A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas.
A North American brain tumor consortium phase II study of poly-ICLC for adult patients with recurrent anaplastic gliomas.
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DOI：
10.1007/s11060-008-9705-3
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发表时间：
2009-01
影响因子：
3.9
通讯作者：
Chang, Susan M.
中科院分区：
文献类型：
--
作者：
Butowski, Nicholas;Lamborn, Kathleen R.;Lee, Bee L.;Prados, Michael D.;Cloughesy, Timothy;DeAngelis, Lisa M.;Abrey, Lauren;Fink, Karen;Lieberman, Frank;Mehta, Minesh;Robins, H. Ian;Junck, Larry;Salazar, Andres M.;Chang, Susan M.
这项II期研究旨在确定复发性幕上间变性胶质瘤成人患者接受免疫调节剂聚赖氨酸和羧甲基纤维素稳定的聚肌苷酸（poly-ICLC）治疗时的客观缓解率和6个月无进展生存期。这是一项开放标签、单组II期研究。患者单独接受聚ICLC治疗。患者可能接受过不超过两次复发的治疗。聚ICLC治疗持续至肿瘤进展。55例患者入组研究。10例在病理学中心审查后不合格。11%的患者（5/45）有放射学缓解。39例患者的至进展时间已知，6例仍在接受治疗。估计6个月无进展生存率为24%。中位生存期为43周。聚ICLC耐受性良好，但与历史数据相比，6个月无进展生存期没有改善，也没有令人鼓舞的客观放射学缓解率。基于这项研究，聚ICLC不能改善复发性间变性胶质瘤患者的6 moPFS，但可能值得与替莫唑胺等药物联合进行进一步研究。
This phase II study was designed to determine the objective response rate and 6-month progression free survival of adult patients with recurrent supratentorial anaplastic glioma when treated with the immune modulator, polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethylcellulose (poly-ICLC). This was an open-labeled, single arm phase II study. Patients were treated with poly-ICLC alone. Patients may have had treatment for no more than two prior relapses. Treatment with poly-ICLC continued until tumor progression. 55 patients were enrolled in the study. 10 were ineligible after central review of pathology. 11% of patients (5 of 45) had a radiographic response. Time to progression was known for 39 patients and 6 remain on treatment. The estimated 6-month progression free survival was 24%. The median survival time was 43 weeks. Poly-ICLC was well tolerated, but there was no improvement in 6-month progression free survival compared to historical database nor was there an encouraging objective radiographic response rate. Based on this study, poly-ICLC does not improve 6moPFS in patients with recurrent anaplastic gliomas but may be worth further study in combination with agents such as temozolomide.
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影响因子：
158.5
作者：
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通讯作者：
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作者：
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