Yao W Q, Yan L Z, Shang J J, Jin S, Shi X L, Yan S, Yan Z, Wang Q Q, Fu C C, Wu D P
The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology, Suzhou 215000, China.
Zhonghua Xue Ye Xue Za Zhi. 2022 Aug 14;43(8):657-662. doi: 10.3760/cma.j.issn.0253-2727.2022.08.007.
This study aimed to evaluate the efficacy and safety of lenalidomide combined with bortezomib and dexamethasone (VRD) in the treatment of newly diagnosed multiple myeloma (MM) . A total of 150 newly diagnosed patients with MM diagnosed in The First Affiliated Hospital of Soochow University from November 2018 to February 2021 and received VRD as the induction regimen were included to evaluate the safety and efficacy of VRD induction therapy for newly diagnosed MM. The median follow-up was 22 months, two patients (1.3%) died early after treatment, and 148 patients (98.7%) completed induction therapy. 116 patients (77.3%) were mobilized to collect autologous hematopoietic stem cells, 101 cases (87.1%) were qualified in the collection, of which 48 cases (41.4%) were excellent in the collection. The 3-year progression-free survival (PFS) rate was 59%, and the 3-year overall survival (OS) rate was 83%. After induction, complete remission (CR) /stringent CR rate was 54.4%, ≥ very good partial remission rate was 77.3%, overall response rate was 86.0%, and minimal residual disease negative rate was 46.0%. There was no statistically significant difference in the efficacy of cytogenetic high-risk patients compared with standard risk patients (=0.456) . The median PFS time of cytogenetic high-risk patients was shorter than that of standard risk patients (not reached 33 months, =0.014) . There was no statistically significant difference in the median OS time (not reached not reached, =0.072) . The highest incidence of hematological adverse events was thrombocytopenia (72%) , followed by neutropenia (42%) and anemia (20%) . The highest incidence of non-hematological adverse events was peripheral neuritis (56.7%) . The main digestive tract symptoms include constipation (30.0%) and diarrhea (17.3%) . Upper respiratory tract infection (23.3%) and lung infection (7.3%) are the main infections. The incidence of adverse thrombocytopenia (90.0% 63.7%, =0.001) , neutropenia (54.2% 36.3%, =0.038) , anemia (33.3% 13.7%, =0.005) , diarrhea (27.1% 12.7%, =0.030) , limb edema (20.8% 3.9%, =0.030) , fever (20.8% 4.9%, =0.006) , thrombosis (8.3% 0, =0.016) , and renal function deterioration (20.8% 3.9%, =0.030) in patients with renal insufficiency was higher than that in patients with normal renal function. The VRD regimen has a significant effect on newly diagnosed MM, does not affect the hematopoietic stem cell collection, and has controllable adverse events; however, the incidence of adverse events was higher in patients with renal insufficiency.
本研究旨在评估来那度胺联合硼替佐米及地塞米松(VRD)治疗新诊断多发性骨髓瘤(MM)的疗效及安全性。纳入2018年11月至2021年2月在苏州大学附属第一医院确诊的150例新诊断MM患者,均接受VRD作为诱导方案,以评估VRD诱导治疗新诊断MM的安全性和疗效。中位随访时间为22个月,2例患者(1.3%)治疗后早期死亡,148例患者(98.7%)完成诱导治疗。116例患者(77.3%)进行了自体造血干细胞动员采集,101例(87.1%)采集合格,其中48例(41.4%)采集优良。3年无进展生存(PFS)率为59%,3年总生存(OS)率为83%。诱导治疗后,完全缓解(CR)/严格CR率为54.4%,≥非常好的部分缓解率为77.3%,总缓解率为86.0%,微小残留病阴性率为46.0%。细胞遗传学高危患者与标准风险患者的疗效无统计学显著差异(P = 0.456)。细胞遗传学高危患者的中位PFS时间短于标准风险患者(未达到vs 33个月,P = 0.014)。中位OS时间无统计学显著差异(未达到vs未达到,P = 0.072)。血液学不良事件发生率最高的是血小板减少(72%),其次是中性粒细胞减少(42%)和贫血(20%)。非血液学不良事件发生率最高的是周围神经炎(56.7%)。主要消化道症状包括便秘(30.0%)和腹泻(17.3%)。上呼吸道感染(23.3%)和肺部感染(7.3%)是主要感染。肾功能不全患者血小板减少(90.0% vs 63.7%,P = 0.001)、中性粒细胞减少(54.2% vs 36.3%,P = 0.038)、贫血(33.3% vs 13.7%,P = 0.005)、腹泻(27.1% vs 12.7%,P = 0.030)、肢体水肿(20.8% vs 3.9%,P = 0.030)、发热(20.8% vs 4.9%,P = 0.006)、血栓形成(8.3% vs 0,P = 0.016)及肾功能恶化(20.8% vs 3.9%,P = 0.030)的发生率高于肾功能正常患者。VRD方案对新诊断MM有显著疗效,不影响造血干细胞采集,不良事件可控;然而,肾功能不全患者不良事件发生率更高。