Menopausal Status as Defined in Breast Cancer Clinical Trials

  • The definition of menopause:
    • Is defined as the permanent cessation of menses
  • The use of the term in breast cancer clinical trials has resulted in a variety of definitions, including:
    • A profound and permanent decrease in ovarian estrogen synthesis
  • According to the NCCN guidelines:
    • Reasonable criteria for determining menopause includes the following:
      • History of bilateral oophorectomy
      • Age greater than or equal to 60
      • Age less than 60 and amenorrheic for 12 or more months:
        • In the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and follicle-stimulating hormone (FSH) and estradiol in the postmenopausal range
      • If taking tamoxifen or toremifene, and age less than 60:
        • Then FSH and plasma estradiol level in postmenopausal ranges
  • It is not possible to assign menopausal status:
    • To women who are receiving an LHRH agonist or antagonist
  • In women premenopausal at the beginning of adjuvant chemotherapy:
    • Amenorrhea is not a reliable indicator of menopausal status:
      • As ovarian function may still be intact or resume despite anovulation / amenorrhea after chemotherapy:
        • For these women with therapy-induced amenorrhea:
          • Oophorectomy or serial measurement of FSH and/or estradiol:
            • Are needed to ensure postmenopausal status:
              • If the use of aromatase inhibitors is being considered as endocrine therapy
  • References:
    • Yu B, Douglas N, Ferrin MJ, et al. Changes in markers of ovarian reserve and endocrine function in young women with breast cancer undergoing adjuvant chemotherapy. Cancer. 2010;116(9):2099-2105.
    • National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines for Oncology: Breast Cancer. Published January 2016. Accessed January 31, 2017.

#Arrangoiz #BreastSurgeon #BreastCancer #CancerSurgeon #SurgicalOncologist

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