硼替佐米在自体干细胞移植前后可克服新诊断多发性骨髓瘤肾功能损害的不良预后影响：HOVON-65/GMMG-HD4 试验的亚组分析。
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.
出版信息
Haematologica. 2014 Jan;99(1):148-54. doi: 10.3324/haematol.2013.087585. Epub 2013 Aug 30.
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<0.001) with a progression-free survival rate at 3 years of 16% in the VAD-arm versus 48% in the PAD-arm (P=0.004). Overall and progression-free survival rates in the PAD-arm were similar in patients with a baseline creatinine ≥ 2 mg/dL or <2 mg/dL. We conclude that a bortezomib-containing treatment before and after autologous stem cell transplantation overcomes the negative prognostic impact of renal impairment in patients with newly diagnosed multiple myeloma. The trial was registered at www.trialregister.nl as NTR213 and at www.controlled-trials.com as ISRCTN 64455289.
肾功能损害在多发性骨髓瘤患者中很常见，与预后不良相关。本分析评估了在一项前瞻性随机 III 期试验中，接受硼替佐米治疗的多发性骨髓瘤患者中肾功能损害的预后作用。HOVON-65/GMMG-HD4 试验中 827 例新诊断的骨髓瘤患者被随机分为接受 3 个周期长春新碱、阿霉素、地塞米松（VAD）或硼替佐米、阿霉素、地塞米松（PAD），随后进行自体干细胞移植，并使用沙利度胺 50mg 每日（VAD 组）或硼替佐米 1.3mg/m(2)每 2 周（PAD 组）进行维持治疗。81 例患者的基线血清肌酐为 2mg/dL 或更高（Durie-Salmon 分期 B），746 例患者的基线血清肌酐<2mg/dL（分期 A）。在基线肌酐≥2mg/dL 的骨髓瘤患者中，VAD 组的肾脏反应率为 63%，PAD 组为 81%（P=0.31）。VAD 组的总体骨髓瘤反应率为 64%，PAD 组为 89%，VAD 组的完全缓解率为 13%，PAD 组为 36%（P=0.01）。基线肌酐≥2mg/dL 的患者的 3 年总生存率在 VAD 组为 34%，在 PAD 组为 74%（P<0.001），VAD 组的 3 年无进展生存率为 16%，PAD 组为 48%（P=0.004）。在基线肌酐≥2mg/dL 或<2mg/dL 的患者中，PAD 组的总生存率和无进展生存率相似。我们的结论是，在自体干细胞移植前后接受硼替佐米治疗可克服新诊断多发性骨髓瘤患者肾功能损害的负性预后影响。该试验在 www.trialregister.nl 上注册为 NTR213，在 www.controlled-trials.com 上注册为 ISRCTN64455289。
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