Ma Y, Xiao X B, Chen X L, Yuan S Z, Lu Y, Zhao S H, Chen J L, Shi G N, Wang Y Q, Cheng N N, Feng P, Ding M S, Huang W R
Department of Lymphoma & Plasma Cell Disease, Senior Department of Hematology, the Fifth Medical Center of PLA General Hospital, Beijing 100071, China.
Zhonghua Xue Ye Xue Za Zhi. 2023 Dec 14;44(12):1016-1021. doi: 10.3760/cma.j.issn.0253-2727.2023.12.008.
This study aimed to evaluate the efficacy and safety of daratumumab as a maintenance treatment after autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with newly diagnosed multiple myeloma (NDMM) . The clinical data, hematological and renal response, and safety of 15 post-transplant patients with NDMM who had received daratumumab maintenance between May 1, 2022 and June 30, 2023 were retrospectively analyzed. Fifteen patients (11 males and 4 females) with a median age of 58 (41-72) years were included. Thirteen patients did not receive daratumumab during induction therapy and auto-HSCT, 6 patients had renal impairment, and nine patients had high-risk cytogenetics. The median infusion of daratumumab was 12 (6-17) times, and the median duration of maintenance was 6 (1.5-12) months. The treatment efficacy was evaluated in all 15 patients, and daratumumab maintenance therapy increased the rate of stringent complete response from 40% to 60%. The renal response rate and median estimated glomerular filtration rate of six patients with RI-NDMM were also improved. During daratumumab maintenance therapy, the most common hematological grade 3 adverse event (AE) was lymphopenia [4 of 15 patients (26.67%) ], whereas the most common nonhematologic AEs were infusion-related reactions [7 of 15 patients (46.67%) ] and grade 3 pneumonia [5 of 15 patients (33.33%) ]. The five patients with pneumonia were daratumumab naive [5 of 13 patients (38.46%) ], with a median of 8 (6-10) infusions. Among them, the chest computed tomography of three patients showed interstitial infiltrates, and treatment with methylprednisolone was effective. With a median follow-up of 12 months, the 1-year overall survival rate was 93.33%, and only one patient died (which was not related to daratumumab treatment) . Daratumumab was safe and effective as a maintenance agent for post-auto-HSCT patients with NDMM, and AEs were controllable. The most common nonhematologic AE was grade 3 pneumonia, and a less dose-intense maintenance regimen for the first 8 weeks could reduce the incidence of pneumonia.
本研究旨在评估达雷妥尤单抗作为新诊断多发性骨髓瘤（NDMM）患者自体造血干细胞移植（auto-HSCT）后维持治疗的疗效和安全性。回顾性分析了2022年5月1日至2023年6月30日期间接受达雷妥尤单抗维持治疗的15例移植后NDMM患者的临床资料、血液学和肾脏反应以及安全性。纳入15例患者（11例男性和4例女性），中位年龄58（41 - 72）岁。13例患者在诱导治疗和auto-HSCT期间未接受达雷妥尤单抗，6例患者有肾功能损害，9例患者有高危细胞遗传学特征。达雷妥尤单抗的中位输注次数为12（6 - 17）次，中位维持时间为6（1.5 - 12）个月。对所有15例患者评估了治疗效果，达雷妥尤单抗维持治疗使严格完全缓解率从40%提高到60%。6例RI-NDMM患者的肾脏反应率和中位估计肾小球滤过率也有所改善。在达雷妥尤单抗维持治疗期间，最常见的血液学3级不良事件（AE）是淋巴细胞减少[15例患者中有4例（26.67%）]，而最常见的非血液学AE是输注相关反应[15例患者中有7例（46.67%）]和3级肺炎[15例患者中有5例（33.33%）]。5例肺炎患者未接受过达雷妥尤单抗治疗[13例患者中有5例（38.46%）]，中位输注次数为8（6 - 10）次。其中3例患者的胸部计算机断层扫描显示间质浸润，甲泼尼龙治疗有效。中位随访12个月，1年总生存率为93.33%，仅1例患者死亡（与达雷妥尤单抗治疗无关）。达雷妥尤单抗作为auto-HSCT后NDMM患者的维持药物是安全有效的，AE可控。最常见的非血液学AE是3级肺炎，前8周采用剂量强度较低的维持方案可降低肺炎的发生率。
