Abstract:
This systematic literature review evaluated frontline treatment burden in pediatric and adolescent/young adult (AYA) patients with high-risk classical Hodgkin lymphoma (cHL) among studies originating from the United States. Data were extracted from 32 publications (screened: total, n = 3115; full-text, n = 98) representing 12 studies (randomized controlled trials [RCTs], n = 2; non-comparative, non-randomized, n = 7; observational, n = 3). High-risk disease definitions varied across studies. Five-year event-free survival (EFS)/progression-free survival (PFS) was 86%-100% and 79%-94%, and complete response rates were 35%-100% and 5%-64% for brentuximab vedotin (BV)-containing and chemotherapy-alone regimens, respectively. In identified RCTs, BV-containing compared with chemotherapy-alone regimens demonstrated significantly longer 3-year EFS/5-year PFS. Hematological and peripheral neuropathy were the most commonly reported adverse events of interest, although safety data were inconsistently reported. Few studies evaluated humanistic and no studies evaluated economic burden. Results from studies with the highest quality of evidence indicate an EFS/PFS benefit for frontline BV-containing versus chemotherapy-alone regimens for pediatric/AYA patients with high-risk cHL.
摘要:
这项系统的文献综述评估了来自美国的研究中,患有高风险经典霍奇金淋巴瘤(cHL)的儿童和青少年/年轻成人(AYA)患者的一线治疗负担。数据来自32份出版物(筛选:总计,n=3115;全文,n=98)代表12项研究(随机对照试验[RCTs],n=2;非比较性,非随机化,n=7;观察性,n=3)。高风险疾病的定义因研究而异。五年无事件生存率(EFS)/无进展生存率(PFS)分别为86%-100%和79%-94%,对于含有维多丁(BV)的本妥昔单抗和单独化疗方案,完全缓解率为35%-100%和5%-64%,分别。在确定的随机对照试验中,与单独化疗方案相比,含BV方案显示3年EFS/5年PFS明显更长。血液病和周围神经病变是最常见的不良事件。尽管安全性数据报告不一致.很少有研究评估人文主义,也没有研究评估经济负担。来自具有最高证据质量的研究的结果表明,对于高风险cHL的儿科/AYA患者,一线含BV方案与单独化疗方案相比,EFS/PFS获益。