Daniela A Bota, Jinah Chung, Manisha Dandekar, Jose A Carrillo, Xiao-Tang Kong, Beverly D Fu, Frank Pk Hsu, Axel H Schönthal, Florence M Hofman, Thomas C Chen, Raphael Zidovetzki, Chrystel Pretto, Ankie Strik, Virgil Ejc Schijns, Apostolos Stathopoulos
{"title":"ERC1671联合贝伐单抗与贝伐单抗联合安慰剂治疗复发性胶质母细胞瘤的II期研究:中期结果和与CD4+ t淋巴细胞计数的相关性","authors":"Daniela A Bota, Jinah Chung, Manisha Dandekar, Jose A Carrillo, Xiao-Tang Kong, Beverly D Fu, Frank Pk Hsu, Axel H Schönthal, Florence M Hofman, Thomas C Chen, Raphael Zidovetzki, Chrystel Pretto, Ankie Strik, Virgil Ejc Schijns, Apostolos Stathopoulos","doi":"10.2217/cns-2018-0009","DOIUrl":null,"url":null,"abstract":"<p><strong>Aim: </strong>ERC1671 is an allogeneic/autologous therapeutic glioblastoma (GBM) vaccine - composed of whole, inactivated tumor cells mixed with tumor cell lysates derived from the patient and three GBM donors.</p><p><strong>Methods: </strong>In this double-blinded, randomized, Phase II study bevacizumab-naive patients with recurrent GBM were randomized to receive either ERC1671 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine<sup>®</sup> or sargramostim) and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. Interim results: Median overall survival (OS) of patients treated with ERC1671 plus bevacizumab was 12 months. In the placebo plus bevacizumab group, median OS was 7.5 months. The maximal CD4<sup>+</sup> T-lymphocyte count correlated with OS in the ERC1671 but not in the placebo group.</p><p><strong>Conclusion: </strong>The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity.</p>","PeriodicalId":10469,"journal":{"name":"CNS Oncology","volume":null,"pages":null},"PeriodicalIF":0.0000,"publicationDate":"2018-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.2217/cns-2018-0009","citationCount":"42","resultStr":"{\"title\":\"Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4<sup>+</sup> T-lymphocyte counts.\",\"authors\":\"Daniela A Bota, Jinah Chung, Manisha Dandekar, Jose A Carrillo, Xiao-Tang Kong, Beverly D Fu, Frank Pk Hsu, Axel H Schönthal, Florence M Hofman, Thomas C Chen, Raphael Zidovetzki, Chrystel Pretto, Ankie Strik, Virgil Ejc Schijns, Apostolos Stathopoulos\",\"doi\":\"10.2217/cns-2018-0009\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Aim: </strong>ERC1671 is an allogeneic/autologous therapeutic glioblastoma (GBM) vaccine - composed of whole, inactivated tumor cells mixed with tumor cell lysates derived from the patient and three GBM donors.</p><p><strong>Methods: </strong>In this double-blinded, randomized, Phase II study bevacizumab-naive patients with recurrent GBM were randomized to receive either ERC1671 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine<sup>®</sup> or sargramostim) and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. Interim results: Median overall survival (OS) of patients treated with ERC1671 plus bevacizumab was 12 months. In the placebo plus bevacizumab group, median OS was 7.5 months. The maximal CD4<sup>+</sup> T-lymphocyte count correlated with OS in the ERC1671 but not in the placebo group.</p><p><strong>Conclusion: </strong>The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity.</p>\",\"PeriodicalId\":10469,\"journal\":{\"name\":\"CNS Oncology\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2018-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://sci-hub-pdf.com/10.2217/cns-2018-0009\",\"citationCount\":\"42\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"CNS Oncology\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.2217/cns-2018-0009\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2018/8/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"CNS Oncology","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2217/cns-2018-0009","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2018/8/29 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
Phase II study of ERC1671 plus bevacizumab versus bevacizumab plus placebo in recurrent glioblastoma: interim results and correlations with CD4+ T-lymphocyte counts.
Aim: ERC1671 is an allogeneic/autologous therapeutic glioblastoma (GBM) vaccine - composed of whole, inactivated tumor cells mixed with tumor cell lysates derived from the patient and three GBM donors.
Methods: In this double-blinded, randomized, Phase II study bevacizumab-naive patients with recurrent GBM were randomized to receive either ERC1671 in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) (Leukine® or sargramostim) and cyclophosphamide plus bevacizumab, or placebo plus bevacizumab. Interim results: Median overall survival (OS) of patients treated with ERC1671 plus bevacizumab was 12 months. In the placebo plus bevacizumab group, median OS was 7.5 months. The maximal CD4+ T-lymphocyte count correlated with OS in the ERC1671 but not in the placebo group.
Conclusion: The addition of ERC1671/GM-CSF/cyclophosphamide to bevacizumab resulted in a clinically meaningful survival benefit with minimal additional toxicity.