Bibliographic Citation
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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 Date | 1996 Sep 01 |
OSTI Identifier | OSTI ID: 20420980 |
Other Number(s) | ISSN 0360-3016; IOBPD3 ; TRN: US03R3050005385 |
Resource Type | Journal Article |
Resource Relation | International 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 |
Subject | 62 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 Publication | United States |
Language | English |
Format | page(s) 289 |
System Entry Date | 2004 Feb 16 |
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