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David E. Schuller, MD; John C. Grecula, MD; Reinhard A. Gahbauer, MD; Constance Bauer, MD; Jessie L.-S. Au, PharmD, PhD; Roy E. Smith, MD; Jeffrey R. Haller, MD; Rodney E. Mountain, MB, ChB; Donn C. Young, PhD; Subir Nag, MD

Arch Otolaryngol Head Neck Surg. 1997;123(2):139-144.

Abstract
Objective
To devise an intensified treatment regimen for patients with advanced, resectable head and neck squamous cell carcinomas.

Design
Phase I/II clinical trial consisting of perioperative cisplatin chemoradiotherapy, surgical resection, intraoperative radiotherapy, and postoperative cisplatin chemoradiotherapy.

Setting
The Ohio State University Comprehensive Cancer Center, Columbus.

Patients
Thirty-seven patients (median age, 63 years) with advanced oral cavity, oropharyngeal, or hypopharyngeal carcinomas.

Results
The range of time at risk was 1 to 30 months (median, 21 months). Thirty of the 37 registered patients were analyzable; 11 have died (5 with distant metastases; 1 of lung carcinoma; and 5 were cancer-free); 2 experienced second primary tumors in the oral cavity (out of or adjacent to the previous radiotherapy portals). Treatment compliance was excellent (92%), morbidity was low, and excellent locoregional control was achieved.

Conclusions
The initial results are encouraging; the future strategy will intensify the systemic component of therapy based on results from concurrent laboratory studies.

Arch Otolaryngol Head Neck Surg. 1997;123:139-144

Author Affiliations
From the Department of Otolaryngology, Comprehensive Cancer Center Head and Neck Oncology Program (Drs Schuller, Haller, and Mountain), the Division of Radiation Oncology, Department of Radiology (Drs Grecula, Gahbauer, Bauer, and Nag), College of Pharmacy (Dr Au), the Division of Hematology/Oncology, Department of Internal Medicine (Dr Smith), and the Comprehensive Cancer Center Biostatistics Unit (Dr Young), Arthur G. James Cancer Hospital and Research Institute, The Ohio State University, Columbus.

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