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Real-life experience with the combination of polatuzumab vedotin, rituximab, and bendamustine in aggressive B-cell lymphomas

机译:具有Polatuzumab Vedotin,Rituximab和Bendamustine在侵袭性B细胞淋巴瘤中的结合的现实生活经验

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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.
机译:移植不合格的复发/难治(rr)弥漫性大B细胞淋巴瘤(DLBCL)患者代表着未满足的医疗需求。Polatuzumab-vedotin(Pola)是一种抗CD79b抗体药物结合物(ADG),与苯达莫司汀-利妥昔单抗(BR)合用,根据GO29365 IIb期试验,最近在美国和欧洲获得了对这些患者的批准。Pola的真实数据极其有限。我们报告了61名希腊患者的结果,他们主要在同情性使用计划中接受Pola-(B)R。治疗周期长达6个21天。由于之前的短暂反应,有三例未使用本达莫司汀。49名rrDLBCL(疗效队列EC)和58名rr侵袭性B-NHL(安全队列SC)患者至少接受了1个Pola-BR周期。21例(43%)EC患者以12/49(25%)CR和9/49(18%)PR作为最佳反应。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%的患者经历了≥3级的不良事件,主要是血液学。治疗中断和治疗期间死亡主要是由于疾病进展。22名(41%)患者接受了进一步治疗;11/22仍然活着,包括一个在CAR-T细胞后,两个在干细胞移植后。我们的数据证实,Pola-BR对rrDLBCL患者是一种很有前途的治疗方法,具有足够的应答率和可接受的毒性。在进一步巩固治疗之前,Pola-BR可作为桥接治疗。

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