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泊洛妥珠单抗、苯达莫司汀和利妥昔单抗用于复发/难治性弥漫性大B细胞淋巴瘤患者,包括作为CAR-T细胞疗法或异基因造血干细胞移植的桥接治疗的结果

[Polatuzumab vedotin, bendamustine, and rituximab in patients with relapsed/refractory diffuse large B-cell lymphoma, including the outcome as a bridging treatment to CAR-T cell therapy or allogeneic hematopoietic stem cell transplant].

作者信息

Morita Yuka, Yagi Yu, Kanemasa Yusuke, Sasaki Yuki, Ishimine Kento, Hayashi Yudai, Mino Mano, Ohigashi An, Tamura Taichi, Nakamura Shohei, Okuya Toshihiro, Shimizuguchi Takuya, Shingai Naoki, Toya Takashi, Shimizu Hiroaki, Najima Yuho, Kobayashi Takeshi, Haraguchi Kyoko, Doki Noriko, Okuyama Yoshiki, Ohashi Kazuteru, Shimoyama Tatsu

机构信息

Department of Medical Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital.

Department of Radiation Oncology, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital.

出版信息

Rinsho Ketsueki. 2023;64(7):586-595. doi: 10.11406/rinketsu.64.586.

Abstract

Pola-BR (polatuzumab vedotin, bendamustine, and rituximab) therapy received approval for relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) in Japan in March 2021. There have been few reports on the efficacy and safety of Pola-BR therapy in Japanese clinical practice. A retrospective analysis was performed on twenty-nine patients with R/R DLBCL who received Pola-BR therapy at our institution (intent to cellular immunotherapy cohort: 20 patients, stand-alone treatment cohort: nine patients). The overall response rate was 69.0% (complete response 27.6%). The median progression-free survival was 5.1 months, with a 9.5-month median overall survival. In the intent to cellular immunotherapy cohort, 11 of 19 patients received chimeric antigen receptor T-cell (CAR-T) infusions, and one patient received allogeneic stem cell transplantation. Four patients received Pola-BR therapy, including bendamustine before leukapheresis, and all produced CAR-T products successfully. 3 of the 28 patients experienced grade3 or higher adverse events, and two required treatment discontinuation. Our single institution, a real-world cohort of R/R DLBCL patients showed high efficacy outcomes and a tolerable toxicity profile for Pola-BR therapy, which is comparable to previous studies. More cases are needed to determine its impact on CAR-T therapy and stem cell transplantation.

摘要

2021年3月,泊洛妥珠单抗-苯达莫司汀-利妥昔单抗(Pola-BR)疗法在日本获批用于复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)。关于Pola-BR疗法在日本临床实践中的疗效和安全性的报道较少。对在我们机构接受Pola-BR疗法的29例R/R DLBCL患者进行了回顾性分析(细胞免疫治疗意向性队列:20例患者,单独治疗队列:9例患者)。总缓解率为69.0%(完全缓解率为27.6%)。中位无进展生存期为5.1个月,中位总生存期为9.5个月。在细胞免疫治疗意向性队列中,19例患者中有11例接受了嵌合抗原受体T细胞(CAR-T)输注,1例患者接受了异基因干细胞移植。4例患者接受了Pola-BR疗法,包括在白细胞分离术前使用苯达莫司汀,所有患者均成功制备了CAR-T产品。28例患者中有3例发生3级或更高等级的不良事件,2例需要停药。我们单机构的R/R DLBCL患者真实世界队列显示,Pola-BR疗法具有高疗效结果和可耐受的毒性特征,与先前的研究相当。需要更多病例来确定其对CAR-T疗法和干细胞移植的影响。

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