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Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results of a randomized trial; Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorlaeufige Ergebnisse einer prospektiv randomisierten Untersuchung

Abstract

Purpose: Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine. We investigated this issue in a randomized trial comparing radiochemotherapy (RCT) versus radiochemotherapy and amifostine (RCT+A) in patients with head and neck cancer. Patients and methods: Forty-seven patients with pharyngeal or laryngeal cancer (T{sub 1-2}N{sub 1-2}G{sub 3},T{sub 3-4}N{sub 0-2}G{sub 1-3}) were randomized to receive RCT alone (21 patients) or RCT+A (21 patients). Patients were irradiated up to 60 Gy (R{sub 0}) or 70 Gy (R{sub 1/2}). Chemotherapy consisted of 70 mg/m{sup 2} carboplatin and was administered over 5 days in the 1st and 5th week of the radiotherapy course. 250 mg amifostine were applied daily just before each radiotherapy session. Acute toxicity was evaluated according to the Common Toxicity Criteria (CTC). As for xerostomia no patients with laryngeal cancer were assessed because in these cases only small volumes of the salivary glands were within the treatment volume. To evaluate the overall toxicity a summarized CTC score of all observed side effects was calculated. Results: Forty-two patients were evaluable. Clinical characteristics (age, sex, Karnofsky index, tumor-staging) were well balanced in both treatment groups. Amifostine provided reduction in xerostomia and mucositis. Conclusions: According to our preliminary results amifostine  More>>
Authors:
Vacha, P; Marx, M; Engel, A; Richter, E; Feyerabend, T [1] 
  1. Medizinische Univ. Luebeck (Germany). Klinik fuer Strahlentherapie und Nuklearmedizin
Publication Date:
Nov 01, 1999
Product Type:
Journal Article
Reference Number:
EDB-00:019560
Resource Relation:
Journal Name: Strahlentherapie und Onkologie; Journal Volume: 175; Journal Issue: 4,Suppl.; Other Information: PBD: Nov 1999
Subject:
62 RADIOLOGY AND NUCLEAR MEDICINE; 63 RADIATION, THERMAL, AND OTHER ENVIRONMENTAL POLLUTANT EFFECTS ON LIVING ORGANISMS AND BIOLOGICAL MATERIALS; RADIOTHERAPY; CHEMOTHERAPY; HEAD; NECK; PATIENTS; EFFICIENCY; SIDE EFFECTS; EARLY RADIATION EFFECTS; SURGERY; FRACTIONATED IRRADIATION; MUCOUS MEMBRANES; SALIVARY GLANDS; RADIOPROTECTIVE SUBSTANCES
OSTI ID:
20022056
Country of Origin:
Germany
Language:
German
Other Identifying Numbers:
Journal ID: ISSN 0179-7158; STONE4; TRN: DE00F0223
Submitting Site:
DEN
Size:
page(s) 18-22
Announcement Date:
May 12, 2000

