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

Arch Otolaryngol Head Neck Surg. 2006;132:385-389.

Objective  To determine feasibility, compliance, long-term survival, and disease control rates in the intensification regimen for advanced resectable hypopharyngeal carcinoma.

Design  Prospective, nonrandomized, controlled phase 2 trial with a median follow-up period of 89 months (range, 3.4-140.0 months).

Setting  Cancer center at a state university.

Patients  Thirty-two patients (age range, 44-79 years; median age, 59 years) with advanced (69% stage IV, 31% stage III) resectable hypopharyngeal carcinoma.

Interventions  Combination of surgery, radiation therapy, and chemotherapy (cisplatin and paclitaxel) along with intraoperative radiation therapy.

Main Outcome Measures  Compliance, long-term survival, and locoregional and systemic disease control rates and functional outcome.

Results  The protocol compliance rate was 62% (20 of 32 patients), and the overall 5-year survival rate was 56%. Local recurrence occurred in 3 patients (9%). The systemic disease control rate was 91% (29 of 32 patients). Total laryngectomy was required in 15 patients (47%); preservation of the larynx was possible in 17 patients (53%). Only 3 (13%) of 6 patients were percutaneous endoscopic gastrostomy tube dependent in the long-term follow-up.

Conclusions  The intensification regimen described in this study accomplished excellent long-term survival and disease control rates in patients with advanced resectable hypopharyngeal carcinoma. The future plan is to proceed with a phase 3 trial if the single-institutional experience at The Ohio State University can be duplicated in a multi-institutional phase 2 study.

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

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