Sun Jian, Yang Xue-jun, Yang Shu-yuan
Department of Neurosurgery, General Hospital, Tianjin Medical University, Tianjin, China.
Zhonghua Yi Xue Za Zhi. 2013 Jan 15;93(3):165-8.
To evaluate the efficacy and safety of temozolomide (TMZ) versus semustine (Me-CCNU) in the treatment of recurrent glioblastoma multiforme (GBM) or anaplastic astrocytoma (AA).
A total of 151 patients with recurrent GBM or AA were enrolled into this randomized, multicentre 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.
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).
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.
评估替莫唑胺（TMZ）与司莫司汀（Me-CCNU）治疗复发性多形性胶质母细胞瘤（GBM）或间变性星形细胞瘤（AA）的疗效和安全性。
151例复发性GBM或AA患者纳入这项随机、多中心、开放标签研究。144例患者（意向性治疗（ITT）人群）随机分为两组。TMZ在化疗前按200或150mg×m⁻²d⁻¹口服5天，每28天重复一次。Me-CCNU按150mg×m⁻²×d⁻¹口服一次，每28天重复一次。治疗期为2至6个月，随访期为6个月。治疗后2、3和6个月进行钆喷酸葡胺磁共振成像（GD-MRI）或增强计算机断层扫描以评估基于影像学的进展情况。评估无进展生存期（PFS）、随访期末的总生存率和不良事件发生率。
TMZ组6个月时的PFS为78.87%，Me-CCNU组为55.88%（P<0.05）。随访期末的总生存率TMZ组为96.89%，Me-CCNU组为97.30%（P>0.05）。TMZ组和Me-CCNU组的客观缓解率分别为完全缓解（CR）（19.44%对6.38%）、部分缓解（PR）（26.39%对14.89%）、疾病稳定（SD）（26.39%对34.03%）和疾病进展（PD）（27.78%对44.68%，P<0.01）。TMZ和Me-CCNU的不良事件发生率分别为29.11%和45.15%（P<0.05）。
TMZ治疗复发性GBM或AA患者的疗效优于Me-CCNU。且TMZ具有可接受的安全性，其不良事件大多为轻度。
