Evaluating the effectiveness and safety of docetaxel given every 2 weeks plus androgen deprivation therapy in patients with metastatic castration-naïve prostate cancer.

This study evaluated the effectiveness and safety of docetaxel (Taxotere) given every 2 weeks plus androgen-deprivation therapy (ADT) in patients with metastatic castration-naïve prostate cancer (mCNPC). The data showed that docetaxel given every 2 weeks plus ADT was safe and effective in these patients.

MCNPC is an aggressive form of prostate cancer that has spread beyond the prostate gland and has not yet been treated with hormonal therapy such as ADT. Men with mCNPC usually have high levels of prostate-specific antigen (PSA). PSA is a protein made by the cells of the prostate gland. ADT reduces the production of androgens (male sex hormones such as testosterone). Reducing these androgens prevents cancer cell growth and spread.

For such patients, ADT can be given in combination with either abiraterone (Zytiga), prednisone (Deltasone), apalutamide (Erleada), or enzalutamide (Xtandi). Other treatment options include combining chemotherapy like docetaxel with ADT. The standard docetaxel and ADT regimen involves giving 75mg/m² of docetaxel every 3 weeks. However, this regimen was associated with side effects like low counts of white blood cells with fever. An alternative regimen involving giving docetaxel every week or every 2 weeks with ADT has not been previously evaluated in patients with mCNPC. 

This study involved 42 men with previously untreated mCNPC. All patients received docetaxel every 2 weeks plus ADT. The average follow-up time was 25 months.

95% of the patients had a PSA decrease of 50% or more after treatment. The average lowest PSA value was 0.42ng/ml.

The average survival without developing resistance to hormonal therapy was 26.4 months. After 1 year, 79% of the patients were alive without resistance to hormonal therapy.

Patients who were fully active in their daily life were 73% more likely to have a better survival without developing resistance to hormonal therapy.

The most common side effects were anemia (95%), nail changes (33%), tiredness (29%), and painful mouth inflammation with ulcers (26%).

This study concluded that docetaxel given every 2 weeks plus ADT is safe and effective in patients with previously untreated mCNPC.

The sample size was very small and only included patients from a single institution in South Korea. Larger studies at different institutions around the world are required to validate the conclusions. This study was funded by Sanofi-Aventis, the manufacturer of docetaxel.