INTRAVENOUS RECOMBINANT INTERFERON BETA IN PATIENTS WITH RECURRENT MALIGNANT GLIOMAS - A PHASE-I PHASE-II STUDY

被引:78
作者
YUNG, WKA
PRADOS, M
LEVIN, VA
FETELL, MR
BENNETT, J
MAHALEY, MS
SALCMAN, M
ETCUBANAS, E
机构
[1] Department of Neuro-Oncology, University of Texas, MD Anderson Cancer Center, Houston, TX 77030
关键词
D O I
10.1200/JCO.1991.9.11.1945
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
A multicenter phase I/II trial of a human recombinant interferon beta (Betaseron; Triton Biosciences, Alameda, CA) was conducted in patients with recurrent glioblastoma and anaplastic astrocytoma in six centers between 1986 and 1988. Betaseron was given intravenously three times per week, starting at 90 x 106 IU per dose and escalating by 90 x 106 IU every 2 weeks up to a maximum dose of 540 x 106 per treatment. All patients had failed prior radiotherapy, and most had failed one or more courses of chemotherapy. Of the 72 patients entered into the protocol, 65 were considered assessable. Of 65 patients, 41 had glioblastoma, and 24 had anaplastic astrocytoma. Of the 65 assessable patients, 15 (23%) had an objective response (R), and 18 (28%) had stable disease (S), with a combined R and S rate of 51%. The Kaplan-Meier median time to progression was 24 weeks for the responders, 10 weeks for the nonresponders, and 23 weeks for the whole group. These results suggest that Betaseron has definite activity in recurrent gliomas, with an R + S rate of 51%. The maximum-tolerated dose (MTD) is between 180 and 360 x 106 IU, with neurotoxicity being the most troublesome toxicity at higher doses. Two patients died of treatment-related complication. Since most responders showed responses at the 180 x 106 IU dose range, further studies using a lower dose of Betaseron aimed at decreasing toxicity and allowing chronic maintenance therapy are merited.
引用
收藏
页码:1945 / 1949
页数:5
相关论文
共 29 条
[1]   INTERFERON-BETA IN PATIENTS WITH LOW-GRADE ASTROCYTOMAS - A PHASE-I-STUDY [J].
BOGDAHN, U ;
FLEISCHER, B ;
HILFENHAUS, J ;
ROTHIG, HJ ;
KRAUSENECK, P ;
MERTENS, HG ;
PRZUNTEK, H .
JOURNAL OF NEURO-ONCOLOGY, 1985, 3 (02) :125-130
[2]   PHASE-II TRIAL OF INTERFERON-BETA FOR TREATMENT OF RECURRENT GLIOBLASTOMA-MULTIFORME [J].
DUFF, TA ;
BORDEN, E ;
BAY, J ;
PIEPMEIER, J ;
SIELAFF, K .
JOURNAL OF NEUROSURGERY, 1986, 64 (03) :408-413
[3]  
FETELL MR, 1990, CANCER, V65, P78, DOI 10.1002/1097-0142(19900101)65:1<78::AID-CNCR2820650117>3.0.CO
[4]  
2-5
[5]  
HAWKINS MJ, 1985, CANCER RES, V45, P5941
[6]  
HIRAKAWA K, 1983, CANCER, V51, P1976, DOI 10.1002/1097-0142(19830601)51:11<1976::AID-CNCR2820511103>3.0.CO
[7]  
2-D
[8]   CHEMOTHERAPY FOR MALIGNANT GLIOMAS [J].
KORNBLITH, PL ;
WALKER, M .
JOURNAL OF NEUROSURGERY, 1988, 68 (01) :1-17
[9]  
LEVIN VA, 1984, CANCER TREAT REP, V68, P969
[10]   BLOCK OF A GLIOMA CELL-LINE IN S BY INTERFERON [J].
LUNDBLAD, D ;
LUNDGREN, E .
INTERNATIONAL JOURNAL OF CANCER, 1981, 27 (06) :749-754