Abstract:
Although the incorporation of bortezomib into induction regimens has improved response rates in patients with multiple myeloma (MM), the role of bortezomib in the peripheral blood stem cell (PBSC) mobilization remains unclear. We assessed the PBSC mobilization efficacy, safety, and disease response of intermediate-dose cyclophosphamide and bortezomib in the PBSC mobilization. Twenty-one patients with newly diagnosed MM were enrolled in a phase II, non-randomized study that used bortezomib (1.3 mg/m2/day on days 1, 4, 8, and 11) and intermediate-dose cyclophosphamide (2 g/m2/day on days 2, 3) (Bor-ID-CY). The data from 15 patients who received intermediate-dose cyclophosphamide (ID-CY) were used as a historical control group. The total CD34 + cell yield of Bor-ID-CY and ID-CY groups were not significantly different (median 6.3 ×106/kg vs. 6.5 ×106/kg, p = 0.26). All three patients with mobilization failure of two groups had t(11;14). Six patients in Bor-ID-CY group were upgraded from a status that was less than a very good partial response (VGPR) at the time of PBSC mobilization to a VGPR or better after PBSC mobilization (p = 0.014). Four patients in Bor-ID-CY group developed sepsis. The time to engraftment was similar in the two groups. The addition of bortezomib to ID-CY did not impact the stem cell yield or quality.
摘要:
虽然硼替佐米在诱导方案中的掺入有所改善,多发性骨髓瘤(MM)患者的反应率,硼替佐米的作用,外周血干细胞(PBSC)动员仍不清楚.我们评估了,PBSC动员功效,安全,和中等剂量的疾病反应,环磷酰胺和硼替佐米在PBSC动员中的作用。21名患者,新诊断的MM进入II期,非随机研究使用,硼替佐米(第1、4、8和11天为1.3mg/m2/天)和中等剂量,环磷酰胺(在第2、3天为2g/m2/天)(Bor-ID-CY)。15名患者的数据,谁接受了中等剂量的环磷酰胺(ID-CY)被用作历史,对照组。Bor-ID-CY和ID-CY组的总CD34+细胞产量没有,显着不同(中位数6.3×106/kg与6.5×106/kg,p=0.19)。所有三个病人,两组的动员失败有t(11;14)。Bor-ID-CY组6例,从低于非常好的部分响应(VGPR)的状态升级,在PBSC动员到VGPR时或在PBSC动员后更好,(p=0.014)。Bor-ID-CY组4例患者出现脓毒症。时间,两组的植入相似。将硼替佐米添加到ID-CY中没有,影响干细胞产量或质量。