an acceptable safety profile and its adverse events are mostly mild.
出处
《中华医学杂志》
CAS
CSCD
北大核心
2013年第3期165-168,共4页
National Medical Journal of China
