文章：

来那度胺联合地塞米松治疗肾功能受损的复发性多发性骨髓瘤患者：PrE1003，一项PrECOG研究

Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study

原文发布日期：2018-08-29

DOI: 10.1038/s41408-018-0110-7

类型: Article

开放获取: 是

英文摘要：

Renal insufficiency is common in patients with relapsed multiple myeloma and can often limit choice of therapy. Lenalidomide, a critical agent in the treatment of relapsed multiple myeloma, is renally cleared., This phase I/II trial evaluated the efficacy and safety of lenalidomide with dexamethasone in patients with relapsed multiple myeloma and renal insufficiency. Three groups were treated, with creatinine clearance 30–60 cc/hr (group A), CrCl < 30 not on dialysis (group B), and patients on dialysis (group C) at escalating doses of lenalidomide. A total of 63 patients were treated and no DLTs were observed in phase I. All three groups were able to escalate to full dose lenalidomide 25 mg daily 21/28 days, although due to reduced accrual the phase II component was not entirely completed for groups B and C. Adverse events were as expected, including anemia, diarrhea and fatigue. Ten patients experienced grade 3–4 pneumonia. Overall response rate was 54% across all groups. PFS was 7.5 months and OS was 19.7 months. Lenalidomide can be given at full dose 25 mg daily 21/28 in patients with a CrCl > 30, and can be given daily to those with CrCl < 30, even when on dialysis, at doses of at least 15 mg daily.

摘要翻译： 

肾功能不全在复发多发性骨髓瘤患者中较为常见，且常限制治疗方案的选择。来那度胺作为治疗复发多发性骨髓瘤的关键药物，需经肾脏清除。本I/II期临床试验评估了来那度胺联合地塞米松在伴有肾功能不全的复发多发性骨髓瘤患者中的疗效与安全性。研究共纳入三组患者：肌酐清除率30-60毫升/分钟（A组）、肌酐清除率<30毫升/分钟未接受透析者（B组）以及接受透析的患者（C组），均接受来那度胺递增剂量治疗。共63例患者入组，I期试验中未观察到剂量限制性毒性。尽管因入组速度减缓导致B组和C组的II期试验未能完全完成，但所有三组患者均能递增至来那度胺全剂量（25毫克/日，28天周期中用药21天）。不良事件符合预期，包括贫血、腹泻和疲劳。10例患者出现3-4级肺炎。所有组别的总体缓解率为54%，无进展生存期为7.5个月，总生存期为19.7个月。对于肌酐清除率>30毫升/分钟者，来那度胺可给予全剂量25毫克/日（28天周期中用药21天）；对于肌酐清除率<30毫升/分钟者（包括透析患者），每日至少15毫克的剂量亦可安全使用。

原文链接：

Lenalidomide and dexamethasone in patients with relapsed multiple myeloma and impaired renal function: PrE1003, a PrECOG study