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Michael E. Poole, PA-C, MPH; Scott L. Sailer, MD; Julian G. Rosenman, MD; Joel E. Tepper, MD; Mark C. Weissler, MD; William W. Shockley, MD; Wendell G. Yarbrough, MD; Harold C. Pillsbury III, MD; Michael J. Schell, PhD; Stephen A. Bernard, MD

Arch Otolaryngol Head Neck Surg. 2001;127:1446-1450.

Objectives  To measure the efficacy and toxic effects of our chemoradiotherapy regimen by means of response and survival in patients with advanced squamous cell carcinoma of the head and neck (HNSCC) for organ preservation in resectable disease or palliation in unresectable disease.

Design  All patients underwent evaluation by the multidisciplinary head and neck cancer team, with pathological diagnosis and staging. All patients underwent assessment for response to therapy using results of physical examination and radiologic imaging. Patients were followed up at 3-month intervals for a planned period of 5 years.

Setting  Academic center.

Patients  Thirty-eight previously untreated patients with newly diagnosed HNSCC were treated from June 1, 1996, through December 31, 1998, of whom 20 had resectable and 18 had unresectable tumors.

Intervention  Patients received intravenous cisplatin, 100 mg/m² for 1 hour on days 1 and 29; a 24-hour continuous infusion of fluorouracil, 1000 mg/m² on days 1 through 4 and 29 through 32; and radiation therapy, 150 rad twice daily for 12 days. The patients were given a 7- to 10-day break, and radiation therapy was restarted on day 29 for 12 additional days (total dose, 7200 rad).

Main Outcome Measures  Complete, partial, and total response rates; disease-free survival; overall survival; and toxic effects.

Results  Toxic effects of treatment were moderately severe, including grades III to IV mucositis (89%), neutropenia (71%), and renal toxic effects (8%). In the 18 patients in the unresectable group, complete response in the 17 primary tumors and 15 cervical nodal metastases was achieved in 12 (71%) and 9 (60%), respectively; in the 20 patients undergoing organ preservation, complete response rates were 100% in the 23 primary tumors and 15 cervical nodal metastases. Complete response for all 38 patients was achieved in 31 (82%). In the unresectable group, the Kaplan-Meier relapse-free survival estimate is 56%, with follow-up from 29 to 45 months. In the organ preservation group, 75% of patients are alive without disease, and 8 have been followed up for 36 to 48 months. Of the 5 patients who have died, only 2 died of disease, with recurrences at 13.0 and 16.5 months.

Conclusions  Chemoradiotherapy consisting of cisplatin, fluorouracil, and twice-daily external beam radiation is highly effective in achieving durable complete responses in patients with resectable HNSCC undergoing organ preservation and patients with unresectable HNSCC undergoing palliation. Toxic effects of this regimen were moderate to severe.

From the Division of Hematology/Oncology, Department of Medicine (Mr Poole and Dr Bernard), and the Departments of Radiation Oncology (Drs Sailer, Rosenman, and Tepper) and Otolaryngology–Head and Neck Surgery (Drs Weissler, Shockley, Yarbrough, and Pillsbury), University of North Carolina School of Medicine, and the University of North Carolina Lineberger Comprehensive Cancer Center (Dr Schell), Chapel Hill.

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