Hormone Therapy (ADT) along with the chemotherapy drug Taxotere (docetaxel) and Estramustine improves survival in men with high risk, localized castration-resistant prostate cancer over ADT alone.
In a randomized phase III trial performed at 26 hospitals in France, a phase III trial enrolled men with treatment-naive prostate cancer and at least one risk factor (i.e., stage T3-T4 disease, Gleason score of ≥8, prostate-specific antigen concentration >20 ng/mL, or pathological node-positive). All men had a staging pelvic lymph node dissection.
The men were randomly assigned (1:1) to either androgen deprivation therapy (ADT; with goserelin) plus four cycles of docetaxel and Estramustine or ADT only. The primary endpoint was relapse-free survival. Follow-up for other endpoints is ongoing.
The trial randomly assigned 207 men to the ADT plus docetaxel and Estramustine group and 206 to the ADT only group. Median follow-up was 8.8 years. Eighty-eight (88 or 43%) of 207 men in the ADT plus docetaxel and Estramustine group had an event (relapse or death) versus one hundred and eleven (111 or 54%) of 206 in the ADT only group.
Eight (8) year relapse-free survival was 62% in the ADT plus docetaxel and Estramustine group versus 50% in the ADT only group.
This study has demonstrated that docetaxel-based chemotherapy improves relapse-free survival in men with high-risk localized prostate cancer. Longer follow-up is needed to assess whether this benefit translates into improved metastasis-free survival and overall survival.
However, the study does not tell us if the addition of the Estramustine to the docetaxel is superior to the current standard of care of Early Chemotherapy with docetaxel alone.
This study is registered with ClinicalTrials.gov, number NCT00055731
Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, Institut National du Cancer.
Lancet Oncol. 2015 Jul;16(7):787-94. doi: 10.1016/S1470-2045(15)00011-X. Epub 2015 May 28.
Joel T Nowak, MA, MSW