新药时代早期复发对新诊断多发性骨髓瘤患者预后的影响及其危险因素分析

Analysis of the Prognostic Value and Risk Factors of Early Relapse for Newly Diagnosed Multiple Myeloma Patients in the Era of Novel Agents

目的:探讨新药时代早期复发对新诊断多发性骨髓瘤(NDMM)患者预后的影响及其危险因素,为早期识别高危人群和指导治疗提供依据。方法:回顾性分析2011年11月至2022年5月本院收治的NDMM患者的临床资料及实验室指标,根据无病生存期(PFS)是否超过12个月将患者分为早期复发组和晚期复发组,分析两组患者的高危因素,包括年龄、贫血、肾功能不全、高钙血症、乳酸脱氢酶水平升高、髓外病变、国际分期系统(ISS)分期、修订版国际分期系统(R-ISS)分期、荧光原位杂交(FISH)检测结果及疗效,筛选出有意义的临床指标并采用多因素分析探讨早期复发的高危因素。结果:170例NDMM患者被纳入分析,其中早期复发者25例(14.7%),晚期复发者145例(85.3%)。早期复发组中位OS时间为20个月,晚期复发组中位OS时间为140个月,比较差异有统计学意义(P<0.001)。早期复发组最佳疗效≥VGPR为14例(56%),晚期复发组为113例(77.9%),差异有统计学意义(P=0.011)。对于不同的缓解程度,早期复发患者均预后不良。多因素分析结果显示,高危遗传学异常和髓外病变是NDMM患者早期复发的独立危险因素。结论:新药时代NDMM早期复发者预后差,髓外病变和高危遗传学异常是早期复发的独立危险因素。

Objective: To investigate the influece of early relapse in the era of novel drugs on the prognosis of the patients with newly diagnosed multiple myeloma(NDMM) and risk factors, and to provide the basis for the early identification of the high-risk patients and guiding the treatment. Methods: The clinical data of the patients with NDMM admitted to our hospital from November 2011 to May 2022 were retrospectively analyzed. According to whether the progression free survival(PFS) was more than 12 months, they were divided into early relapse group(≤12 months) and late relapse group(>12 months). The high-risk factors of the patients in two groups were analyzed, including age, anemia, renal insufficiency, hypercalcemia, increasing of lactate dehydrogenase(LDH) level, Extramedullary disease(EMD), International Staging System(ISS) stage, Revised International Staging System(R-ISS) stage, cytogenetic abnormalities(CA) detected by fluorescence in situ hybridization(FISH), and treatment efficacy. The meaningful clinical indicators were screened, and multivariate analysis was used to explore the high-risk factors of early relapse. Results: 170 patients with NDMM were collected, including 25 cases in early relapse group and 145 cases in late relapse group. The median OS time of the patients in early death group was 20 months, and 140 months in late relapse group by the end of follow-up, there was significant difference in OS of the patients between two groups(P<0.001). Fifteen patients(56.0%)in early relapse group obtained ≥VGPR, and 113(77.9%) patients in late relapse group, the difference was statistically significant(P=0.011). Survival outcomes remained poor among early relapse patients irrespective of depth of response to initial therapy. M ultivariate analysis show ed that the EM D and high-risk CA predicted early relapse. Conclusion: The prognosis of patients w ith early relapse in NDM M is poor. EM D and high-risk CA is an independent prognostic factor of early relapse.