Fracture-related hospitalisations in newly diagnosed high-risk localised or metastatic hormone-sensitive prostate cancer: secondary analysis of the STAMPEDE phase III trials of docetaxel and zoledronic acid using healthcare systems data
Abstract
BACKGROUND: Androgen deprivation therapy (ADT), the mainstay systemic treatment for high risk non-metastatic (M0) and metastatic (M1) prostate cancer is associated with bone loss and increased fracture risk. The STAMPEDE trial tested the addition of zoledronic acid (ZA) ± docetaxel (with prednisolone) to ADT. Both regimens may impact bone health. However, long-term fracture incidence remains uncertain.
PATIENTS AND METHODS: Health systems data were obtained for patients recruited from England and randomised to standard-of-care (SOC) ADT compared with SOC plus ZA or docetaxel or both docetaxel and ZA. ICD10 diagnosis and OPCS procedure codes from inpatient hospital admissions were used to identify fracture-related hospitalisations. Flexible parametric competing risks models were used to estimate 5- and 10-year cumulative incidence and sub-distribution hazard ratios (SDHR).
RESULTS: 2140 of 2705 (79%) patients recruited from trial sites in England were eligible for this secondary analysis. Linked data were available for 2042/2140 (96%) pts (734 M0, 1308 M1). 5-year cumulative incidence of fracture for M0 and M1 patients treated with SOC only was 11% [95% confidence interval (CI), 8% to 15%] and 23% (95% CI, 19% to 28%), respectively. 10-year cumulative incidence in M0 patients was 26% (95% CI, 20% to 33%). Allocation to ZA significantly reduced the risk of fracture in M1 patients (SDHR 0.73, 95% CI 0.55-0.97; P = 0.015) but not M0 patients (SDHR 0.88, 95% CI 0.59-1.32; P =…
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Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence.
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