Department of Medicine V, University Hospital of Heidelberg, Heidelberg.
Ann Oncol. 2014 Jan;25(1):189-95. doi: 10.1093/annonc/mdt509.
High-dose therapy (HDT) with autologous stem cell transplantation (ASCT) is considered the standard of care for multiple myeloma (MM) patients <65 years. Safety and outcome of ASCT for patients >65 years is currently uncertain, especially since the introduction of novel agents for induction and maintenance therapy. Furthermore, there are no conclusive data available on risk assessment in elderly patients treated with HDT.
We retrospectively analyzed 202 patients ≥60 years with newly diagnosed MM who underwent ASCT at our institution. Patients were stratified by age into three groups (60-64, 65-69 and 70-75 years). For safety assessment, we compared data about hospitalization, hematopoetic reconstitution and early mortality. Remission before and after ASCT was analyzed according to age and application of novel agents. Event-free (EFS) and overall survival (OS) were analyzed to identify impact of age, remission before/after ASCT and maintenance therapy as well as ISS score and cytogenetic aberrations on outcome in elderly patients.
The assessment of safety, remission before/after ASCT as well as EFS and OS showed no significant differences between the three groups (median EFS: 60-64 years: 27 months; 65-69 years: 23 months; 70-75 years: 23 months; median OS: not reached). Patients receiving novel agents as part of induction therapy achieved significantly higher nCR + CR rates than patients treated without novel agents. In Cox regression analysis, ISS and cytogenetics as well as remission after ASCT had the highest prognostic impact on EFS and OS. Maintenance therapy was associated with longer EFS in uni- and multivariate analyses.
ASCT is feasible for selected patients >65 and >70 years without increased mortality. Age at transplantation has no prognostic significance on outcome after ASCT. Novel agents during induction therapy and maintenance therapy improves outcome of older patients eligible for ASCT. ISS and cytogenetic analysis should be carried out routinely for risk assessment.
大剂量化疗（HDT）联合自体造血干细胞移植（ASCT）被认为是 65 岁以下多发性骨髓瘤（MM）患者的标准治疗方法。对于 65 岁以上患者接受 ASCT 的安全性和疗效目前尚不确定，特别是在新型诱导和维持治疗药物问世后。此外，对于接受 HDT 治疗的老年患者，尚无风险评估的明确数据。
我们回顾性分析了 202 例在我院接受 ASCT 的新诊断为 MM 且年龄≥60 岁的患者。患者按年龄分为三组（60-64 岁、65-69 岁和 70-75 岁）。为了评估安全性，我们比较了住院、造血重建和早期死亡率方面的数据。根据年龄和新型药物的应用，分析了 ASCT 前后的缓解情况。通过分析无事件生存（EFS）和总生存（OS），以确定年龄、ASCT 前后缓解情况、维持治疗以及 ISS 评分和细胞遗传学异常对老年患者的影响。
三组间安全性、ASCT 前后缓解情况以及 EFS 和 OS 差异无统计学意义（中位 EFS：60-64 岁：27 个月；65-69 岁：23 个月；70-75 岁：23 个月；中位 OS：未达到）。接受新型药物诱导治疗的患者 nCR+CR 率明显高于未接受新型药物治疗的患者。Cox 回归分析显示，ISS 和细胞遗传学以及 ASCT 后缓解情况对 EFS 和 OS 具有最高的预后影响。单因素和多因素分析均显示维持治疗与 EFS 延长相关。
对于选择合适的>65 岁和>70 岁患者，ASCT 是可行的，且不会增加死亡率。移植时的年龄对 ASCT 后患者的生存结果无预后意义。新型药物诱导治疗和维持治疗可改善适合接受 ASCT 的老年患者的预后。ISS 和细胞遗传学分析应常规进行，以进行风险评估。
