New FDA-approved drug combo reduces prostate cancer death risk by 40 percent
A promising breakthrough in prostate cancer treatment shows new hope for men, especially if their cancer as resurfaced, following a primary surgery or radiation therapy. The recent findings from the third phase trial reveals a combination of two FDA-approved drugs, enzalutamide and leuprolide, significantly improves overall survival rates in patients with locally advanced prostate cancer, reducing the risk of death over by almost 40%. This advance could actually change the way dotors approach treatment, offering patients a better chance at longer, healthier lives.
Background:
Prostate cancer is among the most common cancers affecting men worldwide. Although with the advancement in technology, surgery ad radiation therapy are curative measure for many cases, approximately, one-third of patients experience cancer recurrence, this recurrence is often detected through rising prostate-specific antigen (PSA) levels, a biomarker that signals cancer activity even before symptoms arise.Patients with rapidly rising PSA levels, defined as a PSA doubling time of nine months or less, are at high risk for their cancer spreading (metastasizing) to other parts of the body, particularly the bones. Unfortunately, treatment options for these patients remain limited, and managing recurrent prostate cancer effectively has been a significant challenge.
The EMBARK trial :
Recent findings from the phase 3 EMBARK trial, first published on October 19 in the New England Journal of Medicine. This trial was funded by Pfizer and Astellas Pharma, enrolled over 1,000 patients across 244 sites in 17 countries, all of whom had a high risk recurrent prostate cancer. Participants were randomly assigned to receive either leuprolide alone, and enzalutamide alone, or a combination of both drugs.The drugs in question, Enzalutamide, is an androgen receptor blocker, that typically prevents cancer cells from using male hormones to grow, while leuprolide is a hormone therapy that lowers testosterone production. Though this combination is already FDA-approved for metastatic prostate cancer, researchers wanted to determine if using it earlier before metastasis becomes evident, could extend survival.
Key findings:
After eight years of follow-up, patients treated with combination therapy had an overall survival rate of 78.9%, compared to 69.5% among those receiving leuprolide alone. This translates to a striking 40% reduction in the risk of death. These results demonstrate that combining enzalutamide with leuprolide early in the disease course can not delay cancer progression, as previously shown but can significantly add to prolong life.For those who took enzulutamide by itself, the survival rate was only about 73% which was not much of a difference from the leurolide only group. The outcomes of the trail are consistent with how and what was discovered earlier in the parts of the study, showing that the treatment was generally safe and effective.
Limitations of this trial
The only limitation of the EMBARK trial was the absence of PSMA PET scan, a new imaging technique that more accurately detects metastatic cancer, but this also raises the possibility that some patients in the study had undiagnosed metastases and therefore, it might have been candidates for the drug combination regardless.
