A new drug combination to treat advanced recurring prostate cancer has shown remarkable results in a long-term trial, lowering the risk of death after eight years by 40.3%. What’s more, the drug treatments are already approved for use on their own.
The findings from the trial led by Cedars-Sinai Cancer researchers were presented at the European Society for Medical Oncology Congress (ESMO) on Sunday, October 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.”
Up to 40% of men who undergo radiation or surgery for prostate cancer will see it return and be more difficult to treat in the same way. In this new study featuring more than 1,000 participants at 244 sites in 17 countries, patients received either enzalutamide plus leuprolide (the combination group), leuprolide (the leuprolide-alone group), or enzalutamide monotherapy (the monotherapy group). While the drugs on their own showed no meaningful significance in enhanced survival rates, when they were combined they lowered the risk of death by 40.3% after an average follow-up of 94 months.
Traditionally, hormone therapeutic leuprolide is prescribed to treat recurrent prostate cancer – something indicated by elevated levels of prostate specific antigen (PSA) following initial treatment. High PSA protein levels in the blood are a red flag for the cancer not just returning but for the likelihood it will spread into bones or the 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, a professor of urology.
Enzalutamide is already approved by the US Food and Drug Administration (FDA) and listed in National Comprehensive Cancer Network treatment guidelines, so based on the study’s results could be easily incorporated into a frontline combo intervention with the common hormone therapy.
While survival from recurrent prostate cancer is dependent on many factors, a 2006 paper published by Freedland found that elevated PSA levels within three years of initial treatment – the clinical sign of it returning – was linked to a 15-year survival rate of 41%. For these men, in particular, better intervention could indeed be lifesaving.
“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.”
The research was published in The New England Journal of Medicine.
Source: Cedars-Sinai Medical Center via MedicalXpress
