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一项在马来西亚同情用药项目中,对接受基于泊洛妥珠单抗的方案治疗的复发/难治性弥漫性大B细胞淋巴瘤患者结局的多中心真实世界研究。

A Multicenter Real-World Study of Outcomes in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with a Polatuzumab Vedotin-Based Regimen in a Compassionate Use Program in Malaysia.

作者信息

Wahid S Fadilah Abdul, Muhamad Nor Asiah, Ismail Nor Azimah, Rosli Izzah Athirah, Kien Chiang Su, Lim Soo Min, Chew Lee Ping, Kamini Kirubamoorthy, Selvaratnam Veena, Kori Ahlam Naila, Seng Teh Hiok, Ng Soo-Chin

机构信息

Pusat Terapi Sel (PTS), Hospital Canselor Tuanku Muhriz Universiti Kebangsaan Malaysia (HCTM UKM), Kuala Lumpur, Malaysia.

Sector for Evidence-based Healthcare, National Institutes of Health, Ministry of Health Malaysia, Putrajaya, Malaysia.

出版信息

Asia Pac J Clin Oncol. 2025 Jun 27:e14208. doi: 10.1111/ajco.14208.


DOI:10.1111/ajco.14208
PMID:40576066
Abstract

BACKGROUND: Polatuzumab vedotin + bendamustine + rituximab (Pola-BR) was recently approved in Malaysia for treating relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). A multicenter retrospective study was conducted to assess the effectiveness of this regimen among patients in a compassionate use program. OBJECTIVE: To determine treatment response and survival rates for R/R DLBCL patients treated with Pola-BR in Malaysia. METHODOLOGY: Safety and efficacy data of 23 adults with R/R DLBCL treated with Pola-BR at nine centers in Malaysia (September 2019-February 2021) were used. Of the 23 patients, 13 received six cycles of Pola-BR. The median follow-up was 10 months (1-37 months). The primary endpoint was complete response (CR) rate; secondary endpoints were overall survival (OS), progression-free survival (PFS), and adverse events (AEs). RESULTS: The overall response rate was 56.5%, with 34.8% achieving CR. The 1-, 2-, and 3-year OS rates were 51.6%, 51.6%, and 44.2%, respectively, with a median OS of 27 months. The 1- and 2-year PFS rates were 48.2% and 41.3%, respectively, with a median PFS of 10 months; 60% of the nonresponders had progressive disease. Cox proportional hazard regression analysis showed that bulky disease was a significant hazard for disease progression. A total of 42 AEs were recorded, of which 66.7% were grade ≥ 3 AEs; 90.5% of the AEs were hematological and resolved with treatment; only one patient succumbed to neutropenic sepsis. CONCLUSIONS: Pola-BR has a favorable safety profile for R/R DLBCL treatment in Malaysia, although larger sample sizes and longer follow-ups are needed to confirm these results.

摘要

背景:泊洛妥珠单抗维达替尼+苯达莫司汀+利妥昔单抗(Pola-BR)最近在马来西亚被批准用于治疗复发/难治性(R/R)弥漫性大B细胞淋巴瘤(DLBCL)。开展了一项多中心回顾性研究,以评估该方案在一项同情用药计划中的患者中的有效性。 目的:确定在马来西亚接受Pola-BR治疗的R/R DLBCL患者的治疗反应和生存率。 方法:使用了2019年9月至2021年2月在马来西亚9个中心接受Pola-BR治疗的23例R/R DLBCL成人患者的安全性和疗效数据。在这23例患者中,13例接受了6个周期的Pola-BR治疗。中位随访时间为10个月(1-37个月)。主要终点为完全缓解(CR)率;次要终点为总生存期(OS)、无进展生存期(PFS)和不良事件(AE)。 结果:总缓解率为56.5%,34.8%的患者达到CR。1年、2年和3年的OS率分别为51.6%、51.6%和44.2%,中位OS为27个月。1年和2年的PFS率分别为48.2%和41.3%,中位PFS为10个月;60%的无反应者出现疾病进展。Cox比例风险回归分析显示,大包块疾病是疾病进展的显著危险因素。共记录了42例AE,其中66.7%为≥3级AE;90.5%的AE为血液学不良反应,经治疗后缓解;只有1例患者死于中性粒细胞减少性败血症。 结论:在马来西亚,Pola-BR对R/R DLBCL治疗具有良好的安全性,尽管需要更大的样本量和更长的随访时间来证实这些结果。

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[1]
A Multicenter Real-World Study of Outcomes in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma Treated with a Polatuzumab Vedotin-Based Regimen in a Compassionate Use Program in Malaysia.

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