Ren Yuhong, Tan Hui, Zhuang Jingli, Cheng Luya, Yuan Ling, Ji Lili, Ke Yang, Zhang Xuejiao, Cheng Zhixiang, Li Jing, Liu Peng
Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, China.
Department of Nuclear Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
Ann Hematol. 2025 May 16. doi: 10.1007/s00277-025-06412-z.
First-line treatment balancing efficacy and safety is urgently needed for frail and elderly diffuse large B-cell lymphoma (DLBCL) patients. We designed a triplet chemo-light regimen, Pola-ZR, in previously untreated frail and elderly DLBCL patients to assess the efficacy and safety in a prospective DLBCL cohort (NCT06203652). Polatuzumab vedotin was given 1.8 mg/KG intravenously on day 1, zanubrutinib 160 mg twice a day orally from day 1 to day 21, and rituximab 375 mg/m intravenously on day 1. Twenty-one days were a cycle. If assessed complete response (CR) after 6 cycles, patients would receive zanubrutinib alone for another 6 cycles. PET/CT or contrast-enhanced CT scan was scheduled every 3 cycles. The primary end point was overall response rate (ORR) after 6 cycles. Twenty-four patients were enrolled from 01 Apr 2023 to 20 Dec 2023. Median age was 73. Sixteen (66.7%) patients had an international prognostic index score of 3 to 5. After a median follow-up of 10.2 months, the CR rate and ORR after 6 cycles was 83% and 83%. Non-responders had high total metabolic tumour volume. Lung infection was the major safety concern. PJP prophylaxis was recommended. Pola-ZR regimen showed rapid and deep response with manageable safety profiles in both GCB and non-GCB subtypes.
对于体弱和老年弥漫性大B细胞淋巴瘤（DLBCL）患者，迫切需要一种平衡疗效和安全性的一线治疗方案。我们为先前未接受治疗的体弱和老年DLBCL患者设计了一种三联轻化疗方案Pola-ZR，以在前瞻性DLBCL队列（NCT06203652）中评估其疗效和安全性。第1天静脉注射1.8mg/KG的泊洛妥珠单抗，第1天至第21天每天口服两次160mg的泽布替尼，第1天静脉注射375mg/m²的利妥昔单抗。21天为一个周期。如果在6个周期后评估为完全缓解（CR），患者将再接受6个周期的单药泽布替尼治疗。每3个周期安排一次PET/CT或增强CT扫描。主要终点是6个周期后的总缓解率（ORR）。从2023年4月1日至2023年12月20日共纳入24例患者。中位年龄为73岁。16例（66.7%）患者的国际预后指数评分为3至5分。中位随访10.2个月后，6个周期后的CR率和ORR均为83%。无反应者的总代谢肿瘤体积较高。肺部感染是主要的安全问题。建议进行肺孢子菌肺炎（PJP）预防。Pola-ZR方案在GCB和非GCB亚型中均显示出快速且深度的反应，安全性可控。
