利妥昔单抗联合多药化疗治疗初诊 CD20 阳性急性淋巴细胞白血病：一项前瞻性 II 期研究。
Rituximab plus multiagent chemotherapy for newly diagnosed CD20-positive acute lymphoblastic leukemia: a prospective phase II study.
机构信息
Department of Hematology/Oncology, Kyungpook National University Hospital, School of Medicine, Kyungpook National University, Daegu, Korea.
Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
出版信息
Korean J Intern Med. 2023 Sep;38(5):734-746. doi: 10.3904/kjim.2022.401. Epub 2023 Jun 20.
BACKGROUND/AIMS: We performed a prospective study to determine the efficacy and safety of rituximab including chemotherapy in CD20-positive acute lymphoblastic leukemia (ALL).
METHODS
Patients with newly diagnosed ALL, aged ≥ 15 years, were eligible for the study if their leukemic blast cells in bone marrow expressed CD20 ≥ 20% at the time of diagnosis. Patients received multiagent chemotherapy with rituximab. After achieving complete remission (CR), patients received five cycles of consolidation with concomitant rituximab. Rituximab was administered monthly from day 90 of transplantation for patients who received allogeneic hematopoietic cell transplantation.
RESULTS
In patients with Philadelphia (Ph)-negative ALL, 39 of 41 achieved CR (95.1%), the 2- and 4-year relapse-free survival (RFS) rates were 50.4% and 35.7%, and the 2- and 4-year overall survival (OS) rates were 51.5% and 43.2%, respectively. In the group with Ph-positive ALL, all 32 patients achieved CR, the 2- and 4-year RFS rates were 60.7% and 52.1%, and the 2- and 4-year OS rates were 73.3% and 52.3%, respectively. In the Ph-negative ALL group, patients with higher CD20 positivity experienced more favorable RFS (p < 0.001) and OS (p = 0.06) than those with lower CD20 positivity. Patients who received ≥ 2 cycles of rituximab after transplantation had significantly improved RFS (hazard ratio [HR], 0.31; p = 0.049) and OS (HR, 0.29; p = 0.021) compared with those who received < 2 cycles.
CONCLUSION
The addition of rituximab to conventional chemotherapy for CD20-positive ALL is effective and tolerable (Clinicaltrials. gov NCT01429610).
背景/目的：我们进行了一项前瞻性研究，以确定包括化疗在内的利妥昔单抗在 CD20 阳性急性淋巴细胞白血病（ALL）中的疗效和安全性。
方法
本研究纳入了新诊断的 ALL 患者，年龄≥15 岁，如果其骨髓中的白血病原始细胞在诊断时表达 CD20≥20%，则符合研究条件。患者接受包含利妥昔单抗的多药化疗。达到完全缓解（CR）后，患者接受 5 个周期的巩固治疗，并同时给予利妥昔单抗。对于接受异基因造血细胞移植的患者，在移植后第 90 天开始每月给予利妥昔单抗。
结果
在 Ph-阴性 ALL 患者中，41 例患者中有 39 例（95.1%）获得 CR，2 年和 4 年无复发生存（RFS）率分别为 50.4%和 35.7%，2 年和 4 年总生存（OS）率分别为 51.5%和 43.2%。在 Ph 阳性 ALL 患者中，所有 32 例患者均获得 CR，2 年和 4 年 RFS 率分别为 60.7%和 52.1%，2 年和 4 年 OS 率分别为 73.3%和 52.3%。在 Ph-阴性 ALL 组中，CD20 阳性程度较高的患者 RFS（p<0.001）和 OS（p=0.06）更有利。与接受<2 个周期利妥昔单抗治疗的患者相比，接受≥2 个周期利妥昔单抗治疗的患者 RFS（风险比[HR]，0.31；p=0.049）和 OS（HR，0.29；p=0.021）明显改善。
结论
CD20 阳性 ALL 患者在常规化疗的基础上加用利妥昔单抗是有效且耐受良好的（Clinicaltrials.gov NCT01429610）。
Zotero 插件