Key clinical point: Addition of docetaxel to hormone therapy can be considered for the treatment of patients with metastatic hormone-naive prostate cancer, irrespective of the metastatic burden.
Main finding: Docetaxel demonstrated a benefit over standard-of-care (SOC) on overall survival (hazard ratio [HR], 0.81; 95% CI, 0.69-0.95), failure-free survival (HR, 0.66; 95% CI, 0.57-0.76), and progression-free survival (HR, 0.69; 95% CI, 0.59-0.81); and the benefit was not affected by the metastatic burden.
Study details: The data come from long-term efficacy analyses of the STAMPEDE trial, stratified by metastatic burden for M1 patients. In the STAMPEDE trial, patients were randomly assigned (2:1) to either SOC or SOC plus docetaxel.
Disclosures: The study was supported by the Cancer Research UK, Medical Research Council, Astellas, Clovis Oncology, Janssen, Novartis, Pfizer, and Sanofi-Aventis. The corresponding has received fees for consultancy and lectureships from Sanofi Aventis, Janssen, Astellas, Pfizer, AstraZeneca, Bayer, and Ferring pharmaceuticals. Other authors have received grants and personal fees from multiple pharmaceutical companies.
Treatment of patients with metastatic castrate-sensitive prostate cancer has undergone an evolution. Options for treatment include docetaxel, abiraterone, and androgen receptor blockade. Metastatic burden has been postulated to correlate with outcomes. Previously, docetaxel was associated with lower efficacy in patients with low metastatic burden. In the updated analysis of the STAMPEDE trial, the authors report an analysis of the effects of metastatic burden in patients who either received docetaxel plus standard of care (SOC) or SOC. Clarke et al. used retrospectively collected baseline imaging for this analysis. No evidence for heterogeneity of response for high burden disease (4 or more bone metastases with one outside the vertebral body or pelvis, visceral metastases, or both) compared with low burden disease. The authors postulate that the discrepancy with previous findings may be related to a higher proportion of patients with de-novo metastatic disease in the STAMPEDE trial, suggesting more studies are warranted.—Mark Klein, MD
Clarke NW et al. Ann Oncol. 2020 Jan 8. doi: 10.1093/annonc/mdz396.