Phase I Study Shows 40-50% Long-term Treatment Success, Increased Survivorship

PHILADELPHIA, PA - An interdisciplinary team of specialists from the University of Pennsylvania Cancer Center's Head and Neck Program are the first to demonstrate dose tolerance levels and successful long-term treatment for head and neck cancer patients by administering the chemotherapy drug, Taxol -- intravenously and continuously for 24 hours a day, seven days a week, for seven weeks -- concurrently with radiation therapy.

n a Phase I Study of 19 patients who completed the seven-week trial, nine of them were free of cancer after three years. That is nearly a 40-50% long-term treatment success compared to about 20-30% when only radiation therapy is used.

The large majority of patients with locally advanced head and neck cancers which include the mouth, tongue, tonsil, voice box and throat are squamous cell carcinomas. The challenge is to control these cancers in critical sites that affect breathing, swallowing and speech. In advanced cancers, surgery might not even be an option.

David I. Rosenthal, MD, associate director of the Head and Neck Cancer Program at the University of Pennsylvania's Cancer Center and head of the Phase I study said, "The goal of our Phase I study was to determine the maximum tolerated dose of continuous Taxol infusions with Radiation therapy. Nobody had ever given Taxol by continuous infusion like this before; not for this long and not with radiation therapy. Other studies had indicated that Taxol sensitizes cancer cells to radiation, improving cancer control. Another showed that more prolonged exposure to Taxol at more modest doses may be more important than giving higher doses less often. That's what provoked us to try the round-the-clock infusion."

Phase I started by giving the same Taxol dose and same radiation therapy to three patients. When Taxol was well tolerated without significant toxicity, then the next group of three patients were given a higher Taxol dose. "With continuous Taxol infusions," said Dr. Rosenthal, "we hope that each day we give the radiation therapy we kill more of the Taxol-sensitized tumor cells and hopefully, by the end, all of them. That's something radiation alone does not always do."

The continuous infusion is given through an I.V. port placed on the chest wall or upper arm to give the patient as much arm and hand movement as possible. The infusion pump is carried in a little case on a strap over the shoulder or from a belt. Nurses refill the reservoir as needed. This treatment was primarily designed for patients who had advanced cancers that weren't operable because they involved critical structures such as the skull base or the carotid artery that provides blood to the brain.

ould not be removed surgically because it involved the carotid artery and the patient had a paralyzed vocal cord, a very hoarse voice and significant difficulty swallowing. "This patient was treated three years ago on this protocol and now has no evidence of any cancer. The vocal cord became mobile and now the patient has a normal voice and is swallowing essentially normally. He is very happy with the quality of his life. So we have patients who had very advanced cancers that I wouldn't dream radiation therapy alone could control, but we've seen some amazing results by the addition of the seven-week Taxol infusion."

Dr. Rosenthal started this study before coming to Penn with Vanderbilt Cancer Center medical oncologist David P. Carbone. MD, when both were at the University of Texas Southwestern Medical Center, Dallas. The Penn preliminary Phase I data about dose tolerance levels of continuous infusion of Paclitaxel concurrent with radiation therapy in advanced head and neck squamous carcinomas is described in the March issue of The Journal of Clinical Oncology, Vol. 19, no. 5 (March) 2001, pages 1363-1373.

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About the University of Pennsylvania Cancer Center's Head and Neck Cancer Program Founded ten years ago and directed by Randal S. Weber, MD, FACS, the University of Pennsylvania Head and Neck Cancer Program brings together nationally recognized experts in the development of new treatments that are designed to cure head and neck cancer, while preserving a patient's appearance, and vital functions such as eating, swallowing and speaking. The Program offers on-going clinical trials, which evaluate the effectiveness of new therapies and give patients access to the latest advances in the field. For more information about survivorship, specific types of cancer, research advances, cancer treatment, and clinical trials, visit the Cancer Center's resource on the World Wide Web at

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