Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Department of Biostatistics, University of Michigan, Ann Arbor, MI, USA.
Oncologist. 2022 Jul 5;27(7):595-599. doi: 10.1093/oncolo/oyac066.
Denosumab is an effective treatment for giant cell tumor of the bone (GCTB) but can cause clinically significant adverse effects. Current approved dosing is every 4 weeks after 3 weekly loading doses. We assessed whether alternative, longer dosing intervals are associated with differences in efficacy or bone toxicity.
Single institution retrospective chart review was conducted on patients with GCTB over 18 years old who received at least 1 year of standard denosumab dosing. Patients identified using a free-text search engine with keywords "giant cell tumor" and "denosumab" from January 1998 to August 2020.
Approximately 37 patients with GCTB (19F, 18M) were identified with median age of 37 years (range 22-73). Dosing interval was increased in 38% (n = 14), with the most common final dosing interval 12 weeks (n = 8). Six patients (16%) had bone complications: osteonecrosis of the jaw (n =5), atypical fracture (n = 1), and nonhealing dental wounds (n = 2). All patients with bone complications were on the monthly dosing schedule, but there was no statistically significant difference compared to longer dosing intervals (P = .22). No statistically significant difference in median PFS was noted (P = .97). However, 5-year PFS was superior in patients treated with less frequent versus standard dosing of denosumab (P = .036).
Increasing the interval of denosumab dosing for GCTB provided similar tumor control compared to standard dosing and lower absolute number of bone toxicity events. Larger studies are needed to better define the optimal interval of denosumab administration and the effect on efficacy, toxicity, and associated healthcare expense.
地舒单抗是治疗骨巨细胞瘤(GCTB)的有效药物,但会引起明显的临床不良反应。目前批准的剂量方案是每 4 周使用 3 次负荷剂量后开始使用。我们评估了不同的延长剂量间隔是否与疗效或骨毒性的差异相关。
对在我院接受地舒单抗治疗且治疗时间至少 1 年的 18 岁以上 GCTB 患者进行了回顾性单中心病历分析。我们使用关键词“giant cell tumor”和“denosumab”在医院病历系统中进行了检索,检索时间从 1998 年 1 月至 2020 年 8 月。
共纳入了 37 名 GCTB 患者(19 名女性,18 名男性),中位年龄为 37 岁(范围 22-73 岁)。38%(n=14)的患者增加了地舒单抗的给药间隔,最常见的最终给药间隔为 12 周(n=8)。6 名患者(16%)出现了骨并发症:下颌骨坏死(n=5)、非典型骨折(n=1)和未愈合的牙科伤口(n=2)。所有发生骨并发症的患者都接受了每月一次的剂量方案,但与延长的剂量间隔相比,差异没有统计学意义(P=0.22)。中位无进展生存期(PFS)无显著差异(P=0.97)。然而,与标准剂量方案相比,接受地舒单抗较少剂量治疗的患者 5 年 PFS 更高(P=0.036)。
对于 GCTB,增加地舒单抗的给药间隔与标准剂量方案相比可提供相似的肿瘤控制效果,且发生骨毒性事件的绝对数量更少。需要更大规模的研究来更好地确定地舒单抗给药的最佳间隔以及对疗效、毒性和相关医疗费用的影响。