Evolving Role of Docetaxel in Metastatic Prostate Cancer

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The earlier use of docetaxel for men with prostate cancer could potentially be one of the most important advances uncovered in the past year, according to Charles J. Ryan, MD. Although docetaxel has been available for a while, a series of studies has provided data that are transforming the way docetaxel is being used in metastatic prostate cancer.

In the CHAARTED study, 790 men with hormone-sensitive metastatic prostate cancer were randomized to receive hormonal therapy with or without upfront chemotherapy (docetaxel). The study found that docetaxel added to initial androgen deprivation therapy (ADT) led to a significant improvement in median survival: 57.6 months in the ADT plus docetaxel arm and 44.0 months in the ADT alone arm (HR = 0.61; 95% CI, 0.47-0.80; P = .0003). Survival was most pronounced in patients with extensive disease (defined in the study as individuals with at least 4 bone metastases), states Ryan.

GETUG-AFU 15, another phase III trial, used a similar study design, but allowed enrollment of individuals with lower burden of disease. There was no significant survival benefit seen in the overall study population, nor in the high-volume disease or low-volume disease subgroup analyses.

STAMPEDE, a phase III trial led by the United Kingdom, is evaluating several treatment approaches, including the use of ADT plus docetaxel. Early results showed that adding docetaxel to ADT improved survival by 24% (HR = 0.76; 95% CI, 0.63-0.91; P = .003) and failure-free survival by 38% (HR = 0.62) compared with ADT alone.

The standard of care in the United States is changing rapidly, notes Ryan, as individuals are receiving docetaxel early on in both inpatient and community settings. Retreating with docetaxel and sequencing of docetaxel with other therapies is also being investigated.