In a nutshell
This study reported the long-term effectiveness and safety outcomes of apalutamide (Erleada) in combination with androgen deprivation therapy (ADT) for the treatment of metastatic castration-sensitive prostate cancer (mCSPC). The data showed that this combination improved survival, delayed castration resistance, and maintained the quality of life in these patients.
mCSPC is an aggressive form of prostate cancer that has spread beyond the prostate gland and is still responsive to hormonal therapy such as ADT. ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens prevents cancer cell growth.
Apalutamide is an anti-androgen medication. It blocks testosterone from reaching PC cells. Apalutamide plus ADT has been shown to improve clinical outcomes like overall survival and lowering the risk of disease progression and spread in men with mCSPC. However, the long-term effectiveness, safety, and patient-reported quality of life outcomes of apalutamide and ADT are still unknown.
Methods & findings
This study involved 1052 men with mCSPC. Patients were randomly assigned to receive either apalutamide plus ADT (525 patients) or placebo plus ADT (527 patients). After an average follow-up time of 22.7 months, 208 patients from the placebo plus ADT group were treated with apalutamide (crossover group). Patients were followed up for an average of 44 months.
The average time of treatment was 39.3 months for apalutamide plus ADT group, 20.2 months for placebo plus ADT, and 15.4 months for the crossover group.
Apalutamide plus ADT significantly lowered the risk of death by 35% versus placebo plus ADT. The overall survival rates at 48 months were 65.1% for the apalutamide plus ADT group and 51.8% for the placebo plus ADT group. In the crossover group, apalutamide plus ADT significantly lowered the risk of death by 48% versus placebo plus ADT.
Apalutamide plus ADT significantly delayed the risk of cancer progression by 38%. It also reduced the risk of castration resistance (resistance to hormonal therapy) by 66% compared to placebo plus ADT.
Progression of prostate-specific antigen levels (PSA; a marker of prostate cancer) occurred in 26.3% of apalutamide plus ADT treated patients compared to 65.3% of placebo plus ADT treated patients. Apalutamide plus ADT significantly reduced the risk of PSA progression by 73% compared to placebo plus ADT.
The most common side effects related to apalutamide treatment were skin rash and tiredness. Health-related quality of life was not changed with apalutamide compared to placebo.
The bottom line
This study concluded that adding apalutamide to ADT improved survival, delayed castration resistance, and maintained the quality of life in men with mCSPC.
The fine print
This study was funded by Janssen Research and Development, the manufacturer of apalutamide.
Published By :
Journal of clinical oncology
Apr 29, 2021
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