The first 2 authors contributed equally to this article.
Phase 2 study of neoadjuvant docetaxel plus bevacizumab in patients with high-risk localized prostate cancer†
A Prostate Cancer Clinical Trials Consortium trial
Article first published online: 26 JAN 2012
Copyright © 2012 American Cancer Society
Volume 118, Issue 19, pages 4777–4784, 1 October 2012
How to Cite
Ross, R. W., Galsky, M. D., Febbo, P., Barry, M., Richie, J. P., Xie, W., Fennessy, F. M., Bhatt, R. S., Hayes, J., Choueiri, T. K., Tempany, C. M., Kantoff, P. W., Taplin, M. E. and Oh, W. K. (2012), Phase 2 study of neoadjuvant docetaxel plus bevacizumab in patients with high-risk localized prostate cancer . Cancer, 118: 4777–4784. doi: 10.1002/cncr.27416
Presented in part at the 2009 American Society of Clinical Oncology Annual Meeting; May 29 to June 2, 2009; Orlando, FL and the 2011 American Society of Clinical Oncology Annual Meeting; June 3-7, 2011; Chicago, IL.
- Issue published online: 19 SEP 2012
- Article first published online: 26 JAN 2012
- Manuscript Accepted: 29 NOV 2011
- Manuscript Revised: 17 NOV 2011
- Manuscript Received: 3 OCT 2011
- prostate cancer;
- high-risk localized
Treatment of high-risk localized prostate cancer remains inadequate. The authors performed a phase 2 multicenter trial of neoadjuvant docetaxel plus bevacizumab before radical prostatectomy.
Eligibility included any of the following: prostate-specific antigen (PSA) >20 ng/mL or PSA velocity >2 ng/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 70 mg/m2 every 3 weeks for 6 cycles and bevacizumab 15 mg/m2 every 3 weeks for 5 cycles. The primary endpoint was partial response by endorectal MRI.
Forty-one patients were treated. Median age was 55 years (range, 40-66 years). Baseline characteristics included: median PSA, 10.1 ng/mL; cT2, 49%, cT3, 32%; and Gleason score 8 to 10, 73%. Thirty-eight of 41 (93%) patients completed all 6 cycles. 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.
Neoadjuvant docetaxel and bevacizumab is safe, and results in reductions in both tumor volume and serum 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. Cancer 2012. © 2012 American Cancer Society.