A randomized phase II trial of short-course androgen deprivation therapy with or without bevacizumab for patients with recurrent prostate cancer after definitive local therapy Journal Article


Authors: McKay, R. R.; Zurita, A. J.; Werner, L.; Bruce, J. Y.; Carducci, M. A.; Stein, M. N.; Heath, E. I.; Hussain, A.; Tran, H. T.; Sweeney, C. J.; Ross, R. W.; Kantoff, P. W.; Slovin, S. F.; Taplin, M. E.
Article Title: A randomized phase II trial of short-course androgen deprivation therapy with or without bevacizumab for patients with recurrent prostate cancer after definitive local therapy
Abstract: Purpose: Patients with recurrent prostate cancer after local treatment make up a heterogeneous population for whom androgen deprivation therapy (ADT) is the usual treatment. The purpose of this randomized phase II trial was to investigate the efficacy and toxicity of short-course ADT with or without bevacizumab in men with hormone-sensitive prostate cancer. Patients and Methods: Eligible patients had an increasing prostate-specific antigen (PSA) of ≤ 50 ng/mL and PSA doubling time of less than 18 months. Patients had either no metastases or low burden, asymptomatic metastases (lymph nodes < 3 cm and five or fewer bone metastases). Patients were randomly assigned 2:1 to a luteinizing hormone-releasing hormone agonist, bicalutamide and bevacizumab or ADT alone, for 6 months. The primary end point was PSA relapse-free survival (RFS). Relapse was defined as a PSA of more than 0.2 ng/mL for prostatectomy patients or PSA of more than 2.0 ng/mL for primary radiation therapy patients. Results: Sixty-six patients received ADT + bevacizumab and 36 received ADT alone. Patients receiving ADT + bevacizumab had a statistically significant improvement in RFS compared with patients treated with ADT alone (13.3 months for ADT + bevacizumab v 10.2 months for ADT alone; hazard ratio, 0.47; 95% CI, 0.29 to 0.77; log-rank P = .002). Hypertension was the most common adverse event in patients receiving ADT + bevacizumab (36%). Conclusion: ADT combined with bevacizumab resulted in an improved RFS for patients with hormone-sensitive prostate cancer. Long-term follow-up is needed to determine whether some patients have a durable PSA response and are able to remain off ADT for prolonged periods. Our data provide rationale for combining vascular endothelial growth factor-targeting therapy with ADT in hormone-sensitive prostate cancer. © 2016 by American Society of Clinical Oncology.
Journal Title: Journal of Clinical Oncology
Volume: 34
Issue: 16
ISSN: 0732-183X
Publisher: American Society of Clinical Oncology  
Date Published: 2016-06-01
Start Page: 1913
End Page: 1920
Language: English
DOI: 10.1200/jco.2015.65.3154
PROVIDER: scopus
PUBMED: 27044933
PMCID: PMC5321094
DOI/URL:
Notes: Article -- Export Date: 1 July 2016 -- Source: Scopus
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MSK Authors
  1. Susan Slovin
    178 Slovin
  2. Philip Wayne Kantoff
    60 Kantoff