Effect of Vitamin D Supplementation on Relapse-Free Survival Among Patients With Digestive Tract Cancers: The AMATERASU Randomized Clinical Trial
Urashima M, Ohdaira H, Akutsu T, Okada S, Yoshida M, Kitajima M, Suzuki Y
JAMA · 116 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Eventos clínicos como enfermedad o muerte
Quién lo pagó
- Financiación
- Financiación independiente
- Universidad u hospital
- Jikei University School of Medicine
Según 1 financiador declarado.
Publicación
- Publicado
- 2019-04-09 · JAMA · vol. 321 · número 14 · pág. 1361
- Editorial
- American Medical Association
- Citado
- 147 citas · más que el 99% de estudios similares · 11.4× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 34 trabajos
- Acceso
- Lectura gratuita
- Áreas de investigación
- Vitamin D Research Studies · Nutritional Studies and Diet · Head and Neck Cancer Studies
- Palabras clave
- vitamin D supplementation, vitamin D3, digestive tract cancer, relapse-free survival, overall survival, 25-hydroxyvitamin D, gastric cancer, colorectal cancer, esophageal cancer, vitamin D deficiency, VDR polymorphisms
- MeSH
- humans, gastrointestinal neoplasms, neoplasm recurrence, local, cholecalciferol, vitamins, vitamin d, disease-free survival, treatment outcome, postoperative care, administration, oral, proportional hazards models, survival analysis, double-blind method, polymorphism, single nucleotide, dietary supplements, adult, aged, aged, 80 and over, middle aged, female, male
7 autores
- Mitsuyoshi Urashima🇯🇵 · autor de correspondenciaJikei University School of Medicine
- Hironori Ohdaira🇯🇵International University of Health and Welfare Hospital
- Taisuke Akutsu🇯🇵Jikei University School of Medicine
- Shinya Okada🇯🇵International University of Health and Welfare Hospital
- Masashi Yoshida🇯🇵International University of Health and Welfare Hospital
- Masaki Kitajima🇯🇵International University of Health and Welfare Hospital
- Yutaka Suzuki🇯🇵International University of Health and Welfare Hospital
Resumen
El texto original del estudio, en el idioma en que se publicó.
Importance
Randomized clinical trials of vitamin D supplementation for secondary prevention in patients with cancer are needed, given positive results of observational studies.
Objective
To determine whether postoperative vitamin D3 supplementation can improve survival of patients with digestive tract cancers overall and in subgroups stratified by 25-hydroxyvitamin D (25[OH]D) levels.
Design, setting, and participants
The AMATERASU trial, a randomized, double-blind, placebo-controlled trial conducted at a single university hospital in Japan. Enrollment began in January 2010 and follow-up was completed in February 2018. Patients aged 30 to 90 years with cancers of the digestive tract from the esophagus to the rectum, stages I to III, were recruited. Of 439 eligible patients, 15 declined and 7 were excluded after operation.
Interventions
Patients were randomized to receive oral supplemental capsules of vitamin D (2000 IU/d; n = 251) or placebo (n = 166) from the first postoperative outpatient visit to until the end of the trial.
Main outcomes and measures
The primary outcome was relapse-free survival time to relapse or death. The secondary outcome was overall survival time to death due to any cause. Subgroups analyzed had baseline serum 25(OH)D levels of 0 to less than 20 ng/mL, 20 to 40 ng/mL, and greater than 40 ng/mL; because of small sample size for the highest-baseline-level group, interactions were tested only between the low- and middle-baseline-level groups.
Results
All 417 randomized patients (mean age, 66 years; male, 66%; esophageal cancer, 10%; gastric cancer, 42%; colorectal cancer, 48%) were included in the analyses. There was 99.8% follow-up over a median 3.5 (interquartile range, 2.3-5.3) years, with maximal follow-up of 7.6 years. Relapse or death occurred in 50 patients (20%) randomized to vitamin D and 43 patients (26%) randomized to placebo. Death occurred in 37 (15%) in the vitamin D group and 25 (15%) in the placebo group. The 5-year relapse-free survival was 77% with vitamin D vs 69% with placebo (hazard ratio [HR] for relapse or death, 0.76; 95% CI, 0.50-1.14; P = .18). The 5-year overall survival in the vitamin D vs placebo groups was 82% vs 81% (HR for death, 0.95; 95% CI, 0.57-1.57; P = .83). In the subgroup of patients with baseline serum 25(OH)D levels between 20 and 40 ng/mL, the 5-year relapse-free survival was 85% with vitamin D vs 71% with placebo (HR for relapse or death, 0.46; 95% CI, 0.24-0.86; P = .02; P = .04 for interaction). Fractures occurred in 3 patients (1.3%) in the vitamin D group and 5 (3.4%) in the placebo group. Urinary stones occurred in 2 patients (0.9%) in the vitamin D group and 0 in the placebo group.
Conclusions and relevance
Among patients with digestive tract cancer, vitamin D supplementation, compared with placebo, did not result in significant improvement in relapse-free survival at 5 years.
Trial registration
UMIN Identifier: UMIN000001977.
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