Birtas Atesoglu Elif, Gulbas Zafer, Uzay Ant, Ozcan Muhit, Ozkalemkas Fahir, Dal Mehmet Sinan, Kalyon Hakan, Akay Olga Meltem, Deveci Burak, Bekoz Huseyin, Sevindik Omur Gokmen, Toptas Tayfur, Yilmaz Fergun, Koyun Derya, Alkis Nihan, Alacacioglu Inci, Sonmez Mehmet, Yavasoglu Irfan, Tombak Anil, Mehtap Ozgur, Kurnaz Fatih, Yuce Orhan Kemal, Karakus Volkan, Turgut Mehmet, Kurekci Derya Deniz, Ayer Mesut, Keklik Muzaffer, Buyuktas Deram, Ozbalak Murat, Ferhanoglu Burhan
Department of Internal Medicine, Division of Hematology, Koc University School of Medicine, Istanbul, Turkey.
Division of Hematology, Anadolu Medical Center, Kocaeli, Turkey.
Hematol Oncol. 2023 Oct;41(4):663-673. doi: 10.1002/hon.3174. Epub 2023 May 22.
Glofitamab is a CD3xCD20 bi-specific antibody with two fragments directed to the CD20 antigen and a single CD3-binding fragment. Encouraging response and survival rates were recently reported in a pivotal phase II expansion trial conducted in patients with relapsed/refractory (R/R) B-cell lymphoma. However, the real-world data of patients of all ages with no strict selection criteria are still lacking. Herein, this retrospective study aimed to evaluate the outcomes of diffuse large B-cell lymphoma (DLBCL) patients who received glofitamab via compassionate use in Turkey. Forty-three patients from 20 centers who received at least one dose of the treatment were included in this study. The median age was 54 years. The median number of previous therapies was 4, and 23 patients were refractory to first-line treatment. Twenty patients had previously undergone autologous stem cell transplantation. The median follow-up time was 5.7 months. In efficacy-evaluable patients, 21% and 16% of them achieved complete response and partial response, respectively. The median response duration was 6.3 months. The median progression-free survival (PFS) and overall survival (OS) was 3.3 and 8.8 months, respectively. None of the treatment-responsive patients progressed during the study period, and their estimated 1-year PFS and OS rate was 83%. The most frequently reported toxicity was hematological toxicity. Sixteen patients survived, while 27 died at the time of the analysis. The most common cause of death was disease progression. One patient died of cytokine release syndrome during the first cycle after receiving the first dose of glofitamab. Meanwhile, two patients died due to glofitamab-related febrile neutropenia. This is the largest real-world study on the effectiveness and toxicity of glofitamab treatment in R/R DLBCL patients. The median OS of 9 months seems promising in this heavily pretreated group. The toxicity related mortality rates were the primary concerns in this study.
戈利妥单抗是一种CD3×CD20双特异性抗体,有两个片段靶向CD20抗原,一个CD3结合片段。最近在一项针对复发/难治性(R/R)B细胞淋巴瘤患者的关键II期扩展试验中报告了令人鼓舞的缓解率和生存率。然而,目前仍缺乏针对所有年龄、无严格选择标准患者的真实世界数据。在此,这项回顾性研究旨在评估在土耳其通过同情用药接受戈利妥单抗治疗的弥漫性大B细胞淋巴瘤(DLBCL)患者的治疗结果。本研究纳入了来自20个中心的43例接受至少一剂该治疗的患者。中位年龄为54岁。既往治疗的中位次数为4次,23例患者对一线治疗耐药。20例患者此前接受过自体干细胞移植。中位随访时间为5.7个月。在疗效可评估的患者中,分别有21%和16%的患者达到完全缓解和部分缓解。中位缓解持续时间为6.3个月。中位无进展生存期(PFS)和总生存期(OS)分别为3.3个月和8.8个月。在研究期间,所有治疗有反应的患者均未进展,其估计的1年PFS率和OS率为83%。最常报告的毒性是血液学毒性。分析时,16例患者存活,27例死亡。最常见的死亡原因是疾病进展。1例患者在接受第一剂戈利妥单抗后的第一个周期死于细胞因子释放综合征。同时,2例患者死于与戈利妥单抗相关的发热性中性粒细胞减少症。这是关于戈利妥单抗治疗R/R DLBCL患者有效性和毒性的最大规模真实世界研究。在这个经过大量预处理的群体中,9个月的中位OS似乎很有前景。毒性相关死亡率是本研究的主要关注点。
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