Objective: To investigate the efficacy and tolerability of Polatuzumab vedotin+rituximab±bendamustine (Pola-(B)R) in relapse/refractory diffuse large B cell lymphoma (R/R DLBCL) patients. Methods: The clinical data of 21 patients enrolled in Chinese Pola compassionate use program (CUP) in 4 centers from November 2019 to August 2020 were collected. There were 15 males and 6 females, and the median age was 56 years (ranged 25-76 years). Of the patients, 10 cases received Pola-BR regimen and the other 11 received Pola-R. Their clinical features, regimens, efficacy, and adverse events (AEs) were retrospectively analyzed. Results: Twenty-one patients with at least one efficacy evaluation were included. At data analysis cut-off point (12 Aug. 2020), the best overall response (BOR) rate was 81.0% (17/21) and the complete response (CR) rate was 19.0% (4/21). Kaplan-Meier survival estimation was performed, at a median follow-up of 54 days, three patients (14.3%) had disease progressed, and 18 patients (85.7%) were censored; the median progression-free survival (mPFS) was estimated to be 148 days. The incidence of adverse effects (AEs) of any grade was higher in Pola-BR group than Pola-R group (80.0% vs 63.6%). However, the incidence of grade 3-4 AEs were close in the two groups (30.0% vs 29.3%). The most common hematological toxicities were thrombocytopenia (28.6%, 6/21), neutropenia (28.6%, 6/21) and anemia (14.3%, 3/21), respectively. One patient with pneumonia and 1 patient with hemophagocytic syndrome recovered after symptomatic treatment. No peripheral neuropathy of grade≥2 was observed. Conclusions: The preliminary data suggested that, for heavily treated Chinese R/R DLBCL, the Pola-(B)R regimen still achieves promising efficacy and tolerable safety.
目的： 分析Polatuzumab vedotin（Pola）联合利妥昔单抗±苯达莫司汀［Pola-（B）R］对复发难治性弥漫大B细胞性淋巴瘤（R/R DLBCL）的疗效及安全性。 方法： 回顾分析2019年11月至2020年8月期间中国Pola同情用药项目（CUP）4个肿瘤中心收治的21例患者资料，其中男15例，女6例；中位年龄56（25~76）岁。10例接受Pola-BR治疗，另外11例仅接受Pola-R治疗。分析其临床特征、用药方案、疗效及不良反应发生情况。 结果： 纳入已接受至少一次疗效评估的21例患者，分析截止于2020年8月12日的数据，最佳总体缓解（BOR）率为81.0%（17/21），完全缓解（CR）率为19.0%（4/21）。用Kaplan-Meier方法估算无进展生存期（PFS），中位随访54 d，发生疾病进展3例（14.3%），删失病例数为18（85.7%），预估中位PFS为148 d。Pola-BR组任何等级的不良反应发生率高于Pola-R组（80.0%比63.6%），但两组3~4级不良反应发生率接近（30.0%比29.3%）。最常见的血液学相关不良反应为：血小板减低（28.6%，6/21）、中性粒细胞减低（28.6%，6/21）及贫血（14.3% 3/21）。1例肺感染及1例合并噬血细胞综合征的患者经对症治疗后康复。所有患者未出现≥2级周围神经病变。 结论： 对于既往多线治疗的中国R/R DLBCL患者，Pola-（B）R方案仍能取得满意的疗效，具有可接受的安全性和耐受性。.