[A multicenter randomized controlled study of temozolomide in 97 patients with malignant brain glioma].
OBJECTIVE
To investigate the efficacy and safety of temozolomide (TMZ) and lomustine (CCNU) in malignant brain gliomas.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Qian
Zheng-zi
ZZ
Department of Medical Oncology, Tianjin Medical University Cancer Hospital, Key Laboratory of Cancer Prevention and Therapy, Tianjin 300060, China.
Wang
Hua-qing
HQ
Liu
Xian-ming
XM
Yang
Shu-yuan
SY
Fu
Zhen
Z
Chang
Yi
Y
Liu
Xiu-ying
XY
Yu
Hao
H
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D001932:Brain Neoplasms / Q000188:drug therapy*; D003606:Dacarbazine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D005910:Glioma / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077204:Temozolomide; D055815:Young Adult
D018906:Antineoplastic Agents, Alkylating; D003606:Dacarbazine; D000077204:Temozolomide