Phase 2 study of neoadjuvant docetaxel plus bevacizumab in patients with high-risk localized prostate cancer
Ross RW et al. – Neoadjuvant docetaxel and bevacizumab is safe, and results in reductions in both tumor volume and serum prostate–specific antigen (PSA), in men with high–risk localized prostate cancer. The role of neoadjuvant chemotherapy in prostate cancer, and perioperative antiangiogenic therapy in general, requires further elucidation through ongoing and planned trials.Methods
- Eligibility included any of the following: prostate–specific antigen (PSA) >20ng/mL or PSA velocity >2ng/mL/y, cT3 disease, any biopsy Gleason score 8 to 10, and Gleason score 7 with T3 disease by endorectal magnetic resonance imaging (MRI) at 1.5 T.
- Also, those with ≥50% biopsy cores involved and either Gleason score 7, PSA >10, or cT2 disease were eligible.
- Patients were treated with docetaxel 70mg/m2 every weeks for 6cycles and bevacizumab 15mg/m2 every 3weeks for 5cycles.
- The primary endpoint was partial response by endorectal MRI.
- Forty–one patients were treated.
- Median age was 55years (range, 40–66years).
- Baseline characteristics included: median PSA, 10.1ng/mL; cT2, 49%, cT3, 32%; and Gleason score 8 to 10, 73%.
- Thirty–eight of 41 (93%) patients completed all 6cycles.
- Grade ≥3 adverse events were rare, although 3 of 41 (7%) experienced febrile neutropenia.
- Twelve patients (29%; 95% confidence interval [CI], 16%–45%) achieved a >50% reduction in tumor volume, and 9 patients (22%; 95% CI, 11%–38%) achieved a >50% post–treatment decline in PSA.
- Thirty–seven of the 41 patients underwent radical prostatectomy; there were no complete pathologic responses.