Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group.
Long-term pamidronate treatment of advanced multiple myeloma patients reduces skeletal events. Myeloma Aredia Study Group.
复制标题
晚期多发性骨髓瘤患者的长期帕米膦酸钠治疗可减少骨骼事件。
DOI：
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发表时间：
1998
影响因子：
45.3
通讯作者：
R. Knight
中科院分区：
文献类型：
--
作者：
J. Berenson;A. Lichtenstein;L. Porter;M. Dimopoulos;R. Bordoni;S. George;A. Lipton;A. Keller;O. Ballester;M. Kovacs;H. Blacklock;R. Bell;J. Simeone;D. Reitsma;M. Heffernan;J. Seaman;R. Knight
目的
确定帕米膦酸二钠治疗晚期多发性骨髓瘤患者的21个月周期的疗效和安全性。
患者和方法
患有III期骨髓瘤和至少一处溶解性病变的患者接受安慰剂或帕米膦酸盐90 mg静脉给药，每月4小时输注，共21个周期。在进入研究时，根据患者是否接受一线（第1层）或二线（第2层）抗骨髓瘤化疗对患者进行分层。每月评估骨骼事件（病理性骨折、骨骼放疗或手术以及脊髓压迫）和高钙血症。
结果
将先前报道的前9个循环的结果扩展到21个循环。在392名随机化患者中，198名接受帕米膦酸盐治疗的患者和179名接受安慰剂治疗的患者可以评估疗效。21个周期后，帕米膦酸盐组发生任何骨骼事件的患者比例较低（P = 0.015）。帕米膦酸二钠组每年骨骼事件的平均数（1.3）低于安慰剂组（2.2; P = 0.008）。虽然帕米膦酸二钠治疗组和安慰剂组患者的总体生存期没有差异，但接受帕米膦酸二钠治疗的第2层患者比接受安慰剂治疗的患者生存时间更长（14 vs 21个月，P = 0.041）。在21个周期的治疗中，帕米膦酸二钠是安全的，耐受性良好。
结论
长期每月输注帕米膦酸二钠作为化疗的辅助治疗在减少III期多发性骨髓瘤患者骨骼事件方面上级单独化疗，并可能改善接受挽救治疗的患者的生存率。
PURPOSE
To determine the efficacy and safety of 21 monthly cycles of pamidronate therapy in patients with advanced multiple myeloma.
PATIENTS AND METHODS
Patients with stage III myeloma and at least one lytic lesion received either placebo or pamidronate 90 mg intravenously administered as a 4-hour infusion monthly for 21 cycles. At study entry, the patients were stratified according to whether they were to receive first-line (stratum 1) or second-line (stratum 2) antimyeloma chemotherapy. Skeletal events (pathologic fracture, radiation or surgery to bone, and spinal cord compression) and hypercalcemia were assessed monthly.
RESULTS
The results of the first nine previously reported cycles are extended to 21 cycles. Of the 392 randomized patients, efficacy could be evaluated in 198 who received pamidronate and 179 who received placebo. After 21 cycles, the proportion of patients who developed any skeletal event was lower in the pamidronate-group (P = .015). The mean number of skeletal events per year was less in the pamidronate-group (1.3) than in placebo-treated patients (2.2; P = .008). Although survival was not different between the pamidronate-treated group and placebo patients overall, stratum 2 patients who received pamidronate lived longer than those who received placebo (14 v 21 months, P = .041). Pamidronate was safe and well tolerated during the 21 cycles of therapy.
CONCLUSION
Long-term monthly infusions of pamidronate as an adjunct to chemotherapy are superior to chemotherapy alone in reducing skeletal events in stage III multiple myeloma patients, and may improve the survival of patients on salvage therapy.
影响因子：
11.2
作者：
Akira Sasaki;Brendan F. Boyce;B. Story;Kenneth R. Wright;Mark Chapman;Rogely Boyce;G. R. Mundy;Toshiyuki Yoneda
通讯作者：
Akira Sasaki;Brendan F. Boyce;B. Story;Kenneth R. Wright;Mark Chapman;Rogely Boyce;G. R. Mundy;Toshiyuki Yoneda
影响因子：
4
作者：
G. Mundy;D. Bertolini
通讯作者：
G. Mundy;D. Bertolini