Mass spectrometry (MS) is a promising tool for monitoring monoclonal protein in plasma cell dyscrasias. We included 480 transplant-eligible newly-diagnosed multiple myeloma (MM) patients from the GMMG-MM5 trial (EudraCT No. 2010-019173-16) and performed a retrospective MS analysis at baseline (480 patients) and at the pre-defined, consecutive time points after induction (444 patients), prior to maintenance (305 patients) and after one year of maintenance (227 patients). We found that MS negativity was significantly associated with improved progression-free survival (PFS) even in patients with complete response (CR) at all investigated follow-up time points. The prognostic impact was independent of established risk factors, such as the revised International Staging System. Combining MS and baseline cytogenetics improved the prediction of outcome: MS-positive patients with high-risk cytogenetics had a dismal PFS of 1.9 years (95% confidence interval [CI]: 1.6–2.3 years) from the start of maintenance. Testing the value of sequential MS prior to and after one year of maintenance, patients converting from MS positivity to negativity had an excellent PFS (median not reached) while patients converting from MS negativity to positivity progressed early (median 0.6 years, 95% CI: 0.3-not reached). Among patients with sustained MS positivity, the baseline high-risk cytogenetic status had a significant impact and defined a group with poor PFS. Combining minimal residual disease (MRD) in the bone marrow and MS allowed the identification of double negative patients with a favorable PFS (median 3.33 years, 95% CI: 3.08-not reached) and no overall survival events. Our study provides strong evidence that MS is superior to conventional response monitoring, highlighting the potential of MS to become a new standard. Our data indicate that MS should be performed sequentially and combined with baseline disease features and MRD to improve its clinical value. Clinical Trials Register: EudraCT No. 2010-019173-16
质谱分析是监测浆细胞疾病中单克隆蛋白的一种前景广阔的工具。我们纳入了GMMG-MM5试验中480例适合移植的新诊断多发性骨髓瘤患者，并分别在基线时、诱导治疗后预设连续时间点、维持治疗前及维持治疗一年后进行了回顾性质谱分析。研究发现，即使在所有随访时间点达到完全缓解的患者中，质谱阴性也与无进展生存期的显著改善相关。其预后影响独立于既定风险因素，如修订后的国际分期系统。结合质谱分析与基线细胞遗传学能改善预后预测：具有高危细胞遗传学特征的质谱阳性患者，从维持治疗开始后的无进展生存期仅为1.9年。通过评估维持治疗前及治疗一年后序贯质谱检测的价值，发现从质谱阳性转为阴性的患者无进展生存期优异，而从阴性转为阳性的患者则早期进展。在持续质谱阳性的患者中，基线高危细胞遗传学状态具有显著影响，并定义了无进展生存期较差的群体。结合骨髓微小残留病与质谱检测，可识别出双重阴性患者，该群体无进展生存期良好且未出现总生存事件。本研究为质谱分析优于传统疗效监测提供了有力证据，凸显其成为新标准的潜力。数据表明，质谱检测应序贯进行，并与基线疾病特征及微小残留病结合以提高临床价值。临床试验注册号：EudraCT 2010-019173-16。
肿瘤(癌症)患者之家