title: Low rate of clinician-scored gynecomastia induced by 6 months of combined androgen blockade in a randomized trial: Implications for prophylactic breast irradiation.
abstract: OBJECTIVE
  To determine the incidence and predictors of clinician-scored gynecomastia induced by 6 months of combined androgen blockade (CAB) in a randomized trial.
  
  
  METHODS
  We studied 94 men with intermediate or high-risk prostate cancer randomized to radiation plus 6 months of neoadjuvant CAB consisting of a gonadotropin-releasing hormone agonist and antiandrogen (flutamide). Patients were assessed for breast symptoms monthly as per protocol. Patients reporting breast tenderness or enlargement were then examined shirtless.
  
  
  RESULTS
  Median age at entry was 72.1 years. While 52 patients (55.3%) reported either breast tenderness or enlargement, only 9 patients (9.6%) were scored as having gynecomastia when examined shirtless by a single clinician. Four patients received radiation for self-reported breast tenderness or enlargement without clinician-scored gynecomastia. If these 4 had not been radiated, the total incidence of clinician-scored gynecomastia may have been as high as 13 of 94 (13.8%). No patient variable, such as age, body-mass index, and Adult Comorbidity Evaluation-27 score, or discontinuation of the antiandrogen, was associated with the development of gynecomastia.
  
  
  CONCLUSIONS
  While many patients self-reported breast tenderness or enlargement with short-course CAB, the incidence of breast enlargement noticeable to an examiner when the patient was shirtless was less than 15%, which is much lower than the 60% to 80% rates typically reported with antiandrogen monotherapy. Given that the long-term risks of prophylactic breast irradiation are not well characterized, these data suggest that prophylactic breast irradiation may not be as necessary in men receiving short-course CAB.
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Amar U
authors.initials: AU
authors.lastname: Kishan
authors.affiliation: Department of Statistics, University of Connecticut, Storrs, Connecticut.
authors.forename: Ming-Hui
authors.initials: MH
authors.lastname: Chen
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Marian
authors.initials: M
authors.lastname: Loffredo
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Dongsun
authors.initials: D
authors.lastname: Kim
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Clair J
authors.initials: CJ
authors.lastname: Beard
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Mark D
authors.initials: MD
authors.lastname: Hurwitz
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Neil E
authors.initials: NE
authors.lastname: Martin
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Peter F
authors.initials: PF
authors.lastname: Orio
authors.affiliation: Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts.
authors.forename: Philip W
authors.initials: PW
authors.lastname: Kantoff
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
authors.forename: Anthony V
authors.initials: AV
authors.lastname: D'Amico
authors.affiliation: Department of Radiation Oncology, Dana-Farber Cancer Institute and Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: pnguyen@LROC.harvard.edu.
authors.forename: Paul L
authors.initials: PL
authors.lastname: Nguyen