Bortezomib before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in newly diagnosed multiple myeloma: a subgroup analysis from the HOVON-65/GMMG-HD4 trial
Bortezomib before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in newly diagnosed multiple myeloma: a subgroup analysis from the HOVON-65/GMMG-HD4 trial
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DOI：
10.3324/haematol.2013.087585
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发表时间：
2014-01-01
期刊：
影响因子：
10.1
通讯作者：
Lokhorst, Henk M.
中科院分区：
文献类型：
--
作者：
Scheid, Christof;Sonneveld, Pieter;Lokhorst, Henk M.
肾脏损害在多发性骨髓瘤患者中很常见，并与预后不良相关。在一项前瞻性随机III期试验中，该分析评估了自体干细胞移植前后接受硼替佐米治疗的骨髓瘤患者肾脏损害的预后作用。在HOVON-65/GMMG-HD4试验中，827名新诊断的骨髓瘤患者随机接受三个周期的长春新碱、阿霉素、地塞米松（VAD）或硼替佐米、阿霉素、地塞米松（PAD）治疗，随后进行自体干细胞移植，并维持每日50 mg的沙利度胺（VAD-组）或1.3 mg/m(2)的硼替佐米（PAD-组）每2周。746例患者基线血清肌酐低于2mg /dL （duie - salmona期），81例患者基线血清肌酐低于2mg /dL （B期）。基线肌酸酐>= 2 mg/dL的骨髓瘤患者，vad组的肾反应率为63%，pad组为81% （P=0.31）。vad组的总体骨髓瘤缓解率为64%，而pad组为89%；vad组的完全缓解率为13%，而pad组为36% （P=0.01）。基线肌酸酐bb0 = 2 mg/dL的患者3年总生存率在vad组为34%，而在pad组为74% （P= 2 mg/dL或P= 2 mg/dL）
Renal impairment is frequent in patients with multiple myeloma and is correlated with an inferior prognosis. This analysis evaluates the prognostic role of renal impairment in patients with myeloma treated with bortezomib before and after autologous stem cell transplantation within a prospective randomized phase III trial. Eight hundred and twenty-seven newly diagnosed myeloma patients in the HOVON-65/GMMG-HD4 trial were randomized to receive three cycles of vincristine, adriamycin, dexamethasone (VAD) or bortezomib, adriamycin, dexamethasone (PAD) followed by autologous stem cell transplantation and maintenance with thalidomide 50 mg daily (VAD-arm) or bortezomib 1.3 mg/m(2) every 2 weeks (PAD-arm). Baseline serum creatinine was less than 2 mg/dL (Durie-Salmon-stage A) in 746 patients and 2 mg/dL or higher (stage B) in 81. In myeloma patients with a baseline creatinine >= 2 mg/dL the renal response rate was 63% in the VAD-arm and 81% in the PAD-arm (P=0.31). The overall myeloma response rate was 64% in the VAD-arm versus 89% in the PAD-arm with 13% complete responses in the VAD-arm versus 36% in the PAD-arm (P=0.01). Overall survival at 3 years for patients with a baseline creatinine >= 2 mg/dL was 34% in the VAD-arm versus 74% in the PAD-arm (P= 2 mg/dL or