A phase 2 study of estramustine, docetaxel, and bevacizumab in men with castrate‐resistant prostate cancer

Year: 2010

Type: article

Abstract: BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Source: Cancer

DOI: 10.1002/cncr.25421

Authors: Joel Picus, Susan Halabi, W. Kevin Kelly, Nicholas J. Vogelzang, Young E. Whang, Ellen B. Kaplan, Walter M. Stadler, Eric J. Small, for Cancer and Leukemia Group B

Institutions: Washington University in St. Louis, Duke University, Duke Medical Center, Yale Cancer Center, Yale University, University of North Carolina at Chapel Hill, University of Chicago, University of California, San Francisco

Language: English

Topic: Prostate Cancer Treatment and Research

Subfield: Pulmonary and Respiratory Medicine

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: bronze

Funders: Sanofi, University of Nebraska Medical Center, Ohio State University, Syracuse University, Wake Forest University, University of Minnesota, National Institutes of Health, University of North Carolina at Chapel Hill, National Cancer Institute

OpenAlex ID: W2023288243