HR+ BCa: high-dose vitamin D fails to prevent aromatase inhibitor-induced arthralgia

  • Niravath P & al.
  • Breast Cancer Res Treat
  • 19 Jun 2019

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

  • High-dose vitamin D3 fails to prevent aromatase inhibitor-induced arthralgia (AIA) in postmenopausal women with hormone receptor (HR)-positive breast cancer (BCa).
  • Study was terminated early, based on results of planned futility analysis.

Why this matters

  • AIA affects 50% of recipients of AI therapy.
  • Results suggest that vitamin D3 plays no role in AIA onset.

Study design

  • Randomized controlled trial of standard-dose vitamin D3 (800 international units [IU]/day planned for 52 weeks) vs high-dose vitamin D3 (50,000 IU/week for 12 weeks, followed by 2000 IU/day planned for 40 weeks) in patients starting AI therapy.
  • Futility analysis was planned when half of patients were enrolled.

Key results

  • 93 patients (47 standard dose; 46 high dose) were evaluated for efficacy at 12 weeks.
  • High-dose group had higher mean serum level of vitamin D3 at 12 weeks (50 vs 29.3 ng/mL in the standard-dose group; P<.0001>
  • No difference in the development of AIA between groups (54% of high-dose vs 57% of standard-dose groups; 1-tailed P value=.3818, leading to early termination of study for futility).
  • 1 patient in the high-dose group developed renal stones.

Limitations

  • Unblinded.
  • Many patients were counted as failures because they did not complete questionnaires.

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