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首页> 外文期刊>Blood: The Journal of the American Society of Hematology >Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment.
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Safety and efficacy of bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide maintenance (VMPT-VT) versus bortezomib-melphalan-prednisone (VMP) in untreated multiple myeloma patients with renal impairment.

机译：硼替佐米-美法仑-泼尼松-沙利度胺联合硼替佐米-沙利度胺维持（VMPT-VT）与硼替佐米-美法仑-泼尼松（VMP）在未经治疗的多发性骨髓瘤肾功能不全患者中的安全性和有效性。

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We assessed efficacy, safety, and reversal of renal impairment (RI) in untreated patients with multiple myeloma given bortezomib-melphalan-prednisone-thalidomide followed by bortezomib-thalidomide (VMPT-VT) maintenance or bortezomib-melphalan-prednisone (VMP). Exclusion criteria included serum creatinine >/= 2.5 mg/dL. In the VMPT-VT/VMP arms, severe RI (estimated glomerular filtration rate [eGFR] 50 mL/min), were 6%/7.9%, 24.1%/24.9%, and 69.8%/67.2%, respectively. Statistically significant improvements in overall response rates and progression-free survival were observed in VMPT-VT versus VMP arms across renal cohorts, except in severe RI patients. In the VMPT group, severe RI reduced overall survival (OS). RI was reversed in 16/63 (25.4%) patients receiving VMPT-VT versus 31/77 (40.3%) receiving VMP. Multivariate analysis showed male sex (P = .022) and moderate RI (P = .003) significantly predicted RI recovery. VMP patients achieving renal response showed longer OS. In both arms, greater rates of severe hematologic adverse events were associated with RI (eGFR < 50 mL/min), however, therapy discontinuation rates were unaffected. VMPT-VT was superior to VMP for cases with normal renal function and moderate RI, whereas VMPT-VT failed to outperform VMP in patients with severe RI, although the relatively low number of cases analyzed preclude drawing definitive conclusions. VMPT-VT had no advantage in terms of RI reversal over VMP.
机译：我们评估了未经治疗的多发性骨髓瘤患者接受硼替佐米-美法仑-泼尼松-沙利度胺治疗后再进行硼替佐米-沙利度胺（VMPT-VT）维持或硼替佐米-美法仑-泼尼松（VMP）的疗效，安全性和肾损害的逆转。排除标准包括血清肌酐> / = 2.5 mg / dL。在VMPT-VT / VMP臂中，严重RI（估计的肾小球滤过率[eGFR] 50 mL /分钟）分别为6％/ 7.9％，24.1％/ 24.9％和69.8％/ 67.2％。除严重的RI患者外，在整个肾脏队列中，VMPT-VT相对于VMP组的总体缓解率和无进展生存期均具有统计学上的显着改善。在VMPT组中，严重的RI降低了总生存期（OS）。在接受VMPT-VT的16/63（25.4％）患者中，RI逆转，而接受VMP的31/77（40.3％）患者则相反。多变量分析显示，男性（P = .022）和中度RI（P = .003）显着预测了RI的恢复。达到肾脏反应的VMP患者表现出更长的OS。在两组中，严重血液学不良事件的发生率与RI相关（eGFR <50 mL / min），但是治疗中止率不受影响。对于肾功能正常和中度RI的患者，VMPT-VT优于VMP，而对于重度RI的患者，VMPT-VT不能胜过VMP，尽管分析的病例相对较少，无法得出明确的结论。与RI相比，VMPT-VT在RI反转方面没有优势。

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