May 2015, Vol. 2, No. 3

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Cell Cycle Progression Test Impacts Treatment Decisions

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The cell cycle progression (CCP) test has the power to alter treatment decisions. Results from a prospective registry of newly diagnosed patients with prostate cancer showed that the CCP risk score led to an increase (12%) or decrease (31%) in actual treatment administered in 44% of patients, according to data presented at the 2015 Genitourinary Cancers Symposium.

“In this interim analysis,” said Neal Shore, MD, Medical Director for the Carolina Urologic Research Center in Myrtle Beach, SC, “the CCP risk assessment score had a significant impact in helping physicians and patients reach consensus on an appropriate personalized treatment decision, often with major reductions in interventional treatment burden.”

According to Shore, the CCP test is a validated molecular assay that assesses risk of prostate cancer?specific disease progression and mortality when combined with standard clinicopathologic parameters. Translated into the field at large, this can help deal with the pressing concerns of overdetection and overtreatment of prostate cancer that is unlikely to progress or metastasize.

“Because prostate cancer is a heterogeneous disease,” said Shore, “adding novel prognostic markers like [the CCP score]…is a long-awaited step forward in making treatment decisions that match an individual’s cancer aggressiveness.”

PROCEDE-1000 is a prospective registry designed to evaluate the impact of the CCP test on personalizing prostate cancer treatment. It’s also the largest clinical utility trial to date for a genomic assay.

As Shore explained, the study enrolled 816 untreated patients diagnosed within the past 6 months with clinically localized prostate adenocarcinoma. One hundred five physicians in 20 states recorded their initial therapy recommendation (pre-CCP) on the first questionnaire. The CCP test was then conducted on prostate biopsy tissue.

“Three post-CCP questionnaires recorded the physician’s revised treatment recommendation, physician/patient treatment decision, and actual treatment administered,” Shore detailed. “Changes in treatments between the pre-CCP and post-CCP questionnaires demonstrated the impact of CCP testing on treatment decisions at each stage.”

The results were impressive.

“Visual analog scale measurements indicated a significant increase (P = .0125) in the physician’s likelihood of recommending noninterventional treatment post-CCP test,” said Shore. “There was an increase in active surveillance from the initial interventional therapy recommendation.”

From pre-CCP therapy recommendation, the CCP score led to a change in actual treatment administered in 44% of patients, with 72% of these changes being reductions in treatment. Reductions occurred in the following procedures: radical prostatectomy (27%), radiation therapy (44% primary; 56% adjuvant), brachytherapy (46% interstitial; 66% high-dose rate), and hormonal therapy (33% neoadjuvant; 68% concurrent).

Notably, for every 1-unit increase in mortality risk, researchers discovered an associated 3.3% rise in the odds of increase in treatment and a 3.3% drop in the odds of decrease in treatment.

Whereas 35.9% of patients were recommended for conservative management pre-CCP testing, there was a 6.5% increase in noninterventional treatments during actual follow-up. Overall, however, there was a significant reduction in the number of treatment options at each successive evaluation (P <.0001).

“Results to date are compelling evidence that this genomic assay biomarker, when coupled with standard clinicopathologic parameters, can have a significant impact in personalizing treatment for men with localized prostate cancer,” Shore concluded. “Future analyses are likely to result in meaningful new insights about how patients and their providers use [CCP] to make treatment decisions.”

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