Measuring response among patients with multiple myeloma is essential for the care of patients. Deeper responses are associated with better progression free survival (PFS) and overall survival (OS). To test the hypothesis that Mass-Fix, a mass spectrometry-based means to detect monoclonal proteins, is superior to existing methodologies to predict for survival outcomes, samples from the STAMINA trial (NCT01109004), a trial comparing three transplant approaches, were employed. Samples from 575 patients from as many as three time points (post-induction [post-I; pre-maintenance [pre-M]; 1 year post enrollment [1YR]) were tested when available. Four response parameters were assessed: Mass-Fix, serum immunofixation, complete response, and measurable residual disease (MRD) by next generation flow cytometry. Of the four response measures, only MRD and Mass-Fix predicted for PFS and OS at multiple testing points on multivariate analyses. Although MRD drove Mass-Fix from the model for PFS at post-I and pre-M, 1YR Mass-Fix was independent of 1YR MRD. For OS, the only prognostic pre-I measure was Mass-Fix, and the only 1YR measures that were prognostic on multivariate analysis were 1YR MRD and 1YR Mass-Fix. SIFE and CR were not. Mass-Fix is a powerful means to track response.
在多发性骨髓瘤患者中评估治疗反应对于患者管理至关重要,更深度的治疗反应与更长的无进展生存期(PFS)及总生存期(OS)相关。为验证基于质谱技术的单克隆蛋白检测方法Mass-Fix在预测生存结局方面优于现有方法的假说,本研究采用STAMINA临床试验(编号NCT01109004,该试验比较了三种移植方案)的患者样本进行分析。共纳入575名患者在最多三个时间点(诱导治疗后、维持治疗前、入组后1年)的可用样本进行检测。评估了四种反应参数:Mass-Fix、血清免疫固定电泳、完全缓解以及新一代流式细胞术检测的可测量残留病灶(MRD)。在多变量分析中,四种检测方法中仅MRD与Mass-Fix能在多个检测时间点预测PFS和OS。虽然在诱导治疗后和维持治疗前时间点,MRD使Mass-Fix在PFS预测模型中失去显著性,但入组后1年的Mass-Fix检测结果独立于同期MRD结果。对于OS预测,诱导治疗前唯一具有预后价值的指标是Mass-Fix;而入组后1年时间点,多变量分析中仅1年MRD和1年Mass-Fix具有预后意义,血清免疫固定电泳和完全缓解状态则无此作用。Mass-Fix是一种监测治疗反应的有效手段。