Kuppen Malou C P, Westgeest Hans M, van den Eertwegh Alfons J M, van Moorselaar Reindert J A, van Oort Inge M, Tascilar Metin, Mehra Niven, Lavalaye Jules, Somford Diederik M, Aben Katja K H, Bergman Andre M, de Wit Ronald, van den Bergh A C M Fons, de Groot Carin A Uyl-, Gerritsen Winald R
Institute for Medical Technology Assessment, Erasmus School of Health Policy and Management, Rotterdam, the Netherlands.
Department of Internal Medicine, Amphia Hospital, Breda, the Netherlands.
Clin Genitourin Cancer. 2022 Feb;20(1):43-52. doi: 10.1016/j.clgc.2021.10.008. Epub 2021 Nov 2.
Patients with metastatic castration resistant prostate cancer (mCRPC) are at risk of symptomatic skeletal events (SSE). Bone health agents (BHA, ie bisphosphonates and denosumab) and new life-prolonging drugs (LPDs) can delay SSEs. The aim of this study is to investigate the use of BHAs in relation to SSEs in treated real-world mCRPC population.
We included patients from the CAPRI registry who were treated with at least one LPD and diagnosed with bone metastases prior to the start of first LPD (LPD1). Outcomes were SSEs (external beam radiation therapy (EBRT) to the bone, orthopedic surgery, pathologic fracture or spinal cord compression) and SSE-free survival (SSE-FS) since LPD1.
One-thousand nine hundred and twenty-three patients were included with a median follow-up from LPD1 of 16.7 months. Fifty-two percent (n = 996) started BHA prior or within 4 weeks after the start of LPD1 (early BHA). In total, 41% experienced at least one SSE. SSE incidence rate was 0.29 per patient year for patients without BHA and 0.27 for patients with early BHA. Median SSE-FS from LPD1 was 12.9 months. SSE-FS was longer in patients who started BHA early versus patients without BHA (13.2 vs. 11.0 months, P = .001).
In a real-world population we observed an undertreatment with BHAs, although patients with early BHA use had lower incidence rates of SSEs and longer SSE-FS. This finding was irrespective of type of SSE and presence of risk factors. In addition to LPD treatment, timely initiation of BHAs is recommended in bone metastatic CRPC-patients with both pain and/or opioid use and prior SSE.
转移性去势抵抗性前列腺癌（mCRPC）患者有发生有症状骨骼事件（SSE）的风险。骨健康药物（BHA，即双膦酸盐和地诺单抗）和新型延长生命药物（LPD）可延迟SSE的发生。本研究的目的是调查在真实世界中接受治疗的mCRPC患者群体中BHA与SSE的使用情况。
我们纳入了来自CAPRI注册研究的患者，这些患者接受了至少一种LPD治疗，且在首次LPD（LPD1）开始前被诊断为骨转移。观察指标为自LPD1以来的SSE（针对骨骼的外照射放疗（EBRT）、骨科手术、病理性骨折或脊髓压迫）和无SSE生存期（SSE-FS）。
共纳入1923例患者，自LPD1起的中位随访时间为16.7个月。52%（n = 996）的患者在LPD1开始前或开始后4周内开始使用BHA（早期BHA）。总体而言，41%的患者经历了至少一次SSE。未使用BHA的患者SSE发病率为每年0.29例，早期使用BHA的患者为每年0.27例。自LPD1起的中位SSE-FS为12.9个月。早期开始使用BHA的患者的SSE-FS长于未使用BHA的患者（13.2个月对11.0个月，P = 0.001）。
在真实世界人群中，我们观察到BHA治疗不足，尽管早期使用BHA的患者SSE发病率较低且SSE-FS较长。这一发现与SSE的类型和危险因素的存在无关。除LPD治疗外，对于有疼痛和/或使用阿片类药物且既往有SSE的骨转移CRPC患者，建议及时开始使用BHA。
