In a pivotal Phase III study published in the New England Journal of Medicine, the oral anti-angiogenic therapy lenvatinib appears to be a very promising new treatment for patients with advanced radioiodine-refractory thyroid cancer.

According to the National Cancer Institute, 60,000 people will be diagnosed with thyroid cancer in 2015 and almost 2,000 will die from the disease. The thyroid gland is located in the front of the neck and is attached to the lower part of the voice box (larynx) and to the upper part of the windpipe (trachea). It has two sides, or lobes, that are connected by a narrow neck. The thyroid gland produces thyroid hormones, which regulate metabolism, growth, and development and are essential for life.

Advanced thyroid cancers have historically not responded to treatment with chemotherapy. It has been thought, however, that tyrosine kinase inhibitors may be effective in the treatment of this form of thyroid cancer, as tyrosine kinases have been implicated in the development of the disease. According to the current study’s senior author and the international principal investigator, Dr. Sherman, “About 10 years ago, with the growing availability of novel targeted agents and multi-targeted  kinase inhibitors, we began to recognize potential for treating this subgroup of patients with anti-angiogenic therapy and sought to enroll those with refractory disease in clinical trials.”

The current international study enrolled 392 patients with progressive, refractory thyroid cancer from 21 countries. Patients were treated with either lenvatinib or placebo, and directly compared. At the time of disease-progression, patients treated with placebo arm could receive lenvatinib.

For those who received lenvatinib, 64.8% of patients experienced a partial or complete disappearance of their cancer following treatment, and the median progression-free survival was 18.3 months, compared with 3.6 months in those who received placebo. The median overall survival has not yet been reached in either group.

The drug is not without side effects; more than 40 percent of patients that received lenvatinib experienced some reaction, with hypertension being the most common. Other side effects included:  diarrhea, fatigue, nausea, and decreased appetite. Six deaths that occurred during the treatment period were determined to be drug-related by their treating physicians.

A number of follow up studies with lenvatinib are in development, including in other types of thyroid cancers, and in combination with other novel therapies for radioiodine refractory patients. Patients should discuss the potential risks and benefits of treatment or participation in one of these ongoing trials with their physician.

Reference: Schlumberger M, Makoto T, Wirth L, et al.  The New England Journal of Medicine; 372:621-630 February 12, 2015.

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