James "Tate" T. Thigpen, MD, professor of medicine, director of medical oncology, University of Mississippi School of Medicine, discusses the use of agents in ovarian cancer that are not approved by the FDA.

There may be some problems with insurance coverage in some states, Thigpen says, creating inconsistent coverage across the country. Further, pharmaceutical companies cannot promote a drug for an indication unless FDA approval is granted. This creates a major disadvantage in making a physician aware of what an agent can and cannot do.

The support for CME conferences to represent unbiased points of view has been lagging in the gynecologic cancers area, Thigpen says. This is unfortunate because perspective on overall literature is crucial to the educational process.

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Dr. Thigpen on Ovarian Cancer Drugs Not Approved by FDA 

James "Tate" T. Thigpen, MD, professor of medicine, director of medical oncology, University of Mississippi School of Medicine, discusses the comparison of treatment options in ovarian cancer.

In ovarian cancer studies, researchers cannot control what therapies a patient will receive following progression on a study therapy. After progression, Thigpen says, additional lines of therapy are introduced at random -- sometimes up to 8-10 lines. These additional treatments obviously have an impact on survival but it becomes difficult to make an accurate comparison of therapies.

There is a need for a clinical trial endpoint to allow for a clean comparison, which Thigpen says could be progression-free survival (PFS). It has been shown that PFS can be assessed in a consistent fashion.

James "Tate" T. Thigpen, MD, Professor of Medicine, Director, Division of Medical Oncology, University of Mississippi School of Medicine, discusses the comparison of treatment options in ovarian cancer.

James T. Thigpen, MD

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