Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate
Long-term prevention of skeletal complications of metastatic breast cancer with pamidronate
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DOI：
10.1200/jco.1998.16.6.2038
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发表时间：
1998-06-01
影响因子：
45.3
通讯作者：
Reitsma, DJ
中科院分区：
文献类型：
--
作者：
Hortobagyi, GN;Theriault, RL;Reitsma, DJ
目的：帕米膦酸盐是一种氨基二膦酸盐，已被证明可降低接受化疗的IV期乳腺癌女性中与溶骨性病变相关的骨骼并发症风险长达1年。我们研究了长期的有效性和安全性，继续治疗与静脉注射帕米膦酸盐输注长达2 years.Patients和方法：三百八十二名妇女转移性乳腺癌和溶骨性病变谁接受化疗被随机分配到接受90毫克的帕米膦酸盐或安慰剂静脉注射，每3至4周在这个双盲，多中心，平行组试验。每月对患者的骨骼并发症进行评估，持续2年，其中包括病理性骨折，需要放疗或手术治疗骨骼并发症，脊髓压迫和高钙血症。骨痛，止痛剂的使用，骨生化标志物，性能状态，生活质量，放射学反应在骨，和survival.Results：在治疗的第一年，任何骨骼并发症的患者比例是显着低于帕米膦酸盐组比安慰剂组在15，18，21，24个月（P <0.001）。与安慰剂组相比，帕米膦酸二钠组发生任何病理性骨折（即椎骨和非椎骨骨折）、需要放疗或手术治疗骨并发症以及高钙血症的患者比例在统计学上也较低。帕米膦酸二钠组首次出现骨骼并发症的中位时间为13.9个月，安慰剂组为7.0个月（P <0.001）。结论：帕米膦酸二钠90 mg/月可显著降低转移性乳腺癌溶骨性病变并发症的发生率，且这种作用可维持至少2年，帕米膦酸二钠是转移性乳腺癌姑息治疗中标准化疗的有效辅助药物。
Purpose: Pamidronate, an aminabisphosphonate, has been shown to lower the risk of skeletal complications associated with lytic bone lesions for up to 1 year in women with stage IV breast cancer who received chemotherapy. We studied the long-term effectiveness and safety of continued treatment with intravenous pamidronate infusions for up to 2 years.Patients and Methods: Three hundred eighty-two women with metastatic breast cancer and lytic bone lesions who received chemotherapy were randomly assigned to receive either 90 mg of pamidronate or placebo intravenously every 3 to 4 weeks in this double-blind, multicenter, parallel-group trial. Patients were evaluated monthly for 2 years for skeletal complications, which included pathologic fractures, need for radiation or surgery to treat bone complications, spinal cord compression, and hypercalcemia. Bone pain, analgesic use, bone biochemical markers, performance status, quality of life, radiologic response in bone, and survival were also evaluated.Results: As in the first year of treatment, the proportion of patients with any skeletal complication was significantly less for the pamidronate than the placebo group at 15, 18, 21, and 24 months (P < .001). The proportions of patients with any pathologic fracture (ie, vertebral and nonvertebral fractures), need for radiation or surgery to treat bone complications, and hypercalcemia were also statistically less for the pamidronate than the placebo group, The median time to the first skeletal complication was 13.9 months in the pamidronate-treated women and 7.0 months in the placebo group (P < .001). Long term treatment did not result in any unexpected adverse events, Survival did not differ between the two groups.Conclusion: The risk for osteolytic bone lesion complications in metastatic breast cancer was significantly decreased with monthly infusions of 90 mg of pamidronate, and this effect wets maintained for at least 2 years, Pamidronate is a useful adjunct to standard chemotherapy in the palliative treatment of metastatic breast cancer.