19 May Genomic Profile Can Improve Confidence in Active Surveillance of Prostate Cancer
MedicalResearch.com Interview with:
Bela S. Denes, MD, FACS
Senior Director Medical Affairs
Genomic Health Inc.
Redwood City, CA. 94063
MedicalResearch.com: What is the background for this study?
Response: This is a prospective community based non-interventional study designed to provide information on the utility of Oncotype GPS in the management of men presenting with a new diagnosis of clinically localized low risk prostate cancer. We sought to understand the impact of incorporating a molecular marker into the shared treatment decision in practices already well versed in Active Surveillance (AS) as measured by persistence on surveillance at 2 years as well as a number of patient reported outcomes. The current publication reports on the results of a one year pre-specified interim analysis.
MedicalResearch.com: What are the main findings?
Response: The key findings in this study are that in practices with relatively high baseline AS rates (40%) incorporation of GPS as a molecular marker of tumor aggressiveness resulted in a 22% increase in the rate of AS. This increase in Active Surveillance selection increased the pool of men pursuing AS at one year by an absolute 21% and a relative 62% compared to baseline. Physicians also reported increased confidence following incorporation of GPS into decision making and patients reported a marked decrease in decision conflict.
MedicalResearch.com: What should readers take away from your report?
Response: Genomic or molecular markers are established as the standard of care in several solid tumors including breast cancer, lung cancer and colon cancer. Because prostate cancer is multifocal and heterogenous it presents a challenge to accurate staging and grading often resulting in overtreatment of indolent disease.
Genomic biomarkers like the Oncotype DX GPS (Genomic Prostate Score) have the potential to reveal the underlying tumor biology and thus help not only identify men who can pursue surveillance safely but those men with more aggressive disease who would benefit from intervention. We saw in the recently published ProtecT trial that 50% of patients randomized to active monitoring had an intervention by 10 years. While this shows that surveillance or monitoring does spare a large number of men from the side effects of surgery and/or radiation, it also suggests that half the men who were randomized to surgery or radiation did not benefit. Molecular tests like the Oncotype DX GPS should improve on this by refining risk estimates that ultimately guide treatment selection.
I would like to remind the readers that the data presented here is from the one year interim analysis and additional data sets will be forthcoming next year when the two year study results will be available.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: Molecular markers are still relatively new in this space and long term outcomes are not yet available but will be forthcoming. I expect that we will see more markers being developed including markers that are not only prognostic but predictive as well so called liquid biopsy assays that will allow us to better monitor the course of the disease and response to treatments when needed.
MedicalResearch.com: Is there anything else you would like to add?
Response: As I said earlier we are at the beginning of the genomic revolution in the management of prostate cancer and these tests allow us to provide personalized information to guide individual treatment or management decisions, that is precision medicine.
As for disclosures, I am an employee of Genomic Health Inc., have been with the company nearly 5 years with over 25 years of clinical Urology experience.
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Urology. 2017 Apr 25. pii: S0090-4295(17)30374-6. doi: 10.1016/j.urology.2017.02.052. [Epub ahead of print]
Use of a 17-gene prognostic assay in contemporary urologic practice: results of an interim analysis in an observational cohort.
Eure G1, Germany R2, Given R1, Lu R3, Shindel AW3, Rothney M3, Glowacki R4, Henderson J2, Richardson T5, Goldfischer E6, Febbo PG3, Denes B7.
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