Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma:: Safety and efficacy of re-treatment
Rituximab anti-CD20 monoclonal antibody therapy in non-Hodgkin's lymphoma:: Safety and efficacy of re-treatment
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DOI：
10.1200/jco.2000.18.17.3135
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发表时间：
2000-09-01
影响因子：
45.3
通讯作者：
Levy, R
中科院分区：
文献类型：
--
作者：
Davis, TA;Grillo-López, AJ;Levy, R
目的：这项 II 期试验研究了利妥昔单抗（一种嵌合抗 CD20 单克隆抗体）对利妥昔单抗治疗有反应后复发的低度或滤泡性非霍奇金淋巴瘤患者进行再治疗的安全性和有效性。 患者和方法： 58 名患者参加了本研究，其中 2 名患者在研究中接受了再治疗。患者每周接受静脉输注 375 mg/m(2) 利妥昔单抗，持续 4 周。所有患者均接受过至少两次既往治疗，并接受过至少一个先前的利妥昔单抗疗程，利妥昔单抗疗程之间的中位间隔为 14.5 个月。 结果：Mort 不良事件 (AE) 是治疗期间发生的短暂 1 级或 2 级事件。未观察到临床上显着的骨髓抑制；血液学毒性一般较轻且可逆，治疗后没有患者产生人抗嵌合抗体，本研究中AE的类型、频率和严重程度与利妥昔单抗III期试验中报告的没有明显差异，57名可评估患者的总体缓解率为40%（11%完全缓解和30%部分缓解），尚未达到缓解者的中位进展时间（TTP）和中位缓解持续时间（DR），但Kaplan-Meier 估计中位数分别为 17.8 个月（范围为 5.4+ 至 26.6 个月）和 16.3 个月（范围为 3.71+ 至 25.1 个月）。这些估计的中位数长于患者之前的利妥昔单抗疗程（TTP 和 DR 分别为 12.4 和 9.8 个月，P >.1）和之前报道的 III 期试验（应答者的 TTP 和 DR 分别为 13.2 和 11.6 个月）中达到的中位数。 23 名应答者中的 7 名正在进行应答。结论：在这个再治疗人群中，安全性和有效性与初始利妥昔单抗暴露后没有明显不同。 (C) 2000 年美国临床肿瘤学会。
Purpose: This phase II trial investigated the safety and efficacy of re-treatment with rituximab, a chimeric anti-CD20 monoclonal antibody, in patients with low-grade or follicular non-Hodgkin's lymphoma who relapsed after a response to rituximab therapy.Patients and Methods: Fifty-eight patients were enrolled onto this study, and two were re-treated within the study. patients received an intravenous infusion of 375 mg/m(2) of rituximab weekly for 4 weeks. All patients had at least two prior therapies and had received at least one prior course of rituximab, with a median interval of 14.5 months between rituximab courses.Results: Mort adverse experiences (AEs) were transient grade 1 or 2 events occurring during the treatment period. Clinically significant myelosuppression was not observed; hematologic toxicity was generally mild and reversible, No patient developed human antichimeric antibodies after treatment, The type, frequency, and severity of AEs in this study were not apparently differ-ent from those reported in the phase III trial of rituximab, The overall response rate in 57 assessable patients was 40% (11% complete response and 30% partial responses), Median time to progression (TTP) in responders and median duration of response (DR) have not been reached, but Kaplan-Meier estimated medians are 17.8 months (range, 5.4+ to 26.6 months) and 16.3 months (range, 3.71+ to 25.1 months), respectively. These estimated medians are longer than the medians achieved in the patients' prior course of rituximab (TTP and DR of 12.4 and 9.8 months, respectively, P >.1) and in a previously reported phase III trial (TTP in responders and DR of 13.2 and 11.6 months, respectively). Responses are ongoing in seven of 23 responders.Conclusion: In this re-treatment population, safety and efficacy were not apparently different from those after initial rituximab exposure. (C) 2000 by American Society of Clinical Oncology.