High-dose therapy and autologous blood stem-cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: Long-term results of a randomized control trial from the group myelome-autogreffe
High-dose therapy and autologous blood stem-cell transplantation compared with conventional treatment in myeloma patients aged 55 to 65 years: Long-term results of a randomized control trial from the group myelome-autogreffe
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DOI：
10.1200/jco.2005.03.0551
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发表时间：
2005-12-20
影响因子：
45.3
通讯作者：
Ravaud, P
中科院分区：
文献类型：
--
作者：
Fermand, J;Katsahian, S;Ravaud, P
目的：研究自体干细胞支持的大剂量治疗（HDT）对年龄在55 - 65岁之间的有症状多发性骨髓瘤（MM）患者的影响。患者和方法：190例年龄在55 - 65岁之间的新诊断的II期或III期MM患者被随机分配接受常规化疗或常规化疗。（CCT;即长春新碱、美法仑、环磷酰胺和强的松）或HDT和自体造血干细胞移植（移植前细胞减灭术使用美法仑200 mg/m2静脉注射或美法仑140 mg/m2静脉注射加白消安16 mg/kg口服）结果：在中位随访120个月内，HDT和CCT组的中位无事件生存（EFS）时间分别为25和19个月。HDT组的中位总生存期（OS）为47.8个月，而CCT组为47.6个月。观察到更好的EFS趋势（P = .07）有利于HDT，而OS曲线无统计学差异（P = .91）。HDT患者的无症状、无治疗和无治疗毒性的时间（TwiSTT）显著长于CCT患者结论：中位随访时间约为10年，这项随机试验证实了HDT在EFS和TwiSTT方面的益处，但没有提供HDT在55至65岁患者OS方面优于CCT的证据年有症状的新诊断MM。
Purpose: To study the impact of high-dose therapy (HDT) with autologous stem-cell support in patients with symptomatic multiple myeloma (MM) between the ages of 55 and 65 years.Patients and Methods: One hundred ninety patients between 55 and 65 years old who had newly diagnosed stage II or III MM were randomly assigned to receive either conventional chemotherapy (CCT; ie, monthly courses of a regimen of vincristine, melphalan, cyclophosphamide, and prednisone) or HDT and autologous blood stem-cell transplantation (using either melphalan alone 200 mg/m(2) intravenous [IV] or melphalan 140 mg/m(2) IV plus busulfan 16 mg/kg orally as pretransplantation cytoreduction).Results: Within a median follow-up of 120 months, median event-free survival (EFS) times were 25 and 19 months in the HDT and CCT groups, respectively. Median overall survival (OS) time was 47.8 months in the HDT group compared with 47.6 months in the CCT group. A trend to better EFS (P = .07) was observed in favor of HDT, whereas OS curves were not statistically different (P = .91). The period of time without symptoms, treatment, and treatment toxicity (TwiSTT) was significantly longer for the HDT patients than for the CCT patients (P = .03).Conclusion: With a median follow-up time of approximately 10 years, this randomized trial confirmed a benefit of HDT in terms of EFS and TwiSTT but did not provide evidence for superiority of HDT over CCT in OS of patients aged 55 to 65 years with symptomatic newly diagnosed MM.