Zinzani P L, Sasse S, Radford J, Shonukan O, Bonthapally V
Institute of Haematology and Medical Oncology, 'L. & A. Seràgnoli', University of Bologna, Bologna, Italy.
University Hospital of Cologne, Cologne, Germany.
Crit Rev Oncol Hematol. 2015 Sep;95(3):359-69. doi: 10.1016/j.critrevonc.2015.03.011. Epub 2015 Apr 27.
Brentuximab vedotin was made available via a Named Patient Program (NPP) to non-US/Canadian patients with relapsed/refractory (R/R) Hodgkin lymphoma (HL) or systemic anaplastic large-cell lymphoma (sALCL) until approval in their respective countries. We re-evaluated the efficacy and safety NPP data in a pooled analysis. Through a systematic literature review, 21 NPP publications were identified describing 14 cohorts (N=245). Among patients with a specified diagnosis, 207 had HL, 28 had ALCL, and one had CD30+ T-cell lymphoma (not specified). In cohorts reporting response, overall response and complete remission rates were 67% and 26%, respectively, in R/R HL, and 75% and 74%, respectively, in R/R ALCL. Incidences of grade 3/4 neurologic and hematologic toxicities were 6% and 12%, respectively; 5% of patients discontinued because of toxicity. In real-world practice, response rates and tolerability to brentuximab vedotin are similar to those reported in the two pivotal phase 2 trials in these settings.
在其各自国家获批之前，通过指定患者计划（NPP）向复发/难治性（R/R）霍奇金淋巴瘤（HL）或系统性间变性大细胞淋巴瘤（sALCL）的非美国/加拿大患者提供本妥昔单抗。我们在一项汇总分析中重新评估了NPP数据的疗效和安全性。通过系统的文献综述，确定了21篇NPP出版物，描述了14个队列（N=245）。在有明确诊断的患者中，207例患有HL，28例患有ALCL，1例患有CD30+T细胞淋巴瘤（未明确）。在报告缓解情况的队列中，R/R HL的总体缓解率和完全缓解率分别为67%和26%，R/R ALCL的总体缓解率和完全缓解率分别为75%和74%。3/4级神经毒性和血液学毒性的发生率分别为6%和12%；5%的患者因毒性而停药。在实际临床实践中，本妥昔单抗的缓解率和耐受性与在这些情况下的两项关键2期试验中报告的相似。
