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J Clin Oncol. 2016 Jun 1;34(16):1913-20. doi: 10.1200/JCO.2015.65.3154. Epub 2016 Apr 4.

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.

Author information

1
Rana R. McKay, Lillian Werner, Christopher J. Sweeney, Philip W. Kantoff, and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Boston; Robert W. Ross, Bluebird Bio, Cambridge, MA; Amado J. Zurita and Hai T. Tran, MD Anderson Cancer Center, Houston, TX; Justine Y. Bruce, University of Wisconsin Carbone Cancer Center, Madison, WI; Michael A. Carducci, Johns Hopkins University; Arif Hussain, Greenebaum Cancer Center, Baltimore, MD; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Elisabeth I. Heath, Karmanos Cancer Institute, Detroit, MI; and Philip W. Kantoff and Susan F. Slovin, Memorial Sloan Kettering Cancer Center, New York, NY.
2
Rana R. McKay, Lillian Werner, Christopher J. Sweeney, Philip W. Kantoff, and Mary-Ellen Taplin, Dana-Farber Cancer Institute, Boston; Robert W. Ross, Bluebird Bio, Cambridge, MA; Amado J. Zurita and Hai T. Tran, MD Anderson Cancer Center, Houston, TX; Justine Y. Bruce, University of Wisconsin Carbone Cancer Center, Madison, WI; Michael A. Carducci, Johns Hopkins University; Arif Hussain, Greenebaum Cancer Center, Baltimore, MD; Mark N. Stein, Rutgers Cancer Institute of New Jersey, New Brunswick, NJ; Elisabeth I. Heath, Karmanos Cancer Institute, Detroit, MI; and Philip W. Kantoff and Susan F. Slovin, Memorial Sloan Kettering Cancer Center, New York, NY. mtaplin@partners.org.

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.

PMID:
27044933
PMCID:
PMC5321094
DOI:
10.1200/JCO.2015.65.3154
[Indexed for MEDLINE]
Free PMC Article

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