[VRD方案自体造血干细胞移植在新诊断多发性骨髓瘤患者中的疗效和安全性]。

S Yan, S Jin, P F Wang, L Z Yan, J J Shang, X L Shi, X J Wu, Y Y Zhai, W Q Yao, J Wang, Y Yao, C C Fu
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引用次数: 0

摘要

目的:探讨70岁及以下新诊断的多发性骨髓瘤(MM)患者采用VRD(硼替佐米、来那度胺和地塞米松)治疗后自体干细胞移植(ASCT)的干细胞收集率、疗效和安全性。方法:回顾性病例系列研究。收集2018年8月1日至2020年6月30日苏州大学第一附属医院和苏州希望血液医院123例符合VRD方案序贯ASCT的新诊断MM患者的临床资料。回顾性分析ASCT的临床特点、诱导治疗后的疗效、自体干细胞动员方案、自体干细胞收集率、不良反应及疗效。结果:123例患者中,男性67例。患者年龄中位数为56岁(范围:31-70岁)。IgG型占47.2% (58/123),IgA型占23.6% (29/123),IgD型占3.2%(4/123),轻链型占26.0%(32/123)。此外,4个疗程VRD方案后,25.2%(31/123)的患者出现肾功能不全(肌酐清除率+细胞≥2×106/kg)为89.1%(82/92),收集率(CD34+细胞≥5×106/kg)为56.5%(52/92)。77例患者接受VRD方案序贯ASCT治疗。所有患者均有4级中性粒细胞减少症和血小板减少症。在ASCT期间的非血液学不良事件中,胃肠道反应发生率最高(76.6%,59/77),其次是口腔黏膜炎(46.8%,36/77)、转氨酶升高(44.2%,34/77)、发热(37.7%,29/77)、感染(16.9%,13/77)和心脏相关不良事件(11.7%,9/77)。不良事件中,3级不良事件包括恶心(6.5%,5/77)、口腔黏膜炎(5.2%,4/77)、呕吐(3.9%,3/77)、感染(2.6%,2/77)、输液后血压升高(2.6%,2/77)、丙氨酸转氨酶升高(1.3%,1/77)、肛周黏膜炎(1.3%,1/77);无4级及以上非血液学不良事件。VRD序贯ASCT术后达到VGPR及以上的患者比例为100%(75/75),最小残留病阴性(-4级)患者比例为82.7%(62/75)。结论:70岁及以下新发MM患者采用VRD诱导治疗,自体干细胞采集率好,随访ASCT后疗效和耐受性良好。
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[Efficacy and safety of VRD regimen of autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma].

Objective: To explore the stem cell collection rate and efficacy and safety of patients aged 70 and below with newly diagnosed multiple myeloma (MM) treated with the VRD (bortezomib, lenalidomide and dexamethasone) regimen followed by autologous stem cell transplantation (ASCT). Methods: Retrospective case series study. The clinical data of 123 patients with newly diagnosed MM from August 1, 2018, to June 30, 2020, at the First Affiliated Hospital of Soochow University and Suzhou Hopes Hematology Hospital, who were eligible for VRD regimen sequential ASCT, were collected. The clinical characteristics, efficacy after induction therapy, mobilization regimen of autologous stem cells, autologous stem cell collection rate, and side effects and efficacy of ASCT were retrospectively analyzed. Results: Of the 123 patients, 67 were males. The median patient age was 56 (range: 31-70) years. Patients with IgG, IgA, IgD, and light-chain types accounted for 47.2% (58/123), 23.6% (29/123), 3.2% (4/123), and 26.0% (32/123) of patients, respectively. In addition, 25.2% (31/123) of patients had renal insufficiency (creatinine clearance rate<40 ml/min). Patients with Revised-International Staging System (R-ISS) Ⅲ accounted for 18.2% (22/121) of patients. After induction therapy, the rates of partial response and above, very-good partial response (VGPR) and above, and complete response (CR)+stringent CR were 82.1% (101/123), 75.6% (93/123), and 45.5% (56/123), respectively. Overall, 90.3% (84/93) of patients were mobilized with cyclophosphamide+granulocyte colony-stimulating factor (G-CSF) and 8 patients with G-CSF or G-CSF+plerixafor due to creatinine clearance rate<30 ml/min and one of them was mobilized with DECP (cisplatin, etoposide, cyclophosphamide and dexamethasone)+G-CSF for progressive disease. The rate of autologous stem cell collection (CD34+cells≥2×106/kg) after four courses of VRD regimen was 89.1% (82/92), and the rate of collection (CD34+cells≥5×106/kg) was 56.5% (52/92). Seventy-seven patients treated with the VRD regimen sequential ASCT. All patients had grade 4 neutropenia and thrombocytopenia. Among the nonhematologic adverse events during ASCT, the highest incidence was observed for gastrointestinal reactions (76.6%, 59/77), followed by oral mucositis (46.8%, 36/77), elevated aminotransferases (44.2%, 34/77), fever (37.7%, 29/77), infection (16.9%, 13/77) and heart-related adverse events (11.7%, 9/77). Among the adverse events, grade 3 adverse events included nausea (6.5%, 5/77), oral mucositis (5.2%, 4/77), vomiting (3.9%, 3/77), infection (2.6%, 2/77), elevated blood pressure after infusion (2.6%, 2/77), elevated alanine transaminase (1.3%, 1/77), and perianal mucositis (1.3%, 1/77); there were no grade 4 or above nonhematologic adverse events. The proportion of patients who achieved VGPR and above after VRD sequential ASCT was 100% (75/75), and the proportion of patients who were minimal residual disease-negative (<10-4 level) was 82.7% (62/75). Conclusion: In patients aged 70 and below with newly diagnosed MM treated with VRD induction therapy, the collection rate of autologous stem cells was good, and good efficacy and tolerability were noted after follow-up ASCT.

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