Which endocrine therapy regimen would result in highest (or best) disease-free survival in a 32 year old women one year out from a pT2, pN1, ER positive, HER2 negative invasive ductal carcinoma of the right breast?

• The Tamoxifen and Exemestane Trial (TEXT) and the Suppression of Ovarian Function Trial (SOFT):
  • Investigated adjuvant endocrine therapies:
    • For premenopausal women:
      • With hormone receptor-positive breast cancer
• Randomizing women to:
  • Exemestane plus ovarian function suppression (OFS)
  • Tamoxifen plus OFS
  • Tamoxifen alone:
    • For 5 years
• The studies were combined for primary analysis:
  • After enrolling:
    • 4690 patients
  • After a median follow-up of:
    • 68 months:
      • DFS was:
        • 91.1% in the exemestane-ovarian suppression arm versus
        • 87.3% in the tamoxifen-ovarian suppression arm
          • p<0.001
  • Overall survival:
    • Did not differ between the groups
  • Adverse events were reported for:
    • 30.6% of exemestane-ovarian suppression patients and
    • 29.4% of tamoxifen-ovarian suppression group
• Women on an aromatase inhibitor or who experience ovarian failure secondary to treatment:
  • Should have monitoring of bone health:
    • With a bone mineral density scan:
      • At baseline and periodically thereafter
• The use of estrogen, progesterone, or selective ER modulators:
  • To treat osteoporosis or osteopenia in women with breast cancer:
    • Is discouraged
  • The use of a bisphosphonate:
  • Is generally the preferred intervention:
    • To improve bone mineral density
      • Optimal duration of bisphosphonate therapy:
        • Has not been established:
          • Factors to consider for duration of anti-osteoporosis therapy include:
            • Bone mineral density
            • Response to therapy
            • Risk factors for continued bone loss or fracture
  • Women treated with a bisphosphonate:
    • Should undergo a dental examination with preventive dentistry prior to the initiation of therapy, and
    • Should take supplemental calcium and vitamin D
• References:
  • Pagani O, Regan MM, Walley BA, et al. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014;371(2):107-118.
  • Wilkinson GS, Kuo Y-F, Freeman JL, Goodwin JS. Intravenous bisphosphonate therapy and inflammatory conditions or surgery of the jaw: a population-based analysis. J Natl Cancer Inst. 2007;99(13):1016-1024.
  • Regan MM, Francis PA, Pagani O, et al. Absolute benefit of adjuvant endocrine therapies for premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative early breast cancer: TEXT and SOFT Trials. J Clin Oncol. 2016;34(19):2221-2231.

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