Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
Venetoclax-Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia
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DOI：
10.1056/nejmoa1713976
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发表时间：
2018-03-22
影响因子：
158.5
通讯作者：
Kater, A. P.
中科院分区：
文献类型：
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作者：
Seymour, J. F.;Kipps, T. J.;Kater, A. P.
背景：VENTOCLAX抑制BCL2，这是一种在病理上过度表达的抗凋亡蛋白，对慢性淋巴细胞白血病细胞的生存至关重要。方法：在这项随机开放的3期试验中，我们随机将389名患者分为两组，分别接受维奈替克和利妥昔单抗治疗2年(从第1周期的第1天开始)或苯达莫司汀加利妥昔单抗治疗6个月(苯达莫司汀-利妥昔单抗组)。试验设计不包括苯达莫司汀-利妥昔单抗组中进展的患者交叉到万乃馨加利妥昔单抗。结果经过23.8个月的中位随访期，维那普利妥昔单抗组(194名患者发生32个进展或死亡事件)的无进展生存率显著高于苯达莫司汀-利妥昔单抗组(195名患者114个事件)；2年无进展生存率分别为84.9%和36.3%(进展或死亡风险比为0.17；95%可信区间[CI]为0.11~0.25；P
BACKGROUNDVenetoclax inhibits BCL2, an antiapoptotic protein that is pathologically overexpressed and that is central to the survival of chronic lymphocytic leukemia cells. We evaluated the efficacy of venetoclax in combination with rituximab in patients with relapsed or refractory chronic lymphocytic leukemia.METHODSIn this randomized, open-label, phase 3 trial, we randomly assigned 389 patients to receive venetoclax for up to 2 years (from day 1 of cycle 1) plus rituximab for the first 6 months (venetoclax-rituximab group) or bendamustine plus rituximab for 6 months (bendamustine-rituximab group). The trial design did not include crossover to venetoclax plus rituximab for patients in the bendamustine-rituximab group in whom progression occurred. The primary end point was investigator-assessed progression-free survival.RESULTSAfter a median follow-up period of 23.8 months, the rate of investigator-assessed progression-free survival was significantly higher in the venetoclax-rituximab group (32 events of progression or death in 194 patients) than in the bendamustine-rituximab group (114 events in 195 patients); the 2-year rates of progression-free survival were 84.9% and 36.3%, respectively (hazard ratio for progression or death, 0.17; 95% confidence interval [CI], 0.11 to 0.25; P