title: Evaluation of tamoxifen and anastrozole in the prevention of gynecomastia and breast pain induced by bicalutamide monotherapy of prostate cancer.
abstract: OBJECTIVE
  To determine whether tamoxifen or anastrozole prevents gynecomastia and breast pain caused by bicalutamide (150 mg) without compromising efficacy, safety, or sexual functioning.
  
  
  METHODS
  A double-blind, placebo-controlled trial was performed in patients with localized, locally advanced, or biochemically recurrent prostate cancer. Patients (N = 114) were randomly assigned to either bicalutamide (150 mg/d) plus placebo or in combination with tamoxifen (20 mg/d) or anastrozole (1 mg/d) for 48 weeks. Gynecomastia, breast pain, prostate-specific antigen (PSA), sexual functioning, and serum levels of hormones were assessed.
  
  
  RESULTS
  Gynecomastia developed in 73% of patients in the bicalutamide group, 10% of patients in the bicalutamide-tamoxifen group, and 51% of patients in the bicalutamide-anastrozole group (P < .001); breast pain developed in 39%, 6%, and 27% of patients, respectively (P = .006). Baseline PSA level decreased by > or = 50% in 97%, 97%, and 83% of patients in the bicalutamide, bicalutamide-tamoxifen, and bicalutamide-anastrozole groups, respectively (P = .07); and adverse events were reported in 37%, 35%, and 69% of patients, respectively (P = .004). There were no major differences among treatments in sexual functioning parameters from baseline to month 6. Elevated testosterone levels occurred in each group; however, free testosterone levels remained unchanged in the bicalutamide-tamoxifen group because of increased sex hormone-binding globulin levels.
  
  
  CONCLUSIONS
  Anastrozole did not significantly reduce the incidence of bicalutamide-induced gynecomastia and breast pain. In contrast, tamoxifen was effective, without increasing adverse events, at least in the short-term follow-up. These data support the need for a larger study to determine any effect on mortality.
authors.affiliation: University and National Cancer Research Institute, University of Genoa, Genoa, Italy. f.boccardo@unige.it
authors.forename: F
authors.initials: F
authors.lastname: Boccardo
authors.forename: A
authors.initials: A
authors.lastname: Rubagotti
authors.forename: M
authors.initials: M
authors.lastname: Battaglia
authors.forename: P
authors.initials: P
authors.lastname: Di Tonno
authors.forename: F P
authors.initials: FP
authors.lastname: Selvaggi
authors.forename: G
authors.initials: G
authors.lastname: Conti
authors.forename: G
authors.initials: G
authors.lastname: Comeri
authors.forename: A
authors.initials: A
authors.lastname: Bertaccini
authors.forename: G
authors.initials: G
authors.lastname: Martorana
authors.forename: P
authors.initials: P
authors.lastname: Galassi
authors.forename: F
authors.initials: F
authors.lastname: Zattoni
authors.forename: A
authors.initials: A
authors.lastname: Macchiarella
authors.forename: A
authors.initials: A
authors.lastname: Siragusa
authors.forename: G
authors.initials: G
authors.lastname: Muscas
authors.forename: F
authors.initials: F
authors.lastname: Durand
authors.forename: D
authors.initials: D
authors.lastname: Potenzoni
authors.forename: A
authors.initials: A
authors.lastname: Manganelli
authors.forename: V
authors.initials: V
authors.lastname: Ferraris
authors.forename: F
authors.initials: F
authors.lastname: Montefiore
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000077384:Anastrozole; D000813:Anilides / Q000009:adverse effects*; D001941:Breast Diseases / Q000517:prevention & control*; D004311:Double-Blind Method; D006177:Gynecomastia / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009570:Nitriles / Q000009:adverse effects / Q000627:therapeutic use*; D010146:Pain / Q000517:prevention & control*; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000523:psychology; D011788:Quality of Life; D013629:Tamoxifen / Q000009:adverse effects / Q000627:therapeutic use*; D013739:Testosterone / Q000097:blood; D014105:Tosyl Compounds; D014230:Triazoles / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000813:Anilides; D009570:Nitriles; D014105:Tosyl Compounds; D014230:Triazoles; D013629:Tamoxifen; D000077384:Anastrozole; D013739:Testosterone; C053541:bicalutamide; D017430:Prostate-Specific Antigen