Department of Internal Medicine, Division of Pulmonary, Allergy, and Sleep Medicine, HELIOS Clinic Wuppertal, 163483Witten/Herdecke University, Witten, Germany.
Cancer Control. 2020 Jul-Aug;27(3):1073274820934822. doi: 10.1177/1073274820934822.
Denosumab is a human monoclonal antibody that has been used successfully in the treatment of giant cell tumors of bone. These tumors are rare and, in principle, benign, but they are highly aggressive, locally advanced, osteolytic bone tumors that can metastasize to the lungs. Denosumab is an effective treatment when these tumors cannot be surgically removed or when surgical resection is likely to lead to severe morbidity (eg, loss of limbs or joints). The aim of this systematic review and meta-analysis was to investigate patients with giant cell tumors of bone who experienced tumor progression during treatment with denosumab and to compare them with patients who experienced reduction of their giant cell tumors of bone during treatment with denosumab.
Embase, Cochrane Library, and MEDLINE/PubMed databases were searched for trials submitted by January 7, 2020, that reported the efficacy and safety of denosumab in patients with giant cell tumors of bone.
Sixty studies were reviewed, involving a total of 1074 patients who had giant cell tumors of bone and were treated with denosumab. Of the 60 studies, 58% of the patients were from case series studies, 39% from open-label phase II studies, and 3% from case reports. The response rate for denosumab as a treatment for giant cell tumors of bone was 97.5%, with statistical significance ( < .0001). Pain in the limbs was statistically the most common adverse event for denosumab treatment in case series studies ( < .0001). No treatment-related deaths occurred in the reviewed studies.
Cumulative evidence supports the addition of surgery to optimal medical therapy with denosumab to reduce tumor size, clinical symptoms, and mortality among patients with giant cell tumors of bone.
地舒单抗是一种人源化单克隆抗体，已成功用于治疗骨巨细胞瘤。这些肿瘤罕见，原则上为良性，但具有侵袭性，为局部晚期、溶骨性骨肿瘤，可转移至肺部。当这些肿瘤无法手术切除，或手术切除可能导致严重发病率（如肢体或关节丧失）时，地舒单抗是一种有效的治疗方法。本系统评价和荟萃分析的目的是研究接受地舒单抗治疗的骨巨细胞瘤患者发生肿瘤进展的情况，并将其与接受地舒单抗治疗后骨巨细胞瘤缩小的患者进行比较。
检索了截至 2020 年 1 月 7 日提交的临床试验，这些试验报告了地舒单抗治疗骨巨细胞瘤患者的疗效和安全性，数据库包括 Embase、Cochrane 图书馆和 MEDLINE/PubMed。
共 60 项研究被审查，共纳入 1074 例接受地舒单抗治疗的骨巨细胞瘤患者。60 项研究中，58%的患者来自病例系列研究，39%来自开放标签二期研究，3%来自病例报告。地舒单抗治疗骨巨细胞瘤的缓解率为 97.5%，具有统计学意义（<0.0001）。在病例系列研究中，肢体疼痛是地舒单抗治疗最常见的不良事件（<0.0001）。在审查的研究中，没有发生与治疗相关的死亡。
累积证据支持将手术与地舒单抗最佳药物治疗联合应用，以降低骨巨细胞瘤患者的肿瘤大小、临床症状和死亡率。
