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New Prostate Cancer Prognostic Model For Enzalutamide

October 12, 2018
By: Jessica Hyland, Writer

Figure 1. A nomogram is used to assign each of 11 prognostic factors with a point range from 0 to 100 in a graphic interface, based on the estimated regression coefficients from the final multivariable Cox proportional hazards model predicting overall survival (OS). The nomogram results match with the algorithm. The 1-, 2-, and 3-year survival probability versus total points were also generated to allow the clinical partition to predict OS. The nomogram was developed using SAS® enterprise version 7.1.Researchers at the Duke Prostate & Urologic Cancer Center, led by genitourinary oncologist Andrew Armstrong, MD, have recently developed a novel nomogram, a prognostic model that measures overall survival for men with metastatic prostate cancer who were treated with enzalutamide, according to study results published in Annals of Oncology.

The investigator-initiated study analyzed a large dataset from the PREVAIL study, a prospective, phase 3 trial of enzalutamide, an oral androgen-receptor inhibitor that prolongs survival in men with metastatic castration-resistant prostate cancer (mCRPC). From the PREVAIL data, Armstrong developed and validated a prognostic model that is clinically useful and accurate in terms of predicting overall prognosis and potential length of time that a patient could benefit from enzalutamide, as well as other outcomes such as PSA response rates.

“As a physician, a common question that I’m asked after a patient receives a cancer diagnosis is ‘will this impact my life and if so, how long do I have to live?’ because when men have metastatic disease, they understand that while treatments can be effective, that until cures are developed, treatment outcomes can be uncertain, and having accurate information allows men to be as prepared as possible,” explained Armstrong. “This model allows us to develop an individual prognosis for each patient based on different benchmarks from personalized factors. It can also be used more broadly for groups of patients to design new clinical trials to try to improve upon these outcomes.  At Duke, as we design new trials and treatments for these men, these outcomes can serve as benchmarks for us to beat on behalf of our patients.”

While the study was intended to identify predictive and prognostic variables for overall survival, the model can also identify other outcomes, including time until resistance, chance of response and how long patients will maintain quality of life.

“Enzalutamide is approved globally and is an effective therapy for most men in this first line setting prior to chemotherapy,” said Armstrong. “This prognostic model is immediately applicable to patients and physicians around the world, who should be able to use the nomogram to have personalized conversations with their patients about overall survival and other outcomes while on this treatment.”

Committed to research that optimizes the use of cancer drugs, Armstrong and his team plans to develop this nomogram into a software program or mobile app that is accessible worldwide.

“In research, you continue learning about a drug long after its major publication and approvals,” explained Armstrong. “At Duke, we are constantly furthering our understanding of treatments – utilizing them to their greatest effect, identifying which groups will benefit the most from the drug and tracking how patients will respond over time. Treatments are always changing, and prognosis gets better as treatments get better.”

For more information about the study, please visit Annals of Oncology.

In addition to Armstrong, study authors include Lin, Ping; Higano, Celestia; Sternberg, Cora Sonpavde, Guru; Tombal, Bertrand; Templeton, Arnoud; Fizazi, Karim; Phung, De; Wong, Elaine; Krivoshik, Andrew and Beer, Tomasz M.