骨病病灶切除手术对新诊断多发性骨髓瘤患者的疗效影响和预后分析

Efficacy and prognostic analysis of orthopedic surgery in patients with newly diagnosed multiple myeloma

目的评估骨病病灶切除手术治疗新诊断多发性骨髓瘤(NDMM)患者的效果及对预后的影响。方法回顾性队列研究。收集2003年1月1日至2021年12月31日于北京协和医院血液科诊治的NDMM患者的临床资料。排除仅进行穿刺活检及椎体成形术的患者,纳入因脊柱不稳、脊髓压迫或长骨病变骨折或存在骨折风险而接受病灶切除手术的患者(手术组),选择骨病程度相同而无手术经历的NDMM患者作为对照(非手术组),比较手术前后疼痛视觉模拟评分(VAS)、美国东部肿瘤协作组体力状况(ECOG)评分、无进展生存(PFS)时间、总生存(OS)时间。统计学方法主要采用χ^(2)检验、t检验、Kaplan-Meier法及Cox回归模型。结果手术组(40例,43例次手术)与非手术组(80例)性别、年龄、M蛋白类型、国际分期系统(ISS)分期、骨破坏病灶数目、细胞遗传学异常、一线治疗方案和自体干细胞移植(ASCT)比例等基线资料匹配(均P>0.05)。手术组血M蛋白定量显著低于非手术组[(21.95±16.44)比(36.18±20.85)g/L,P=0.005]。中轴骨手术占比79.1%(34/43),四肢长骨手术占比20.9%(9/43)。术后VAS、ECOG评分均较术前显著改善[(2.30±0.80)比(6.60±1.50)分,(2.09±0.59)比(3.09±0.73)分,均P<0.001]。中位随访时间51个月。Kaplan-Meier法生存分析显示手术组与非手术组中位PFS时间(25比29个月)及OS时间(46比60个月)差异均无统计学意义(均P>0.05)。分层分析显示,在ISS Ⅰ期及ASCT患者中,手术组与非手术组PFS差异无统计学意义(均P>0.05),而OS更劣(P=0.005、0.017)。在ISS Ⅱ/Ⅲ期患者或非移植患者中,两组PFS及OS差异均无统计学意义(均P>0.05)。Cox回归模型分析显示ISS分期(HR=0.42,95%CI 0.19~0.93,P=0.031)及是否ASCT(HR=0.41,95%CI 0.18~0.97,P=0.041)为NDMM的独立预后因素,骨科手术对预后无显著影响(P=0.233)。结论骨病病灶切除手术可减少并发症,改善生活质量,但对NDMM的PFS、OS无显著影响。

Objective To evaluate the efficacy and prognosis of orthopedic surgical resection surgery in patients with newly diagnosed multiple myeloma(NDMM).Methods This retrospective cohort study collected clinical data of patients with NDMM who underwent surgery due to spinal cord compression or pathological long-bone fractures at the Peking Union Medical College Hospital from 1 January 2003 to 31 December 2021.Patients who received biopsy or vertebroplasty/kyphoplasty were excluded and patients with the same degree of bone disease and who did not undergo any surgical intervention were selected as controls.Visual analogue scale(VAS)and physical status(ECOG)scores,progression-free survival(PFS),and overall survival(OS)were compared.Statistical analysis included the χ^(2)-test,t-test,and Kaplan-Meier methods.Results Baseline data were compared between the surgical group(n=40 with 43 interventions)and the non-surgical group(n=80),and included sex,age,paraprotein type,International Staging System(ISS),number of lytic lesions,cytogenetic abnormalities,first-line treatment,and the proportion of patients receiving autologous stem cell transplantation(ASCT)(all P>0.05).Serum M protein levels in the surgical group were significantly lower than those of the non-surgical group[(21.95±16.44)g/L vs.(36.18±20.85)g/L,P=0.005].The surgical lesions involved the axial skeleton(79.1%,34/43)or the extremities(20.9%,9/43).VAS and ECOG scores improved significantly after surgery(VAS:2.30±0.80 vs.6.60±1.50,P<0.001;ECOG:2.09±0.59 vs.3.09±0.73,P<0.001).The median follow-up time was 51 months.Kaplan-Meier survival analysis suggested that the median PFS(25 vs.29 months)and OS(46 vs.60 months)were comparable between the surgical and non-surgical intervention groups(both P>0.05).Subgroup analysis showed that among patients with ISSⅠor those who had received ASCT,PFS in the surgical group was similar to that of the non-surgical intervention group(both P>0.05),while OS was worse(P=0.005,0.017).Patients with ISS Ⅱ/Ⅲ scores or without ASCT had similar PFS and OS between the surgical and non-surgical intervention groups(all P>0.05).Cox multivariate analysis suggested that ISS and ASCT were independent prognostic factors for OS(ISS:HR=0.42,95%CI 0.19-0.93,P=0.031;ASCT:HR=0.41,95%CI 0.18-0.97,P=0.041),while orthopedic surgery did not influence survival(P=0.233).Conclusion For patients with NDMM,orthopedic surgical resection decreased bone-related complications and improved quality of life,but did not affect survival.