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John C. Grecula, MD; David E. Schuller, MD; Chris A. Rhoades, MD; Jessie L.-S. Au, PhD, PharmD; Subir Nag, MD; Constance J. Bauer, MD; Amit Agrawal, MD; Rafael Martinez-Monge, MD, PhD; Andrew Johnson, PhD; Donn Young, PhD; Reinhard A. Gahbauer, MD

Arch Otolaryngol Head Neck Surg. 1999;125:1313-1318.

Objective  To determine the feasibility, toxicity, and compliance of an intense treatment regimen for patients with advanced, previously untreated, resectable head and neck squamous cell carcinomas.

Design  Prospective, nonrandomized, controlled (phase 1 or 2) clinical trial; median time at risk, 25 months (range, 7 days to 36 months).

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

Patients  Forty-three patients (median age, 59 years; range, 32-76 years) with resectable, previously untreated stage III or IV squamous cell carcinomas of the oral cavity, oropharynx, or hypopharynx or stage II squamous cell carcinomas of the hypopharynx (referred sample of patients).

Interventions  Days 1 to 4, perioperative, slightly accelerated, hyperfractionated radiotherapy (9.1 Gy) to off cord fields; days 1 to 3, cisplatin, 30 mg/m² per day; day 4, surgical resection and intraoperative radiotherapy boost (7.5 Gy); days 45 to 52, postoperative radiotherapy (40 Gy to the primary site and upper neck and 45 Gy to the supraclavicular areas); days 24, 45, and 66, paclitaxel, 135 mg/m²per 24 hours, with routine granulocyte colony-stimulating factor support; and days 25 and 46, cisplatin, 100 mg/m².

Main Outcome Measures  Toxicity, compliance, local control, and distant metastatic rates.

Results  Patient compliance was 91% (39 of 43 patients), but protocol compliance was only 58% (25 of 43 patients), reflecting increased toxicity of the systemic regimen (2 [5%] of the 43 patients experienced grade 5 hematologic toxicity due to the regimen; 16 [37%], grade 4; and 10 [23%], grade 3). Local-regional control was 92% (23 of 25 patients), and the distant metastatic rate was 8% (2 of 25) in patients completing treatment per protocol. One patient had surgical salvage of a second primary tumor.

Conclusions  Local control and patient compliance were encouraging, but systemic toxicity was unacceptable. Thus, the paclitaxel was changed to a weekly regimen.

From the Divisions of Radiation Oncology (Drs Grecula, Nag, Bauer, Martinez-Monge, and Gahbauer) and Medical Oncology (Dr Rhoades), the Department of Otolaryngology (Drs Schuller and Agrawal), the College of Pharmacy (Drs Au and Johnson), and the Biostatistics Unit (Dr Young), Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University Comprehensive Cancer Center, Columbus.

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