期刊
EUROPEAN JOURNAL OF CANCER
卷 73, 期 -, 页码 30-37出版社
ELSEVIER SCI LTD
DOI: 10.1016/j.ejca.2016.12.003
关键词
Glioblastoma; CpG-ODN; CpG-28; TLR9; Phase II
类别
资金
- Fondation pour la Recherche Medicale (FRM)
- Agence Nationale de la Recherche (ANR RIB)
- Association Oligocyte
- Association pour la Recherche sur les Tumeurs Cerebrales (ARTC)
- Assistance Publique-Hopitaux de Paris (AP-HP)
- INCa (SIRIC PACA-Ouest)
Background: Immunostimulating oligodeoxynucleotides containing unmethylated cytosine-guanosine motifs (CpG-ODN) have shown a promising efficacy in several cancer models when injected locally. A previous phase II study of CpG-ODN in patients with recurrent glioblastoma (GBM) has suggested some activity and has shown a limited toxicity. This multicentre single-blinded randomised phase II trial was designed to study the efficacy of a local treatment by CpG-ODN in patients with de novo glioblastomas. Patients and methods: Patients with a newly diagnosed glioblastoma underwent large surgical resection and CpG-ODN was randomly administrated locally around the surgical cavity. The patients were then treated according to standard of care (SOC) with radiotherapy and temozolomide. The primary objective was 2-year survival. Secondary outcomes were progression free survival (PFS), and tolerance. Results: Eighty-one (81) patients were randomly assigned to receive CpG-ODN plus SOC (39 patients) or SOC (42 patients). The 2-year overall survival was 31% (19%; 49%) in the CpG-ODN arm and 26% (16%; 44%) in the SOC arm. The median PFS was 9 months in the CpG-ODN arm and 8.5 months in the SOC arm. The incidence of adverse events was similar in both arms; although fever and post-operative haematoma were more frequent in the CpG-ODN arm. Conclusions: Local immunotherapy with CpG-ODN injected into the surgical cavity after tumour removal and followed by SOC, although well tolerated, does not improve survival of patients with newly diagnosed GBM. (C) 2016 Elsevier Ltd. All rights reserved.
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