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Supradose Intra-Arterial Cisplatin and Concurrent Radiation Therapy for the Treatment of Stage IV Head and Neck Squamous Cell Carcinoma Is Feasible and Efficacious in a Multi-Institutional Setting: Results of Radiation Therapy Oncology Group Trial 9615

From the Southern Illinois University School of Medicine, Springfield, IL; University of Southern California, Keck School of Medicine, Los Angeles; University of California San Diego, San Diego; University of California San Francisco, San Francisco, CA; Radiation Therapy Oncology Group, Philadelphia, PA; University of Iowa, Iowa City, IA; Vanderbilt University Medical Center, Nashville, TN; University of Vermont, Burlington, VT; University of Virginia, Charlottesville, VA; The George Washington University, Washington, DC; and University of Washington, Seattle, WA.

Address reprint requests to K. Thomas Robbins, MD, Southern Illinois University School of Medicine, Division of Otolaryngology Head and Neck Surgery, PO Box 19662, Springfield, IL 62794-9662; e-mail: trobbins{at}siumed.edu

PURPOSE: To determine the feasibility of high-dose intra-arterial (IA) cisplatin and concurrent radiation therapy (RT) for head and neck squamous cell carcinoma in the multi-institutional setting (Multi-RADPLAT).

PATIENTS AND METHODS: Eligibility included T4 squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received cisplatin (150 mg/m² IA with sodium thiosulfate 9 g/m² intravenous [IV], followed by 12 g/m² IV over 6 hours, weekly for 4 weeks) and concurrent RT (70 Gy, 2.0 Gy/fraction, daily for 5 days over 7 weeks). Between May 1997 and December 1999, 67 patients from three experienced and eight inexperienced centers were enrolled, of whom 61 were eligible for analysis.

RESULTS: Multi-RADPLAT was feasible (ie, three or four infusions of IA cisplatin and full dose of RT) in 53 patients (87%). The complete response (CR) rate was 85% at the primary site and 88% at nodal regions, and the overall CR rate was 80%. At a median follow-up of 3.9 years for alive patients (range, 0.9 to 6.1 years), the estimated 1-year and 2-year locoregional tumor control rates are 66% and 57%, respectively. The estimated 1-year and 2-year survival rates are 72% and 63%, respectively. The estimated 1-year and 2-year disease-free survival rates are 62% and 46%, respectively. The rates of grade 4 and 5 toxicities at the experienced and the inexperienced institutions were 14% and 0% v 47% and 4%, respectively.

CONCLUSION: This intensive treatment regimen for head and neck cancer is feasible and effective in a multi-institutional setting.

Supported by grant No. ROI-CA-95-012 from the National Cancer Institute, Bethesda, MD (K.T.R.).

Authors’ disclosures of potential conflicts of interest are found at the end of this article.

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