brought to you by Mary
Shomon
June 2004 --
Final data was presented from a clinical study evaluating Genzyme Corporation's Thyrogen
(thyrotropin alfa for injection) as a therapy for the ablation of thyroid tumor remnants in patients who
have thyroid cancer tumors. The data was presented at the Annual Meeting of the Endocrine Society
in New Orleans. It was Genzyme's first clinical study to evaluate Thyrogen in a therapeutic application.
Thyrogen has been on the market since 1998 as a diagnostic tool used in the management of patients
being followed for the recurrence of well-differentiated thyroid cancer. The
comparative study enrolled 63 patients in nine centers across Europe, Canada and the United States. All patients had well-differentiated thyroid cancer and had recently undergone thyroidectomy. The study
measured the rates of ablation of thyroid remnants in patients undergoing standard withdrawal from
thyroid hormone, compared to patients who were treated with thyroid hormone and then used Thyrogen.
Radioiodine ablation is often performed after thyroidectomy in patients with thyroid cancer to remove
remnant thyroid tissue and microscopic cancer, reducing both the risk of relapse and the likelihood that
the patient will have recurrent disease later in life. Withholding thyroid hormone therapy following
surgery increases the thyroid stimulating hormone (TSH) level in a patient's circulation, enhancing
thyroid uptake of radioiodine. However, withholding thyroid hormone also causes patients to become
hypothyroid.
The comparative study sought to determine if Thyrogen would be as effective for remnant ablation as
thyroid hormone withdrawal, and therefore spare patients the debilitating effects associated with becoming hypothyroid. The study also evaluated the safety profile of Thyrogen when used for remnant ablation and assessed thyroid hormone withdrawal associated morbidity.
Study Findings
Findings demonstrate that Thyrogen met the study's primary endpoint and was shown to be similar to
withdrawal from thyroid hormone in achieving ablation of thyroid remnant tissue. Thyrogen was also
shown to significantly reduce the side-effects of thyroid hormone withdrawal by allowing patients to
remain on their hormone therapy. Lastly, Thyrogen was determined to be well- tolerated.
The patients in the study were randomized into one of two study arms within two weeks following
surgery: hypothyroidism, in which thyroid hormone was withheld for 4-6 weeks, or normal thyroid
function in which thyroid hormone was administered after surgery, followed by Thyrogen at the time of
ablation. Both groups then received radioactive iodine to ablate thyroid cancer remnants.
Success of ablation was evaluated using a Thyrogen whole body scan and radioiodine uptake measurement taken eight months following ablation, and was based upon a primary endpoint of no visible thyroid bed uptake or, if visible, uptake less than 0.1 percent of administered isotope. By this primary criterion, 100 percent of patients in both treatment groups were successfully ablated.
"This study strongly supports the use of Thyrogen in combination with radioiodine to treat patients
following thyroidectomy," stated Furio Pacini, M.D., of the University of Siena in Pisa, Italy and the
clinical trial's lead investigator in Europe. "My patients treated with Thyrogen significantly benefited by
avoiding the hypothyroid state, the current standard of care."
The American Cancer Society estimates that about 23,600 new cases of thyroid cancer will be diagnosed in the United States this year. It is three times more common in women than in men. Most cases of thyroid cancer are discovered during a routine physical examination when a painless lump is found in the thyroid. In accordance with major guidelines for treating thyroid cancer, the majority of patients undergo adioiodine ablation which, in addition to facilitating follow-up monitoring, may reduce recurrences of thyroid cancer.
Thyrogen also is being evaluated in another therapeutic indication, non- toxic multinodular goiter.
Preliminary data from a phase 1 clinical study are expected in early 2005.
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Is an undiagnosed or improperly treated thyroid condition causing you to pack on the pounds, or dooming you to diet failure? On September 1, 2004, you'll have the answer, with the publication of The Thyroid Diet.
It's the first book written to help thyroid patients -- and those who don't even know they have a thyroid problem yet -- to effectively lose weight. The book features 400 pages of information, including:
- Diet Planning Worksheets
- Eating Plans
- Food Lists
- Gourmet Recipes
- Information on Safe & Helpful Supplements and Herbs
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The Thyroid Diet: Manage Your Metabolism for Lasting Weight Loss, by Mary J. Shomon
Coming Sept. 1, 2004 from HarperCollins, 400 pages, ISBN: 0-06-052444-8
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