Phase 2 trial of temozolomide and pegylated liposomal doxorubicin in the treatment of patients with glioblastoma multiforme following concurrent radiotherapy and chemotherapy

被引:91
作者
Ananda, Sumitra [1 ]
Nowak, Anna K. [2 ,6 ]
Cher, Lawrence [3 ]
Dowling, Anthony [4 ]
Brown, Chris [5 ]
Simes, John [5 ]
Rosenthal, Mark A. [1 ,5 ]
机构
[1] Royal Melbourne Hosp, Dept Med Oncol, Melbourne, Vic 3050, Australia
[2] Sir Charles Gairdner Hosp, Dept Med Oncol, Perth, WA, Australia
[3] Austin Hlth, Dept Med Oncol, Melbourne, Vic, Australia
[4] St Vincents Hosp, Dept Med Oncol, Melbourne, Vic, Australia
[5] Univ Sydney, NHMRC Clin Trials Ctr, Sydney, NSW 2006, Australia
[6] Univ Western Australia, Sch Med & Pharmacol, Nedlands, WA 6009, Australia
关键词
Glioblastoma; Pegylated liposomal doxorubicin; Temozolomide; HIGH-GRADE GLIOMAS; ADJUVANT TEMOZOLOMIDE; MALIGNANT GLIOMA; BRAIN-TUMORS; II TRIAL; THERAPY; METAANALYSIS; ASTROCYTOMA; CONCOMITANT; SURVIVAL;
D O I
10.1016/j.jocn.2011.02.026
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Concurrent and post-radiotherapy temozolomide (T) significantly improves survival in patient with newly diagnosed glioblastoma multiforme. We aimed to assess the activity of the combination of T and pegylated liposomal doxorubicin (PLD) in this population. A combination of T (days 1-5, 200 mg/m(2) orally) and PLD (day 1, 40 mg/m(2) intravenous) was given every 4 weeks for six cycles following chemo-radiotherapy as a post-operative treatment. The primary endpoint was 6-month progression free survival (6PFS). Of the 40 patients who enrolled (53 years median age, 73% male), the 6PFS was 58% (95% confidence interval [CI], 41-72%). The median time to progression was 6.2 months (95% CI, 5.6-8.0 months) and overall survival (OS) was 13.4 months (95% CI, 12.7-15.8 months). Thirty-four patients had measurable disease: one had a complete response (3%), 28 had stable disease (82%), and five had progressive disease (15%). Treatment was well tolerated: hematological toxicity included grade 3 neutropenia (8%). Grade 3 non-hematologic toxicity included nausea and vomiting (8%) and palmar-plantar toxicity (5%). We concluded that combination T and PLD is well tolerated but does not add significant clinical benefit regarding 6PFS and OS. Crown Copyright (C) 2011 Published by Elsevier Ltd. All rights reserved.
引用
收藏
页码:1444 / 1448
页数:5
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