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: 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.
  
  
  
  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.
  
  
  
  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%).
  
  
  
  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.
authors.affiliation: 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.
authors.forename: Rana R
authors.initials: RR
authors.lastname: McKay
authors.affiliation: 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.
authors.forename: Amado J
authors.initials: AJ
authors.lastname: Zurita
authors.affiliation: 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.
authors.forename: Lillian
authors.initials: L
authors.lastname: Werner
authors.affiliation: 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.
authors.forename: Justine Y
authors.initials: JY
authors.lastname: Bruce
authors.affiliation: 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.
authors.forename: Michael A
authors.initials: MA
authors.lastname: Carducci
authors.affiliation: 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.
authors.forename: Mark N
authors.initials: MN
authors.lastname: Stein
authors.affiliation: 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.
authors.forename: Elisabeth I
authors.initials: EI
authors.lastname: Heath
authors.affiliation: 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.
authors.forename: Arif
authors.initials: A
authors.lastname: Hussain
authors.affiliation: 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.
authors.forename: Hai T
authors.initials: HT
authors.lastname: Tran
authors.affiliation: 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.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Sweeney
authors.affiliation: 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.
authors.forename: Robert W
authors.initials: RW
authors.lastname: Ross
authors.affiliation: 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.
authors.forename: Philip W
authors.initials: PW
authors.lastname: Kantoff
authors.affiliation: 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.
authors.forename: Susan F
authors.initials: SF
authors.lastname: Slovin
authors.affiliation: 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.
authors.forename: Mary-Ellen
authors.initials: ME
authors.lastname: Taplin
mesh_terms: D000328:Adult; D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D000068258:Bevacizumab / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors*
chemical_list: D000726:Androgen Antagonists; D042461:Vascular Endothelial Growth Factor A; D000068258:Bevacizumab; D017430:Prostate-Specific Antigen