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A 12-Year Experience

David E. Schuller, MD; Enver Ozer, MD; Amit Agrawal, MD; John C. Grecula, MD; Chris A. Rhoades, MD; Donn C. Young, PhD

Arch Otolaryngol Head Neck Surg. 2007;133(4):320-326.

Objective  To determine the feasibility of, compliance with, and long-term survival with intensification treatment regimens for patients with advanced, resectable, previously untreated head and neck squamous cell carcinoma.

Design  Prospective phase 2 clinical trial (3 similar, consecutively evolved trials).

Setting  Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University.

Patients  One hundred twenty-three patients (median age, 60 years; range, 30-78 years) with previously untreated, resectable, advanced squamous cell carcinomas of the oral cavity, oropharynx, or hypopharynx.

Interventions  Perioperative cisplatin chemoradiotherapy, surgical resection with intraoperative radiotherapy, and postoperative paclitaxel and cisplatin chemoradiotherapy.

Main Outcome Measures  The feasibility, compliance, and long-term survival associated with the 3 intensification regimens.

Results  Compliance with all 3 intensification regimens averaged 61% (75/123). Patient-directed noncompliance occurred in 16 patients (13%). The average locoregional (112/123, 91%) and systemic (106/123, 86%) disease control rates were excellent. Overall long-term disease-specific survival was 73%. Median time at risk was 62.5 months (range, 1 day to 100.4 months).

Conclusions  The intensification regimens result in excellent disease control rates and long-term survival in this particular patient population. Future evolution of these regimens will include some modifications to further decrease toxic effects followed by phase 2 multi-institutional trials to determine whether the single-institutional experience can be duplicated. The results of these studies will determine whether phase 3 trials can be proposed.

Author Affiliations: Department of Otolaryngology–Head and Neck Surgery (Drs Schuller, Ozer, and Agrawal), Division of Radiation Oncology, Department of Radiation Medicine (Dr Grecula), Division of Medical Oncology, Department of Internal Medicine (Dr Rhoades), and Biostatistics Unit (Dr Young), Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University, Columbus.

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