Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases
Efficacy of pamidronate in reducing skeletal complications in patients with breast cancer and lytic bone metastases
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DOI：
10.1056/nejm199612123352401
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发表时间：
1996-12-12
影响因子：
158.5
通讯作者：
Reitsma, DJ
中科院分区：
文献类型：
--
作者：
Hortobagyi, GN;Theriault, RL;Reitsma, DJ
背景双膦酸盐，如帕米膦酸二钠抑制破骨细胞诱导的骨吸收与癌症，已转移到bone.Methods妇女与第四阶段乳腺癌谁正在接受细胞毒性化疗，并至少有一个溶骨性病变给予安慰剂或帕米膦酸二钠（90毫克）作为两个小时静脉输注每月12个周期。每月评估一次骨骼并发症，包括病理性骨折、骨放射或骨手术的需要、脊髓压迫和高钙血症（血清钙浓度高于12 mg/dl [3.0 mmol/L]或升高到任何程度并需要治疗）。骨痛，使用止痛药，性能状态，和生活质量进行了评估，在整个trial.Results的治疗效果进行了评估，在380 382例随机患者，185接受帕米膦酸二钠和195接受安慰剂。帕米膦酸二钠组发生首次骨骼并发症的中位时间长于安慰剂组（13.1个月vs. 7.0个月，P=0.005），发生任何骨骼并发症的患者比例较低（43% vs. 56%，P=0.008）。与安慰剂组相比，帕米膦酸二钠组的骨痛增加（P=0.046）和体力状态恶化（P=0.027）明显较少。帕米膦酸二钠耐受良好。结论帕米膦酸二钠作为化疗的补充，每月输注可以防止骨骼并发症的妇女IV期乳腺癌溶骨性骨转移。(C)1996年，马萨诸塞州医学会。
Background Bisphosphonates such as pamidronate disodium inhibit osteoclast-induced bone resorption associated with cancer that has metastasized to bone.Methods Women with stage IV breast cancer who were receiving cytotoxic chemotherapy and had at least one lytic bone lesion were given either placebo or pamidronate (90 mg) as a two-hour intravenous infusion monthly for 12 cycles. Skeletal complications, including pathologic fractures, the need for radiation to bone or bone surgery, spinal cord compression, and hypercalcemia (a serum calcium concentration above 12 mg per deciliter [3.0 mmol per liter] or elevated to any degree and requiring treatment), were assessed monthly. Bone pain, use of analgesic drugs, performance status, and quality of life were assessed throughout the trial.Results The efficacy of treatment was evaluated in 380 of 382 randomized patients, 185 receiving pamidronate and 195 receiving placebo. The median time to the occurrence of the first skeletal complication was greater in the pamidronate group than in the placebo group (13.1 vs. 7.0 months, P=0.005), and the proportion of patients in whom any skeletal complication occurred was lower (43 percent vs. 56 percent, P=0.008). There was significantly less increase in bone pain (P=0.046) and deterioration of performance status (P=0.027) in the pamidronate group than in the placebo group. Pamidronate was well tolerated.Conclusions Monthly infusions of pamidronate as a supplement to chemotherapy can protect against skeletal complications in women with stage IV breast cancer who have osteolytic bone metastases. (C) 1996, Massachusetts Medical Society.