硼替佐米与地塞米松联合用于新诊断的多发性骨髓瘤

[Combination of bortezomib and dexamethasone for newly diagnosed multiple myeloma].

作者信息

Li Juan, Zeng Li-jin, Zhao Ying, Su Chang, Huang Bei-hui

机构信息

Department of Hematology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.

出版信息

Zhonghua Xue Ye Xue Za Zhi. 2009 Aug;30(8):543-7.

PMID:19954643

Abstract

OBJECTIVE

To analyzed retrospectively two groups of patients with newly diagnosed multiple myeloma (MM) receiving bortezomib and dexamethasone (VD) regimen and vincristine combined with pirarubicin and dexamethasone and melphalan(VADM) regimen.

METHODS

Twenty-four patients were enrolled in a group of VD, receiving bortezomib 1.3mg/m(2) on days 1, 4, 8, 11 and dexamethasone 20mg on days 1-4 intravenously of every 21-day cycle. EBMT Standard was used to evaluate the efficacy and NCI-CTC V3.0 was used to decide the adverse effect. Thirty matched patients with newly diagnosed MM who received VADM were used as control group, receiving vincristine 0.4 mg/d and pirarubicin 9 mgxm(-2)xd(-1) and dexamethasone 20 mg/d and melphalan 12 mg/d on days 1 - 4 intravenously of every 28 day cycle.

RESULTS

With a median follow-up of 10.5 months in VD group, there were 87.5% patients (21/24) responded, including 12 cases (50.0%) of complete remission (CR) or near complete remission (nCR). The total response rate (RR) was 76.7% in VADM group, with no significant difference in VD group (P = 0.483). CR + nCR rate was significantly higher in VD group than in VADM group (10%) (P = 0.001). RR and CR + nCR of light chain patients in VD group were significantly higher than in VADM group (P = 0.025 and 0.040, respectively). The median time to response and to best response were significantly shorter in VD group than in VADM group. In VD group, the RR of 8 patients with renal dysfunction was 87.5%, and that of 16 with normal renal function was 75% (P = 0.631). There was no significant difference in adverse effects between patient with renal dysfunction and normal function (P > 0.05). The main adverse effects in VD group were fatigue (66.7%), diarrhea (58.3%), peripheral neuropathy (54.2%), thrombocytopenia (29.2%), infection (29.2%), fever (25.0%) and constipation (25.0%). Most of the adverse effects were mild (grade 1 - 2) and could be relieved by symptomatic treatments. The most common adverse event in VADM group was neutropenia (83.8%), infection (35.5%), vomiting (35.5%), loss of hair (32.5%) and thrombocytopenia (16.2%).

CONCLUSION

VD has higher CR + nCR rate compared with VADM and can be tolerant in most patients. VD is safe in patients with renal inadequacy.

摘要

目的

回顾性分析两组新诊断的多发性骨髓瘤（MM）患者，分别接受硼替佐米与地塞米松（VD）方案以及长春新碱联合吡柔比星、地塞米松与美法仑（VADM）方案的治疗情况。

方法

24例患者入组VD组，每21天为1个周期，第1、4、8、11天静脉注射硼替佐米1.3mg/m²，第1 - 4天静脉注射地塞米松20mg。采用欧洲血液与骨髓移植协会（EBMT）标准评估疗效，采用美国国立癌症研究所通用毒性标准（NCI - CTC）V3.0判定不良反应。30例匹配的新诊断MM患者接受VADM方案作为对照组，每28天为1个周期，第1 - 4天静脉注射长春新碱0.4mg/d、吡柔比星9mg·m⁻²·d⁻¹、地塞米松20mg/d以及美法仑12mg/d。

结果

VD组中位随访10.5个月，87.5%（21/24）的患者有反应，其中12例（50.0%）完全缓解（CR）或接近完全缓解（nCR）。VADM组总缓解率（RR）为76.7%，与VD组无显著差异（P = 0.483）。VD组CR + nCR率显著高于VADM组（10%）（P = 0.001）。VD组轻链患者的RR和CR + nCR显著高于VADM组（分别为P = 0.025和0.040）。VD组的中位反应时间和最佳反应时间显著短于VADM组。VD组8例肾功能不全患者的RR为87.5%，16例肾功能正常患者的RR为75%（P = 0.631）。肾功能不全患者与肾功能正常患者的不良反应无显著差异（P > 0.05）。VD组主要不良反应为疲劳（66.7%）、腹泻（58.3%）、周围神经病变（54.2%）、血小板减少（29.2%）、感染（29.2%）、发热（25.0%）和便秘（25.0%）。大多数不良反应为轻度（1 - 2级），可通过对症治疗缓解。VADM组最常见的不良事件为中性粒细胞减少（83.8%）、感染（35.5%）、呕吐（35.5%）、脱发（32.5%）和血小板减少（16.2%）。