title: Patterns of failure in patients with locally advanced head and neck cancer treated postoperatively with irradiation or concomitant irradiation with Mitomycin C and Bleomycin.
abstract: OBJECTIVE
  The long term results and patterns of failure in patients with squamous cell head and neck carcinoma (SCHNC) treated in a prospective randomized trial in which concomitant postoperative radiochemotherapy with Mitomycin C and Bleomycin (CRT) was compared with radiotherapy only (RT), were analyzed.
  
  
  METHODS
  Between March 1997 and December 2001, 114 eligible patients with Stage III or IV SCHNC were randomized. 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/m2 after 10 Gy and 5 mg of Bleomycin twice weekly during irradiation. Median follow-up was 76 months (48-103 months).
  
  
  RESULTS
  At 5 years in the RT and CRT arms, the locoregional control was 65% and 88% (p = 0.026), disease-free survival 33% and 53% (p = 0.035), and overall survival 37% and 55% (p = 0.091) respectively. Patients who benefited from chemotherapy were those with high-risk factors. The probability of distant metastases was 22% in RT and 20% in CRT arm (p = 0.913), of grade III or higher late toxicity 19% in RT and 26% in CRT arm (p = 0.52) and of thyroid dysfunction 36% in RT and 56% in CRT arm (p = 0.24). The probability to develop a second primary malignancy (SPM) was 34% in the RT and 8% in the CRT arm (p = 0.023). One third of deaths were due to infection, but there was no difference between the 2 groups.
  
  
  CONCLUSIONS
  With concomitant radiochemotherapy, locoregional control and disease free survival were significantly improved. Second primary malignancies in the CRT arm compared to RT arm were significantly less frequent. The high probability of post treatment hypothyroidism in both arms warrants regular laboratory evaluation.
authors.affiliation: Institute of Oncology, Ljubljana, Slovenia. bzakotnik@onko-i.si
authors.forename: Branko
authors.initials: B
authors.lastname: Zakotnik
authors.forename: Marjan
authors.initials: M
authors.lastname: Budihna
authors.forename: Lojze
authors.initials: L
authors.lastname: Smid
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: Hotimir
authors.initials: H
authors.lastname: Lesnicar
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001761:Bleomycin / Q000008:administration & dosage; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D003131:Combined Modality Therapy / Q000379:methods; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery; D006801:Humans; D016685:Mitomycin / Q000008:administration & dosage; D016609:Neoplasms, Second Primary / Q000209:etiology; D011336:Probability; D011446:Prospective Studies; D011879:Radiotherapy Dosage; D017211:Treatment Failure
chemical_list: D001761:Bleomycin; D016685:Mitomycin