SOFT / TEXT Trials

  • In the SOFT / TEXT trials:
    • Premenopausal women were given ovarian function suppression with adjuvant aromatase inhibitor or tamoxifen:
      • Outcomes were compared to tamoxifen alone for 5 years
    • The SOFT / TEXT trials showed a:
      • Disease-free survival benefit of 2.1%
      • Overall survival benefit of 4.3%:
        • At 8 years with GnRH agonist and tamoxifen over tamoxifen alone in the cohort of women who had prior chemotherapy
      • Premenopausal patients with high-risk disease and who received prior chemotherapy:
        • The most effective adjuvant endocrine therapy would include ovarian function suppression with a GnRH agonist per the SOFT / TEXT trials
  • Tamoxifen alone:
    • Is still an effective endocrine therapy and would be appropriate if the patient chooses not to use ovarian function suppression
  • In premenopausal patients an aromatase inhibitor would be ineffective unless she was rendered post-menopausal
  • Raloxifene is a selective ER modulator similar to tamoxifen:
    • It is FDA-approved only for breast cancer risk reduction in post-menopausal women
  • Oophorectomy alone is not as effective without additional endocrine therapy.
  • References
    • Francis PA, Regan MM, Fleming GF, Lang I, Ciruelos E, Bellet M, et al. Adjuvant ovarian suppression in premenopausal breast cancer. New Engl J Med. 2015;372(5):436-446.
    • Francis PA, Pagani O, Fleming GF, Walley BA, Colleoni M, Lang I, et al. Tailoring adjuvant endocrine therapy for premenopausal breast cancer. N Engl J Med. 2018;379(2):122-137.
    • Vogel VG. The NSABP Study of Tamoxifen and Raloxifene (STAR) trial. Expert review of anticancer therapy. 2009;9(1):51-60.

#Arrangoiz #BreastCancer #BreastSurgeon #CancerSurgeon #SurgicalOncologist #Miami #CASO #CenterforAdvancedSurgicalOncology

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