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Title: [Efficacy and safety of VRD regimen of autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma].
Author: Yan S, Jin S, Wang PF, Yan LZ, Shang JJ, Shi XL, Wu XJ, Zhai YY, Yao WQ, Wang J, Yao Y, Fu CC.
Journal: Zhonghua Nei Ke Za Zhi; 2023 Jul 01; 62(7):819-825. PubMed ID: 37394852.
Abstract:
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. 目的： 探讨70岁及以下初诊多发性骨髓瘤（MM）患者接受VRD方案（硼替佐米、来那度胺联合地塞米松）诱导治疗后自体造血干细胞采集率和行序贯自体造血干细胞移植术的疗效及安全性。 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日在苏州大学附属第一医院和苏州弘慈血液病医院诊治的123例适合行VRD方案序贯自体造血干细胞移植的初诊MM患者的临床资料，回顾性分析其临床特征、诱导治疗后效果、动员自体干细胞方案、自体造血干细胞采集率，以及自体造血干细胞移植的副作用和疗效。 结果： 123例患者中男性67例，中位年龄为56岁（范围31~70岁），IgG、IgA、IgD、轻链型分别占47.2%（58例）、23.6%（29例）、3.2%（4例）、26.0%（32例）；肾功能不全（肌酐清除率<40 ml/min）占25.2%（31例）；修订的国际分期体系（R-ISS分期）Ⅲ期者占18.2%（22/121）。123例患者经过诱导治疗后部分缓解及以上率为82.1%（101例），非常好的部分缓解（VGPR）及以上率为75.6%（93例），完全缓解+严格意义的完全缓解率为45.5%（56例）。90.3%（84/93）患者行环磷酰胺+粒细胞集落刺激因子（G-CSF）动员，8例患者因肌酐清除率<30 ml/min行G-CSF单药动员方案或G-CSF+普乐沙福方案动员，1例患者因疾病进展行DECP（顺铂+依托泊苷+环磷酰胺+地塞米松）+G-CSF方案动员。自体干细胞采集CD34⁺细胞数≥2×10⁶/kg体重的比例为89.1%（82/92），细胞数≥5×10⁶/kg体重的比例为56.5%（52/92）。77例行VRD方案序贯自体造血干细胞移植患者的中性粒细胞减少及血小板计数减少不良反应均达到4级。非血液学不良反应发生率由高到低分别为消化道反应（76.6%，59/77）、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）、心脏相关不良反应（11.7%，9/77）；其中3级不良反应有恶心（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）、输注后血压升高（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反应。自体造血干细胞移植后患者获得VGPR及以上疗效比例为100%（75/75），骨髓流式细胞检测微小残留病灶阴性（<10^-4水平）比例为82.7%（62/75）。 结论： 70岁及以下初诊多发性骨髓瘤患者行VRD诱导治疗后经化疗动员可采集足够自体干细胞，后序贯自体造血干细胞移植具有良好的疗效及耐受性。.

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