摘要
目的 探讨应用沙利度胺、亚砷酸、地塞米松、维生素C(thalidomide, arsenic trioxide, dexamethasone, ascorbic acid, TADA)方案治疗多发性骨髓瘤(multiple myeloma, MM)早期复发患者(初治达缓解后12个月内肿瘤再次进展)的疗效及安全性。方法 本研究回顾性分析2008—2020年间就诊于延边大学附属医院血液内科的62例接受TADA化疗方案和57例接受硼替佐米、来那度胺、地塞米松(velcade, revlimid, dexamethasone, VRD)化疗方案的MM早期复发患者。收集所有患者的一般资料、治疗3个疗程期间的随访资料、化疗前后的实验室数据。通过总缓解率(overall response rate, ORR)和完全缓解率(complete response rate, CRR)评估患者的疗效,并收集不良反应的发生情况进行统计分析。绘制TADA组和VRD组在不同肾功能情况、细胞遗传学不同危险度分层、不同国际分期系统(International Staging System, ISS)下的Kaplan-Meier曲线,分析TADA化疗方案患者的预后。结果 两组患者在年龄、性别、免疫化学亚型、ISS分期和高危FISH指标上均无统计学差异(P>0.05)。化疗后,TADA组患者的血红蛋白和血清白蛋白显著低于VRD组,而血钙、血β2微球蛋白、肌酐、骨髓浆细胞比例显著高于VRD组(P<0.05)。此外,周围神经病变发生率显著低于VRD组(P<0.05),其他不良反应无统计学差异(P>0.05)。TADA组与VRD组相比,总生存期(overall survival, OS)(χ2=8.201,P=0.004)、无进展生存期(progression free survival, PFS)(χ2=7.568,P=0.006)生存曲线具有统计学意义;TADA组入组时肾功能正常与肾功能受损患者OS(χ2=3.924,P=0.048)以及PFS(χ2=9.008,P=0.003)、入组时ISSⅠ/Ⅱ期和ISSⅢ期OS(χ2=9.330,P=0.002)以及PFS(χ2=16.090,P<0.001)、入组时高危细胞遗传学(FISH)和非高危患者OS(χ2=10.149,P<0.001)以及PFS (χ2=11.286,P<0.001)生存曲线结果差异有统计学意义。结论 TADA方案对MM早期复发患者具有较好的疗效和安全性,肾功能、ISS分期和FISH分层是影响患者预后的重要因素。
Objective To explore the efficacy and safety of thalidomide,arsenic trioxide,dexamethasone and ascorbic acid(TADA)regimen in the treatment of early relapsed multiple myeloma(MM)patients(tumor progression within 12 months after initial treatment).Methods This study retrospectively analyzed 62 patients on TADA chemotherapy regimen and 57 patients on bortezomib,lenalidomide,dexamethasone(velcade,revlimid,dexamethasone,VRD)chemotherapy regimen for multiple myeloma(MM)in early stage relapse,who visited the Department of Hematology of Yanbian University Hospital between 2008 and 2020.We collected the general data profile,follow-up data during 3 courses of treatment,and laboratory data of all patients before and after chemotherapy.The efficacy of the patients was assessed by overall response rate(ORR)and complete response rate(CRR),and the occurrence of adverse reactions was collected for statistical analysis.Kaplan-Meier curves were plotted for the TADA and VRD groups under different renal function conditions,cytogenetically different risk stratification,and different ISS scenarios;the prognosis of patients on the TADA chemotherapy regimen was analyzed.Results There were no statistical differences in age,gender,immunochemical subtypes,ISS staging and high-risk FISH indicators between the two groups(P>0.05).After chemotherapy,the haemoglobin and serum albumin of patients in the TADA group were significantly lower than those in the VRD group,whereas the percentage of blood calcium,bloodβ2 microglobulin,creatinine and bone marrow plasma cells were significantly higher than those in the VRD group(P<0.05).In addition,the incidence of peripheral neuropathy was significantly lower than that in the VRD group(P<0.05),and there was no statistically significant difference in other adverse reactions(P>0.05).The two groups of patients were comparable at the baseline level,and patients in the TADA group had significantly better overall efficiency,hemoglobin,blood calcium,bloodβ2-microglobulin,and bone marrow plasma cell ratio after chemotherapy than those in the VRD group(P<0.05),whereas the incidence of peripheral neuropathy was significantly lower than that in the VRD group(P<0.05);there was no statistically significant difference in the other adverse effects(P>0.05).Compared with those in the VRD group,the overall survival(OS)(χ2=8.201,P=0.004)and progression free survival(PFS)(χ2=7.568,P=0.006)survival curves were statistically significant in the TADA group.In the TADA group OS(χ2=3.924,P=0.048)in patients with normal and impaired renal function at the time of enrolment and PFS(χ2=9.008,P=0.003),OS(χ2=9.330,P=0.002)and PFS(χ2=16.090,P<0.001)in ISS stageⅠ/Ⅱand ISS stageⅢat enrolment,OS(χ2=10.149,P<0.001)in high-risk FISH a nd non-high-risk patients at enrolment and PFS(χ2=11.286,P<0.001)survival curve results showed statistically significant differences.Conclusion The TADA regimen has better efficacy and safety in patients with early recurrence of MM.Renal function,ISS staging and FISH stratification are important factors affecting patients’prognosis.
作者
李媚婷
朴哲
崔文昊
王阔
马天泽
LI Meiting;PIAO Zhe;CUI Wenhao;WANG Kuo;MA Tianze(Department of Diagnostics,Faculty of Medicine,Luohe Medical College,Luohe 462000;Department of Hematology,Affiliated Hospital of Yanbian University,Yanbian 133002;Jilin University,Changchun 130015,China)
出处
《西安交通大学学报（医学版）》
CAS
CSCD
北大核心
2024年第4期637-644,共8页
Journal of Xi’an Jiaotong University（Medical Sciences）
基金
国家自然科学基金资助项目(No.81700205)。
作者简介
通信作者:马天泽,教授.E-mail:tianze70@163.com。
