DOI: 10.1097/01.COT.0000418358.69679.58

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Issn Print: 0276-2234

Publication Date: 2012/07/25


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Metastatic Prostate Cancer: Intermittent ADT ‘Not Non-inferior’ to Continuous

Robert H. Carlson

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Excerpt

CHICAGO—Is “not non-inferior” the same as “inferior”? This was one of two major questions confronting researchers of the long-term, multicenter Phase III SWOG 9346 study reported here in the Plenary Session of the ASCO Annual Meeting (Abstract 4), which compared the use of intermittent androgen-deprivation therapy (ADT) with continuous ADT in men with metastatic prostate cancer.
The researchers concluded that intermittent androgen deprivation was not non-inferior to continuous androgen deprivation in men with newly diagnosed, hormone-sensitive metastatic prostate cancer. In secondary analyses, a subset of patients with minimally extensive disease had statistically significantly shorter overall survival with intermittent vs. continuous therapy, while the outcomes were essentially the same in men with extensive disease.
And that raised a second question: Whether the definitions of extensive and minimal used in this trial were clinically or biologically relevant.
Lead author Maha Hussain, MD, Professor of Medicine and Urology and Associate Director for Clinical Research at the University of Michigan Comprehensive Cancer Center, who presented the data here, concluded that “survival with intermittent therapy is inferior to continuous therapy.
“Intermittent androgen deprivation is not proven to be non-inferior to continuous androgen deprivation,” she and her colleagues wrote in their abstract. “For extensive disease patients, intermittent androgen deprivation was non-inferior; however, intermittent androgen deprivation was statistically inferior in minimal disease patients, suggesting that continuous androgen deprivation is the preferred treatment in this group.”
Some experts attending the meeting said the study might convince them to continue with continuous androgen deprivation, the standard of care, despite the well-known adverse effects.
But the results might change practice for others who consider the cost of continuous therapy in terms of patient quality of life, and discount the small difference in overall survival. One reason for the differing opinions stems from the study protocol, which was not designed for statistical subset analysis, even though the stratification by minimal or extensive disease was factored in.

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