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.

The STAMPEDE trial tested the addition of zoledronic acid (ZA) ± docetaxel (with prednisolone) to ADT.

STAMPEDE试验测试了将唑来膦酸（ZA）±多西他赛（加泼尼松）添加到ADT中的效果。

Both regimens may impact bone health.

两种治疗方案都可能影响骨骼健康。

However, long-term fracture incidenceremains uncertain.

然而，长期骨折发生率仍然不确定。

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.

从英格兰招募的患者中获取了卫生系统数据，这些患者被随机分配接受标准治疗（SOC）雄激素剥夺治疗（ADT），与SOC加唑来膦酸（ZA）或多西他赛或两者均接受ZA和多西他赛治疗。

ICD10 diagnosis and OPCS procedure codes from inpatient hospital admissions were used to identify fracture-related hospitalisations.

使用住院医院收治的ICD10诊断和OPCS手术代码来识别与骨折相关的住院治疗。

Flexible parametric competing risks models were used to estimate 5- and 10-year cumulative incidenceand sub-distribution hazard ratios (SDHR).

使用了灵活参数的竞态风险模型来估计5年和10年的累积发生率以及亚分布风险比（SDHR）

Results

2140 of 2705 (79%) patients recruited from trial sites in England were eligible for this secondary analysis.

在英格兰的试验现场招募的2705名患者中，有2140名（79%）符合本次次要分析的资格

Linked data were available for 2042/2140 (96%) pts (734 M0, 1308 M1). 5-year cumulative incidenceof 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 incidencein M0 patients was 26% (95% CI, 20% to 33%).

共有2042/2140（96%）的患者（734例M0，1308例M1）的数据可用。仅接受标准治疗（SOC）的M0和M1患者的5年骨折累积发生率分别为11%（95%置信区间（CI），8%至15%）和23%（95% CI，19%至28%）。M0患者的10年骨折累积发生率为26%（95% CI，20%至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 = 0.549).

分配至唑来膦酸（ZA）显著降低了M1患者的骨折风险（SDHR 0.73，95% CI 0.55-0.97；P = 0.015），但对M0患者的骨折风险没有显著影响（SDHR 0.88，95% CI 0.59-1.32；P = 0.549）。

Docetaxel had no clear effect on the risk of fracture in M0 (P = 0.570) or M1 (P = 0.264) patients.

多西他赛对M0期（P = 0.570）或M1期（P = 0.264）患者的骨折风险没有明显影响。

Conclusions

High cumulative incidenceof fracture was observed in both M0 and M1 prostate cancer patients receiving ADT.

接受雄激素剥夺治疗（ADT）的M0期和M1期前列腺癌患者观察到高累积骨折发生率。

The addition of ZA to ADT ± docetaxel significantly reduced long-term fracture risk in M1 participants but had no clear effect in M0 disease.

唑来膦酸联合雄激素剥夺治疗±多西他赛显著降低了转移性前列腺癌患者的长期骨折风险，但在非转移性患者中未见明确效果。

These data support the use of bone protective agents to reduce fracture risk in men with M1 prostate cancer undergoing ADT.

这些数据支持在接受雄激素剥夺治疗的转移性前列腺癌男性中使用骨保护剂以减少骨折风险。