Yan S, Jin S, Wang P F, Yan L Z, Shang J J, Shi X L, Wu X J, Zhai Y Y, Yao W Q, Wang J, Yao Y, Fu C C
Department of Hematology, the First Affiliated Hospital of Soochow University, Suzhou 215006, China.
Department of Hematology, Soochow Hopes Hematology Hospital, Suzhou 215128, China.
Zhonghua Nei Ke Za Zhi. 2023 Jul 1;62(7):819-825. doi: 10.3760/cma.j.cn112138-20220918-00694.
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). 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. 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 (CD34cells≥2×10/kg) after four courses of VRD regimen was 89.1% (82/92), and the rate of collection (CD34cells≥5×10/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 level) was 82.7% (62/75). 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.
探讨采用VRD（硼替佐米、来那度胺和地塞米松）方案治疗后行自体干细胞移植（ASCT）的70岁及以下新诊断多发性骨髓瘤（MM）患者的干细胞采集率、疗效及安全性。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希望血液病医院符合VRD方案序贯ASCT条件的123例新诊断MM患者的临床资料。对其临床特征、诱导治疗后的疗效、自体干细胞动员方案、自体干细胞采集率以及ASCT的副作用和疗效进行回顾性分析。123例患者中，男性67例。患者中位年龄为56岁（范围：31 - 70岁）。IgG、IgA、IgD和轻链型患者分别占患者总数的47.2%（58/123）、23.6%（29/123）、3.2%（4/123）和26.0%（32/123）。此外，25.2%（31/123）的患者存在肾功能不全（肌酐清除率<40 ml/min）。国际分期系统修订版（R-ISS）Ⅲ期患者占患者总数的18.2%（22/121）。诱导治疗后，部分缓解及以上、非常好的部分缓解（VGPR）及以上、完全缓解（CR）+严格意义的CR率分别为82.1%（101/123）、75.6%（93/123）和45.5%（56/123）。总体而言，90.3%（84/93）的患者采用环磷酰胺+粒细胞集落刺激因子（G-CSF）进行动员，8例因肌酐清除率<30 ml/min采用G-CSF或G-CSF+普乐沙福进行动员，其中1例因疾病进展采用DECP（顺铂、依托泊苷、环磷酰胺和地塞米松）+G-CSF进行动员。VRD方案4个疗程后自体干细胞采集率（CD34细胞≥2×10⁶/kg）为89.1%（82/92），采集率（CD34细胞≥5×10⁶/kg）为56.5%（52/92）。77例患者接受VRD方案序贯ASCT。所有患者均出现4级中性粒细胞减少和血小板减少。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），其次为口腔黏膜炎（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）。在不良事件中，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）、谷丙转氨酶升高（1.3%，1/77）和肛周黏膜炎（1.3%，1/77）；无4级及以上非血液学不良事件。VRD序贯ASCT后达到VGPR及以上的患者比例为100%（75/75），微小残留病阴性（<10⁻⁶水平）的患者比例为82.7%（62/75）。对于采用VRD诱导治疗的70岁及以下新诊断MM患者，自体干细胞采集率良好，随访ASCT后疗效和耐受性良好。
