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Prostate-selective ? antagonists increase fracture risk in prostate cancer patients with and without a history of androgen deprivation therapy: a nationwide population-based study.

ABSTRACT: Prostate-selective ? antagonists are recommended for relief of lower urinary tract symptoms in prostate cancer patients despite uncertainty of fracture risk as an addition to androgen deprivation therapy (ADT). The purpose of this study is to estimate fracture risk associated with these medications in prostate cancer patients who did and did not receive ADT.The Taiwan National Health Insurance database was used to identify prostate cancer patients. We identified all 90-day person-quarters exposed to and not exposed to prostate-selective ? antagonists. A generalized estimating equation model was used to estimated adjusted odd ratios (ORs) and 95% confidence intervals (CIs) for fracture associated with prostate-selective ? antagonists with consideration for confounding by indication bias using propensity score.During 1997-2008, 16,601 persons received a diagnosis of prostate cancer, among whom 13,694 received ADT. Among prostate cancer patients receiving ADT, fracture was significantly more common in person-quarters with prostate-selective ? antagonist use than in quarters without such treatment (OR, 1.08; 95% CI, 1.00-1.18). Prostate-selective ? antagonist use was most strongly associated with femur fracture (OR, 1.22; 95% CI, 1.09-1.38), followed by skull fracture (OR, 1.29; 95% CIs: 0.93-1.80). Among patients who did not receive ADT, fracture was more common in person-quarters with prostate-selective ? antagonist use than in those without medication use (OR, 1.19; 95% CI, 0.91-1.55).Prostate-selective ? antagonist is associated with an increased fracture risk, particular for fractures in skull and femur. Patients should be well-informed on this potential risk before taking prostate-selective ? antagonists.

SUBMITTER: Kao WH

PROVIDER: S-EPMC5797048 | biostudies-literature | 2018 Jan

REPOSITORIES: biostudies-literature

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Prostate-selective α antagonists increase fracture risk in prostate cancer patients with and without a history of androgen deprivation therapy: a nationwide population-based study.

Kao Wei-Heng WH Kuo Chang-Fu CF Chou I-Jun IJ See Lai-Chu LC Huang Wen-Kuan WK Chiou Meng-Jiun MJ Zhang Weiya W Doherty Michael M Wang Chun-Chieh CC Hsu Jun-Te JT Chen Hsien-Hsin HH Hong Ji-Hong JH

Oncotarget 20180102 4

<h4>Introductions</h4>Prostate-selective α antagonists are recommended for relief of lower urinary tract symptoms in prostate cancer patients despite uncertainty of fracture risk as an addition to androgen deprivation therapy (ADT). The purpose of this study is to estimate fracture risk associated with these medications in prostate cancer patients who did and did not receive ADT.<h4>Methods</h4>The Taiwan National Health Insurance database was used to identify prostate cancer patients. We identi ...[more]

PMID: 29435177

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Project description:BackgroundCastration resistance occurs in most patients with metastatic hormone-sensitive prostate cancer who are receiving androgen-deprivation therapy. Replacing androgens before progression of the disease is hypothesized to prolong androgen dependence.MethodsMen with newly diagnosed, metastatic, hormone-sensitive prostate cancer, a performance status of 0 to 2, and a prostate-specific antigen (PSA) level of 5 ng per milliliter or higher received a luteinizing hormone-releasing hormone analogue and an antiandrogen agent for 7 months. We then randomly assigned patients in whom the PSA level fell to 4 ng per milliliter or lower to continuous or intermittent androgen deprivation, with patients stratified according to prior or no prior hormonal therapy, performance status, and extent of disease (minimal or extensive). The coprimary objectives were to assess whether intermittent therapy was noninferior to continuous therapy with respect to survival, with a one-sided test with an upper boundary of the hazard ratio of 1.20, and whether quality of life differed between the groups 3 months after randomization.ResultsA total of 3040 patients were enrolled, of whom 1535 were included in the analysis: 765 randomly assigned to continuous androgen deprivation and 770 assigned to intermittent androgen deprivation. The median follow-up period was 9.8 years. Median survival was 5.8 years in the continuous-therapy group and 5.1 years in the intermittent-therapy group (hazard ratio for death with intermittent therapy, 1.10; 90% confidence interval, 0.99 to 1.23). Intermittent therapy was associated with better erectile function and mental health (P<0.001 and P=0.003, respectively) at month 3 but not thereafter. There were no significant differences between the groups in the number of treatment-related high-grade adverse events.ConclusionsOur findings were statistically inconclusive. In patients with metastatic hormone-sensitive prostate cancer, the confidence interval for survival exceeded the upper boundary for noninferiority, suggesting that we cannot rule out a 20% greater risk of death with intermittent therapy than with continuous therapy, but too few events occurred to rule out significant inferiority of intermittent therapy. Intermittent therapy resulted in small improvements in quality of life. (Funded by the National Cancer Institute and others; ClinicalTrials.gov number, NCT00002651.).

Dataset Information

Prostate-selective ? antagonists increase fracture risk in prostate cancer patients with and without a history of androgen deprivation therapy: a nationwide population-based study.

Publications

Prostate-selective α antagonists increase fracture risk in prostate cancer patients with and without a history of androgen deprivation therapy: a nationwide population-based study.

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