title: Postoperative concomitant irradiation and chemotherapy with mitomycin C and bleomycin for advanced head-and-neck carcinoma.
abstract: OBJECTIVE
  In a prospective randomized clinical study, simultaneous postoperative application of irradiation (RT), mitomycin C, and bleomycin was tested in a group of patients with operable advanced head-and-neck carcinoma. It was expected that the planned combined postoperative therapy would reduce the number of locoregional recurrences and prolong survival.
  
  
  METHODS
  A total of 114 eligible patients with Stage III or IV squamous cell head-and-neck carcinoma were randomized to receive postoperative RT alone (Group 1) or RT combined with simultaneous mitomycin C and bleomycin (Group 2). Patients were stratified according to the stage and site of the primary tumor and the presence or absence of high-risk prognostic factors. Primary surgical treatment was performed with curative intent in all patients. Patients in both groups were postoperatively irradiated to the total dose of 56-70 Gy. Chemotherapy included mitomycin C 15 mg/m(2) after 10 Gy and 5 mg of bleomycin twice a week during RT to the planned total dose of 70 mg.
  
  
  RESULTS
  At 2 years, patients in the radiochemotherapy group had better locoregional control (86%) than those in the RT alone group (69%; p = 0.037). Disease-free survival and overall survival was also better in the radiochemotherapy group compared with the RT-alone group (76% vs. 60%, p = 0.099; and 74% vs. 64%, p = 0.036, respectively). Patients who benefited from chemotherapy were those with high-risk factors.
  
  
  CONCLUSIONS
  The results of the present study indicate that concomitant postoperative radiochemotherapy with mitomycin C and bleomycin improves locoregional control and survival in patients with advanced head-and-neck carcinoma. The patients who benefited from chemotherapy were those with high-risk factors.
authors.affiliation: University Department of Otorhinolaryngology and Cervicofacial Surgery, Ljubljana, Slovenia. lojze.smid@mf.uni-lj
authors.forename: Lojze
authors.initials: L
authors.lastname: Smid
authors.forename: Marjan
authors.initials: M
authors.lastname: Budihna
authors.forename: Branko
authors.initials: B
authors.lastname: Zakotnik
authors.forename: Erika
authors.initials: E
authors.lastname: Soba
authors.forename: Primoz
authors.initials: P
authors.lastname: Strojan
authors.forename: Igor
authors.initials: I
authors.lastname: Fajdiga
authors.forename: Miha
authors.initials: M
authors.lastname: Zargi
authors.forename: Irena
authors.initials: I
authors.lastname: Oblak
authors.forename: Marta
authors.initials: M
authors.lastname: Dremelj
authors.forename: Hotimir
authors.initials: H
authors.lastname: LeSnicar
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000008:administration & dosage / Q000009:adverse effects; D010349:Patient Compliance; D011182:Postoperative Care; D011446:Prospective Studies; D011878:Radiotherapy / Q000009:adverse effects
chemical_list: D001761:Bleomycin; D016685:Mitomycin