Prognostic value of premaintenance FDG PET/CT response in patients with newly diagnosed myeloma from the CASSIOPEIA trial.

The companion study, CASSIOPET, assessed the prognostic value of premaintenance (PM) positron emission tomography (PET)/computed tomography (CT) response, based on the standardized Deauville score on PFS and overall survival(OS), in addition to bone marrow (BM) minimal residual disease (MRD) detection by multiparameter flow cytometry (MFC) at 10-5 level.

伴随研究CASSIOPET评估了诱导治疗前（PM）正电子发射断层扫描（PET）/计算机断层扫描（CT）反应的预后价值，基于标准化Deauville评分对无进展生存期（PFS）和总生存期（OS）的影响，以及通过多参数流式细胞术（MFC）在10^-5水平上检测骨髓（BM）微小残留病（MRD）。

PM PET/CT was available for 225 patients: 112 patients treated with daratumumab after D-VTd (59) or bortezomib, thalidomide, and dexamethasone (VTd; 53), and 113 patients followed by observation after D-VTd (56) or VTd (57).

PM PET/CT可用于225名患者：其中112名患者在D-VTd（59名）或硼替佐米、thalidomide和地塞米松（VTd；53名）治疗后接受了达雷妥尤单抗治疗，另外113名患者在D-VTd（56名）或VTd（57名）治疗后仅进行观察。

At PM, 92% of the 175 baseline PET-positive patients achieved PET negativity, with a longer PFS in univariate analysis (P = .019) and a major trend of prolonged OS (P = .056).

在PM时，175名基线PET阳性患者中有92%达到了PET阴性，单变量分析显示无进展生存期（PFS）更长（P = .019），总生存期（OS）有显著延长趋势（P = .056）。

In univariate analysis, patients who achieved both PET and MFC negativity were found to have a better PFS (P < .0001) than those who had at least 1 positive result.

在单变量分析中，同时达到PET和MFC阴性的患者比至少有一个阳性结果的患者有更好的无进展生存期（P < .0001）。

In daratumumab-treated patients, PM PET negativity was associated with prolonged PFS and OS in univariate analysis (P = .0023 and P = .033, respectively), and double MFC and PET negativity was independently associated with PFS by multivariate analysis (P = .0006).

在达雷妥尤单抗治疗的患者中，PM PET阴性与无进展生存期和总生存期的延长相关（P = .0023 和 P = .033），双阴性的MFC和PET在多变量分析中独立地与无进展生存期相关（P = .0006）。

This study confirms the prognostic relevance of a PM PET response in patients with NDMM treated with daratumumab in addition to MRD detection by MFC at the BM level.

本研究证实了在使用达雷妥尤单抗治疗的NDMM患者中，通过骨髓水平的MFC检测MRD之外，PM PET反应的预后相关性。

This trial was registered at ww.clinicaltrials.gov as #NCT02541383.

这项试验已在www.clinicaltrials.gov上注册，注册号为#NCT02541383。