First Department of Medicine, Charles University and General University Hospital, Prague, Czech Republic.
Department of Hematology and Oncology, Faculty of Medicine, Masaryk University and University Hospital, Brno, Czech Republic.
Eur J Haematol. 2022 Aug;109(2):162-165. doi: 10.1111/ejh.13784. Epub 2022 May 11.
Polatuzumab vedotin with bendamustine and rituximab (Pola-BR) was approved for treatment of transplant-ineligible patients with relapsed/refractory DLBCL (R/R DLBCL). However, the number of patients treated in the GO29365 trial including the extension cohort was limited, and more data evaluating the efficacy of this treatment regimen is needed.
We analyzed 21 patients with R/R DLBCL to determine real-life efficacy and safety of Pola-BR regimen. Data of all patients entered the database of the NiHiL project (NCT03199066).
Median overall survival was 8.7 months, and progression-free survival 3.8 months. The overall response rate was 33%. Grade 3-4 neutropenia was detected in 29%, thrombocytopenia in 38%, anemia in 19%, infections in 24% cases, and peripheral neuropathy in 5%. Discontinuation of treatment was caused by progression in 50%, adverse events in 31%, and intended bridging to CAR-T therapy in 19%.
Although the outcome of patients is worse than in GO29365 trial, the use of Pola-BR regimen in the real world demonstrates tolerable toxicity profile and efficacy in transplant-ineligible patients with R/R DLBCL. Moreover, this regimen might represent a perspective option as a bridge to CAR-T therapy.
泊洛妥珠单抗联合苯达莫司汀和利妥昔单抗(Pola-BR)获批用于治疗不适合移植的复发/难治性弥漫性大 B 细胞淋巴瘤(R/R DLBCL)患者。然而,GO29365 试验包括扩展队列的治疗患者数量有限,需要更多数据来评估该治疗方案的疗效。
我们分析了 21 例 R/R DLBCL 患者,以确定 Pola-BR 方案的真实疗效和安全性。所有患者的数据均纳入 NiHiL 项目数据库(NCT03199066)。
中位总生存期为 8.7 个月,无进展生存期为 3.8 个月。总缓解率为 33%。3-4 级中性粒细胞减少症发生率为 29%,血小板减少症发生率为 38%,贫血发生率为 19%,感染发生率为 24%,周围神经病变发生率为 5%。治疗中断的原因是疾病进展(50%)、不良事件(31%)和计划桥接 CAR-T 治疗(19%)。
尽管患者的结局不如 GO29365 试验,但在真实世界中使用 Pola-BR 方案在不适合移植的 R/R DLBCL 患者中显示出可耐受的毒性特征和疗效。此外,该方案可能是一种有前途的桥接 CAR-T 治疗的选择。