Randomized trial of vitamin D3 to prevent worsening of musculoskeletal symptoms in women with breast cancer receiving adjuvant letrozole. The VITAL trial.

Autor: Khan QJ; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA., Kimler BF; Department of Radiation Oncology, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS, 66160-7321, USA. bkimler@kumc.edu., Reddy PS; Cancer Center of Kansas, Wichita, KS, USA., Sharma P; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA., Klemp JR; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA., Nydegger JL; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA., Yeh HW; Laureate Institute for Brain Research, Tulsa, OK, USA., Fabian CJ; Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS, USA.
Jazyk: angličtina
Zdroj: Breast cancer research and treatment [Breast Cancer Res Treat] 2017 Nov; Vol. 166 (2), pp. 491-500. Date of Electronic Publication: 2017 Aug 02.
DOI: 10.1007/s10549-017-4429-8
Abstrakt: Purpose: Aromatase inhibitor-associated musculoskeletal symptoms (AIMSS) frequently occur in women being treated for breast cancer. Prior studies suggest high prevalence of vitamin D deficiency in breast cancer patients with musculoskeletal (MS) pain. We conducted a randomized, placebo-controlled trial to determine if 30,000 IU vitamin D3 per week (VitD3) would prevent worsening of AIMSS in women starting adjuvant letrozole for breast cancer.
Methods: Women with stage I-III breast cancer starting adjuvant letrozole and 25(OH)D level ≤40 ng/ml were eligible. All subjects received standard daily supplement of 1200 mg calcium and 600 IU vitamin D3 and were randomized to 30,000 IU oral VitD3/week or placebo. Pain, disability, fatigue, quality of life, 25(OH)D levels, and hand grip strength were assessed at baseline, 12, and 24 weeks. The primary endpoint was incidence of an AIMSS event.
Results: Median age of the 160 subjects (80/arm) was 61. Median 25OHD (ng/ml) was 25 at baseline, 32 at 12 weeks, and 31 at 24 weeks in the placebo arm and 22, 53, and 57 in the VitD3 arm. There were no serious adverse events. At week 24, 51% of women assigned to placebo had a protocol defined AIMSS event (worsening of joint pain using a categorical pain intensity scale (CPIS), disability from joint pain using HAQ-II, or discontinuation of letrozole due to MS symptoms) vs. 37% of women assigned to VitD3 (p = 0.069). When the brief pain inventory (BPI) was used instead of CPIS, the difference was statistically significant: 56 vs. 39% (p = 0.024).
Conclusions: Although 30,000 IU/week of oral vitamin D3 is safe and effective in achieving adequate vitamin D levels, it was not associated with a decrease in AIMSS events based on the primary endpoint. Post-hoc analysis using a different tool suggests potential benefit of vitamin D3 in reducing AIMSS.
Databáze: MEDLINE
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