title: Results of phase I-II trial of concomitant hyperfractionated radiation and oral etoposide (VP-16) in patients with unresectable squamous cell carcinoma of the head and neck.
abstract: OBJECTIVE
  The purpose of the current study was to investigate the efficacy of concomitant oral etoposide and hyperfractionated radiation for patients with unresectable head and neck squamous cell carcinoma.
  
  
  METHODS
  A prospective nonrandomized phase I-II study was conducted using concomitant oral etoposide (50 mg/d for 13-27 days) and hyperfractionated radiotherapy (1.2 Gy twice daily to a total of 7440 rads) for patients with unresectable squamous cell carcinoma of the head and neck. Toxicity was graded according to the NCI common toxicity criteria. Patients were followed for a minimal period of 2 years. Endpoints for follow-up were recurrence or death.
  
  
  RESULTS
  Seventeen patients were enrolled in the study. Grade III hematological toxicity occurred in 1 patient and moderate to severe mucositis occurred in all but 2 patients requiring a gastrostomy tube (n = 13) or intravenous fluids hydration (n = 2). One patient died of cardiac arrest unrelated to the treatment regimen. The overall response rates in patients that finished the protocol were 80% for the primary site and 100% for the neck. A complete response was observed in 47% at the primary site and 33% in the neck. Local control and disease-free survival (DFS) at an average follow-up of 3.7 years were 47% and 29%, respectively.
  
  
  CONCLUSIONS
  Concomitant etoposide and hyperfractionated radiation is well tolerated and seems to be effective in the treatment of unresectable HNSCC with acceptable mucosal toxicity.
authors.affiliation: Department of Otolaryngology-Head and Neck Service, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
authors.forename: Avi
authors.initials: A
authors.lastname: Khafif
authors.forename: Vikki A
authors.initials: VA
authors.lastname: Canfield
authors.forename: Elizabeth J
authors.initials: EJ
authors.lastname: Syzek
authors.forename: Jesus E
authors.initials: JE
authors.lastname: Medina
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D019583:Dose Fractionation, Radiation; D004334:Drug Administration Schedule; D005047:Etoposide / Q000627:therapeutic use*; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide