Effective salvage options inducing high complete metabolic response (CMR) rates without significant toxicity are needed for Hodgkin lymphoma (HL) patients failing induction treatment and who are candidate to autologous stem cell transplantation (ASCT). Brentuximab vedotin (BV) and bendamustine are active monotherapies in the relapsed/refractory setting and their combination (the BBV regimen) possibly enhances their activity. This single-arm multicenter phase 2 study investigated the efficacy and safety of BBV as first salvage therapy in 40 patients with relapsed/refractory HL. Thirty-eight patients were evaluable for efficacy: 30 (78.9%) had a CMR and 2 (5.3%) a partial response, leading to an overall response rate (ORR) of 84.2%. The ORR in the primary refractory subset was 75.0%, among relapsed patients it was 94.4%. Thirty-five patients could mobilize peripheral blood stem cells and 33 underwent ASCT. At a median follow-up of 23 months, the estimated 3-year overall survival and progression-free survival are 88.1% and 67.3%. During therapy, only 3 grade IV cases of neutropenia occurred and resolved within a week. No grade 4 extrahematologic toxicities were reported; skin reactions were however rather frequent (65%). These results suggest that the BBV regimen exhibits promising efficacy and a manageable toxicity in a challenging subpopulation of HL patients.

中文翻译：

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在霍奇金淋巴瘤中首次使用苯达莫司汀和布仑妥昔单抗维多汀进行挽救治疗：Fondazione Italiana Linfomi的2期研究。

对于未接受诱导治疗且适合自体干细胞移植（ASCT）的霍奇金淋巴瘤（HL）患者，需要有效的挽救选择，以诱导较高的完全代谢反应（CMR）率且无明显毒性。在复发/难治性环境中，Brentuximab vedotin（BV）和苯达莫司汀是有效的单一疗法，它们的组合（BBV方案）可能会增强它们的活性。这项单臂多中心2期研究研究了BBV作为40例复发/难治性HL患者的首次抢救治疗的有效性和安全性。38例患者的疗效可评估：30例（78.9％）发生CMR，2例（5.3％）部分缓解，总体缓解率（ORR）为84.2％。原发性难治性亚组的ORR为75.0％，复发患者为94.4％。35名患者可以动员外周血干细胞，其中33例接受了ASCT。在23个月的中位随访中，估计的3年总生存率和无进展生存率分别为88.1％和67.3％。在治疗期间，仅3例IV级中性粒细胞减少症在一周内发生并消退。尚无4级血液学外毒性的报道。然而，皮肤反应相当频繁（65％）。这些结果表明，BBV方案在具有挑战性的HL患者亚群中显示出有希望的疗效和可控的毒性。尚无4级血液学外毒性的报道。然而，皮肤反应相当频繁（65％）。这些结果表明，BBV方案在具有挑战性的HL患者亚群中显示出有希望的疗效和可控的毒性。尚无4级血液学外毒性的报道。然而，皮肤反应相当频繁（65％）。这些结果表明，BBV方案在具有挑战性的HL患者亚群中显示出有希望的疗效和可控的毒性。