Randomized phase iii trial of postoperative radiochemotherapy ± amifostine in head and neck cancer: Is there evidence for radioprotection?

Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine (A). We investigated this issue in a randomized trial comparing radiochemotherapy (RT + CT) versus radiochemotherapy plus amifostine (RC + CT + A) in patients with head and neck cancer. 56 patients w...

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Published in:Strahlentherapie und Onkologie 2003-06, Vol.179 (6), p.385-389
Main Authors: VACHA, Peter, FEHLAUER, Fabian, MAHLMANN, Birgit, MARX, Meinolf, HINKE, Axel, SOMMER, Konrad, RICHTER, Eckart, FEYERABEND, Thomas
Format: Article
Language:English
Subjects:
Amifostine - therapeutic use
Antineoplastic agents
Antineoplastic Agents - therapeutic use
Biological and medical sciences
Carboplatin - therapeutic use
Combined Modality Therapy
Combined treatments (chemotherapy of immunotherapy associated with an other treatment)
Female
Head and Neck Neoplasms - drug therapy
Head and Neck Neoplasms - radiotherapy
Head and Neck Neoplasms - surgery
Humans
Hypopharyngeal Neoplasms - drug therapy
Hypopharyngeal Neoplasms - pathology
Hypopharyngeal Neoplasms - radiotherapy
Hypopharyngeal Neoplasms - surgery
Laryngeal Neoplasms - drug therapy
Laryngeal Neoplasms - pathology
Laryngeal Neoplasms - radiotherapy
Laryngeal Neoplasms - surgery
Male
Medical sciences
Middle Aged
Mouth Mucosa - radiation effects
Neoplasm Staging
Patient Selection
Pharmacology. Drug treatments
Radiation-Protective Agents - therapeutic use
Radiotherapy - adverse effects
Radiotherapy Dosage
Time Factors
Xerostomia - etiology
Xerostomia - prevention & control
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Summary:Experimental and clinical data suggest a reduction of radiation-induced acute toxicity by amifostine (A). We investigated this issue in a randomized trial comparing radiochemotherapy (RT + CT) versus radiochemotherapy plus amifostine (RC + CT + A) in patients with head and neck cancer. 56 patients with oro-/hypopharynx or larynx cancer (T1-2 N1-2 G3, T3-4 N0-2 G1-3) were randomized to receive RC + CT alone or RC + CT + A. Patients were irradiated up to 60 Gy (R0) or 70 Gy (R1/2) and received chemotherapy (70 mg/m(2) carboplatin, day 1-5 in week 1 and 5 of radiotherapy). 250 mg amifostine were applied daily before each radiotherapy session. Acute toxicity was evaluated according to the Common Toxicity Criteria (CTC). As for acute xerostomia, patients with laryngeal cancer were excluded from evaluation. 50 patients were evaluable (25 patients in the RC + CT, 25 patients in the RC + CT + A group). Clinical characteristics were well balanced in both treatment groups. Amifostine provided reduction in acute xerostomia and mucositis but had no obvious influence on Karnofsky performance status, body weight, cutaneous side effects, and alopecia. The differences between both groups were statistically significant for acute xerostomia and nonsignificant, but with a trend for mucositis. According to our results, there is a radioprotective effect on salivary glands and a potential effect on oral mucosa by amifostine in postoperative radiotherapy combined with carboplatin. To improve the radio- and chemoprotective effects of amifostine in clinical practice, the application of a higher dose (> 250 mg) seems to be necessary.
ISSN:0179-7158
1439-099X
DOI:10.1007/s00066-003-1016-1