Wick, Wolfgang and Roth, Patrick and Hartmann, Christian and Hau, Peter and Nakamura, Makoto and Stockhammer, Florian and Sabel, Michael C. and Wick, Antje and Koeppen, Susanne and Ketter, Ralf and Vajkoczy, Peter and Eyupoglu, Ilker and Kalff, Rolf and Pietsch, Torsten and Happold, Caroline and Galldiks, Norbert and Schmidt-Graf, Friederike and Bamberg, Michael and Reifenberger, Guido and Platten, Michael and von Deimling, Andreas and Meisner, Christoph and Wiestler, Benedikt and Weller, Michael (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). pp. 1529-1537. ISSN 1522-8517, 1523-5866
Full text not available from this repository. (Request a copy)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: | Article |
|---|---|
| Uncontrolled Keywords: | MGMT PROMOTER METHYLATION; IDH1 MUTATION; CLASSIFICATION; OLIGODENDROGLIOMA; ASTROCYTOMAS; TUMORS; PROCARBAZINE; PROGNOSIS; SURVIVAL; DIFFUSE; 1p/19q; anaplastic gliomas; CIMP; MGMT |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Neurologie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 24 Apr 2019 09:04 |
| Last Modified: | 24 Apr 2019 09:04 |
| URI: | https://pred.uni-regensburg.de/id/eprint/4036 |
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