French Trial Shows Addition of Docetaxel and Estramustine to ADT Improves Relapse-Free Survival in High-Risk Localized Prostate Cancer
In a French phase III trial (GETUG 12) reported in The Lancet Oncology, Fizazi et al found that the addition of docetaxel and estramustine (Emcyt) to androgen-deprivation therapy (ADT) improved relapse-free survival among patients with high-risk localized prostate cancer.
Study Details
In the open-label trial, 413 patients with treatment-naive disease and at least one risk factor (stage T3-T4, Gleason score ≥ 8, prostate-specific antigen [PSA] concentration > 20 ng/mL, or pathologic node-positive disease) underwent staging pelvic lymph node dissection and were randomized to ADT (goserelin 10.8 mg every 3 months for 3 years) plus four cycles of docetaxel 70 mg/m2 on day 2 and estramustine 10 mg/kg/d on days 1 to 5 every 3 weeks (n = 207) or ADT alone (n = 206). Local treatment was administered at 3 months. The primary endpoint was relapse-free survival in the intention-to-treat population. Follow-up for other endpoints is ongoing.
The chemotherapy and ADT alone groups were balanced for age (median 62 and 62 years), Gleason score (42% and 43% ≥ 8), pathologic node-positive status (29% in both), and serum PSA level (> 20 ng/mL in 59% in both).
Increased Relapse-Free Survival
After a median follow-up of 8.8 years, relapse or death had occurred in 43% of patients in the ADT plus docetaxel/estramustine group, vs 54% of the ADT only group. Eight-year relapse-free survival was 62% (95% confidence interval [CI] = 55%–69%), vs 50% (95% CI = 44%–57%; adjusted hazard ratio = 0.71, P = .017).
Data on adverse events during treatment are reported elsewhere. Among patients who had received radiotherapy and had data available, 31 (21%) of 151 in the ADT plus chemotherapy group vs 26 (18%) of 143 in the ADT only group had grade ≥ 2 long-term adverse events (P = .61). Second cancers were observed in 13% vs 11% (P = .57). No treatment-related deaths were reported.
The investigators concluded: “Docetaxel-based chemotherapy improves relapse-free survival in patients 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.”
Karim Fizazi, MD, of Institut Gustave Roussy, is the corresponding author of The Lancet Oncology article.
The study was funded by Ligue Contre le Cancer, Sanofi-Aventis, AstraZeneca, and Institut National du Cancer.
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