Genomic prostate score shown to predict BCR

The Oncotype DX prostate cancer test (Genomic Health, Inc.) is a predictor of not only adverse surgical pathology at radical prostatectomy but also long-term risk of biochemical recurrence after surgery, according to research presented at the European Society for Medical Oncology Congress in Madrid, Spain.

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The independent clinical validation study was conducted in collaboration with the Uniformed Services University of the Health Sciences' (USU) Center for Prostate Disease Research (CPDR), Bethesda, MD, supported by a multidisciplinary team of investigators under a cooperative research and development agreement with USU.

In the prospectively designed study, Oncotype DX genomic prostate score (GPS) results were obtained using archival biopsy tumor tissue from 402 men, including 82 African-American patients, treated with radical prostatectomy for National Comprehensive Cancer Network very low-, low-, or intermediate-risk prostate cancer at two U.S. military medical centers between 1990 and 2012.

Among the findings reported:

• The biopsy-based Oncotype DX GPS was a robust and independent measure of multiple clinically relevant endpoints, including adverse surgical pathology (p<.001) and long-term risk of biochemical recurrence after surgery (p<.001).

• The Oncotype DX GPS was very similarly predictive of outcomes in Caucasian and African-American men regardless of their race.

• The established multiple prostate cancer-specific pathways contributed to the robust predictive value of the Oncotype DX GPS.

The Oncotype DX GPS was also significantly predictive of metastatic prostate cancer recurrence (p=.032).

"There is a clear need for more accurate risk stratification and treatment optimization of men with newly diagnosed prostate cancer. Our rigorously conducted study provides further validation of the earlier studies at Cleveland Clinic and University of California, San Francisco, which showed the Oncotype DX prostate cancer test is an independent predictor of clinical outcomes to inform decisions regarding active surveillance versus immediate treatment in patients with low- and intermediate-risk disease," said senior author David McLeod, MD, of CPDR and USU in a press release.

The analysis showed that GPS distribution was very similar between African-American and Caucasian patients. Additionally, specific gene groups incorporated in GPS-androgen signaling and stromal response-were more strongly associated with biochemical recurrence, while all four biologic pathways measured by GPS were significant predictors of adverse pathology.

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The ESMO Congress also saw presentation of data from two phase II clinical studies of the autologous cellular immunotherapy sipuleucel-T (Provenge). The research provided further evidence of potential sequences of sipuleucel-T with other treatments in advanced prostate cancer.

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Preliminary data from STRIDE suggest that sipuleucel-T manufactured concurrently with enzalutamide (XTANDI) elicits product potency and immunologic prime-boost similar to that of sipuleucel-T manufactured alone, with an acceptable safety profile, according to a press release from Dendreon Corp.

In addition, findings from the phase II STAND study indicate that androgen deprivation therapy sequencing does not appear to affect sipuleucel-T-induced antigen-specific antibody response. Further analyses are under way to evaluate antigen-specific T-cell responses generated by sipuleucel-T sequenced before or after ADT, according to Dendreon.

“The importance of personalized therapies in prostate cancer treatment, particularly immunotherapies, is further supported by the data from the STRIDE and STAND studies,” said Emmanuel S. Antonarakis, MD, of the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore. “We continue to see strong evidence of the value of sequential treatment in prostate cancer care including the use of immunotherapies such as sipuleucel-T. To this end, immunotherapy has the potential to be a nice complement to other standard therapies for the treatment of advanced prostate cancer.”

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