Division of Cancer Medicine, Department of Sarcoma Medical Oncology and Lymphoma/Myeloma, Section of Cytokines and Supportive Oncology, The University of Texas MD Anderson Cancer Center, Houston, USA.
Department of Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.
Ann Oncol. 2012 Dec;23(12):3045-3051. doi: 10.1093/annonc/mds175. Epub 2012 Jul 31.
Patients with metastatic bone disease are living longer in the metastatic stage due to improvements in cancer therapy, making strategies to prevent the aggravation of bone disease and its complications, such as skeletal-related events (SREs) and pain, increasingly important.
In this phase 3 trial in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma, denosumab reduced the risk of radiation to bone by 22% relative to zoledronic acid (P = 0.026), prevented worsening of pain and pain interference (2-point increase in Brief Pain Inventory score; P < 0.05 versus zoledronic acid), and reduced the frequency of a shift from no/weak opioid analgesic use to strong opioids (P < 0.05 versus zoledronic acid at months 3-5). Denosumab delayed the time to moderate-to-severe pain compared with zoledronic acid in patients with mild or no pain at the baseline (P = 0.04), supporting early treatment. Health-related quality-of-life scores were similar in both groups. The number needed to treat to avoid one SRE for denosumab was 3 patient-years versus placebo and 10 patient-years versus zoledronic acid.
The use of denosumab was associated with better prevention of the complications of metastatic bone disease secondary to solid tumors or multiple myeloma versus zoledronic acid.
由于癌症治疗的进步，患有转移性骨病的患者在转移性阶段的存活时间更长，因此制定策略来预防骨病及其并发症（如骨骼相关事件[SRE]和疼痛）的恶化变得越来越重要。
在这项针对晚期癌症（不包括乳腺癌和前列腺癌）或多发性骨髓瘤患者的 3 期试验中，与唑来膦酸相比，地舒单抗降低了 22%的放射性骨风险（P=0.026），预防了疼痛和疼痛干扰的恶化（Brief Pain Inventory 评分增加 2 分；P<0.05 与唑来膦酸相比），并减少了从无/弱阿片类镇痛药转为强阿片类药物的频率（P<0.05 与唑来膦酸在 3-5 个月时相比）。与唑来膦酸相比，地舒单抗在基线时轻度或无疼痛的患者中延迟了中度至重度疼痛的时间（P=0.04），支持早期治疗。两组患者的健康相关生活质量评分相似。与安慰剂相比，地舒单抗避免一次 SRE 所需的治疗人数为 3 患者年，而与唑来膦酸相比则为 10 患者年。
与唑来膦酸相比，地舒单抗的使用与更好地预防实体瘤或多发性骨髓瘤引起的转移性骨病的并发症相关。
