GU Cancers 2019 | Endpoints beyond OS for prostate cancer
Overall survival is a common endpoint used in the assessment of prostate cancer. Speaking at the 2019 Genitourinary Cancers Symposium, held in San Francisco, CA, Andrew Armstrong, MD, of the Duke Cancer Institute, Durham, NC, reviews alternative endpoints measurements.
Transcript (edited for clarity):
So the United States, the FDA, has accepted recently some surrogate end-points. Metastasis-free survival has been established now as a potential surrogate for overall survival in prostate cancer based on the ice-cap data, and now based on multiple studies.
And I think the FDA is also willing to accept other end-points as clinically meaningful. So if you’re seeing substantial improvements in quality of life and delays in pain progression, in delays for the need for subsequent therapies and delaying metastatic progression with good quality of life and safety, the FDA really wants effective therapies that improve outcomes by years, ideally, not just weeks or months, and they want good safety.
It’s not just about survival, but of course survival is the gold standard. But with subsequent therapies and a more long-term natural history for these patients, it’s increasingly important to bring these studies and treatments to our patients early.
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