Disease Progression Modeling Analysis of the Change of Bone Mineral Density by Postoperative Hormone Therapies in Postmenopausal Patients With Early Breast Cancer.
The osteoporosis incidence in postmenopausal patients on aromatase inhibitors (AI) is much higher than in those on tamoxifen, and adverse effects other than musculoskeletal disorders are less on AI than on tamoxifen. In this study we performed disease-progression modeling in postmenopausal patients with early breast cancer who had received 5 years of postoperative hormone therapy. Clinical data from postmenopausal patients who had received postoperative hormonal therapy and met the predefined selection criteria were retrospectively collected in an anonymized way. Disease-progression modeling and simulations were performed using NONMEM version 7.42. A first-order deterioration model with a combination of a symptomatic model (when a drug effect provides a transient bad effect by offsetting the severity of the disease) and a disease-modifying model (when a drug affects the disease progression rate) was used. Vitamin D supplementation was found to have a disease-modifying effect in osteoporosis, whereas AI decreased the bone mineral density by a t score of -0.21. However, after stopping the AI, the estrogen level reverted to normal, thereby reexercising protective effects against bone loss. In the simulation the probability of osteoporosis increased by 10% in the AI group compared with the other groups (tamoxifen, no-treatment group) during the medication period. Tamoxifen showed no significant effects in the final model.
['Yoon|SeokKyu|S|', 'Bae|Kyun-Seop|KS|0000-0001-7399-5879', 'Cho|Yong-Soon|YS|', 'Han|Sunpil|S|0000-0002-4674-7682', 'Kim|Hyungsub|H|', 'Lim|Hyeong-Seok|HS|0000-0003-1420-8200']
D018931:Antineoplastic Agents, Hormonal D047072:Aromatase Inhibitors D015519:Bone Density D050071:Bone Density Conservation Agents D001943:Breast Neoplasms D018450:Disease Progression D005260:Female D006801:Humans D008875:Middle Aged D010024:Osteoporosis D017698:Postmenopause D011184:Postoperative Period D012189:Retrospective Studies D013629:Tamoxifen
Disease progression modeling Bone mineral density Osteoporosis Aromatase inhibitor Tamoxifen