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利妥昔单抗生物类似药 CT-P10(Truxima)联合 CHOP 一线治疗弥漫性大 B 细胞淋巴瘤患者的临床结局:真实世界经验。

The clinical outcomes of rituximab biosimilar CT-P10 (Truxima) with CHOP as first-line treatment for patients with diffuse large B-cell lymphoma: real-world experience.

机构信息

Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

Department of Otolaryngology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.

出版信息

Leuk Lymphoma. 2020 Jul;61(7):1575-1583. doi: 10.1080/10428194.2020.1742906. Epub 2020 Apr 15.

Abstract

We evaluated real-world effectiveness and safety of CT-P10 (Truxima) compared with originator rituximab in diffuse large B-cell lymphoma (DLBCL) treatment. Before and after the introduction of CT-P10 to our institute (November 2017), 221 newly-diagnosed DLBCL patients received rituximab with standard cyclophosphamide, vincristine, doxorubicin and prednisone. Patients received originator rituximab throughout ( = 95), switched from originator rituximab to CT-P10 ( = 36), or received CT-P10 throughout ( = 90). There were no significant differences between groups in overall response rate (91.6% vs 94.4% vs 96.7%, respectively;  = 0.403) or complete response rate (84.2% vs 77.8% vs 86.7%, respectively;  = 0.467). Kaplan-Meier survival curves also showed no significant differences in progression-free survival and overall survival between groups (log-rank  = 0.794 and  = 0.955, respectively). Safety profiles were comparable between treatment groups. These data support the ability of CT-P10 to successfully replace originator rituximab in DLBCL treatment and, given the lowered financial barrier, to improve the overall prognosis for DLBCL patients.

摘要

我们评估了 CT-P10(Truxima)与利妥昔单抗原研药在弥漫性大 B 细胞淋巴瘤(DLBCL)治疗中的真实世界疗效和安全性。在 CT-P10 引入我院(2017 年 11 月)前后,221 例新诊断的 DLBCL 患者接受了利妥昔单抗联合标准环磷酰胺、长春新碱、多柔比星和泼尼松治疗。患者接受了利妥昔单抗原研药( = 95)、从利妥昔单抗原研药转换为 CT-P10( = 36)或全程接受 CT-P10( = 90)治疗。各组之间的总体缓解率(91.6% vs 94.4% vs 96.7%; = 0.403)或完全缓解率(84.2% vs 77.8% vs 86.7%; = 0.467)无显著差异。Kaplan-Meier 生存曲线也显示各组之间无进展生存和总生存无显著差异(对数秩检验  = 0.794 和  = 0.955)。各组之间的安全性特征无显著差异。这些数据支持 CT-P10 成功替代利妥昔单抗原研药用于 DLBCL 治疗,并且由于降低了经济障碍,改善了 DLBCL 患者的总体预后。

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