Lenalidomide is a novel immunomodulatory agent with a unique dual mechanism of action: its tumoricidal effect leads to direct tumor cell death, and its immunomodulatory effect keeps the tumor in remission. Phase III clinical trials have demonstrated that in patients with relapsed/refractory multiple myeloma (MM), lenalidomide in combination with dexamethasone offers high clinical response rates and improved time to disease progression, progression-free survival (PFS), and overall survival (OS) compared with dexamethasone alone. In patients with newly diagnosed MM, the combination of lenalidomide and low-dose dexamethasone prolonged survival compared with lenalidomide and standard high-dose dexamethasone. The benefits of lenalidomide-based treatment regimens can be optimized by initiating treatment early in the disease course, either as a frontline treatment or at first relapse. Lenalidomide is generally well tolerated; the primary adverse events are myelosuppression and venous thromboembolic complications. These adverse events emerge early in the course of treatment and can be managed using standard interventions such as granulocyte colony-stimulating factor, dose reduction, and thromboprophylaxis. The combination of lenalidomide and dexamethasone is effective and generally well tolerated in patients with renal impairment provided that creatinine clearance level and adverse events are carefully monitored and the starting dose of lenalidomide is adjusted appropriately. Early results from phase III trials indicate that in patients with newly diagnosed MM, continuous lenalidomide therapy is well tolerated and associated with significant improvements in PFS, offering a new treatment option for patients with MM - although no OS benefit has yet been seen in this setting. Lenalidomide-based treatment is effective across the spectrum of MM disease phases, allowing for the long-term management of myeloma.

中文翻译：

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来那度胺：来自临床试验的证据更新。

来那度胺是一种新型的免疫调节剂，具有独特的双重作用机理：其杀肿瘤作用导致直接的肿瘤细胞死亡，其免疫调节作用使肿瘤保持缓解。III期临床试验表明，在患有复发/难治性多发性骨髓瘤（MM）的患者中，来那度胺与地塞米松联用可提高临床反应率，缩短疾病进展时间，无进展生存期（PFS）和总体生存期（OS）与单独使用地塞米松相比。与来那度胺和标准大剂量地塞米松相比，在新诊断为MM的患者中，来那度胺和小剂量地塞米松的联合使用可延长生存期。来那度胺为基础的治疗方案的益处可以通过在疾病过程的早期开始治疗来优化，作为一线治疗或第一次复发。来那度胺的耐受性一般良好；主要的不良事件是骨髓抑制和静脉血栓栓塞并发症。这些不良事件会在治疗过程的早期出现，并且可以使用标准干预措施进行管理，例如粒细胞集落刺激因子，剂量减少和血栓预防。来那度胺和地塞米松的组合是有效的，并且在肾功能不全的患者中通常耐受性良好，只要仔细监测肌酐清除水平和不良反应，并适当调整来那度胺的起始剂量即可。III期试验的早期结果表明，在新诊断为MM的患者中，来那度胺的连续治疗耐受性良好，并且与PFS的显着改善相关，为MM患者提供了一种新的治疗选择-尽管在这种情况下尚无OS获益。基于来那度胺的治疗在MM疾病各个阶段均有效，可长期控制骨髓瘤。