In a nutshell
This study investigated whether adding apalutamide (erleada) to androgen-deprivation therapy (ADT) would improve survival in patients with prostate cancer. The authors concluded that adding apalutamide to ADT improved outcomes for these patients.
Androgen deprivation therapy (ADT) is the standard treatment for patients with prostate cancer. Male hormones (androgens) are known to have a role in prostate tumor growth, so the goal of ADT is to decrease the levels of androgens. Previous studies have shown that ADT can lead to better outcomes when combined with other treatments, such as chemotherapy. However, this can lead to serious side effects.
Apalutamide is an anti-androgen drug that reduces levels of androgens in the body. It has been approved for patients with non-metastatic prostate cancer. Because it blocks androgen receptors, studies suggest that it may be more effective than ADT alone. Whether combining apalutamide with ADT leads to better outcomes for patients with metastatic prostate cancer is unclear.
Methods & findings
This study had 1052 patients with metastatic castration-sensitive prostate cancer. All patients received ADT. 525 patients also received apalutamide while 527 patients received a placebo (a substance with no active effect). Patients were followed-up for an average of 22.7 months.
Overall, 365 patients had disease progression (tumor growth or spread). This included 134 patients in the apalutamide group and 231 patients in the placebo group.
Significantly more patients in the apalutamide group survived for 24 months without disease progression compared to the placebo group (68.2% vs. 47.5%). Patients treated with apalutamide had a 52% lower risk of disease progression or mortality compared to the placebo group.
Significantly more patients in the apalutamide group were still alive 2 years later compared to the placebo group (82.4% vs. 73.5%). Patients treated with apalutamide had a 33% lower mortality risk compared to the placebo group.
Slightly more patients in the apalutamide group had serious side effects compared to the placebo group (42.2% vs. 40.8%). The most common side effect was rash (27.1% vs. 8.5%). Mild low thyroid function was also reported (6.5% vs. 1.1%). 42 patients (apalutamide) and 28 patients (placebo) stopped treatment due to side effects.
The bottom line
This study found that adding apalutamide to ADT improved survival outcomes for patients with metastatic prostate cancer. The authors suggest that this combination is safe and effective, with manageable side effects.
The fine print
This study was funded by Janssen Research and Development, the manufacturer of apalutamide. 45 patients withdrew consent and 39 were lost to follow-up.
Talk to your care team about whether apalutamide may be suitable for you.
Published By :
The New England Journal of Medicine
May 31, 2019
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