Low-dose tamoxifen halves recurrence of breast intraepithelial neoplasia

  • DeCensi A & al.
  • J Clin Oncol
  • 11 Apr 2019

  • curated by Miriam Davis, PhD
  • Univadis Clinical Summaries
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Takeaway

  • Low-dose tamoxifen (5 mg/day for 3 years) halves recurrence of hormone receptor (HR)-positive breast intraepithelial neoplasia with limited toxicity.

Why this matters

  • Low-dose tamoxifen offers a new treatment option for breast intraepithelial neoplasia, a condition that increases risk for invasive breast cancer 5- to 10-fold.

Study design

  • Multicenter, double-blinded, randomized controlled trial (RCT) of low-dose tamoxifen (n=253) vs placebo (n=247) in women who had undergone surgery for breast intraepithelial neoplasia, including atypical ductal hyperplasia and lobular or ductal carcinoma in situ (DCIS).
  • Primary outcome was neoplastic events (invasive breast cancer or DCIS).
  • Funding: Italian Ministry of Health; others.

Key results

  • Median follow-up was 5.1 years.
  • Low-dose tamoxifen yielded 52% fewer neoplastic events vs placebo (11.6 vs 23.9/1000 person-years; HR, 0.48; P=.02).
  • Low-dose tamoxifen yielded 75% fewer neoplastic events in the contralateral breast vs placebo (HR, 0.25; P=.02).
  • No differences between groups in patient-reported outcomes, except for a small increase in the frequency of daily hot flashes with low-dose tamoxifen vs placebo (P=.02).
  • Low-dose tamoxifen was associated with fewer serious adverse events; they included 1 deep vein thrombosis and 1 stage I endometrial cancer.

Limitation

  • Fewer than planned breast events.

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