A Phase II study of concurrent temozolomide and cis-retinoic acid with radiation for adult patients with newly diagnosed supratentorial glioblastoma

被引:43
作者
Butowski, N
Prados, MD
Lamborn, KR
Larson, DA
Sneed, PK
Wara, WM
Malec, M
Rabbitt, J
Page, M
Chang, SM
机构
[1] Univ Calif San Francisco, Dept Neurol Surg, Neurooncol Serv, San Francisco, CA 94143 USA
[2] Univ Calif San Francisco, Dept Radiat Oncol, San Francisco, CA 94143 USA
来源
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS | 2005年 / 61卷 / 05期
关键词
supratentorial glioblastoma; temozolomide; 13-cis-retinoic acid; radiation therapy;
D O I
10.1016/j.ijrobp.2004.08.023
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose: This Phase II study was designed to determine the median survival time of adults with supratentorial glioblastoma treated with a combination of temozolomide (TMZ) and 13-cis-retinoic acid (cRA) given daily with conventional radiation therapy (XRT). Methods and Materials: This was a single arm, open-labeled, Phase 11 study. Patients were treated with XRT in conjunction with cRA and TMZ. Both drugs were administered starting on Day 1 of XRT, and chemotherapy cycles continued after the completion of XRT to a maximum of 1 year. Results: Sixty-one patients were enrolled in the study. Time to progression was known for 55 patients and 6 were censored. The estimated 6-month progression-free survival was 38% and the estimated 1-year progression-free survival was 15%. Median time to progression was estimated as 21 weeks. The estimated 1-year survival was 57%. The median survival was 57 weeks. Conclusions: The combined therapy was relatively well tolerated, but there was no survival advantage compared with historical studies using XRT either with adjuvant nitrosourea chemotherapy, with TMZ alone, or with the combination of TMZ and thalidomide. Based on this study, cRA does not seem to add a significant synergistic effect to TMZ and XRT. (c) 2005 Elsevier Inc.
引用
收藏
页码:1454 / 1459
页数:6
相关论文
共 26 条
[1]  
Afra D, 2002, LANCET, V359, P1011
[2]   Retinoids inhibit human glioma cell proliferation and migration in primary cell cultures but not in established cell lines [J].
Bouterfa, H ;
Picht, T ;
Kess, D ;
Herbold, C ;
Noll, E ;
Black, PM ;
Roosen, K ;
Tonn, JC .
NEUROSURGERY, 2000, 46 (02) :419-430
[3]   Phase II study of temozolomide and thalidomide with radiation therapy for newly diagnosed glioblastoma multiforme [J].
Chang, SM ;
Lamborn, KR ;
Malec, M ;
Larson, D ;
Wara, W ;
Sneed, P ;
Rabbitt, J ;
Page, M ;
Nicholas, MK ;
Prados, MD .
INTERNATIONAL JOURNAL OF RADIATION ONCOLOGY BIOLOGY PHYSICS, 2004, 60 (02) :353-357
[4]   Effects of a novel synthetic retinoid on malignant glioma in vitro:: inhibition of cell proliferation, induction of apoptosis and differentiation [J].
Costa, SL ;
Paillaud, E ;
Fages, C ;
Rochette-Egly, C ;
Plassat, JL ;
Jouault, H ;
Perzelova, A ;
Tardy, M .
EUROPEAN JOURNAL OF CANCER, 2001, 37 (04) :520-530
[5]   RECURSIVE PARTITIONING ANALYSIS OF PROGNOSTIC FACTORS IN 3 RADIATION-THERAPY ONCOLOGY GROUP MALIGNANT GLIOMA TRIALS [J].
CURRAN, WJ ;
SCOTT, CB ;
HORTON, J ;
NELSON, JS ;
WEINSTEIN, AS ;
FISCHBACH, AJ ;
CHANG, CH ;
ROTMAN, M ;
ASBELL, SO ;
KRISCH, RE ;
NELSON, DF .
JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (09) :704-710
[6]   A rapid and systematic review of the effectiveness of temozolomide for the treatment of recurrent malignant glioma [J].
Dinnes, J ;
Cave, C ;
Huang, S ;
Milne, R .
BRITISH JOURNAL OF CANCER, 2002, 86 (04) :501-505
[7]   The phase II/III transition: Toward the proof of efficacy in cancer clinical trials [J].
Fazzari, M ;
Heller, G ;
Scher, HI .
CONTROLLED CLINICAL TRIALS, 2000, 21 (04) :360-368
[8]  
FINE HA, 1993, CANCER, V71, P2585, DOI 10.1002/1097-0142(19930415)71:8<2585::AID-CNCR2820710825>3.0.CO
[9]  
2-S
[10]  
HIROTA T, 1997, JPN J CLIN HEMATOL, V38, P1177