Based on the results obtained in clinical trials, the use of the combination of lenalidomide and dexamethasone (Len/Dex) has become a potential therapeutic choice for newly diagnosed multiple myeloma (NDMM) ineligible for autologous stem cell transplantation. This study evaluated 89 frail NDMM patients treated with first-line oral association. At the last follow-up, 34 out of 89 patients (38.2%) were alive, and 22 were still in treatment with Len/Dex. Among 73 evaluable patients who received at least two cycles, the overall response rate was 71% (N = 52). The disease control rate, defined as any level of clinical response to therapy, occurred in 71 patients (97%). We reported one or more adverse events of grade 3 or 4 (G3/4) in 65.2% (N = 58) of patients, with a prevalence of hematological toxicity (24 patients), leading to an overall discontinuation of treatment in two cases. In univariate analysis, high ISS, high serum β2-microglobulin, and creatinine clearance <30 mL/min negatively impact OS, while the depth of response positively impacts OS. Moreover, G3-4 anemia, ISS, frailty score, and ECOG negatively impacts PFS. In conclusion, elderly and more frail patients benefit from the Len/Dex combination also in the era of monoclonal antibodies, ensuring an increased PFS and OS in patients where the therapeutic choice is often limited and usually not very effective.
根据临床试验结果，来那度胺联合地塞米松（Len/Dex）方案已成为不适合自体干细胞移植的新诊断多发性骨髓瘤（NDMM）患者的潜在治疗选择。本研究评估了89例接受一线口服联合方案治疗的虚弱NDMM患者。末次随访时，89例患者中有34例（38.2%）存活，其中22例仍在接受Len/Dex治疗。在至少接受两个周期治疗且可评估的73例患者中，总缓解率为71%（52例）。达到疾病控制率（定义为任何级别的临床治疗反应）的患者为71例（97%）。65.2%（58例）患者报告了≥1项3/4级不良事件，其中血液学毒性最为常见（24例），导致2例患者完全终止治疗。单因素分析显示，高ISS分期、高血清β2微球蛋白及肌酐清除率<30 mL/min对总生存期产生负面影响，而治疗反应深度则对总生存期产生积极影响。此外，3-4级贫血、ISS分期、虚弱评分及ECOG评分对无进展生存期产生负面影响。综上所述，即使在单克隆抗体时代，老年及更虚弱患者仍能从Len/Dex联合方案中获益，该方案为治疗选择常受限且通常疗效不佳的患者提供了更长的无进展生存期与总生存期。
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