This powerful drug combo cuts prostate cancer deaths by 40%

Researchers tested a therapy that combines enzalutamide, an existing cancer drug, with standard hormone therapy. This approach significantly lowered death rates among men whose prostate cancer came back after initial treatment and who had few remaining options. The study findings were published in The New England Journal of Medicine (NEJM) and presented at the European Society for Medical Oncology Congress (ESMO) on Oct. 19 in Berlin.

“After initial treatment, some patients see their prostate cancer come back in an aggressive way and are at risk for their disease to spread quickly,” said Stephen Freedland, MD, director of the Center for Integrated Research in Cancer and Lifestyle at Cedars-Sinai Cancer and co-principal investigator of the study. “Hormone therapy, which is what we’ve been offering patients for 30 years, has not improved survival and neither has anything else. That makes these findings a real game changer.”

The international clinical trial followed more than 1,000 men from 244 medical centers across 17 countries. All participants had high-risk biochemically recurrent prostate cancer, a condition where prostate specific antigen (PSA) levels rise rapidly after surgery or radiation. PSA is a protein used to monitor prostate cancer activity, and a sharp increase after treatment often signals that the disease is likely to return and spread, often to the bones or spine.

“We know these patients are at high risk of developing metastatic disease and dying of their cancer unless we offer a meaningful treatment option,” said Freedland, professor of Urology and the Warschaw, Robertson, Law Families Chair in Prostate Cancer.

Participants were randomly assigned to receive either hormone therapy alone, enzalutamide alone, or both together. After eight years of follow-up, those who received the combination therapy had a 40.3% lower risk of death compared to those in the other two groups, according to Freedland.

“This clinical trial, one of many that Cedars-Sinai Cancer has offered to its patients, is an example of the translational work being done by our physician-scientists,” said Robert Figlin, MD, interim director of Cedars-Sinai Cancer. “The result will be improved treatment and better outcomes for patients everywhere.”

Freedland added that enzalutamide is already approved by the Food and Drug Administration and included in National Comprehensive Cancer Network treatment guidelines based on earlier research by the same team. He said these new results will likely strengthen those recommendations and help establish the enzalutamide and hormone therapy combination as the new standard of care for patients with high-risk biochemically recurrent prostate cancer.

“These important findings identify a treatment that prolongs survival in men with aggressive prostate cancer,” said Hyung Kim, MD, a urologic oncologist and chair of the Department of Urology at Cedars-Sinai. “The latest analysis complements previous studies that found enzalutamide significantly improved survival in other prostate cancer settings, and will change how we take care of our patients.”

Funding: The study was sponsored by Pfizer Inc. and Astellas Pharma Inc., the co-developers of enzalutamide.

Disclosures: Stephen J. Freedland reports being a consultant to Astellas Pharma Inc., AstraZeneca, Bayer, Eli Lilly, Johnson & Johnson Innovative Medicine (formerly Janssen), Merck, Novartis, Pfizer Inc., Sanofi, Sumitomo Pharma America, Inc. (formerly Myovant Sciences, Inc.), and Tolmar.