Citation Formats

Vacha, P, Marx, M, Engel, A, Richter, E, and Feyerabend, T. Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results of a randomized trial; Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorlaeufige Ergebnisse einer prospektiv randomisierten Untersuchung. Germany: N. p., 1999. Web.
Vacha, P, Marx, M, Engel, A, Richter, E, & Feyerabend, T. Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results of a randomized trial; Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorlaeufige Ergebnisse einer prospektiv randomisierten Untersuchung. Germany.
Vacha, P, Marx, M, Engel, A, Richter, E, and Feyerabend, T. 1999. "Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results of a randomized trial; Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorlaeufige Ergebnisse einer prospektiv randomisierten Untersuchung." Germany.
@misc{etde_20022056,
title = {Acute toxicity of postoperative radiochemotherapy with amifostine vs radiochemotherapy alone in head and neck cancer patients. Preliminary results of a randomized trial; Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorlaeufige Ergebnisse einer prospektiv randomisierten Untersuchung}
author = {Vacha, P, Marx, M, Engel, A, Richter, E, and Feyerabend, T}
abstractNote = {Purpose: Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine. We investigated this issue in a randomized trial comparing radiochemotherapy (RCT) versus radiochemotherapy and amifostine (RCT+A) in patients with head and neck cancer. Patients and methods: Forty-seven patients with pharyngeal or laryngeal cancer (T{sub 1-2}N{sub 1-2}G{sub 3},T{sub 3-4}N{sub 0-2}G{sub 1-3}) were randomized to receive RCT alone (21 patients) or RCT+A (21 patients). Patients were irradiated up to 60 Gy (R{sub 0}) or 70 Gy (R{sub 1/2}). Chemotherapy consisted of 70 mg/m{sup 2} carboplatin and was administered over 5 days in the 1st and 5th week of the radiotherapy course. 250 mg amifostine were applied daily just before each radiotherapy session. Acute toxicity was evaluated according to the Common Toxicity Criteria (CTC). As for xerostomia no patients with laryngeal cancer were assessed because in these cases only small volumes of the salivary glands were within the treatment volume. To evaluate the overall toxicity a summarized CTC score of all observed side effects was calculated. Results: Forty-two patients were evaluable. Clinical characteristics (age, sex, Karnofsky index, tumor-staging) were well balanced in both treatment groups. Amifostine provided reduction in xerostomia and mucositis. Conclusions: According to our preliminary results amifostine has a radioprotective effect on salivary glands. Mucositis can be reduced during radiochemotherapy. At this point of patient accrual the difference between both groups are statistically not significant. To improve the radioprotective effects of amifostine in clinical practice the application of a higher dose (>250 mg) seems to be necessary. (orig.) [German] Ziel: Diese Untersuchung soll die Frage beantworten, ob bei der postoperativen Radiochemotherapie von Patienten mit HNO-Tumoren eine zusaetzliche Amifostin-Medikation Ausmass und Haeufigkeit akuter Strahlenreaktionen vermindert. Patienten und Methode: Prospektiv randomisiert wurden Patienten (n=47) mit HNO-Tumoren der Stadien T{sub 1-2}N{sub 1-2}G{sub 3} sowie T{sub 3-4}N{sub 0-2}G{sub 1-3} behandelt. Alle Patienten erhielten eine Radiochemotherapie mit 60 Gy (R{sub 0}-) bzw. 70 Gy (R{sub 1-2}-Resektion) in konventioneller Fraktionierung sowie 70 mg Carboplatin pro m{sup 2} Koerperoberflaeche (KOF) in der ersten und fuenften Behandlungswoche. Eine Gruppe (n=21) erhielt taeglich unmittelbar vor der Radiation 250 mg Amifostin. Die Bewertung der akuten Strahlenreaktionen (Hautreaktionen, Alppezie, Karnofsky-Index, Gewichtsverlauf, Mukositis, Xerostomie) erfolgte woechentlich nach den CTC-Kriterien. Zur Beurteilung der Gesamttoxizitaet der Therapie wurde ein Summations-Score errechnet. Die Bewertung der Xerostomie erfolgte unter Ausschluss der Larynxkarzinome, da hier die Glandulae parotideae nicht oder nur in geringem Umfang bestrahlt wurden. Resultate: Derzeit sind 42 Patienten, jeweils 21 pro Behandlungsgruppe, auswertbar. Beide Behandlungsarme sind hinsichtlich Alter, Geschlecht, Karnofsky-Index, und Tumorhistologie ausgeglichen. Beim Vergleich der Parameter Karnofsky-Index, Gewicht, Hautreaktionen und Alopezie ergaben sich in der vorlaeufigen Auswertung keine eindeutigen Unterschiede. In der Amifostin-Gruppe waren im Behandlungsverlauf die Mundtrockenheit sowie die Schleimhautreaktionen geringer ausgepraegt. Schlussfolgerungen: Die verminderten Strahlenraktionen der Schleimhaeute sowie der Speicheldruesen weisen auf eine protektive Wirkung des Amifostin hin. Statistisch signifikante Behandlungsunterschiede in beiden Behandlungsgruppen bestehen derzeit nicht. Zum jetzigen Zeitpunkt erscheint die Dosis von 250 mg Amifostin zur eindeutigen Senkung der radiogenen Nebenwirkungen als zu gering. (orig.)}
journal = []
issue = {4,Suppl.}
volume = {175}
journal type = {AC}
place = {Germany}
year = {1999}
month = {Nov}
}