Abstract
TPS809 Background: We previously reported that short-term periodic premedication of glucocorticoids (GCs) used with chemotherapy for gastrointestinal cancer (GIC) caused the reduction of bone mineral densities (BMD) and the increase of serum bone alkaline phosphatase (BAP) (ESPRESSO-01 study; ASCO-GI 2016 Abst.523). Surprisingly, it seems that the BMD decreasing levels due to only the 16-week GC usage in GIC chemotherapy were comparable to that of the 12-month adjuvant aromatase inhibitor therapy for early stage breast cancer patients or the 12-month androgen deprivation therapy for nonmetastatic prostate cancer patients. So we conducted this study to evaluate the efficacy and safety of denosumab for prevention of chemotherapy-induced BMD decreasing. Methods: This is a multicenter single-arm prospective study to evaluate the efficacy and safety of denosumab in GIC patients receiving the short-term periodic steroid premedication. The key eligibility criteria are as follows: 1) Histologically confirmed adenocarcinoma in GIC, including esophageal, gastric, pancreatic, and biliary cancer. ; 2) A schedules of periodical intravenous steroid administration as premedication that was weekly, biweekly, and triweekly, and in which > 4-week steroid-free intervals were not allowed. ; 3) High risk patient with steroid induced secondary osteoporosis. ; 4) No prior treatment for osteoporosis. The dose of denosumab (Prolia) is 60mg administered as a single subcutaneous injection within a week before the induction of chemotherapy. All participants should receive adequate calcium and vitamin D supplementation. The primary endpoint is to investigate the BMD change and bone turnover markers (serum NTX and BAP levels) between baseline and 16 weeks after induction of chemotherapy. And the secondary endpoints are to compare and evaluate the difference of primary site, treatment regimen, dose intensity of steroids, newly bone fractures, and the FRAX output. This study is sponsored by Hokkaido Gastrointestinal Cancer Study Group. Clinical trial information: UMIN000023855.
Highlights
Bone health and the management of cancer treatment-induced bone loss (CTIBL) are important for cancer care because the diagnostic and therapeutic advances prolonged patients’ survival
Lumbar spine bone mineral densities (BMD) significantly increased in 71.4% of cases: 2.772%
In a cross-trial comparison with ESPRESSO01, there was no significant difference in the incidence of National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) grade 3 or higher adverse events
Summary
Bone health and the management of cancer treatment-induced bone loss (CTIBL) are important for cancer care because the diagnostic and therapeutic advances prolonged patients’ survival. A fully human monoclonal antibody against Receptor Activator of Nuclear Factor-Kappa B Ligand (RANKL), inhibits osteoclast activity and bone resorption and is being investigated for its clinical utility in men with castration-resistant prostate cancer and in postmenopausal women with breast cancer who are taking AIs as an adjuvant endocrine therapy [7, 8], whereas there is no data for usefulness of denosumab in GIC patients. This prospective study was designed to investigate the efficacy and safety of denosumab in the prevention of CTIBL in GIC patients
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