Yu Q R, Zhou X, Wu H Y, Hao L M, Li X M, Zhong Y P
School of Clinical Medicine, Weifang Medical University, Weifang 261000, China.
Department of Hematology, Qingdao Municipal Hospital (Group), Qingdao 266071, China.
Zhonghua Yi Xue Za Zhi. 2024 Feb 20;104(7):521-525. doi: 10.3760/cma.j.cn112137-20230928-00605.
To investigate the efficacy and safety in relapsed and refractory multiple myeloma (RRMM) patients with combination regimen of daratumumab. The clinical data of 42 RRMM patients admitted to Qingdao Municipal Hospital from December 2020 to November 2023 were retrospectively analyzed, which included 26 males and 16 females, with a median age of 59 (47, 82) years old. According to the number of courses of treatment with Daratumumab, patients were divided into three groups: long course group (≥9 courses, =21), medium course group (7-8 courses, =12), and short course group (≤6 courses, =9). The deadline for follow-up was November 10, 2023, and the follow-up period was 15.6 (6.0, 34.0) months. After completing at least 2 courses of treatment, patients were evaluated for efficacy, including stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), stable disease (SD), and progressive disease (PD). Basic clinical characteristics of patients, overall response rate of treatment, and adverse reactions were statistically analyzed. Kaplan-Meier method was used to compare the differences of progression-free survival (PFS) in patients with different courses of treatment. Among the 42 patients, 15 (35.7%) had extramedullary disease or plasmacytic leukemia, 7 (16.6%) had amyloidosis, and 18 (42.9%) had renal insufficiency. In Mayo stage, 25 patients (59.5%) were at high risk of myeloma cytogenetic stratification, 8 patients (19%) were standard risk, 9 patients (21.4%) had no cytogenetic data. There were 16 patients with second-line treatment (38.0%), 13 patients with third-line treatment (31%), and 13 patients with more than fourth-line treatment (31%). All patients received at least 2 courses of treatment, achieving the best degree of disease response in 4 cases of sCR (9.5%), 3 cases of CR (7.1%), 10 cases of VGPR (23.8%), 11 cases of PR (26.2%), and 6 cases of MR (14.2%). The overall response rate (ORR) was 80.9% (34/42). The overall response rate was 100% (21/21) in the long course group, 91.6% (11/12) in the medium course group and 22.2% (2/9) in the short course group. Kaplan-Meier survival analysis showed that the duration of PFS was 5.0 (95%: 3.1-6.9) months in the short course group,>8.0 months in the medium course group, and>38.0 months in the long course group, the difference was statistically significant (<0.05). Grade≥3 adverse reactions were mainly neutropenia (3 cases) and thrombocytopenia (1 case). None of the patients discontinued treatment due to adverse reactions. Treatment of RRMM with a regimen containing Daratumumab requires a longer course of treatment to achieve maximum efficacy and the adverse reactions can be controlled.
探讨达雷妥尤单抗联合方案治疗复发难治性多发性骨髓瘤（RRMM）患者的疗效及安全性。回顾性分析2020年12月至2023年11月青岛市市立医院收治的42例RRMM患者的临床资料，其中男性26例，女性16例，中位年龄59（47，82）岁。根据达雷妥尤单抗治疗疗程数，将患者分为三组：长疗程组（≥9疗程，=21例）、中疗程组（7 - 8疗程，=12例）和短疗程组（≤6疗程，=9例）。随访截止时间为2023年11月10日，随访时间为15.6（6.0，34.0）个月。在完成至少2个疗程治疗后，对患者进行疗效评估，包括严格完全缓解（sCR）、完全缓解（CR）、非常好的部分缓解（VGPR）、部分缓解（PR）、最小缓解（MR）、疾病稳定（SD）和疾病进展（PD）。对患者的基本临床特征、治疗总缓解率及不良反应进行统计学分析。采用Kaplan - Meier法比较不同疗程患者无进展生存期（PFS）的差异。42例患者中，15例（35.7%）有髓外病变或浆细胞白血病，7例（16.6%）有淀粉样变性，18例（42.9%）有肾功能不全。在Mayo分期中，25例（59.5%）患者处于骨髓瘤细胞遗传学分层高危，8例（19%）为标准风险，9例（21.4%）无细胞遗传学数据。二线治疗16例（38.0%），三线治疗13例（31%），四线及以上治疗13例（31%）。所有患者均接受至少2个疗程治疗，达到最佳疾病缓解程度的有4例sCR（9.5%）、3例CR（7.1%）、10例VGPR（23.8%）、11例PR（26.2%）和6例MR（14.2%）。总缓解率（ORR）为80.9%（34/42）。长疗程组总缓解率为100%（21/21），中疗程组为91.6%（11/12），短疗程组为2
