Ren Yuhong, Cheng Luya, Zhuang Jingli, Wang Zhimei, Yuan Ling, Cheng Zhixiang, Ke Yang, Wang Weiguang, Li Jing, Liu Peng
Department of Hematology, Zhongshan Hospital, Fudan University, 180 Fenglin Road, Shanghai, China.
Ann Hematol. 2025 Aug;104(8):4165-4173. doi: 10.1007/s00277-025-06526-4. Epub 2025 Jul 29.
Polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) improved progression-free survival (PFS) of diffuse large B-cell lymphoma (DLBCL) in Polarix study. But little evidence has been provided for patients with lower international prognostic index (IPI) scores or ineligible for clinical trials. We retrospectively enrolled 117 consecutive DLBCL patients aged over 18 years old who received Pola-R-CHP as first-line therapy to investigate efficacy and safety from April 1, 2023, to October 31, 2024. Polatuzumab vedotin was administered 1.8 mg/KG, rituximab 375 mg/m, cyclophosphamide 750 mg/m, doxorubicin 50 mg/m or epirubicin 70 mg/m, all intravenously on Day 1. Prednisone was given 100 mg orally once daily from Day 1 to Day 5. The primary end point was the complete response (CR) rate after 6 cycles. The median age was 56 years old (range: 18-76). Twenty-four (20.5%) patients had an IPI of 0 to 1. Fifty-seven (48.7%) patients were ineligible for Polarix trial. Forty-seven (40.2%) patients received epirubicin instead of doxorubicin. After a median follow-up of 7.1 months (95% CI: 5.967-8.800), CR rate after 6 cycles was 80.6% in all 72 patients who have reached the primary end point, 91.7% in IPI 0-1 subgroup, and 73.5% in Polarix-ineligible subgroup. Lung infection, neutropenia, and leukopenia were the most common grade 3 to 5 adverse events, accounting for 20.5%, 17.9%, and 12.8%. Dose modification of polatuzumab vedotin occurred in 4 patients in Polarix-ineligible group, and 1 in Polarix-eligible group. Pola-R-CHP performed well in first-line Polarix trial-ineligible and IPI 0-1 DLBCL patients with manageable safety.
在Polarix研究中,泊洛妥珠单抗-维泊妥珠单抗、利妥昔单抗、环磷酰胺、多柔比星和泼尼松(Pola-R-CHP)改善了弥漫性大B细胞淋巴瘤(DLBCL)的无进展生存期(PFS)。但对于国际预后指数(IPI)评分较低或不符合临床试验条件的患者,相关证据较少。我们回顾性纳入了117例年龄在18岁以上、接受Pola-R-CHP作为一线治疗的连续性DLBCL患者,以调查2023年4月1日至2024年10月31日期间的疗效和安全性。泊洛妥珠单抗-维泊妥珠单抗的给药剂量为1.8mg/KG,利妥昔单抗为375mg/m²,环磷酰胺为750mg/m²,多柔比星为50mg/m²或表柔比星为70mg/m²,均于第1天静脉注射。泼尼松从第1天至第5天每天口服100mg。主要终点是6个周期后的完全缓解(CR)率。中位年龄为56岁(范围:18-76岁)。24例(20.5%)患者的IPI为0至1。57例(48.7%)患者不符合Polarix试验条件。47例(40.2%)患者接受表柔比星而非多柔比星治疗。在中位随访7.1个月(95%CI:5.967-8.800)后,所有72例达到主要终点的患者中,6个周期后的CR率为80.6%,IPI 0-1亚组为91.7%,不符合Polarix试验条件的亚组为73.5%。肺部感染、中性粒细胞减少和白细胞减少是最常见的3至5级不良事件,分别占20.5%、17.9%和12.8%。不符合Polarix试验条件组有4例患者发生泊洛妥珠单抗-维泊妥珠单抗剂量调整,符合Polarix试验条件组有1例。Pola-R-CHP在一线不符合Polarix试验条件和IPI 0-1的DLBCL患者中表现良好,安全性可控。