IRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia "Seràgnoli", Bologna, Italy.
Dipartimento di Medicina Specialistica, Diagnostica e Sperimentale, Università di Bologna, Bologna, Italy.
Am J Hematol. 2022 Dec;97(12):1607-1615. doi: 10.1002/ajh.26747. Epub 2022 Oct 18.
The International Myeloma Working Group (IMWG) guidelines recommend using electrophoresis and immunofixation to define response and progressive disease (PD) in immunoglobulin (Ig) secretory multiple myeloma (Ig-MM), whereas the role of serum-free light chain (sFLC) is controversial. We retrospectively analyzed the value of adding sFLC assays in the definition of response and PD according to IMWG criteria in 339 Ig-MM patients treated with a first-line novel agent-based therapy (median follow-up 54 months). sFLC PD was defined according to conventional criteria plus increased sFLC levels, or sFLC escape (sFLCe); progression/sFLCe-free survival (ePFS) was the time from the start of treatment to the date of first PD or sFLCe, or death; overall survival after PD/sFLCe (OS after Pe) was the time from first PD or sFLCe to the date of death. 148 (44%) patients achieved a complete response and 198 (60%) a normal sFLC ratio (sFLCR). sFLCR normalization was an independent prognostic factor for extended PFS (HR = 0.46, p = 0.001) and OS (HR = 0.47, p = 0.006) by multivariable analysis. 175 (52%) patients experienced PD according to the IMWG criteria, whereas 180 (53%) experienced PD or sFLCe. Overall, a sFLCe was observed in 31 (9%) patients. Median PFS and ePFS were both equal to 36 (95% CI = 32-42, and 32-40, respectively) months. sFLC PD adversely affected the OS after Pe compared to PD with increasing monoclonal Ig only (HR = 0.52, p = 0.012). Our results support the inclusion of the sFLC assay for defining response and PD in Ig-MM.
国际骨髓瘤工作组（IMWG）指南建议使用电泳和免疫固定来定义免疫球蛋白（Ig）分泌型多发性骨髓瘤（Ig-MM）的反应和进行性疾病（PD），而血清游离轻链（sFLC）的作用仍存在争议。我们回顾性分析了 339 例接受一线新型药物治疗的 Ig-MM 患者（中位随访 54 个月），根据 IMWG 标准，在反应和 PD 定义中添加 sFLC 检测的价值。根据传统标准加上 sFLC 水平升高或 sFLC 逃逸（sFLCe）定义 sFLC PD；进展/sFLCe 无进展生存期（ePFS）是从治疗开始到首次 PD 或 sFLCe 或死亡的时间；PD/sFLCe 后的总生存期（OS after Pe）是从首次 PD 或 sFLCe 到死亡的时间。148 例（44%）患者达到完全缓解，198 例（60%）患者 sFLC 比值正常（sFLCR）。sFLCR 正常是延长 PFS（HR=0.46，p=0.001）和 OS（HR=0.47，p=0.006）的独立预后因素，这在多变量分析中得到证实。根据 IMWG 标准，175 例（52%）患者发生 PD，180 例（53%）患者发生 PD 或 sFLCe。总的来说，31 例（9%）患者出现 sFLCe。中位 PFS 和 ePFS 均等于 36 个月（95%CI=32-42 和 32-40）。与仅增加单克隆 Ig 的 PD 相比，sFLC PD 对 Pe 后的 OS 产生不利影响（HR=0.52，p=0.012）。我们的结果支持在 Ig-MM 中纳入 sFLC 检测来定义反应和 PD。
