Abstract

Adjuvant treatment for post-menopausal women with early breast cancer (BC) includes aromatase inhibitors (AI), known to decrease bone mineral density (BMD). In this study, we investigate whether denosumab is a valid second option for patients unable to receive standard adjuvant i.v. zoledronic acid (ZA). In total, 212 patients have been evaluated after they did not receive ZA. Of those 194 were included. After evaluation by an endocrinologist, all patients were offered ZA as their first choice and 15% accepted (N = 29). The remaining 85% were offered denosumab (N = 165). All patients were followed prospectively with blood tests up to 24 months. DXA scans were performed at baseline and 24 months. No difference was observed between the two treatment groups at baseline, with regard to anthropometry and standard biochemistry. Markers of bone turnover (p-PINP, p-CTX, p-bone-specific alkaline phosphatase and p-osteocalcin) all showed significant suppression compared to baseline and remained suppressed throughout the 2 years. BMD showed small and significant increases at the spine (0.024 g/cm²) and total hip (0.019 g/cm²) in the denosumab group but no change at the femoral neck(–0.011g/cm²). In the ZA group, we observed no significant change at the spine (0.015 g/cm²) and total hip (–0.001g/cm²) and a small significant decrease at the femoral neck (–0.037 g/cm²). However, when we compared BMD change between the treatment groups, we found no significant difference.

Conclusions: Our data indicate that for BC patients in AI treatment who refused or were not able to receive ZA treatment, denosumab might be recommended as a second choice. Regarding markers of bone turnover and BMD denosumab is equal to ZA.

Summary: Women with early breast cancer receiving anti-estrogen treatment are at risk of developing osteoporosis.

We followed 194 women receiving zoledronic acid (ZA) or denosumab for up to 2 years.

We find that with regard to bone protection, denosumab is a viable alternative to ZA and might be recommended as a second choice

摘要

对患有早期乳腺癌 (BC) 的绝经后妇女的辅助治疗包括芳香酶抑制剂 (AI)，已知可降低骨矿物质密度 (BMD)。在这项研究中，我们调查狄诺塞麦是否是无法接受标准佐剂 iv 唑来膦酸 (ZA) 的患者的有效第二选择。总共有 212 名患者在未接受 ZA 后接受了评估。其中包括 194 个。经内分泌专家评估后，所有患者均被提供 ZA 作为首选，15% 的患者接受（N  = 29）。剩余的 85% 提供了地诺塞麦（N = 165)。所有患者都进行了长达 24 个月的血液检查。在基线和 24 个月时进行 DXA 扫描。在人体测量学和标准生化方面，基线时两个治疗组之间没有观察到差异。与基线相比，骨转换标志物（p-PINP、p-CTX、p-骨特异性碱性磷酸酶和 p-骨钙素）均显示出显着抑制，并在 2 年内保持抑制。^{在狄诺塞麦组中，脊柱 (0.024 g/cm 2} ) 和全髋 (0.019 g/cm ² ) 的BMD 显示小而显着的增加，但股骨颈没有变化 (–0.011g/cm ² )。在 ZA 组中，我们观察到脊柱 (0.015 g/cm ² ) 和全髋 (–0.001g/cm )没有显着变化² ) 和股骨颈的小幅显着下降 (–0.037 g/cm ² )。然而，当我们比较治疗组之间的 BMD 变化时，我们发现没有显着差异。

结论：我们的数据表明，对于拒绝或无法接受 ZA 治疗的接受 AI 治疗的 BC 患者，狄诺塞麦可能被推荐为第二选择。关于骨转换和 BMD 的标志物，狄诺塞麦等于 ZA。

摘要：接受抗雌激素治疗的早期乳腺癌女性有患骨质疏松症的风险。

我们跟踪了 194 名接受唑来膦酸 (ZA) 或地诺单抗长达 2 年的女性。

我们发现在骨骼保护方面，地诺单抗是 ZA 的可行替代品，可能会被推荐为第二选择