Daily amifostine given concomitantly to chemoradiation in head and neck cancer : A pilot study

• Published in: Strahlentherapie und Onkologie 1999-09, Vol.175 (9), p.444-449
• Main Authors: TROG, D, BANK, P, WENDT, T. G, KOSCIELNY, S, BELEITES, E
• Format: Article
• Language: English
• Subjects: Adult; Aged; Amifostine - administration & dosage; Amifostine - adverse effects; Antineoplastic agents; Biological and medical sciences; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - radiotherapy; Cohort Studies; Combined Modality Therapy; Combined treatments (chemotherapy of immunotherapy associated with an other treatment); Dose Fractionation; Female; Humans; Male; Medical sciences; Middle Aged; Mouth Mucosa - radiation effects; Neoplasm Staging; Otorhinolaryngologic Neoplasms - drug therapy; Otorhinolaryngologic Neoplasms - mortality; Otorhinolaryngologic Neoplasms - pathology; Otorhinolaryngologic Neoplasms - radiotherapy; Pharmacology. Drug treatments; Pilot Projects; Premedication; Radiation Injuries - prevention & control; Radiation-Protective Agents - administration & dosage; Radiation-Protective Agents - adverse effects; Stomatitis - prevention & control; Survival Rate
• ISSN: 0179-7158; 1439-099X
• DOI: 10.1007/s000660050034

In patients with loco-regionally advanced head and neck cancer conventionally fractionated radiotherapy alone results in poor loco-regional control and survival rates. Treatment intensification by simultaneous administration of cytotoxic drugs produces higher acute morbidity. Therefore chemical radioprotection of normal tissues may be of clinical benefit. In a pilot study patients with advanced nonresectable head and neck cancer treated with conventionally fractionated radical radiotherapy (60 to 66 Gy total doses) and concomitantly given 5-fluorouracil as protracted venous infusion, 250 mg/sqm/24 h over the entire treatment period were given amifostine 300 mg absolutely before each fraction. Acute treatment related morbidity was scored according to CTC classification and loco-regional control and survival rates were estimated. Comparison was made with a historical control group of identical chemoradiation but without amifostine application. Chemoradiation induced oral mucositis was delayed and showed significant lower degrees at all 10 Gy increments (p < 0.05) except 60 Gy and over (p > 0.05). No significant toxicity was recorded with respect to blood pressure, serum calcium, potassium, hematologic parameters, emesis, nausea or body weight loss. Progression free survival and overall survival probability at 2 years were not statistically different in both cohorts. Amifostine given before each fraction of radiotherapy over 6 weeks has no cumulative toxicity, was well tolerated and may reduce treatment induced oral mucositis. No tumor protective effect was observed.