当前位置： SCI文献检索 > JOURNAL OF NEURO-ONCOLOGY期刊下所有文献 > Randomized, double-blind, placebo-controlled trial of marimastat in glioblastoma multiforme patients following surgery and irradiation.

Randomized, double-blind, placebo-controlled trial of marimastat in glioblastoma multiforme patients following surgery and irradiation.

Abstract：

PURPOSE:Because raised matrix metalloprotease (MMP) levels are associated with glioma invasion and angiogenesis, we tested the efficacy of marimastat (MT) an orally active drug that can reduce MMP levels, in patients with gliomas. PATIENTS AND METHODS:A total of 162 patients with intracranial glioblastoma multiforme or gliosarcomas who had undergone surgery and radiotherapy participated in this multicenter, double-blind, placebo-controlled, parallel group study conducted at 20 institutions. Seventy-nine patients (57 male, 22 female, median age 58 years) were randomized to receive placebo (PB), and 83 patients (51 male, 32 female, median age 57 years) were randomized to receive MT, 10 mg orally twice daily, until tumor progression. RESULTS:This intention-to-treat efficacy analysis showed no statistically significant difference between MT and PB groups with respect to survival (P = 0.38, log rank test). The median survival time from protocol initiation was 37.9 weeks for the PB group and 42.9 weeks for the MT group, with a hazard ratio of 1.16 (95% CI 0.83 to 1.60). There were no statistically significant differences in quality of life between the PB and MT groups, as assessed by the FACT-BR questionnaire. Musculoskeletal toxicities led to dose modification or withdrawal in 20% of MT-treated and 1.2% of PB-treated patients. CONCLUSION:MT does not improve survival in patients with glioblastoma or gliosarcoma following surgery and radiotherapy. Therefore, single-agent MT appears unwarranted; however, MT in combination with cytotoxic chemotherapy may be warranted, as suggested by observations in our study and other studies.

journal_name

J Neurooncol

journal_title

Journal of neuro-oncology

authors

Levin VA,Phuphanich S,Yung WK,Forsyth PA,Maestro RD,Perry JR,Fuller GN,Baillet M

doi

10.1007/s11060-005-9098-5

subject

Has Abstract

pub_date

2006-07-01 00:00:00

pages

295-302

issue

3

eissn

0167-594X

issn

1573-7373

journal_volume

78

pub_type

杂志文章,多中心研究,随机对照试验

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