整合brentuximab vedotin为一线治疗晚期古典霍奇金淋巴瘤:第二阶段随机试验的最终分析德国何杰金氏病研究小组。

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Eichenauer DA, Plutschow Kreissl年代,Sokler M,赫尔穆特JC,迈斯纳J, Mathas年代,Topp女士,百灵达K, Klapper W, Kuhnert G, Dietlein M,科比C, Fuchs M, william Diehl V, Engert, Borchmann P

整合brentuximab vedotin为一线治疗晚期古典霍奇金淋巴瘤:第二阶段随机试验的最终分析德国何杰金氏病研究小组。

柳叶刀杂志。2017;12月18日(12):1680 - 1687。doi: 10.1016 / s1470 - 2045 (17) 30696 - 4。Epub 2017 11月10。

PubMed ID
29133014 (在PubMed
]
文摘

背景:一个高比例的古典霍奇金淋巴瘤复发患者实现响应与抗体药物共轭brentuximab vedotin,和药物耐受良好。我们修改了BEACOPP升级方案(eBEACOPP;博来霉素、依托泊苷、阿霉素、环磷酰胺、长春新碱、甲基苄肼和强的松)和实现brentuximab vedotin与旨在减少毒性作用,同时保持协议的有效性。方法:我们做了一个开放、多中心、随机第二阶段学习20个研究地点在德国。年龄在18 - 60岁之间的成人患者(年)与新诊断、先进、古典霍奇金淋巴瘤被随机分配(1:1)治疗6个周期的BrECAPP (brentuximab vedotin 1.8毫克/公斤1天,依托泊苷200毫克/米2 - 4(2)天,阿霉素35毫克/ m(2) 2天,环磷酰胺1250毫克/天(2)2、甲基苄肼100毫克/天2 - 8 m(2),和强的松40毫克/ m(2)天男童或BrECADD (brentuximab vedotin 1.8毫克/公斤1天,依托泊苷150毫克/米2 - 4(2)天,阿霉素40毫克/ m(2) 2天,环磷酰胺1250毫克/米(2)2天,达卡巴嗪250毫克/天3 - 4(2),和地塞米松40毫克天2 - 5)。随机是由分层集中最小化,学习网站和性别分层因素。co-primary端点被完全缓解化疗完全缓解治疗结束时,由意图治疗评估。患者被发现不符合入选标准随机化或没有挑起数据研究两个周期治疗后被排除在分析主要终点。所有参与研究的患者开始治疗是安全应评税。这份报告提出了最终的分析在17个月的随访中值(差13.2—-21.5)。 The preplanned 2-year follow-up analysis is yet to be reported. This trial is registered with ClinicalTrials.gov, number NCT01569204. FINDINGS: Between Oct 26, 2012, and May 15, 2014, 104 patients were enrolled to the study (52 were assigned to each study arm). Two patients dropped out before the start of study treatment because of acute infection (n=1) and withdrawal of consent (n=1) and one patient was excluded because of intermediate-stage disease (all were assigned BrECAPP). 42 (86%, 95% CI 73-94) of 49 patients assigned BrECAPP achieved a complete response after chemotherapy and 46 (94%, 95% CI 83-99) had complete remission as their final treatment outcome. In the BrECADD group, 46 (88%, 95% CI 77-96) of 52 patients achieved both a complete response after chemotherapy and complete remission as their final treatment outcome. 58 serious adverse events were reported, 32 events in 21 of 50 patients who received BrECAPP and 26 events in 18 of 52 patients who received BrECADD. The most common grade 3-4 toxic effects were haematological adverse events (91 [89%] of 102 patients). Grade 3-4 organ toxic effects were reported in seven (17%) of 42 patients assigned BrECAPP and two (4%) of 46 allocated BrECADD. 16 (32%) of 50 patients assigned BrECAPP and 18 (35%) of 52 allocated BrECADD had grade 1-2 peripheral neuropathy, and one (2%) patient assigned BrECAPP developed grade 3 peripheral neuropathy; all but one case (allocated BrECAPP) resolved. No deaths were reported during the follow-up period. INTERPRETATION: Both eBEACOPP variants met the co-primary efficacy endpoints. Particularly, the BrECADD regimen was associated with a more favourable toxicity profile and was, therefore, selected to challenge standard eBEACOPP for the treatment of advanced classical Hodgkin's lymphoma in the phase 3 HD21 study by the German Hodgkin Study Group (NCT02661503), which aims to further reduce treatment-related morbidity. FUNDING: Takeda Pharmaceuticals.

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