Objective: To explore the efficacy and safety of bortezomib (btz) based chemotherapy in multiple myeloma (MM) patients with renal-function impairment (RI).
Methods: Fifty-six MM patients with impaired renal function treated with bortazomib based regimens in our single center were retrospectively analyzed.
Results: The median age was 59 (ranged 30-77) years. 39.3% were κ-restricted MM, while 57.1% were λ-restricted MM. Nine patients were IgD-MM, and 14 were light chain MM. Median creatinine clearance (CrCl) was 25.33 (7.23-59.55) ml/min. The number of patients with mild, moderate and severe RI was 6, 35 and 15, respectively. Overall response rate of MM was 82.4% (≥MR), including 32.4% complete response (CR), 17.6% very good partial response (VGPR) and 26.5% partial response (PR). The rate of renal response was 89.3%, including 62.5% CR, 14.3% PR and 12.5% minor response (MR). A median time of optimal response was 25.5 (ranged 5-240) days. There was no significant difference in the median overall survival and the time to progress in different RI groups. Adverse events observed were similar to those patients with normal renal function previously reported. Most adverse events were manageable, 55.6% patients developed peripheral neuropathy and 10 patients discontinued bortezomib.
Conclusion: The incidence of RI is higher in patients with IgD-MM and λ restricted MM. Bortezomib based treatment is a highly effective and safe option in MM patients with impaired renal function. In this analysis, renal function was improved in a substantial proportion of patients. Peripheral neuropathy is the major adverse events which limit its use in MM patients.
目的 观察以硼替佐米（Btz）为基础的化疗方案在合并肾功能不全的多发性骨髓瘤（MM）患者中的疗效及安全性。方法 回顾性分析56例伴有肾功能不全且接受以Btz为基础方案化疗的MM患者的临床资料。结果 56例患者中位年龄59（30～77）岁，κ型22例（39.3%），λ型32例（57.1%）；其中IgD型9例（16.1%），轻链型14例（25.0%）。中位内生肌酐清除率（CrCl）为25.33（7.23～59.55）ml/min，轻、中、重度肾功能损害者分别为6、35、15例。34例可判断MM疗效的患者中总体反应率为82.4%，其中完全反应（CR）率32.4%，非常好的部分反应（VGPR）率为17.6%，部分反应（PR）率为26.5%。56例患者肾功能损害的总体反应率为89.3%，其中CR率为62.5%，PR率为14.3%，微小反应（MR）率为 12.5%。达最佳肾脏反应的中位时间为25.5（5～240）d。轻度、中度及重度肾功能损害患者的中位总生存及疾病进展时间组间比较差异均无统计学意义。患者的主要不良反应谱与所报道的肾功能正常患者的不良反应谱相似。末梢神经炎发生率高达55.6%，其中10例患者停止Btz使用。结论 IgD型及λ限制型MM患者肾损害的发生率较高。以Btz为基础的化疗方案对伴有肾功能不全的MM患者高效、安全，同时能够快速逆转其肾功能损害。末梢神经炎是影响Btz应用的主要不良反应。