title: Phase II trial of gemcitabine concurrent with radiation for locally advanced squamous cell carcinoma of the head and neck.
abstract: BACKGROUND
  Concurrent chemoradiation is the current standard of treatment for patients with advanced unresectable head and neck squamous cell carcinoma (HNSCC). Due to the potent radiosensitizing properties of gemcitabine, we decided to assess its efficacy and toxicity with concurrent radiation in patients with advanced HNSCC.
  
  
  METHODS
  From January 1997 to December 2001, 27 patients with locally advanced HNSCC (stage III, 37%; stage IV, 63%) were enrolled. All received a course of radiotherapy (70 Gy over 7 weeks) concurrent with weekly infusions of gemcitabine at 100 mg/m2 or 50 mg/m2.
  
  
  RESULTS
  All patients were assessable for toxicity and 26 for response. Severe mucositis (grade 3-4) was observed in 74% of patients (grade 4, 41%). Severe hematological toxicity was uncommon. Mild and moderate xerostomy was the most common late toxicity in 23 patients (85%). The median radiation dose delivered was 70 Gy (40-80 Gy), 25 patients (93%) received > or = 80% of the intended dose. Gemcitabine dose intensity was > or = 80% in only 13 (48%) patients. The rate of complete and partial responses were 61% and 27%, respectively, for an overall response rate of 88%. At a median follow-up of 13 months (range 6-62), the actuarial 3-year progression-free survival (PFS) and overall survival (OS) were 37% and 33%, respectively. The only variable associated with prolonged survival (P = 0.0001) was the degree of response. No difference was observed in response or toxicity with either gemcitabine 50 or 100 mg/m2.
  
  
  CONCLUSIONS
  The concurrent use of radiotherapy and gemcitabine is effective but produces manageable severe mucositis in a high percentage of patients.
authors.affiliation: Department of Medical Oncology, Instituto Nacional de Cancerología, Mexico City, DF, México. subedu@hotmail.com
authors.forename: J
authors.initials: J
authors.lastname: Aguilar-Ponce
authors.forename: M
authors.initials: M
authors.lastname: Granados-García
authors.forename: V
authors.initials: V
authors.lastname: Villavicencio
authors.forename: A
authors.initials: A
authors.lastname: Poitevin-Chacón
authors.forename: D
authors.initials: D
authors.lastname: Green
authors.forename: A
authors.initials: A
authors.lastname: Dueñas-González
authors.forename: A
authors.initials: A
authors.lastname: Herrera-Gómez
authors.forename: K
authors.initials: K
authors.lastname: Luna-Ortiz
authors.forename: A
authors.initials: A
authors.lastname: Alvarado
authors.forename: H
authors.initials: H
authors.lastname: Martínez-Said
authors.forename: C
authors.initials: C
authors.lastname: Castillo-Henkel
authors.forename: B
authors.initials: B
authors.lastname: Segura-Pacheco
authors.forename: J
authors.initials: J
authors.lastname: De la Garza
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000494:pharmacology*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000494:pharmacology*; D018572:Disease-Free Survival; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011832:Radiation Injuries; D012264:Ribonucleotide Reductases / Q000037:antagonists & inhibitors; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D012264:Ribonucleotide Reductases; D000093542:Gemcitabine