Division of Hematology/Oncology, Department of Medicine, Kameda Medical Center, Chiba, Japan.
Eur J Haematol. 2013 Feb;90(2):134-41. doi: 10.1111/ejh.12050. Epub 2013 Jan 7.
To clarify the impact of serum free light chain (sFLC) ratio normalization in patients with multiple myeloma (MM) treated with novel agents.
Treatment response in 126 consecutive patients over 7 years was assessed by IMWG criteria and sFLC assay.
Thirty-four patients (27%) showed complete response (CR), 37 (29%) very good partial response (VGPR), 39 (31%) partial response (PR), and 16 (13%) stable disease (SD) or less at a median follow-up of 28 months. Fifty-two patients (41%) with sFLC ratio normalization showed superior progression-free survival (PFS) and overall survival (OS) compared to those who did not (3-yr OS, 94% vs. 48%; P < 0.001). This favorable effect of sFLC ratio normalization occurred irrespective of high (>1000 mg/dL) or low (<100 mg/dL) baseline sFLC. Rates of normal sFLC ratio were as follows: CR, 69%; VGPR, 64%; PR, 16%; and SD or less, 0%. OS was significantly superior in patients with than without normal sFCL ratio in respective response groups. Although various factors (advanced age >70, high LDH, ISS stage 3) showed negative prognostic impacts on PFS and OS on univariate analysis, normal sFLC ratio and achievement of CR emerged as the strongest prognostic predictors for longer OS in MM patients on multivariate analysis.
This study demonstrated the significance of obtaining normal sFLC ratio independent of other clinical variables. Analysis of sFLC ratio could identify the favorable group of patients as well as immunofixation test and support the inclusion of sFLC ratio as part of the response criteria for MM.
阐明新型药物治疗多发性骨髓瘤（MM）患者时血清游离轻链（sFLC）比值正常化的影响。
通过 IMWG 标准和 sFLC 检测，评估 7 年内 126 例连续患者的治疗反应。
中位随访 28 个月时，34 例（27%）患者达到完全缓解（CR），37 例（29%）患者达到非常好的部分缓解（VGPR），39 例（31%）患者达到部分缓解（PR），16 例（13%）患者病情稳定或更差。52 例（41%）sFLC 比值正常化患者的无进展生存期（PFS）和总生存期（OS）优于未正常化患者（3 年 OS，94% vs. 48%；P<0.001）。sFLC 比值正常化的这种有利影响与基线 sFLC 高（>1000mg/dL）或低（<100mg/dL）无关。正常 sFLC 比值的发生率如下：CR，69%；VGPR，64%；PR，16%；SD 或更差，0%。在各自的反应组中，OS 在 sFCL 比值正常的患者中明显优于无 sFCL 比值正常的患者。虽然在单因素分析中，各种因素（年龄>70 岁、高 LDH、ISS 分期 3 期）对 PFS 和 OS 有负面预后影响，但在多因素分析中，正常 sFLC 比值和达到 CR 是 MM 患者 OS 更长的最强预后预测因素。
本研究表明，获得独立于其他临床变量的正常 sFLC 比值具有重要意义。sFLC 比值分析可以识别出有利的患者群体，以及免疫固定试验，并支持将 sFLC 比值纳入 MM 的反应标准的一部分。
