title: [Side effects of postoperative radiochemotherapy with amifostine versus radiochemotherapy alone in head and neck tumors. Preliminary results of a prospective randomized trial].
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Forty-seven patients with pharyngeal or laryngeal cancer (T1-2 N1-2 G3, T3-4 N0-2 G1-3) were randomized to receive RCT alone (21 patients) or RCT + A (21 patients). Patients were irradiated up to 60 Gy (R0) or 70 Gy (R1/2). Chemotherapy consisted of 70 mg/m2 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 (Tables 2 and 3). Amifostine provided reduction in xerostomia and mucositis (Figures 5 and 6) but had no obvious influence on Karnofsky index, body weight, cutaneous side effects and alopecia (Figures 1 to 4).
  
  
  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.
authors.affiliation: Klinik für Strahlentherapie und Nuklearmedizin, Medizinische Universität zu Lübeck. vacha@stnuk.mu-luebeck.de
authors.forename: P
authors.initials: P
authors.lastname: Vacha
authors.forename: M
authors.initials: M
authors.lastname: Marx
authors.forename: A
authors.initials: A
authors.lastname: Engel
authors.forename: E
authors.initials: E
authors.lastname: Richter
authors.forename: T
authors.initials: T
authors.lastname: Feyerabend
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000532:radiotherapy / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage / Q000494:pharmacology*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D017567:Karnofsky Performance Status; D008297:Male; D008875:Middle Aged; D011182:Postoperative Care; D011446:Prospective Studies; D011837:Radiation-Protective Agents / Q000008:administration & dosage / Q000494:pharmacology*; D011878:Radiotherapy / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D012469:Salivary Glands / Q000187:drug effects / Q000528:radiation effects; D013280:Stomatitis / Q000209:etiology / Q000517:prevention & control; D013997:Time Factors; D014987:Xerostomia / Q000209:etiology / Q000517:prevention & control
chemical_list: D000970:Antineoplastic Agents; D011837:Radiation-Protective Agents; D016190:Carboplatin; D004999:Amifostine
vernacular_title: Nebenwirkungen einer postoperativen Radiochemotherapie mit Amifostin versus alleiniger Radiochemotherapie bei Kopf-Hals-Tumoren. Vorläufige Ergebnisse einer prospektiv randomisierten Untersuchung.