فعّالية جرعة عالية من فيتامين D3 بالمشاركة مع الكالسيوم وريزيدرونات لتدبير خسارة العظم المصاحبة لمثبطات الأروماتاز لدى مريضات سرطان ثدي باكر

Abstract EN

Background: Aromatase inhibitors (AIs) are indicated for the management of hormone receptorpositive early stages and metastatic breast cancer in postmenopausal women.

However, AIs may lead to an adverse effect known as "Aromatase Inhibitor-Associated Bone Loss" (AIBL).

On the other hand, vitamin D deficiency or insufficiency constitutes a silent epidemic in society and presents a health problem of particular importance for high-risk groups (i.e., breast cancer patients on aromatase inhibitors).

Objective: To evaluate the effectiveness of adding a high-dose (5000 IU) of vitamin D3 to the regimen of the American Society of Clinical Oncology (ASCO) for the AIBL prevention and treatment of non-metastatic breast cancer patients .

Study Design and Methods: This prospective randomized clinical study encompassed hormone receptor-positive breast cancer patients receiving AIs at Al-Biruni and Red Crescent Hospitals in Damascus, from June 2012 to September 2014.

The patients were randomly assigned to one of two study arms; where patients in the (D800) arm received a daily dose of 800 IU of vitamin D3, whereas, patients in the (D5800) arm received an add-on dose of 5000 IU/day, in combination with elemental calcium at 1000 mg daily + risedronate 75 mg twice monthly for both groups.

Bone health of the patients was evaluated with dual emitter x-ray absorptiometry (DXA), and the serum concentrations of related parameters were measured, including 25(OH)D, Phosphorous, Calcium, Urea, Creatinine, Alkaline Phosphatase, PTH and Osteocalcin, before starting and after completing treatment course .

Results: Assessment of patients who met the inclusion criteria (n=48) revealed a high prevalence of osteoporosis (20.9%) and osteopenia (70.8%), as well as vitamin D insufficiency (83.4%).

Patients in both arms exhibited increases of 25(OH)D serum concentrations at the end of the treatment course, with superiority of (D5800) treatment line [22.46±12.88 ng/ml] compared with [15.04 ±10.3 ng/ml] in patients on the (D800), (P =0.034).

Patients on the (D5800) showed enhanced average differential T-Score Z-Score, and BMD at the lumbar vertebrae of [0.44 ± 0.36], [0.92 ±0.84], and [0.048 ±0.04] compared with their counterparts on the (D800) treatment line [0.15 ±0.25], [0.39 ±0.57], [0.17 ±0.03], respectively (P <<0.05 for all comparisons).

Conclusions: This study proves high prevalence of osteoporosis, osteopenia, and vitamin D3 insufficiency.in non-metastatic breast cancer patients treated with Aromatase Inhibitors, and demonstrates improvements in serum vitamin 25(OH)D levels and bone density values and in response to the treatment regimen of calcium and residronate, with either vitamin D3 doses, nevertheless the higher dose was significantly superior.