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
| Autor: | Anna Durigova, L. Roca, Nelly Firmin, Pierre-Jean Lamy, William Jacot, Véronique D'Hondt, S. Gallet, Stéphane Pouderoux, L. Abach, Jean-Pierre Bleuse, Gilles Romieu, Delphine Topart, S. Mirr |
|---|---|
| Přispěvatelé: | Institut de Recherche en Cancérologie de Montpellier (IRCM - U1194 Inserm - UM), CRLCC Val d'Aurelle - Paul Lamarque-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM), Département d'oncologie Médicale, CRLCC Val d'Aurelle - Paul Lamarque, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), CRLC Val d'Aurelle-Paul Lamarque, Herrada, Anthony |
| Jazyk: | angličtina |
| Rok vydání: | 2016 |
| Předmět: |
0301 basic medicine
vitamin D MESH: Dietary Supplements chemotherapy Gastroenterology 0302 clinical medicine MESH: Vitamin D Clinical endpoint Medicine MESH: Aged education.field_of_study [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology MESH: Middle Aged Hematology MESH: Neoplasm Staging Middle Aged Chemotherapy regimen MESH: Drug-Related Side Effects and Adverse Reactions 3. Good health Oncology 030220 oncology & carcinogenesis MESH: Vitamin D Deficiency Female Adult medicine.medical_specialty Drug-Related Side Effects and Adverse Reactions Population Breast Neoplasms [SDV.CAN]Life Sciences [q-bio]/Cancer vitamin D deficiency 03 medical and health sciences Breast cancer [SDV.CAN] Life Sciences [q-bio]/Cancer Internal medicine Vitamin D and neurology Humans early breast cancer education Aged Neoplasm Staging MESH: Humans business.industry MESH: Quality of Life MESH: Adult Vitamin D Deficiency medicine.disease Surgery Clinical trial Regimen 030104 developmental biology Dietary Supplements Quality of Life business MESH: Female MESH: Breast Neoplasms [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | Annals of Oncology Annals of Oncology, Elsevier, 2016, 27 (7), pp.1235-1241. ⟨10.1093/annonc/mdw145⟩ |
| ISSN: | 0923-7534 1569-8041 |
| Popis: | Background 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. Patients and methods 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. Results 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. Conclusion 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. Clinical trial number NCT01480869. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|