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A phase 2 study of estramustine, docetaxel, and bevacizumab in men with castrate-resistant prostate cancer†‡§
Results from Cancer and Leukemia Group B Study 90006
Article first published online: 22 SEP 2010
Copyright © 2010 American Cancer Society
Volume 117, Issue 3, pages 526–533, 1 February 2011
How to Cite
Picus, J., Halabi, S., Kelly, W. K., Vogelzang, N. J., Whang, Y. E., Kaplan, E. B., Stadler, W. M., Small, E. J. and for Cancer and Leukemia Group B (2011), A phase 2 study of estramustine, docetaxel, and bevacizumab in men with castrate-resistant prostate cancer. Cancer, 117: 526–533. doi: 10.1002/cncr.25421
Presented at the 39th Annual Meeting of the American Society of Clinical Oncology; Chicago, Illinois; May 31 to June 3, 2003.
The following institutions participated in this study: Cancer and Leukemia Group B Statistical Office, Durham, NC (Stephen George, PhD); Christiana Care Health Services, Inc., Community Clinical Oncology Program (CCOP), Wilmington, Del (Stephen S. Grubbs, MD); Dana Farber Cancer Institute, Boston, Mass (Eric P. Winer, MD); Mount Sinai Medical Center, Miami, Fla (Rogerio Lilenbaum, MD); North Shore University Hospital, Manhasset, NY (Daniel R. Budman, MD); The Ohio State University Medical Center, Columbus, Ohio (Clara D. Bloomfield, MD); Rhode Island Hospital, Providence, RI (William Sikov, MD); Syracuse Hematology-Oncology Association CCOP, Syracuse, NY (Jeffrey Kirshner, MD); University of California at San Francisco, San Francisco, Calif (Alan P. Venook, MD); University of Chicago, Chicago, Ill (Gini Fleming, MD); University of Minnesota, Minneapolis, Minn (Bruce A. Peterson, MD); University of Nebraska Medical Center, Omaha, Neb (Anne Kessinger, MD); University of North Carolina at Chapel Hill, Chapel Hill, NC (Thomas Shea, MD); Vermont Cancer Center, Burlington, VT (Hyman B. Muss, MD); Wake Forest University School of Medicine, Winston-Salem, NC (David D. Hurd, MD); Washington University School of Medicine, St. Louis, Mo (Nancy L. Bartlett, MD); and Western Pennsylvania Hospital, Pittsburgh, Pa (Richard Shadduck, MD).
The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute.
- Issue published online: 20 JAN 2011
- Article first published online: 22 SEP 2010
- Manuscript Accepted: 12 APR 2010
- Manuscript Revised: 7 APR 2010
- Manuscript Received: 8 FEB 2010
- castrate-resistant prostate cancer;
- progression-free survival
The use of docetaxel prolongs survival for patients with castrate-resistant prostate cancer (CRPC). Inhibition of vascular endothelial growth factor (VEGF) with bevacizumab may further enhance the antitumor effect of docetaxel and estramustine in patients with CRPC.
This cooperative group trial enrolled men with CRPC. Patients received oral estramustine 280 mg 3 times daily on Days 1 through 5 of every cycle plus 70 mg/m2 docetaxel and 15 mg/kg bevacizumab on Day 2 every 3 weeks. Prostate-specific antigen (PSA) values were monitored every cycle, and imaging studies were obtained every 3 cycles. The primary endpoint was progression-free survival (PFS), and the secondary objectives were safety, PSA decline, measurable disease response, and overall survival.
Seventy-nine patients were enrolled; and 77 patients received a median of 8 cycles and were evaluable. A 50% PSA decline was observed in 58 patients (75%). Twenty-three of 39 patients with measurable disease had a partial response (59%). The median PFS was 8 months, and the overall median survival was 24 months. Neutropenia without fever (69%), fatigue (25%), and thrombosis/emboli (9%) were the most common severe toxicities. Twenty-four of 77 patients were removed from protocol treatment because of disease progression, 35 of 77 patients were removed because of a physician or patient decision, and 15 patients were removed secondary to toxicity.
The combination of docetaxel, estramustine, and bevacizumab was tolerable but complicated by toxicity. Although the endpoint of PFS did not meet the desired level, encouraging antitumor activity and overall survival were observed. Further phase 3 evaluation of the role of bevacizumab in CRPC is ongoing. Cancer 2011. © 2010 American Cancer Society.