Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma
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DOI：
10.1200/jco.2008.19.8721
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发表时间：
2009-10-01
影响因子：
45.3
通讯作者：
Cloughesy, Timothy
中科院分区：
文献类型：
--
作者：
Friedman, Henry S.;Prados, Michael D.;Cloughesy, Timothy
目的：我们在一项II期、多中心、开放标签、167名患者被随机分配接受贝伐单抗10 mg/kg单独治疗或与伊立替康340 mg/m2或125 mg/m2联合治疗（分别伴随或不伴随酶诱导抗癫痫药物）每2周一次。主要终点是6个月无进展生存率和客观缓解率，由独立的放射学审查确定。次要终点包括安全性和总survival.ResultsIn的贝伐单抗单药和贝伐单抗加伊立替康组，估计6个月的无进展生存率分别为42.6%和50.3%，分别为28.2%和37.8%，分别和中位总生存时间分别为9.2个月和8.7个月，分别。基线时使用糖皮质激素的患者有随时间稳定或降低剂量的趋势。在单用贝伐单抗或贝伐单抗联合伊立替康治疗的患者中，分别有46.4%和65.8%的患者发生≥ 3级不良事件，其中最常见的是高血压（8.3%）和惊厥（6.0%），贝伐珠单抗+伊立替康组中惊厥（13.9%）、中性粒细胞减少（8.9%）和疲乏（8.9%）。颅内出血中注意到两名患者（2.4%）在贝伐珠单抗单独组（1级）和三名患者（3.8%）在贝伐珠单抗加伊立替康组（等级1，2，和4，分别）。
PurposeWe evaluated the efficacy of bevacizumab, alone and in combination with irinotecan, in patients with recurrent glioblastoma in a phase II, multicenter, open-label, noncomparative trial.Patients and MethodsOne hundred sixty-seven patients were randomly assigned to receive bevacizumab 10 mg/kg alone or in combination with irinotecan 340 mg/m(2) or 125 mg/m(2) (with or without concomitant enzyme-inducing antiepileptic drugs, respectively) once every 2 weeks. Primary end points were 6-month progression-free survival and objective response rate, as determined by independent radiology review. Secondary end points included safety and overall survival.ResultsIn the bevacizumab-alone and the bevacizumab-plus-irinotecan groups, estimated 6-month progression-free survival rates were 42.6% and 50.3%, respectively; objective response rates were 28.2% and 37.8%, respectively; and median overall survival times were 9.2 months and 8.7 months, respectively. There was a trend for patients who were taking corticosteroids at baseline to take stable or decreasing doses over time. Of the patients treated with bevacizumab alone or bevacizumab plus irinotecan, 46.4% and 65.8%, respectively, experienced grade >= 3 adverse events, the most common of which were hypertension (8.3%) and convulsion (6.0%) in the bevacizumab-alone group and convulsion (13.9%), neutropenia (8.9%), and fatigue (8.9%) in the bevacizumab-plus-irinotecan group. Intracranial hemorrhage was noted in two patients (2.4%) in the bevacizumab-alone group (grade 1) and in three patients (3.8%) patients in the bevacizumab-plus-irinotecan group (grades 1, 2, and 4, respectively).ConclusionBevacizumab, alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma.