title: Radiochemotherapy with cisplatin and oral tegafur in advanced head and neck cancer: long-term results of a phase II study.
abstract: OBJECTIVE
  To evaluate the tolerance and efficacy of an original concurrent radiochemotherapy regimen in locally advanced head and neck cancer.
  
  
  METHODS
  Sixty-four patients with stage III or IV squamous cell carcinoma arising from a head and neck mucosal site were eligible. Simultaneous radiochemotherapy consisted of two courses of continuous infusional cisplatin (20 mg/m2/d, days 1-4 and 29-32) and oral tegafur (1200 mg/d, days 1-14 and 29-43), together with conventional radiation therapy up to a total dose of 70-75 Gy over nine weeks.
  
  
  RESULTS
  All the patients were evaluated for toxicity and response. Acute mucositis was the most prevalent complication. Grade 3 toxicities were mucositis (44%), skin toxicity (10%), leukopenia (8%), and thrombocytopenia (1%). No toxic death was observed. Complete response to treatment was observed in 72% of patients. With a median follow-up of 48.5 months (range, 27-84), 5-year actuarial rate of local-regional control, disease-free survival, overall survival and disease-specific survival were 60% (95% confidence interval [CI], 40-70%), 55% (95% CI, 45-65%), 51% (95% CI, 43-59%) and 61% (95% CI, 53-69%), respectively.
  
  
  CONCLUSIONS
  Response, local-regional control and survival rates are equivalent to those reported from other concomitant radiochemotherapy combinations. However, the regimen offers the advantage of its tolerance and toxicity profile.
authors.affiliation: Department of Radiation Oncology, University Hospital "Clínica Puerta de Hierro", Madrid, Spain. atorre.hpth@salud.madrid.org
authors.forename: Alejandro
authors.initials: A
authors.lastname: de la Torre
authors.forename: Jesus
authors.initials: J
authors.lastname: Romero
authors.forename: Angel
authors.initials: A
authors.lastname: Montero
authors.forename: M Isabel
authors.initials: MI
authors.lastname: Garcia-Berrocal
authors.forename: Francisco J
authors.initials: FJ
authors.lastname: Valcarcel
authors.forename: Sofia
authors.initials: S
authors.lastname: Cordoba
authors.forename: Rosa
authors.initials: R
authors.lastname: Magallon
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D017024:Chemotherapy, Adjuvant / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D007970:Leukopenia / Q000209:etiology; D008297:Male; D008875:Middle Aged; D052016:Mucositis / Q000209:etiology; D009367:Neoplasm Staging; D011838:Radiation-Sensitizing Agents / Q000008:administration & dosage; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016019:Survival Analysis; D005641:Tegafur / Q000008:administration & dosage; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D011838:Radiation-Sensitizing Agents; D005641:Tegafur; D002945:Cisplatin