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Organ Preservation Therapy Using Induction Plus Concurrent Chemoradiation for Advanced Resectable Oropharyngeal Carcinoma: A University of Pennsylvania Phase II Trial

From the Department of Radiation Oncology, Division of Medical Oncology, Department of Medicine, and Department of Otorhinolaryngology-Head and Neck Surgery, University of Pennsylvania Medical Center, Philadelphia, and Pocono Medical Center, East Stroudsburg, PA; and Department of Medical Oncology, Falmouth Hospital Oncology Center, Mashpee, MA.

Address reprint requests to Mitchell Machtay, MD, Department of Radiation Oncology, 2 Donner Bldg, University of Pennsylvania Medical Center, 3400 Spruce St, Philadelphia, PA 19104; email: machtay{at}xrt.upenn.edu

PURPOSE: To determine the efficacy, feasibility, and toxicity of a new regimen for locally advanced oropharyngeal carcinoma.

PATIENTS AND METHODS: Patients had technically resectable stage III/IV squamous cell carcinoma of the oropharynx, exclusive of T1-2N1. Induction chemotherapy consisted of carboplatin (area under the curve formula equal to 6) and paclitaxel 200 mg/m² for two cycles, followed by re-evaluation. Patients with major response continued to definitive radiotherapy (70 Gy over 7 weeks) plus concurrent once-weekly paclitaxel (30 mg/m²/wk). Patients with advanced neck disease also underwent post–radiation therapy neck dissection and two more chemotherapy cycles.

RESULTS: Fifty-three patients were enrolled. Median follow-up was 31 months (minimum follow-up for survivors was 18 months). The major response rate to induction chemotherapy was 89%; 90% of patients had a complete response after concurrent chemoradiation. Actuarial survival at 3 years was 70%, and 3-year event-free survival was 59%. The 3-year actuarial locoregional control was 82% and the 3-year actuarial rate of distant metastases was 19%. Organ preservation was achieved in 77% of all patients. One patient (2%) died during therapy. Late grade 3 toxicity occurred in 24% of patients, consisting mainly of chronic dysphagia/aspiration and/or radiation soft tissue ulceration. The treatment-related mortality rate was 4% (two patients died from respiratory failure).

CONCLUSION: Response to induction chemotherapy as studied in this trial was not useful as a predictive marker for ultimate outcome or organ conservation. Overall, however, this regimen offers good disease control and survival for patients with locally advanced oropharyngeal carcinoma, comparable with other concurrent chemoradiation programs. Further study of similar protocols is indicated.

The partial funder of this study, Bristol-Myers-Squibb (the manufacturer of Taxol and carboplatin), did not have any role in the collection or analysis of the data in this trial or the writing of this article.

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