Apalutamide (Erleada) for the treatment of prostate cancer

Apalutamide is taken once a day in tablet form at a dose of 240 mg, which is equivalent to four 60 mg apalutamide tablets.

Patients also continue using hormone blockers.

If severe side effects occur, the treatment with apalutamide can be interrupted temporarily.

For men with non-metastatic, castration-resistant prostate cancer, watchful waiting is an option. Patients also continue using hormone blockers.

In 2020, the Institute for Quality and Efficiency in Health Care (IQWiG, Germany) last looked into the advantages and disadvantages of apalutamide in men with non-metastatic castration-resistant prostate cancer.

To answer this question, the manufacturer provided early results of an ongoing study involving 1,207 men: 806 of them received apalutamide and 401 had a fake treatment (placebo). All of the men continued using hormone blockers.

What are the advantages of apalutamide?

• Life expectancy: Early results suggest that apalutamide can increase life expectancy: Men who did not use apalutamide died after about 59 months on average (median value). Men who used apalutamide died after about 66 months on average (median value).
• Disease-related symptoms: If the prostate cancer progresses, various problems may develop or become worse, such as bone fractures or pain. Additional treatments may also become necessary, such as surgery or radiation therapy. The study suggests that apalutamide can decrease the symptoms and the number of treatments needed due to the progression of the cancer. Progressing cancer caused symptoms or made further treatment necessary in about 19 out of 100 men who took apalutamide, compared to about 25 out of 100 men in the placebo group.
• Severe kidney and urinary tract problems: Early results suggest that apalutamide has an advantage here. Kidney and urinary tract problems occurred in about 8 out of 10 men who took apalutamide, compared to about 12 out of 100 men who didn't use apalutamide.

What are the disadvantages of apalutamide?

Severe side effects: Early results suggest that apalutamide has a disadvantage in terms of various severe side effects:

• Infections: Infections occurred in about 10 out of 100 men who took apalutamide, compared to about 2 out of 100 men in the placebo group.
• Complications resulting from surgical procedures: About 8 out of 100 men who took apalutamide had complications such as a fall or pain after their procedure. This happened in about 2 out of 100 men in the placebo group.
• Diseases of the skin and subcutaneous tissue: The study suggests that apalutamide has a disadvantage here: About 7 out of 100 men who took apalutamide developed severe diseases of the skin and subcutaneous tissue, such as severe rashes. This happened in less than 1 out of 100 men in the placebo group.

Side effects: Early study results also suggest that apalutamide has a disadvantage in terms of various non-severe side effects:

• Joint pain (arthralgia)
• Diseases of the nervous system
• Underactive thyroid (hypothyroidism)

No difference

• Severe side effects and stopping treatment due to side effects: The study did not find any differences between the treatment groups in terms of side effects and stopping treatment due to side effects.
• Quality of life: No difference was found here between the treatment groups.

What remains unanswered?

Overall health: The manufacturer didn't provide any suitable data about overall health.

This information summarizes the main results of reviews produced by the Institute for Quality and Efficiency in Health Care (IQWiG, Germany). The reviews were commissioned by the German Federal Joint Committee (G-BA) as part of the “early benefit assessment of medications.” On the basis of the reviews and the hearings received, the G-BA passed a resolution on the added benefit of apalutamide (Erleada).