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A Phase II Trial of Vinorelbine in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Saxman, Scott M.D.; Mann, Beth Ph.D.; Canfield, Vikki M.D.; Loehrer, Patrick M.D.; Vokes, Everett M.D.

American Journal of Clinical Oncology: August 1998 - Volume 21 - Issue 4 - p 398-400

Forty patients with locally advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated weekly with vinorelbine 30 mg/m2. Thirty-five patients received prior surgery, 20 prior chemotherapy, and 38 prior radiation therapy. Five patients were not evaluable for response and were assumed to be nonresponders. There were three confirmed responders (one complete response, two partial responses) for a response rate of 7.5% (95% confidence interval, 1.6%-20.4%). The median survival time for all patients was 5 months (range, 0.5-50 months), the median progression-free survival time was 2 months (range, 1-49 months). The most common toxicity was myelosuppression, with 60% of patients experiencing grade 3 or higher leukopenia. There was one treatment-related death resulting from sepsis. Vinorelbine has minimal activity in patients with SCCHN that does not exceed that of other currently used agents.

From the Division of Hematology/Oncology, Department of Medicine, Indiana University School of Medicine, Indianapolis, IN, U.S.A. (S.S., B.M., P.L.); Division of Hematology/Oncology, Department of Medicine, University of Oklahoma, Health Science Center, Oklahoma City, Oklahoma, U.S.A. (V.C.); and Division of Oncology, Department of Medicine, University of Chicago (E.V.), Chicago, Illinois, U.S.A.

Supported in part by a grant from Glaxo Wellcome, Research Triangle Park, NC, U.S.A.

Dr. Vokes has worked as a speaker and advisor for Glaxo Wellcome.

Address correspondence and reprint requests to Dr. Scott Saxman, Division of Hematology/Oncology, Department of Medicine, Indiana University School of Medicine, 535 Barnhill Drive, Room RT 440, Indianapolis, IN 46202-5260. U.S.A.

© Lippincott-Raven Publishers.