Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. Protocol 18 Aredia Breast Cancer Study Group.
Pamidronate reduces skeletal morbidity in women with advanced breast cancer and lytic bone lesions: a randomized, placebo-controlled trial. Protocol 18 Aredia Breast Cancer Study Group.
复制标题
帕米膦酸钠可降低患有晚期乳腺癌和溶骨性病变的女性的骨骼发病率：一项随机、安慰剂对照试验。
DOI：
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发表时间：
1999
影响因子：
45.3
通讯作者：
D. Reitsma
中科院分区：
文献类型：
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作者：
R. Theriault;A. Lipton;G. Hortobagyi;R. Leff;S. Glück;J. Stewart;Sean Costello;I. Kennedy;Joseph F. Simeone;J. Seaman;Robert K. Knight;K. Mellars;M. Heffernan;D. Reitsma
目的
评估帕米膦酸二钠是否可以降低接受激素治疗的乳腺癌溶骨性转移妇女的骨骼发病率。
患者和方法
372名患有乳腺癌的妇女，她们至少有一处溶骨性病变，正在接受激素治疗，随机接受90 mg帕米膦酸盐或安慰剂，以双盲方式每4周静脉输注2小时，共24个周期。评估患者的骨骼并发症：病理性骨折、脊髓压迫、骨照射或骨手术或高钙血症。骨骼发病率（骨骼并发症数量与试验时间的比值）是主要疗效变量。还对骨痛、镇痛药的使用、生活质量、体能状态、骨肿瘤反应和生化参数进行了评价。
结果
182名接受帕米膦酸盐治疗的患者和189名接受安慰剂治疗的患者可进行评估。在接受90 mg帕米膦酸盐治疗的患者中，骨骼发病率在第12、18和24个周期显著降低（分别为P = 0.028、0.023和0.008）。在24个周期时，帕米膦酸盐组有任何骨骼并发症的患者比例为56%，安慰剂组为67%（P = 0.027）。接受帕米膦酸二钠治疗的患者首次出现骨骼并发症的时间长于接受安慰剂治疗的患者（P = 0.049）。在生存率或客观骨反应率方面没有统计学差异。帕米膦酸二钠耐受性良好。
结论
在激素治疗的基础上，每4周静脉输注90 mg帕米膦酸二钠2小时，可显著降低溶骨性转移瘤的骨骼发病率。
PURPOSE
To assess whether pamidronate can reduce the frequency of skeletal morbidity in women with lytic bone metastases from breast cancer treated with hormone therapy.
PATIENTS AND METHODS
Three hundred seventy-two women with breast cancer who had at least one lytic bone lesion and who were receiving hormonal therapy were randomized to receive 90 mg of pamidronate or placebo as a 2-hour intravenous infusion given in double-blind fashion every 4 weeks for 24 cycles. Patients were evaluated for skeletal complications: pathologic fractures, spinal cord compression, irradiation of or surgery on bone, or hypercalcemia. The skeletal morbidity rate (the ratio of the number of skeletal complications to the time on trial) was the primary efficacy variable. Bone pain, use of analgesics, quality of life, performance status, bone tumor response, and biochemical parameters were also evaluated.
RESULTS
One hundred eighty-two patients who received pamidronate and 189 who received placebo were assessable. The skeletal morbidity rate was significantly reduced at 12, 18, and 24 cycles in patients treated with 90 mg of pamidronate (P = .028, .023, and .008, respectively). At 24 cycles, the proportion of patients having had any skeletal complication was 56% in the pamidronate group and 67% in the placebo group (P = .027). The time to the first skeletal complication was longer for patients receiving pamidronate than for those given placebo (P = .049). There was no statistical difference in survival or in objective bone response rate. Pamidronate was well tolerated.
CONCLUSION
Treatment with 90 mg of pamidronate as a 2-hour intravenous infusion every 4 weeks in addition to hormonal therapy significantly reduces skeletal morbidity from osteolytic metastases.