title: Quality of life assessment in a chemoprevention trial: fenretinide and oral or transdermal HRT.
abstract: BACKGROUND
  Oral conjugated equine estrogen (CEE) and medroxyprogesterone acetate (MPA) relief menopause symptoms, but may increase breast cancer risk, while the effects of transdermal estradiol (E2) and MPA are less known. In previous studies, fenretinide decreased second breast malignancies in premenopausal but not in postmenopausal women, suggesting a hormone-sensitizing effect. We have evaluated the quality of life through a self-administered questionnaire during a randomized study of oral CEE or transdermal E2 and fenretinide or placebo.
  
  
  METHODS
  A total of 226 postmenopausal women were randomly assigned to either CEE 0.625mg/day and placebo (n=55), or CEE and fenretinide 100mg/bid (n=56), or E2, 50microg/day and placebo (n=59), or E2 and fenretinide (n=56) for 12 months. Sequential MPA 10mg/day was added in all groups. Treatment effects were investigated using a validated questionnaire, the Menopause Quality of Life questionnaire (MENQOL).
  
  
  RESULTS
  Oral CEE and transdermal E2 have a comparable activity in reducing menopausal symptoms (p=ns). Both routes ameliorate significantly the symptoms after 1 year of treatment (p<0.0001). Fenretinide does not modify the effects of hormonal replacement therapy.
  
  
  CONCLUSIONS
  Oral CEE and transdermal E2 have similar effect on menopausal symptoms relief. The choice of the best estrogen replacement therapy (ERT) route should be decided based on a careful analysis of all the clinical aspects of every subject, considering that transdermal therapy may have a safer effect on the cardiovascular system.
authors.affiliation: Division of Chemoprevention, European Institute of Oncology, via Ripamonti 435, 20141 Milan, Italy. davide.serrano@ieo.it
authors.forename: Davide
authors.initials: D
authors.lastname: Serrano
authors.forename: Luigi
authors.initials: L
authors.lastname: Mariani
authors.forename: Serena
authors.initials: S
authors.lastname: Mora
authors.forename: Aliana
authors.initials: A
authors.lastname: Guerrieri-Gonzaga
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Cazzaniga
authors.forename: Cristina
authors.initials: C
authors.lastname: Daldoss
authors.forename: Francesca
authors.initials: F
authors.lastname: Ramazzotto
authors.forename: Irene
authors.initials: I
authors.lastname: Feroce
authors.forename: Andrea
authors.initials: A
authors.lastname: Decensi
authors.forename: Bernardo
authors.initials: B
authors.lastname: Bonanni
mesh_terms: D000279:Administration, Cutaneous; D000284:Administration, Oral; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004958:Estradiol / Q000008:administration & dosage*; D015914:Estrogen Replacement Therapy; D004966:Estrogens, Conjugated (USP) / Q000008:administration & dosage*; D005260:Female; D017313:Fenretinide / Q000008:administration & dosage*; D019584:Hot Flashes / Q000473:pathology / Q000517:prevention & control* / Q000523:psychology; D006801:Humans; D017258:Medroxyprogesterone Acetate / Q000008:administration & dosage; D008593:Menopause; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D004966:Estrogens, Conjugated (USP); D017313:Fenretinide; D004958:Estradiol; D017258:Medroxyprogesterone Acetate