title: A phase II trial of cisplatin and vinorelbine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  We assessed the response rate and the toxicity of cisplatin plus vinorelbine in patients with this condition.
  
  
  METHODS
  Forty-two patients were included. Therapy consisted of cisplatin, 100 mg/m(2) on day 1, and vinorelbine, 25 mg/m(2) on days 1 and 8, given every 21 days. Therapy was continued up to six courses or progressive disease.
  
  
  RESULTS
  One hundred fifty-nine courses were given (median, three per patient). Dose reduction was applied in 13% of courses and 43% of patients. Grade 3 to 4 neutropenia appeared in 11% of courses and 35% of the patients. One patient died of febrile neutropenia. Ten percent of patients attained a complete response, and 23% attained a partial response (overall 33%, 95%CI 19%-47%). The median duration of response and median survival were 6 months. Twenty-four percent of patients remain alive at 1 year.
  
  
  CONCLUSIONS
  The combination of cisplatin and vinorelbine is moderately active in patients with recurrent or metastatic carcinomas of the head and neck and avoids the inconvenience of prolonged infusions of 5-fluorouracil.
authors.affiliation: Servicio de Oncología Médica, Hospital La Paz P de la Castellana, 261, 28046 Madrid, Spain. eespinosa00@hotmail.com
authors.forename: Enrique
authors.initials: E
authors.lastname: Espinosa
authors.forename: Pilar
authors.initials: P
authors.lastname: Zamora
authors.forename: Alfredo
authors.initials: A
authors.lastname: Millá
authors.forename: Serafin
authors.initials: S
authors.lastname: Morales
authors.forename: Raquel
authors.initials: R
authors.lastname: Molina
authors.forename: M
authors.initials: M
authors.lastname: Mira
authors.forename: Manuel
authors.initials: M
authors.lastname: González Barón
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D009362:Neoplasm Metastasis / Q000188:drug therapy; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009503:Neutropenia / Q000209:etiology; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine