You need JavaScript to view this

Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas

Journal Article:

Abstract

Purpose: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas. Methods and Materials: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT + ETA (2.0 g/m{sup 2} thrice weekly for 17 doses), of whom 504 were eligible and analyzable. Treatment assignments were stratified before randomization according to the primary site (oral cavity + hypopharynx vs. supraglottic larynx + oropharynx + nasopharynx), T-stage (T1-3 vs. T4), and N-stage (N0-2 vs. N3). Pretreatment characteristics were balanced. In the RT-alone arm, 39% of patients had T3 and 34% had T4 disease, whereas in the RT + ETA arm, 42% of patients had T3 and 33% had T4 disease. Thirty-eight percent of the RT-alone patients and 37% of the RT + ETA patients had N3 disease. The median follow-up of surviving patients was 3.38 years, with a range between 0.96 and 5.63 years. Results: One hundred  More>>
Publication Date:
Jun 15, 1995
Product Type:
Journal Article
Resource Relation:
Journal Name: International Journal of Radiation Oncology, Biology and Physics; Journal Volume: 32; Journal Issue: 3; Other Information: Copyright (c) 1995 Elsevier Science B.V., Amsterdam, The Netherlands, All rights reserved; Country of input: International Atomic Energy Agency (IAEA); PBD: 15 Jun 1995
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; CARCINOMAS; CHEMOTHERAPY; COMBINED THERAPY; COMPARATIVE EVALUATIONS; HEAD; IMIDAZOLES; NECK; RADIOSENSITIZERS; RADIOTHERAPY
OSTI ID:
20391154
Country of Origin:
United States
Language:
English
Other Identifying Numbers:
Journal ID: ISSN 0360-3016; IOBPD3; TRN: US03R1606057501
Submitting Site:
INIS
Size:
page(s) 567-576
Announcement Date:

Journal Article:

Citation Formats

Dingjen, Lee, Cosmatos, Dennis, Marcial, Victor A, Fu, Karen K, Rotman, Marvin, Cooper, Jay S, Ortiz, Hernando G, Beitler, Jonathan J, Abrams, Ross A, Curran, Walter J, Coleman, C Norman, and Wasserman, Todd H. Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas. United States: N. p., 1995. Web.
Dingjen, Lee, Cosmatos, Dennis, Marcial, Victor A, Fu, Karen K, Rotman, Marvin, Cooper, Jay S, Ortiz, Hernando G, Beitler, Jonathan J, Abrams, Ross A, Curran, Walter J, Coleman, C Norman, & Wasserman, Todd H. Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas. United States.
Dingjen, Lee, Cosmatos, Dennis, Marcial, Victor A, Fu, Karen K, Rotman, Marvin, Cooper, Jay S, Ortiz, Hernando G, Beitler, Jonathan J, Abrams, Ross A, Curran, Walter J, Coleman, C Norman, and Wasserman, Todd H. 1995. "Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas." United States.
@misc{etde_20391154,
title = {Results of an RTOG phase III trial (RTOG 85-27) comparing radiotherapy plus etanidazole with radiotherapy alone for locally advanced head and neck carcinomas}
author = {Dingjen, Lee, Cosmatos, Dennis, Marcial, Victor A, Fu, Karen K, Rotman, Marvin, Cooper, Jay S, Ortiz, Hernando G, Beitler, Jonathan J, Abrams, Ross A, Curran, Walter J, Coleman, C Norman, and Wasserman, Todd H}
abstractNote = {Purpose: The objectives of this study were to determine the efficacy and toxicity of Etanidazole (ETA), a hypoxic cell sensitizer, when combined with conventional radiotherapy (RT) in the management of advanced head and neck carcinomas. Methods and Materials: From March 1988 to September 1991, 521 patients who had Stage III or IV head and neck carcinomas were randomized to receive conventional RT alone (66 Gy in 33 fractions to 74 Gy in 37 fractions, 5 fractions per week) or RT + ETA (2.0 g/m{sup 2} thrice weekly for 17 doses), of whom 504 were eligible and analyzable. Treatment assignments were stratified before randomization according to the primary site (oral cavity + hypopharynx vs. supraglottic larynx + oropharynx + nasopharynx), T-stage (T1-3 vs. T4), and N-stage (N0-2 vs. N3). Pretreatment characteristics were balanced. In the RT-alone arm, 39% of patients had T3 and 34% had T4 disease, whereas in the RT + ETA arm, 42% of patients had T3 and 33% had T4 disease. Thirty-eight percent of the RT-alone patients and 37% of the RT + ETA patients had N3 disease. The median follow-up of surviving patients was 3.38 years, with a range between 0.96 and 5.63 years. Results: One hundred and ninety-four of the 252 (77%) RT + ETA patients received at least 14 doses of the drug. Overall RT protocol compliance rate was 82% in the RT-alone arm and 86% in the RT + ETA arm. No Grade 3 or 4 central nervous system or peripheral neuropathy was observed in the RT + ETA arm. Eighteen percent of the patients developed Grade 1 and 5% developed Grade 2 peripheral neuropathy. Other drug related toxicities included nausea/vomiting (27%), low blood counts (15%), and allergy (9%). Most of these toxicities were Grade 1 and 2. The incidence of severe acute and late radiation effects were similar between the two arms. The 2-year actuarial local-regional control rate (LCR) was 40% for the RT-alone arm and 40% for the RT + ETA arm. Two-year actuarial survival was 41% for the RT-alone arm and 43% for the RT + ETA arm (p = 0.65). Multivariate analyses were performed to investigate the influence of covariates on treatment effects. A strong treatment interaction with N-stage was revealed: LCR (50% vs. 40% at 2 years), RT + ETA improved for patients with N0-2 disease but not for N3 patients (22% for RT + ETA and 40% for RT). Further analyses showed that RT + ETA was more advantageous in N0-1 patients, with a 2-year LCR of 55% for RT + ETA vs. 37% for RT only (p = 0.03). A similar phenomenon was observed when using survival as the end point. Conclusion: The results showed that adding Etanidazole to conventional RT produced no global benefit for patients who had advanced head and neck carcinomas. There was a suggested benefit for patients who had N0-1 disease, and that needs to be confirmed by another study.}
journal = {International Journal of Radiation Oncology, Biology and Physics}
issue = {3}
volume = {32}
journal type = {AC}
place = {United States}
year = {1995}
month = {Jun}
}