Bortezomib, thalidomide and dexamethasone, with or without cyclophosphamide, for patients with previously untreated multiple myeloma: 5-year follow-up
Bortezomib, thalidomide and dexamethasone, with or without cyclophosphamide, for patients with previously untreated multiple myeloma: 5-year follow-up
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DOI：
10.1111/bjh.13582
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发表时间：
2015-11-01
影响因子：
6.5
通讯作者：
Viterbo, Luisa
中科院分区：
文献类型：
--
作者：
Ludwig, Heinz;Greil, Richard;Viterbo, Luisa
这项随机II期研究的随访扩展评估了硼替佐米-沙利度胺-地塞米松（VTD）和VTD-环磷酰胺（VTDC）诱导治疗多发性骨髓瘤的长期结局差异。新诊断的患者（n = 98）随机分为1:1组，静脉注射硼替佐米(1.3 mg/m(2)；第1、4、8、11天)，沙利度胺（100 mg，第1-21天）和地塞米松（40 mg，第1-4、9-12天），加/不加环磷酰胺（400 mg/m，第2天）；第1,8天)，在干细胞动员/移植前进行4个21天周期。中位随访64.8个月后，VTD和VTDC的中位治疗时间分别为51.8个月和47.9个月。两组后续治疗类型相似。在调整不对称审查后，VTD和VTDC的中位进展时间无显著差异[35.7个月对34.5个月；风险比（HR） 1.26, 95%可信区间：0.76-2.09；P = 0.370]。VTD和VTDC的5年生存率分别为69.1%和65.3%。当通过最小残留病（MRD）状态进行分析时，MRD阴性患者的总生存期比骨髓证实完全缓解的MRD阳性患者更长（HR 3.66, P = 0(0)318）。VTD诱导后移植提供了长期的疾病控制，并且与初步分析一致，添加环磷酰胺没有额外的益处。该研究已在ClinicalTrials.gov注册（NCT00531453）。
This follow-up extension of a randomised phase II study assessed differences in long-term outcomes between bortezomib-thalidomide-dexamethasone (VTD) and VTD-cyclophosphamide (VTDC) induction therapy in multiple myeloma. Newly diagnosed patients (n = 98) were randomised 1: 1 to intravenous bortezomib (1.3 mg/m(2); days 1, 4, 8, 11), thalidomide (100 mg; days 1-21), and dexamethasone (40 mg; days 1-4, 9-12), with/without cyclophosphamide (400 mg/m(2); days 1, 8), for four 21-day cycles before stem-cell mobilisation/transplantation. After a median follow-up of 64.8 months, median time-to-next therapy was 51.8 and 47.9 months with VTD and VTDC, respectively. Type of subsequent therapy was similar in both arms. After adjusting for asymmetric censoring, median time to progression was not significantly different between VTD and VTDC [35.7 vs. 34.5 months; Hazard ratio (HR) 1.26, 95% confidence interval: 0.76-2.09; P = 0.370]. Five-year survival was 69.1% and 65.3% with VTD and VTDC, respectively. When analysed by minimal residual disease (MRD) status, overall survival was longer in MRD-negative versus MRD-positive patients with bone marrow-confirmed complete response (HR 3.66, P = 0.(0)318). VTD induction followed by transplantation provides long-term disease control and, consistent with the primary analysis, there is no additional benefit from adding cyclophosphamide. This study was registered at ClinicalTrials.gov (NCT00531453).