title: Gynecologic conditions in participants in the NSABP breast cancer prevention study of tamoxifen and raloxifene (STAR).
abstract: OBJECTIVE
  This study reports the gynecologic conditions in postmenopausal women (intact uterus on enrollment) in the National Surgical Adjuvant Breast and Bowel Project (NSABP) study of tamoxifen and raloxifene (STAR)/P-2 trial.
  
  
  METHODS
  This study, with a median follow-up period of 81 months, evaluated the incidence rates/risks of gynecologic conditions among women who were treated with tamoxifen and raloxifene.
  
  
  RESULTS
  Compared with women who received tamoxifen therapy, women who received raloxifene therapy had a lower incidence of uterine cancer (relative risk, 0.55)/endometrial hyperplasia (relative risk, 0.19), leiomyomas (relative risk, 0.55), ovarian cysts (relative risk, 0.60), and endometrial polyps (relative risk, 0.30) and had fewer procedures performed. Women receiving tamoxifen therapy had more hot flashes (P < .0001), vaginal discharge (P < .0001), and vaginal bleeding (P < .0001).
  
  
  CONCLUSIONS
  Our results suggest that tamoxifen has more of an estrogenic effect on the gynecologic reproductive organs. These effects should be considered in counseling women on options for breast cancer prevention.
authors.affiliation: National Surgical Adjuvant Breast and Bowel Project, National Cancer Institute, Pittsburgh, PA, USA. crunowic@fiu.edu
authors.forename: Carolyn D
authors.initials: CD
authors.lastname: Runowicz
authors.forename: Joseph P
authors.initials: JP
authors.lastname: Costantino
authors.forename: D Lawrence
authors.initials: DL
authors.lastname: Wickerham
authors.forename: Reena S
authors.initials: RS
authors.lastname: Cecchini
authors.forename: Walter M
authors.initials: WM
authors.lastname: Cronin
authors.forename: Leslie G
authors.initials: LG
authors.lastname: Ford
authors.forename: Victor G
authors.initials: VG
authors.lastname: Vogel
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D000368:Aged; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000453:epidemiology* / Q000517:prevention & control; D004714:Endometrial Hyperplasia / Q000453:epidemiology / Q000517:prevention & control; D004965:Estrogen Antagonists / Q000627:therapeutic use; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes / Q000453:epidemiology; D006801:Humans; D015994:Incidence; D007889:Leiomyoma / Q000453:epidemiology* / Q000517:prevention & control; D008875:Middle Aged; D010048:Ovarian Cysts / Q000453:epidemiology / Q000517:prevention & control; D011127:Polyps / Q000453:epidemiology / Q000517:prevention & control; D017698:Postmenopause / Q000187:drug effects; D020849:Raloxifene Hydrochloride / Q000627:therapeutic use*; D012307:Risk Factors; D013629:Tamoxifen / Q000627:therapeutic use*; D014594:Uterine Neoplasms / Q000453:epidemiology* / Q000517:prevention & control; D019522:Vaginal Discharge / Q000453:epidemiology
chemical_list: D018931:Antineoplastic Agents, Hormonal; D004965:Estrogen Antagonists; D013629:Tamoxifen; D020849:Raloxifene Hydrochloride