Safety and efficacy of Ofatumumab in chronic lymphocytic leukemia: a systematic review and meta-analysis
Safety and efficacy of Ofatumumab in chronic lymphocytic leukemia: a systematic review and meta-analysis
复制标题
奥法木单抗治疗慢性淋巴细胞白血病的安全性和有效性：系统评价和荟萃分析
作者：
Yougen Wu;Yang Wang;Yuting Gu;J. Xia;Xiaoyang Kong;Qingqing Qian;Yang Hong
摘要目的：已经进行了越来越多的临床研究，以研究奥法木单抗对慢性淋巴细胞白血病（CLL）患者的治疗效果，但尚未有研究报告治疗效果的汇总估计值。我们对来自13项临床试验的证据进行了荟萃分析，以评估基于奥法木单抗治疗CLL患者的有效性和安全性。方法：检索PubMed、Web of Science、Embase和ClinicalTrials.gov的相关文献。主要疗效结局为无进展生存期（PFS）和总生存期（OS）。第二个终点是不良事件。结果如下：汇总疗效分析显示，PFS [风险比（HR）= 0.88，95%置信区间（CI）= 0.47-1.63，p = 0.677，I2 = 94.9%]和OS无显著差异（HR = 0.97，95% CI = 0.70-1.36，p = 0.878，I2 = 58.7%）。汇总毒性分析显示，与非奥法木单抗治疗相比，奥法木单抗治疗与输注相关反应风险增加相关，但血小板减少和贫血风险降低。此外，感染和输注相关反应在单项奥法木单抗研究的受试者中发生率更高。讨论内容：我们的分析显示，与基于观察或化疗的方案组相比，基于奥法木单抗的治疗（包括奥法木单抗单药治疗、奥法木单抗联合化疗）治疗CLL的PFS在统计学上显著改善。奥法木单抗对CLL患者的OS没有统计学显着改善。除输注相关反应和感染外，以奥法木单抗为基础的治疗总体上可降低不良反应的风险。
ABSTRACT Objectives: Increasing numbers of clinical studies have been carried out to investigate the therapeutic effect of Ofatumumab for patients with chronic lymphocytic leukemia (CLL) but no studies have yet reported a pooled estimate of the treatment effect. We performed a meta-analysis of evidence from 13 clinical trials to assess effectiveness and safety of Ofatumumab-based therapy in patients with CLL. Methods: Relevant publications from PubMed, Web of Science, Embase, and ClinicalTrials.gov were searched. The primary efficacy outcomes were progression-free survival (PFS) and overall survival (OS). The second endpoint was the adverse events. Results: The pooled efficacy analysis showed that there were no significant difference in PFS [hazard ratios (HR) = 0.88, 95% confidence interval (CI) = 0.47–1.63, p = 0.677, I2 = 94.9%] and OS (HR = 0.97, 95% CI = 0.70–1.36, p = 0.878, I2 = 58.7%) between Ofatumumab-based therapy and non-Ofatumumab therapy. The pooled toxicity analysis showed that Ofatumumab-based therapy was associated with an increased risk of infusion-related reaction but decreased risk of thrombocytopenia and anemia compared with non-Ofatumumab-based therapy. Moreover, infections, and infusion-related reaction occurred more frequently in participants with single Ofatumumab studies. Discussion: Our analysis showed PFS was statistically significantly improved with Ofatumumab-based treatments (including Ofatumumab alone, Ofatumumab plus chemotherapy) for CLL compared with observation or chemotherapy-based regimen groups. Ofatumumab had no statistically significant improvement on the OS of patients with CLL. The Ofatumumab-based therapy could generally decrease the risk of adverse effects except infusion-related reaction and infections.
伊布替尼与奥法木单抗在既往治疗过的慢性淋巴细胞白血病中的比较。
DOI：
10.1056/nejmoa1400376
发表时间：
2014-07-17
期刊：
The New England journal of medicine
影响因子：
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作者：
Byrd JC;Brown JR;O'Brien S;Barrientos JC;Kay NE;Reddy NM;Coutre S;Tam CS;Mulligan SP;Jaeger U;Devereux S;Barr PM;Furman RR;Kipps TJ;Cymbalista F;Pocock C;Thornton P;Caligaris-Cappio F;Robak T;Delgado J;Schuster SJ;Montillo M;Schuh A;de Vos S;Gill D;Bloor A;Dearden C;Moreno C;Jones JJ;Chu AD;Fardis M;McGreivy J;Clow F;James DF;Hillmen P;RESONATE Investigators
通讯作者：
RESONATE Investigators