Li Juan, Zeng Li-jin, Zhao Ying, Su Chang, Huang Bei-hui
Department of Hematology, the First Affiliated Hospital of Sun Yat-sen University, Guangzhou 510080, China.
Zhonghua Xue Ye Xue Za Zhi. 2009 Aug;30(8):543-7.
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.
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.
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%).
VD has higher CR + nCR rate compared with VADM and can be tolerant in most patients. VD is safe in patients with renal inadequacy.
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。
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。
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%）。
与VADM相比，VD具有更高的CR + nCR率，且大多数患者可耐受。VD对肾功能不全患者安全。
