The standard of care for prostate cancer is androgen-deprivation therapy (ADT), and although most patients respond to this treatment, many progress to metastatic castration-resistant prostate cancer (mCRPC). Specifically, patients with high-volume disease have poorer outcomes than those with lower volume disease. Sweeney and colleagues reported the results of a study investigating whether adding docetaxel at the time of starting ADT would prolong overall survival (OS) in this patient population (Sweeney C, et al. ESMO 2014: Abstract 756O).
In this randomized trial, men with hormone-naïve mCRPC were randomized in a 1:1 ratio to receive ADT alone or ADT plus docetaxel 75 mg/m2 every 3 weeks for 6 cycles, given within 4 months of starting ADT. The patients were stratified by high-volume versus low-volume disease (high-volume disease consisted of visceral metastases and/or ?4 bone metastases with at least 1 outside the vertebral column and pelvis), antiandrogen use, age, ECOG performance status, previous adjuvant ADT, and treatment with an FDA-approved drug for delaying skeletal-related events. The primary clinical end point was OS.
Of the 790 men recruited for the study, 393 received ADT alone and 397 received ADT plus docetaxel. The results of the intent-to-treat analysis for the high-volume patients are shown in the Table.
Table
Adding docetaxel to ADT significantly increased the median OS, decreased the number of patients with disease progression, and extended the median time to clinical or PSA progression. Grade 3 or 4 treatment-related adverse events in the 2 groups were not significantly different and included neutropenic fever (4% in the ADT-docetaxel group vs 2% in the ADT-only group) and sensory and motor neuropathy (1% in each group).
Sweeney and colleagues concluded that adding docetaxel to ADT significantly improves disease control and OS versus ADT alone in patients with high-volume mCRPC.
