文章：

首次使用苯达莫司汀和维布妥昔单抗作为霍奇金淋巴瘤的挽救治疗：意大利淋巴瘤基金会的一项2期研究

First salvage treatment with bendamustine and brentuximab vedotin in Hodgkin lymphoma: a phase 2 study of the Fondazione Italiana Linfomi

原文发布日期：2019-12-11

DOI: 10.1038/s41408-019-0265-x

类型: Article

开放获取: 是

英文摘要：

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.
 

摘要翻译： 

对于诱导治疗失败且适合进行自体干细胞移植（ASCT）的霍奇金淋巴瘤（HL）患者，需要能够诱导高完全代谢缓解率（CMR）且无明显毒性的有效挽救方案。Brentuximab vedotin（BV）和苯达莫司汀在复发/难治性病例中均为有效的单药疗法，而二者的联合应用（BBV方案）可能增强其疗效。这项单臂多中心2期研究探讨了BBV方案作为首次挽救疗法在40例复发/难治性HL患者中的疗效与安全性。38例患者可进行疗效评估：其中30例（78.9%）达到CMR，2例（5.3%）达到部分缓解，总缓解率（ORR）为84.2%。原发难治性亚组的ORR为75.0%，复发患者组为94.4%。35例患者成功动员外周血干细胞，33例接受了ASCT。中位随访23个月后，预估3年总生存期和无进展生存期分别为88.1%和67.3%。治疗期间仅出现3例IV级中性粒细胞减少症，且均在一周内缓解。未见4级血液外毒性报告，但皮肤反应较为常见（65%）。这些结果表明，BBV方案在难治性HL亚群中展现出令人鼓舞的疗效和可控的毒性。

原文链接：

First salvage treatment with bendamustine and brentuximab vedotin in Hodgkin lymphoma: a phase 2 study of the Fondazione Italiana Linfomi