A Phase 2/3 Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Lenalidomide Versus Investigator's Choice in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

来那度胺 医学 内科学 中性粒细胞减少症 临床研究阶段 美罗华 临床试验 肿瘤科 耐火材料(行星科学) 临床终点 数据监测委员会 耐受性 不利影响 养生 打开标签 胃肠病学 无进展生存期 发热性中性粒细胞减少症 沙利度胺 外科 随机对照试验 弥漫性大B细胞淋巴瘤 淋巴瘤 多发性骨髓瘤 化疗
作者
Myron S. Czuczman,Marek Trneny,Andrew Davies,Jing Wang,Kim Linton,Nina D. Wagner-Johnston,Randy D. Gascoyne,Graham W. Slack,Pierre Brousset,David A. Eberhard,Francisco J. Hernandez-Ilizaliturri,Gilles Salles,Thomas E. Witzig,Pier Luigi Zinzani,George E. Wright,Louis M. Staudt,Yandan Yang,Paul Williams,Chih-Jian Lih,Jacqueline Russo,Anjan Thakurta,Patrick Hagner,Pierre Fustier,Dale Song,Ian D. Lewis
出处
期刊:Clinical Cancer Research [American Association for Cancer Research]
卷期号:23 (15): 4127-4137 被引量:120
标识
DOI:10.1158/1078-0432.ccr-16-2818
摘要

Abstract Purpose: Randomized, multicenter, open-label, phase 2/3 trial investigating lenalidomide versus investigator's choice (IC) in relapsed/refractory diffuse large B-cell lymphoma (DLBCL). Experimental Design: Patients with DLBCL who received ≥2 prior therapies were stratified by DLBCL subtype [germinal center B-cell (GCB) vs. non-GCB; determined by immunohistochemistry (IHC)] and then randomized 1:1 to lenalidomide (25 mg/day, 21 days of 28-day cycle) or IC (gemcitabine, rituximab, etoposide, or oxaliplatin). Crossover to lenalidomide was permitted for IC-treated patients with radiologically confirmed progressive disease. The primary endpoint was overall response rate (ORR). Progression-free survival (PFS), overall survival, and subtype analysis [GCB vs. activated B-cell (ABC)] using gene expression profiling (GEP) were exploratory endpoints. Results: Stage 1: 102 DLBCL patients (by IHC: non-GCB, n = 54; GCB, n = 48) received ≥1 dose of lenalidomide or IC. Hematologic treatment-emergent adverse events with lenalidomide versus IC included neutropenia (42.6%; 36.4%), anemia (33.3%; 47.3%), thrombocytopenia (24.1%; 43.6%), and leukopenia (5.6%; 12.7%), respectively. Overall, lenalidomide-treated patients had an ORR of 27.5% versus 11.8% in IC (ORRs were similar regardless of IHC-defined DLBCL subtype). Median PFS was increased in patients receiving lenalidomide (13.6 weeks) versus IC (7.9 weeks; P = 0.041), with greater improvements in non-GCB patients (15.1 vs. 7.1 weeks, respectively; P = 0.021) compared with GCB (10.1 vs. 9.0 weeks, respectively; P = 0.550). Conclusions: The clinical benefit of lenalidomide monotherapy in DLBCL patients was more evident in the non-GCB subtype. Exploratory analyses suggest that this preferential benefit was more pronounced in the GEP-defined ABC population, demonstrating a need for additional studies of lenalidomide in DLBCL using GEP subtyping. Clin Cancer Res; 23(15); 4127–37. ©2017 AACR.
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