![]() ![]() 3 It resulted in a 6-month improvement in survival rate. That led to a study that with a doublet therapy and an anti-androgen agent called flutamide which was published in 1989 in the New England Journal of Medicine that was the first doublet that was utilized extensively. ![]() We had an effective therapy that usually progressed on within a period of a couple of years. One of the big changing points was the introduction of LHRH agonist back in the mid-1980s. started out with single therapy back in the 1940s with estrogens and orchiectomy. fits very nicely with the evolution of what’s happened in metastatic prostate cancer. Like many of the other out there, people don't die from it they die with it. Additionally, he highlighted how the new treatment option will impact patients with mCRPC and where future efforts need to be focused to help move the needle forward.ĬancerNetwork ®: What does this approval mean for the treatment of prostate cancer treatment? How does it fit into the evolution of treatment for this patient population?Ĭrawford: It represents a significant step forward in our progress of trying to effectively treat this disease and maybe even get to the point where we make it a chronic disease. That’s something that I think is a game changer,” said Crawford.ĬancerNetwork ®spoke with Crawford, editor-in-chief of Grand Rounds in Urology professor of Urology at the University of California, San Diego and an editorial board member of the journal ONCOLOGY ® about the approval and the body of research that led to the regulatory decision. What we have here is a major step forward we have a drug that is added onto ADT and chemotherapy that had an impact. I have some patients with advanced prostate cancer alive at 20 years. Now, I expect that it’s going to get even better. I was seeing patients live 10 years or longer with doublets. “Now we’ve got a triplet, so I’m excited. Patients also had a delay in time to pain progression in the darolutamide arm vs the chemotherapy arm (HR, 0.79 95% CI, 0.66-0.95 1-sided P =. Median OS was not reached in the darolutamide arm at a median follow-up of 43.7 months and was 48.9 months in the chemotherapy arm. 2 The treatment combination was found to have a statistically significant and meaningful improvement in overall survival (OS) among those treated with darolutamide plus docetaxel vs chemotherapy (HR, 0.68 95% CI, 0.57-0.80 P <.0001). The triplet combination was approved based on results from the phase 3 ARASENS trial (NCT02799602). The recent FDA approval of darolutamide (Nubeqa) plus docetaxel and androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC) represents a promising improvement in survival without a significant increase in toxicity vs ADT and chemotherapy alone for patients with advanced disease, according to E. ![]()
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