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.
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.
Khafif
Avi
A
Department of Otolaryngology-Head and Neck Service, Tel-Aviv Sourasky Medical Center, Tel-Aviv, Israel.
Canfield
Vikki A
VA
Syzek
Elizabeth J
EJ
Medina
Jesus E
JE
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
D000972:Antineoplastic Agents, Phytogenic; D005047:Etoposide