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#Grand Rounds

The AMATERASU Trial: Does Vitamin D Lead to Improved Survival in GI Cancers?

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BACKGROUND AND PURPOSE:

  • A precursor of activated vitamin D, 25-hydroxyvitamin-D (25[OH]D) may suppress cancer growth
    • Previous cohort studies show association VitD levels and a lower risk of GI cancer
    • RCTs conflicting
  • Urashima et al. (JAMA, 2019) sought to determine if
    • Postoperative VitD3 increases overall survival in patients with digestive tract cancers subgroup stratification based on 25(OH)D levels

METHODS:

  • AMATERASU trial
    • Randomized, double-blind, placebo-controlled (RCT)
  • Participants
    • Patients with digestive tract cancers
    • Ages 30 to 90 years
    • Cancer stage I to III
  • Intervention
    • Oral supplemental vitamin D capsules (2000 IU/d)
    • Placebo
    • Administered from first outpatient visit post-operation until the end of trial
  • Primary outcome
    • Relapse-free survival time to relapse or death
  • Secondary outcome
    • Overall survival time to death due to any cause
  • 25(OH)D serum level analysis
    • Baseline serum level subgroups
      • <20 ng/mL
      • 20-40 ng/mL
      • >40 ng/mL
    • Note: Highest baseline level group had a small n, so interactions limited to low and middle baseline groups

RESULTS:

  • 417 patients
    • Supplemental vitamin D: 251 | placebo: 166
    • Mean age: 66 years | 34% were female
    • Esophageal 10% | Gastric 42% | Colorectal 48% | Small Bowel 0.5%
    • Disease stage I 44% | II 26% | III 30%
  • Follow up: 99.8% over a median of 3.5 years
    • Interquartile range: 2.3-5.3
    • Maximal follow-up: 7.6 years
  • Relapse or death
    • Vitamin D: 20% (50 individuals)
    • Placebo: 26% (43 individuals)

Outcomes

  • Death from any cause
    • Vitamin D: 15% (37 individuals)
    • Placebo: 15% (25 individuals)
  • Primary outcome: 5-year relapse-free survival – no statistical difference
    • Vitamin D: 88% 
    • Placebo: 69%
    • Hazard ratio (HR) for relapse or death: 0.76 (95% CI, 0.50-1.14; P = .18)
  • Secondary outcome: 5-year overall survival – no statistical difference
    • Vitamin D: 82%
    • Placebo: 81%
    • HR for death: 0.95 (95% CI, 0.57-1.57; P = .83)
  • 5-year relapse free-survival for middle baseline serum 25(OH)D levels 20-40 ng/mL
    • Vitamin D: 85%
    • Placebo: 71%
    • HR for relapse or death: 0.46 (95% CI, 0.24-0.86; P = .02)
  • Fractures
    • Vitamin D: 1.3% (3 individuals)
    • Placebo: 3.4% (5 individuals)
  • Urinary stones
    • Vitamin D: 0.9% (2 individuals)
    • Placebo: 0% (0 individuals)
  • No differences found when comparing
    • Men vs women | Age ≤65 years vs >65 years BMI <25 vs ≥25 | Site of cancer: | Disease stage | Adenocarcinoma vs nonadenocarcinoma

CONCLUSION:

  • Vitamin D does not impact overall relapse-free survival in individuals with GI cancers

Learn More – Primary Sources:

Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers: The AMATERASU Randomized Clinical Trial

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Related ObG Topics:

Results from the VITAL Trial: Does Vitamin D Reduce Cardiovascular and Cancer Risk in the General Population?
Is There a Protective Association Between Vitamin D Levels and Cancer Risk?
Do Vitamin D and Calcium Supplements Decrease Cancer Risk?

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