title: Impact of a tailored oral vitamin D supplementation regimen on serum 25-hydroxyvitamin D levels in early breast cancer patients: a randomized phase III study.
abstract: A minority of early breast cancer (EBC) patients treated with adjuvant or neoadjuvant chemotherapy have sufficient baseline vitamin D (vitD) level. This randomized phase III study assessed the safety and efficacy of a tailored, high-dose, oral vitD supplementation in restoring a normal 25-hydroxy vitD (25OHD) level in this population.
  
  
  
  Participants received a 6-month conventional (C) vitD and calcium supplementation or a 6-month high-dose oral vitD regimen tailored on the deficiency (T) and a conventional calcium supplementation. The primary end point was the 6-month percentage of 25OHD serum level normalization.
  
  
  
  A total of 215 patients including 197 patients with vitD deficiency were recruited, and 195 patients were randomized (T, 100; C, 95). Compliance to the daily oral supplementation was 68.4% and 67% in the C and T arms, respectively. Discontinuous high-dose vitD compliance appeared higher in the T arm (77%). At 6 months, more patients presented with a normalized vitD level in the T arm (30% versus 12.6%; P = 0.003). Supplementation was well tolerated, and no significant difference in the treatment-related toxicity between the two arms was reported. Fifty-two patients without vitD normalization from the C arm switched to the T arm after 6 months. At 12 months, 44% of these patients achieved vitD normalization.
  
  
  
  A tailored high-dose oral vitD supplementation safely allows a higher percentage of the serum 25OHD level normalization compared with a conventional regimen in chemotherapy-treated EBC patients. As compliance to a daily oral supplementation remains poor in this setting, an adaptation of the treatment schedule is warranted.
  
  
  
  NCT01480869.
authors.affiliation: Department of Medical Oncology William.Jacot@icm.unicancer.fr.
authors.forename: W
authors.initials: W
authors.lastname: Jacot
authors.affiliation: Department of Medical Oncology.
authors.forename: N
authors.initials: N
authors.lastname: Firmin
authors.affiliation: Biometrics Unit, Institut régional du Cancer de Montpellier (ICM), Montpellier.
authors.forename: L
authors.initials: L
authors.lastname: Roca
authors.affiliation: Department of Medical Oncology, CHU de Montpellier, Montpellier.
authors.forename: D
authors.initials: D
authors.lastname: Topart
authors.affiliation: Department of Medical Oncology.
authors.forename: S
authors.initials: S
authors.lastname: Gallet
authors.affiliation: Department of Medical Oncology.
authors.forename: A
authors.initials: A
authors.lastname: Durigova
authors.affiliation: Department of Medical Oncology.
authors.forename: S
authors.initials: S
authors.lastname: Mirr
authors.affiliation: Biometrics Unit, Institut régional du Cancer de Montpellier (ICM), Montpellier.
authors.forename: L
authors.initials: L
authors.lastname: Abach
authors.affiliation: Department of Medical Oncology.
authors.forename: S
authors.initials: S
authors.lastname: Pouderoux
authors.affiliation: Department of Medical Oncology.
authors.forename: V
authors.initials: V
authors.lastname: D'Hondt
authors.affiliation: Biometrics Unit, Institut régional du Cancer de Montpellier (ICM), Montpellier.
authors.forename: J P
authors.initials: JP
authors.lastname: Bleuse
authors.affiliation: Specialized Biology and Oncogenetics Laboratory, Institut régional du Cancer de Montpellier (ICM), Montpellier, France.
authors.forename: P J
authors.initials: PJ
authors.lastname: Lamy
authors.affiliation: Department of Medical Oncology.
authors.forename: G
authors.initials: G
authors.lastname: Romieu
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000097:blood / Q000178:diet therapy* / Q000473:pathology; D019587:Dietary Supplements; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011788:Quality of Life; D014807:Vitamin D / Q000008:administration & dosage* / Q000031:analogs & derivatives / Q000097:blood; D014808:Vitamin D Deficiency / Q000097:blood / Q000178:diet therapy* / Q000473:pathology
chemical_list: D014807:Vitamin D; C104450:25-hydroxyvitamin D
keywords: chemotherapy; early breast cancer; vitamin D