title: Radiotherapy, combined with simultaneous chemotherapy with mitomycin C and bleomycin for inoperable head and neck cancer--preliminary report.
abstract: OBJECTIVE
  Prospectively designed randomized clinical study was undertaken to assess the efficacy of simultaneous application of irradiation, Mitomycin C, and Bleomycin in treatment of patients with inoperable head and neck carcinoma.
  
  
  METHODS
  Between March 1991 and October 1993, 49 patients with inoperable head and neck carcinoma were randomly assigned to receive either radiation therapy alone (group A) or radiotherapy combined with simultaneous application of Mitomycin C and Bleomycin (group B). Patients in both groups were irradiated five times weekly with 2 Gy to the total dose of 66-70 Gy. Chemotherapy regimen included intramuscular application of Bleomycin 5 units twice a week, with the planned dose being 70 units and Mitomycin C 15 mg/m2 applied intravenously after delivery of 9-10 Gy of irradiation. The application of Mitomycin C was planned to be repeated on last day of radiotherapy in the dose of 10 mg/m2. In attempt to enhance the effect of chemotherapeutic drugs, patients in group B received also Nicotinamide, Chlorpromazine, and Dicoumarol.
  
  
  RESULTS
  The difference in complete response rate between both treatment groups (24% in group A and 63% in group B) was statistically significant (p = 0.015). The difference in response rate was much more pronounced in patients with oropharyngeal carcinoma only (18% in group A compared to 81% in group B; p = 0.0003), while for all other subgroups added together, there was observed no benefit of multidrug therapy. Median follow-up was 18 months. Disease-free survival of patients in group A (9%) was significantly lower then in group B (48%) (p = 0.001). The difference between both treatment groups was even greater in patients with oropharyngeal carcinoma only: disease-free survival of these patients in group B was 66%, while in group A, all recurred (p = 0.00001).
  
  
  CONCLUSIONS
  From results of our prospective randomized study it seems that the group of patients that received multidrug treatment with Mytomycin C, Bleomycin, Nicotinamide, Chlorpromazine, and Dicoumarol as enhancers of radiotherapy fared better than patients treated by radiotherapy alone.
authors.affiliation: University Department of Otorhinolaryngology and Cerviofacial Surgery, Zaloska, Ljubljana, Slovenia.
authors.forename: L
authors.initials: L
authors.lastname: Smid
authors.forename: H
authors.initials: H
authors.lastname: Lesnicar
authors.forename: B
authors.initials: B
authors.lastname: Zakotnik
authors.forename: E
authors.initials: E
authors.lastname: Soba
authors.forename: M
authors.initials: M
authors.lastname: Budihna
authors.forename: L
authors.initials: L
authors.lastname: Furlan
authors.forename: M
authors.initials: M
authors.lastname: Zargi
authors.forename: Z
authors.initials: Z
authors.lastname: Rudolf
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D002746:Chlorpromazine / Q000008:administration & dosage; D003131:Combined Modality Therapy; D001728:Dicumarol / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage; D009536:Niacinamide / Q000008:administration & dosage; D011446:Prospective Studies; D011879:Radiotherapy Dosage
chemical_list: D001761:Bleomycin; D009536:Niacinamide; D016685:Mitomycin; D001728:Dicumarol; D002746:Chlorpromazine