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DOI http://dx.doi.org/10.1016/S0360-3016(97)85601-5
Title Survival results of a phase I study of etanidazole and radiotherapy in patients with malignant glioma
Creator/Author Chang, Eric L. ; Loeffler, Jay S. ; Riese, Nancy E. ; Wen, Patrick ; Alexander, Eben ; Black, Peter ; Coleman, C. Norman
Publication Date1996 Sep 01
OSTI IdentifierOSTI ID: 20420980
Other Number(s)ISSN 0360-3016; IOBPD3 ; TRN: US03R3050005385
Resource TypeJournal Article
Resource RelationInternational Journal of Radiation Oncology, Biology and Physics ; VOL. 36 ; ISSUE: 1,suppl.1 ; 38. annual meeting of the American Society for Therapeutic Radiology and Oncology (ASTRO), Los Angeles, CA (United States), 27-30 Oct 1996 ; PII: S0360301697856027; Copyright (c) 1996 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); PBD: Sep 1996
Subject62 RADIOLOGY AND NUCLEAR MEDICINE ; ANTINEOPLASTIC DRUGS; CHEMOTHERAPY; COMBINED THERAPY; ELECTRON BEAMS; EXTERNAL IRRADIATION; FRACTIONATED IRRADIATION; GLIOMAS; HISTOLOGY; IRRADIATION PROCEDURES; PARAMETRIC ANALYSIS; RADIATION DOSES; RADIATION SOURCE IMPLANTS; RADIOTHERAPY; SURVIVAL TIME; X RADIATION
Description/Abstract Purpose/Objective: To report the survival from a Phase I study of etanidazole (ETA) and external beam radiotherapy in patients with glioblastoma multiforme (GBM n=50) or anaplastic astrocytoma (AA n=19) and examine survival according to age, Karnofsky Performance Status (KPS), and implant status. Materials and Methods: Seventy previously untreated patients (median age 49) with malignant gliomas were entered in a Phase I study. One patient was excluded from analysis because pathology was unverifiable. All had KPS{>=} 70. Prior to initiation of treatment, patients were stratified according to whether they were candidates for interstitial implantation. The implant patients (IMP n=17) received accelerated fractionation XRT 2 Gy BID (6 h apart) to 40 Gy in 2 weeks with ETA 2gm/m{sup 2} x 6 doses, a 2-week break and then interstitial implant for an additional 50 Gy (4-7 days) with a continuous infusion of ETA over 90-96h. The two sequentially conducted nonimplant arms started with accelerated fractionation XRT 2 Gy BID (6 h apart) to 40 Gy in 2 weeks with ETA 2gm/m{sup 2} x 4-5 doses/week. NonIMP1 arm (n=38) received a 2-week break before standard fractionated boost XRT of 2 Gy/day for 2 weeks to total dose of 60 Gy with ETA. NonIMP2 arm (n=14) did not have the 2-week break. All patients had plasma pharmacokinetic monitoring of ETA. Overall actuarial survival was plotted for all patients and by histologic group. Univariate subset analyses of GBM patients by age ({<=} 49 or> 49 years), KPS ({<=} 80 or> 80) and implant vs. non-implant were also performed. Results: Median survival of GBM patients was 1.1 years and that of anaplastic astrocytoma patients was 3.1 years (p=0.001). In GBM patients, KPS> 80, implantable patients, and age{<=} 49 were factors found not to be associated with improved survival that was statistically significant. Conclusion: The results of survival of patients with anaplastic astrocytoma are encouraging and compare favorably to the results from the use of bromodeoxyuridine (Levin et al, IJROBP 32:1:75-83,1995). The use of etanidazole with accelerated radiotherapy does not appear to improve survival in patients with glioblastoma multiforme compared to those treated with conventional therapies.
Country of PublicationUnited States
LanguageEnglish
Formatpage(s) 289
System Entry Date2004 Feb 16

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