Rotondi Angelachiara, Frescura Valentina, Arcuri Giorgia, Garufi Giovanna, Pontolillo Letizia, Mastrantoni Luca, Di Monte Elena, Maliziola Noemi, Fucile Maria Antonia, Salvatori Francesca, Mondello Rita, Poli Ilaria, Oliva Gaia Rachele, Mongelli Ginevra, Palazzo Antonella, Fabi Alessandra, Bria Emilio, Tortora Giampaolo, Orlandi Armando
Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, 00168 Rome, Italy.
Dipartimento di Medicina e Chirurgia Traslazionale, Università Cattolica del Sacro Cuore, 00168 Rome, Italy.
Curr Oncol. 2025 Jul 26;32(8):421. doi: 10.3390/curroncol32080421.
Adjuvant endocrine therapy for early breast cancer significantly reduces recurrence but increases bone fragility. Given limited data on denosumab (60 mg every 6 months) in premenopausal patients receiving endocrine therapy for early breast cancer, we conducted a retrospective real-world study at the Gemelli Hospital (September 2018-January 2025). A descriptive analysis was performed. The primary endpoint was to assess efficacy, evaluated by changes in bone mineral density via dual-energy X-ray absorptiometry and by monitoring bone turnover markers, particularly serum C-terminal telopeptide of type I collagen. Safety was evaluated based on adverse endocrine therapy events (osteoporotic fractures) and adverse denosumab events (osteonecrosis of the jaw). Sixty-nine patients were eligible for the study. Endocrine therapy included ovarian function suppression with exemestane (89.8%) or tamoxifen (10.1%). Baseline spinal osteoporosis decreased from 20.3% to 5.8%, osteopenia from 39.1% to 34.8%, with normal T-scores rising from 17.4% to 34.8%. Femoral improvements were similar. Serum C-terminal telopeptide of type I collagen levels (evaluated in 35.8%) showed stable reduction in 97%. Denosumab adherence was 89.9%. One osteonecrosis of the jaw case occurred (1.4%); no fractures were reported. Denosumab demonstrated efficacy in improving bone density and reducing bone turnover, with excellent adherence and favorable safety. Longer follow-up is needed to assess post-discontinuation effects.
早期乳腺癌的辅助内分泌治疗可显著降低复发率，但会增加骨质脆弱性。鉴于关于地诺单抗（每6个月60毫克）在接受早期乳腺癌内分泌治疗的绝经前患者中的数据有限，我们在杰梅利医院（2018年9月至2025年1月）进行了一项回顾性真实世界研究。进行了描述性分析。主要终点是评估疗效，通过双能X线吸收法测量骨矿物质密度变化以及监测骨转换标志物，特别是血清I型胶原C端肽来评估。基于内分泌治疗不良事件（骨质疏松性骨折）和地诺单抗不良事件（颌骨坏死）评估安全性。69名患者符合研究条件。内分泌治疗包括使用依西美坦（89.8%）或他莫昔芬（10.1%）抑制卵巢功能。基线时脊柱骨质疏松症从20.3%降至5.8%，骨质减少从39.1%降至34.8%，T值正常者从17.4%升至34.8%。股骨的改善情况类似。血清I型胶原C端肽水平（在35.8%的患者中进行评估）显示97%稳定下降。地诺单抗依从性为89.9%。发生1例颌骨坏死（1.4%）；未报告骨折。地诺单抗在改善骨密度和降低骨转换方面显示出疗效，依从性良好且安全性良好。需要更长时间的随访来评估停药后的影响。
