First Department of Internal Medicine, Propaedeutic, Haematology Clinical Trial Unit, Laikon General Hospital, National and Kapodistrian University of Athens, Athens, Greece.
Second Department of Internal Medicine, Propaedeutic, Hematology Unit, University General Hospital "Attikon", National and Kapodistrian University of Athens, Athens, Greece.
Hematol Oncol. 2021 Aug;39(3):336-348. doi: 10.1002/hon.2842. Epub 2021 Mar 2.
Transplant-ineligible relapsed/refractory (rr) diffuse large B-cell lymphoma (DLBCL) patients represent an unmet medical need. Polatuzumab vedotin (Pola), an anti-CD79b antibody-drug-conjugate (ADG), with bendamustine- rituximab(BR) has recently gained approval for these patients, both in the USA and Europe, based on the GO29365 phase IIb trial. Real-life data with Pola are extremely limited. We report the outcomes of 61 Greek patients, who received Pola-(B)R mainly within a compassionate use program. Treatment was given for up to six 21-day cycles. Bendamustine was omitted in three cases due to previous short-lived responses. Fourty-nine rrDLBCL(efficacy cohort-EC) and 58 rr aggressive B-NHL (safety cohort-SC) patients received at least 1 Pola-BR cycle. Twenty-one (43%) patients of the EC responded with 12/49 (25%) CR and 9/49 (18%) PR as best response. Median progression-free survival, overall survival and duration of response were 4.0, 8.5, and 8.5 months respectively, while 55% of patients experienced a grade ≥3 adverse event, mainly hematologic. Treatment discontinuations and death during treatment were mainly due to disease progression. Twenty-two (41%) patients received further treatment; 11/22 are still alive, including one after CAR-T cells, and two after stem cell transplantation. Our data confirm that Pola-BR is a promising treatment for rrDLBCL patients, inducing an adequate response rate with acceptable toxicity. Pola-BR could be used as bridging therapy before further consolidative treatments.
不适合移植的复发/难治性（rr）弥漫性大 B 细胞淋巴瘤（DLBCL）患者存在未满足的医疗需求。基于GO29365 期 IIb 试验，一种抗 CD79b 抗体-药物偶联物（ADG），与苯达莫司汀-利妥昔单抗（BR）联合使用的泊洛妥珠单抗（Pola）最近在美国和欧洲均获得批准用于这些患者。关于 Pola 的真实世界数据极为有限。我们报告了 61 名希腊患者的结果，他们主要在同情用药计划内接受了 Pola-(B)R 治疗。治疗最多进行六个 21 天周期。由于先前短暂的反应，有三例患者省略了苯达莫司汀。49 名 rrDLBCL（疗效队列-EC）和 58 名 rr 侵袭性 B-NHL（安全性队列-SC）患者接受了至少 1 个 Pola-BR 周期。EC 中有 21 名（43%）患者有反应，其中 12/49（25%）完全缓解，9/49（18%）部分缓解为最佳反应。中位无进展生存期、总生存期和反应持续时间分别为 4.0、8.5 和 8.5 个月，而 55%的患者发生了≥3 级不良事件，主要为血液学毒性。治疗中断和治疗期间的死亡主要是由于疾病进展。22 名（41%）患者接受了进一步的治疗；22 名中有 11 名仍存活，其中包括 1 名接受 CAR-T 细胞治疗后和 2 名接受干细胞移植后。我们的数据证实，Pola-BR 是 rrDLBCL 患者的一种有前途的治疗方法，可诱导足够的缓解率，且毒性可接受。Pola-BR 可作为进一步巩固治疗前的桥接治疗。
