Wick, Wolfgang ORCID: 0000-0002-6171-634X, Roth, Patrick, Hartmann, Christian, Hau, Peter ORCID: 0000-0003-3894-5053, Nakamura, Makoto, Stockhammer, Florian ORCID: 0000-0002-0525-5956, Sabel, Michael C., Wick, Antje, Koeppen, Susanne, Ketter, Ralf, Vajkoczy, Peter, Eyupoglu, Ilker, Kalff, Rolf, Pietsch, Torsten, Happold, Caroline, Galldiks, Norbert ORCID: 0000-0002-2485-1796, Schmidt-Graf, Friederike, Bamberg, Michael, Reifenberger, Guido, Platten, Michael ORCID: 0000-0002-4746-887X, von Deimling, Andreas ORCID: 0000-0002-5863-540X, Meisner, Christoph, Wiestler, Benedikt and Weller, Michael ORCID: 0000-0002-1748-174X (2016). Long-term analysis of the NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic glioma with PCV or temozolomide. Neuro-Oncology, 18 (11). S. 1529 - 1538. CARY: OXFORD UNIV PRESS INC. ISSN 1523-5866

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Abstract

Background. Optimal treatment and precise classification for anaplastic glioma are needed. Methods. The objective for long-term follow-up of NOA-04 is to optimize the treatment sequence for patients with anaplastic gliomas. Patients were randomized 2: 1: 1 to receive the standard radiotherapy (RT) (arm A), procarbazine, lomustine and vincristine (PCV) (arm B1), or temozolomide (TMZ) (arm B2). Results. Primary endpoint was time-to-treatment-failure (TTF), defined as progression after 2 lines of therapy or any time before if no further therapy was administered. Exploratory analyses examined associations of molecular marker status with TTF, progression-free survival (PFS), and overall survival (OS). At 9.5 (95% CI: 8.6-10.2) years, no difference between arms (A vs B1/B2) was observed: median TTF (4.6 [3.4-5.1] y vs 4.4 [3.3-5.3) y), PFS (2.5 [1.3-3.5] y vs 2.7 [1.9-3.2] y), and OS (8 [5.5-10.3] y vs 6.5 [5.4-8.3] y). Oligodendroglial versus astrocytic histology-but more so the subgroups according to CpG island methylator phenotype (CIMP) and 1p/19q co-deletion status-revealed a strong prognostic value of CIMPpos with (CIMPcodel) versus without 1p/19 co-deletion (CIMPnon-codel) versus CIMPneg. but no differential efficacy of RT versus chemotherapy for any of the endpoints. PFS was better for PCV-than for TMZ-treated patients with CIMPcodel tumors (HR B1 vs B2 0.39 [0.17-0.92], P = .31). In CIMPneg. tumors, hypermethylation of the O6-methyl-guanyl-DNA methyltransferase promoter (MGMT) provided a risk reduction for PFS with chemotherapy. Conclusions. There is no differential activity of primary chemotherapy versus RT in any subgroup of anaplastic glioma. Molecular diagnosis is superior to histology. Trial Registration: clinicaltrials.gov Identifier: NCT00717210.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Wick, WolfgangUNSPECIFIEDorcid.org/0000-0002-6171-634XUNSPECIFIED
Roth, PatrickUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hartmann, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hau, PeterUNSPECIFIEDorcid.org/0000-0003-3894-5053UNSPECIFIED
Nakamura, MakotoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stockhammer, FlorianUNSPECIFIEDorcid.org/0000-0002-0525-5956UNSPECIFIED
Sabel, Michael C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wick, AntjeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koeppen, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ketter, RalfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vajkoczy, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eyupoglu, IlkerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kalff, RolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pietsch, TorstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Happold, CarolineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Galldiks, NorbertUNSPECIFIEDorcid.org/0000-0002-2485-1796UNSPECIFIED
Schmidt-Graf, FriederikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bamberg, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reifenberger, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Platten, MichaelUNSPECIFIEDorcid.org/0000-0002-4746-887XUNSPECIFIED
von Deimling, AndreasUNSPECIFIEDorcid.org/0000-0002-5863-540XUNSPECIFIED
Meisner, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wiestler, BenediktUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weller, MichaelUNSPECIFIEDorcid.org/0000-0002-1748-174XUNSPECIFIED
URN: urn:nbn:de:hbz:38-257943
DOI: 10.1093/neuonc/now133
Journal or Publication Title: Neuro-Oncology
Volume: 18
Number: 11
Page Range: S. 1529 - 1538
Date: 2016
Publisher: OXFORD UNIV PRESS INC
Place of Publication: CARY
ISSN: 1523-5866
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
MGMT PROMOTER METHYLATION; CLASSIFICATION; OLIGODENDROGLIOMA; ASTROCYTOMAS; PROCARBAZINE; SURVIVAL; DIFFUSE; TUMORS; ATRX; AGEMultiple languages
Oncology; Clinical NeurologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/25794

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