Qian Zheng-zi, Wang Hua-qing, Liu Xian-ming, Yang Shu-yuan, Fu Zhen, Chang Yi, Liu Xiu-ying, Yu Hao
Department of Medical Oncology, Tianjin Medical University Cancer Hospital, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, China.
Zhonghua Yi Xue Za Zhi. 2009 Aug 4;89(29):2059-62.
To investigate the efficacy and safety of temozolomide (TMZ) and lomustine (CCNU) in malignant brain gliomas.
In this multicenter, randomized, double-blind, positive-controlled study, patients with malignant glioma of a histological grade III/IV were randomly divided into two groups. In experiment group, TMZ capsule 150 mg/m2 was given orally on days 1 through 5 and CCNU placebo 130 mg/m2 while on day 1. In control group, CCNU capsule 130 mg/m2 was taken orally on day 1 and TMZ placebo 150 mg/m2 while on days 1 through 5. In both groups drugs were given on the first 5 days of 28 day therapeutic course. Every patient was administered at least 3 cycles continuously.
97 patients were enrolled in the clinical trial, 86 cases of which were evaluable for efficacy. The basic conditions of patients in both groups were comparable. After 12 weeks, the response rates in TMZ and CCNU group were 35.71% and 9.09% (P < 0.01) respectively, and the clinical benefit rates in TMZ and CCNU group were 90.48% and 75.00% (P < 0.05) respectively. No obvious improvement was showed in quality of life and neural symptoms in both groups. The common side effects of TMZ were nausea and vomiting with grade I/II.
TMZ capsule can produce higher efficacy than CCNU in the treatment for refractory malignant brain glioma patients with an acceptable safety profile , indicating that TMZ could be an ideal chemotherapy selection for malignant brain glioma.
探讨替莫唑胺（TMZ）和洛莫司汀（CCNU）治疗恶性脑胶质瘤的疗效及安全性。
在这项多中心、随机、双盲、阳性对照研究中，组织学分级为III/IV级的恶性胶质瘤患者被随机分为两组。试验组在第1至5天口服TMZ胶囊150mg/m²，第1天口服CCNU安慰剂130mg/m²。对照组在第1天口服CCNU胶囊130mg/m²，第1至5天口服TMZ安慰剂150mg/m²。两组药物均在28天治疗疗程的前5天给予。每位患者连续给药至少3个周期。
97例患者纳入临床试验，其中86例可评估疗效。两组患者的基本情况具有可比性。12周后，TMZ组和CCNU组的有效率分别为35.71%和9.09%（P<0.01），临床受益率分别为90.48%和75.00%（P<0.05）。两组患者的生活质量和神经症状均无明显改善。TMZ的常见副作用为I/II级恶心和呕吐。
TMZ胶囊治疗难治性恶性脑胶质瘤患者的疗效高于CCNU，且安全性可接受，表明TMZ可能是恶性脑胶质瘤理想的化疗选择。
