Abstract
The multi-centre, prospective, observational study was designed to examine the efficacy of continuous combined androgen block (CAB) vs. GnRH agonist monotherapy in terms of bone mineral density (BMD) change during 12 months post-androgen deprivation therapy (ADT) in Asian prostate cancer patients. Multiple regression analysis and estimated the 10-year probability of major fractures among the patients with Fracture Risk Assessment Tool were conducted to investigate the underlying factors affecting BMD. Paired t-test to evaluate the change of BMD from baseline to 12 month, and two sample t-test to examine the difference of BMD changes were used between two groups. BMD significantly decreased in both the CAB and GnRH groups, with no group wise differences. The proportion of osteopenia or osteoporosis was slightly increased after the 12-month post-ADT. Ten-year probability of hip fracture and major osteoporotic fracture was approximately 3% and 5%, respectively. In conclusion, a significant decrease of BMD by 12-month ADT was observed without any differences between the two groups, whereas ADT-related BMD loss did not induce detrimental effects on bone health in terms of increased bone fracture risk. This was the first prospective study on BMD changes as a predictor of fracture during ADT in an Asian population.
Highlights
The androgen deprivation therapy (ADT) comprises two different therapeutic regimens[4]
Combined with the underlying low bone mineral density (BMD) presented as osteopenia or osteoporosis in mostly old-aged patients with prostate cancer[8], ADT-induced bone mineral loss that presents as osteopenia or osteoporosis is a major adverse outcome with the increasing risks of serious complications such as lumbar and hip fractures[9,10,11]
BMD significantly decreased in L1-L4 of both groups, but there were no differences between the 2 groups (p > 0.05; Supplemental Table 3)
Summary
The ADT comprises two different therapeutic regimens[4]. One regimen comprises either orchiectomy or gonadotropin-releasing hormone (GnRH) agonist that reduces testosterone and oestrogen concentrations; and the other of nonsteroidal androgen receptor blocker called bicalutamide that maintains testosterone and oestrogen concentrations. The bicalutamide ADT is reportedly less effective than ADT either with orchiectomy or GnRH agonist in metastatic diseases Another combination regimen of strengthening the efficacy was the combined androgen block (CAB) with GnRH agonist plus bicalutamide, which has significant advantages over castration alone or GnRH agonist monotherapy, such as a higher proportion of patients with complete and partial responses, improved control of pain associated with metastatic disease, longer disease-free survival, and longer overall survival by an average of 3–6 months, as compared with combined treatment with the anti-androgen initiated later[4,5,6]. Combined with the underlying low BMD presented as osteopenia or osteoporosis in mostly old-aged patients with prostate cancer[8], ADT-induced bone mineral loss that presents as osteopenia or osteoporosis is a major adverse outcome with the increasing risks of serious complications such as lumbar and hip fractures[9,10,11]. The study was aimed to examine the effect of CAB vs. GnRH agonist monotherapy on BMD change and to determine the underlying factors affecting BMD during 12 months post-treatment initiation in prostate cancer patients and the 10-year probability of major fractures
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