title: Final results of a phase II single-institutional trial with hyperfractionated radiation therapy (HFX) and four-weekly continuous cisplatin in locally advanced head and neck carcinoma.
abstract: BACKGROUND
  To evaluate the efficacy and toxicity of hyperfractionated radiation therapy and continuous infusion of cisplatin on weeks 1 and 5 in locally advanced head and neck carcinoma.
  
  
  METHODS
  There were 53 patients: 3 (5.7 %) T2 patients, 31 T3 patients (58.4 %), and 19 T4 patients (35.8 %). Forty-one patients (77.4 %) were N-positive. According to the AJCC, 40 (75.4 %) patients had stage IV and the rest stage III. Treatment consisted of hyperfractionated radiation therapy, 120 cGy bid to a dose of 76.8-81.6 Gy, and cisplatin 20 mg/m(2)/day administered by continuous infusion over 120 h during days 1-5 and 21-25 of radiation therapy.
  
  
  RESULTS
  Tumor response and toxicity There were 40 (75.5 %) complete responses, 6 partial responses (11.3 %), and 5 (9.4 %) non-responses or progression. Two patients were non-evaluable for response due to toxic death. All patients had some acute toxicity grade, the most frequent being mucositis (grade 3-4 in 33 patients) and epithelitis (grade 3-4 in 30 patients). Regarding late toxicity, only 2/24 long-term survivors had tracheostomy, and none of them needed enteral nutrition. Survival and local control With a median follow-up of 66 months, the 5-year overall survival rate for all the series was 49.1 % (95 % CI 58.9-39.3 %) with a median survival duration of 32.83 months. Five-year local control was 68.4 % (95 % CI 81.3-55.5 %).
  
  
  CONCLUSIONS
  Hyperfractionated radiation therapy and continuous infusion of cisplatin during weeks 1 and 5 are an active treatment in patients with LAHNC. Nevertheless, new strategies are necessary to increase the local control rates and reduce the incidence of distant metastasis and second tumors.
authors.affiliation: Radiation Oncology Department, Complejo Hospitalario de Navarra, 3 c/Irunlarrea, 31008, Pamplona, Spain, farias.delavega@outlook.es.
authors.forename: F
authors.initials: F
authors.lastname: Arias
authors.forename: G
authors.initials: G
authors.lastname: Asín
authors.forename: M I
authors.initials: MI
authors.lastname: Uzcanga
authors.forename: E
authors.initials: E
authors.lastname: Maraví
authors.forename: I
authors.initials: I
authors.lastname: Quílez
authors.forename: V
authors.initials: V
authors.lastname: Chicata
authors.forename: C
authors.initials: C
authors.lastname: Eito
authors.forename: A
authors.initials: A
authors.lastname: Viudez
authors.forename: I
authors.initials: I
authors.lastname: Hernández
authors.forename: F
authors.initials: F
authors.lastname: Mañeru
authors.forename: M A
authors.initials: MA
authors.lastname: Domínguez
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D059248:Chemoradiotherapy; D002945:Cisplatin / Q000627:therapeutic use*; D019583:Dose Fractionation, Radiation; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D012074:Remission Induction; D015996:Survival Rate
chemical_list: D000970:Antineoplastic Agents; D002945:Cisplatin