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High Survival and Organ Function Rates After Primary Chemoradiotherapy for Intermediate-Stage Squamous Cell Carcinoma of the Head and Neck Treated in a Multicenter Phase II Trial

Ezra E.W. Cohen, Daniel J. Haraf, Marcy A. List, Masha Kocherginsky, Bharat B. Mittal, Fred Rosen, Bruce Brockstein, Rosalyn Williams, Mary Ellyn Witt, Kerstin M. Stenson, Merrill S. Kies, Everett E. Vokes

From the Section of Hematology/Oncology, Department of Medicine, Department of Radiation and Cellular Oncology, Department of Health Studies, and Section of Otolaryngology/Head and Neck Surgery, Department of Surgery, University of Chicago; University of Chicago Cancer Research Center; Department of Radiation Oncology, Northwestern University, Feinberg School of Medicine and Robert H. Lurie Comprehensive Cancer Center; Department of Medicine, John H. Stroger Hospital of Cook County, Chicago; Department of Internal Medicine, Evanston Northwestern Healthcare, Evanston, IL; and Thoracic/Head & Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Ezra Cohen, MD, Section of Hematology/Oncology, Department of Medicine, University of Chicago, 5841 S Maryland Ave, MC2115, Chicago, IL, 60637; e-mail: ecohen{at}medicine.bsd.uchicago.edu

PURPOSE: Patients with intermediate-stage squamous cell carcinoma of the head and neck traditionally have been treated with initial surgical resection followed by radiotherapy (RT) alone or chemoradiotherapy. A previous study in this patient population reported a 91% locoregional control rate and 65% overall survival (OS) rate at 5 years, with chemoradiotherapy used as primary treatment. This study was undertaken to assess whether shortening treatment duration with hyperfractionated RT would be feasible and improve locoregional control, organ preservation, and progression-free survival.

METHODS: Eligible patients with stage II or III disease received fluorouracil, hydroxyurea, and RT given twice daily on a week-on/week-off schedule. Quality-of-life scores were measured using three validated indexes.

RESULTS: All 53 patients enrolled are included in the analysis, with a median follow-up of 42 months (range, 5 to 98 months). Grade 3 or 4 in-field mucositis was observed in 77% and 9%, respectively. No patients required surgical salvage at the primary tumor site (pathological complete response rate, 100%). The 3-year progression-free and OS rates are 67% and 78%, respectively. The 3-year disease-specific mortality rate is 7%. At the time of analysis, 87% of surviving patients do not require enteral feeding support. Quality-of-life and performance assessment indicated that, although acute treatment toxicities were severe, most patients returned to pretreatment function by 12 months.

CONCLUSION: Concurrent chemoradiotherapy with hyperfractionated RT is feasible in this patient population and yields high local control and cure rates. Compared with our historical control using once-daily fractionation, hyperfractionation is accompanied by increased acute in-field toxicity.

Supported by the Valda and Robert Svendsen Foundation and University of Chicago Cancer Research Center (National Cancer Institute Grant No. 5P30CA14599-31).

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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