STUDIES.

SCIENTIFIC RESEARCH
IN FOCUS.

NOA-04

Prospective, randomized phase III trial in anaplastic gliom

Publications:

Integrated DNA methylation and copy-number profiling identify three clinically and biologically relevant groups of anaplastic glioma. Wiestler B, Capper D, Sill M, Jones DT, Hovestadt V, Sturm D, Koelsche C, Bertoni A, Schweizer L, Korshunov A, Weiß EK, Schliesser MG, Radbruch A, Herolde-Mende C, Roth P, Unterberg A, Hartmann C, Pietsch T, Reifenberger G, Lichter P, Radlwimmer B, Platten M, Pfister SM, von Deimling A, Weller M, Wick W. Acta Neuropathol. 2014;128: 561 – 571

Prognostic or predective value of MGMT promotor methylation in gliomas depends on IDH1 mutation. Wick W, Meisner C, Hentschel B, Platten M, Schilling A, Wiestler B, Sabel MC, Koeppen S, Ketter R, Weiler M, Tabatabai G, von Deimling A, Gramatzki D, Westphal M, Schackert G, Loeffler M, Simon M, Reifenberger G, Weller M. Neurology 2013;81:1515 – 1522

ATRX loss refines the classification of anaplastic gliomas and identifies a subgroup of IDH mutant astrocytic tumors with better prognosis. Wiestler B, Capper D, Holland-Letz T, Korshunov A, von Deimling A, Pfister SM, Platten M, Weller M, Wick W. Acta Neuropathol. 2013;126:443 – 451

Temozolomide and 13-cis reinoic acid patients with anaplastic gliomas: a prospective single-arm monocentric phase-II study (RNOP-05). Grauer O, Pascher C, Hartmann C, Zeman F, Weller M, Proescholdt M, Brawanski A, Pietsch T, Wick W, Bogdahn U, Hau P. J Neurooncol. 2011;104: 801 – 809. doi:10.1007/s11060-011-0548-y. Epub 2011 Mar 4. Erratum. in: J Neurooncol. 2011;105: 671

Patients with IDH1 wild type anaplastic astrocytomas exhibit worse prognosis than IDH1-mutated glioblastomas, and IDH1 mutation status accounts for the unfavorable prognostic effect of higher age: implications for classification orf gliomas. Hartmann C, Hentschel B, Wick W, CapperD, Felsberg J, Simon M, Westphal M, Schackert G, Meyermann R, Pietsch T, Reifenberger G, Weller M, Loeffler M, von Deimling A. Acta Neuropathol. 2010;120: 707 – 718

NOA-04 randomized phase III trial of sequential radiochemotherapy of anaplastic gliome with procarbazine, lomustine, and vincristine or temozolomide. Wick W, Hartmann C, Engel C, Stoffels M, Felsberg J, Stockhammer F, Sabel MC, Koeppen S, Ketter R, Meyermann R, Rapp M, Meisner C, Kortmann RD, Pietsch T, Wiestler OD, Erneman U, Bamberg M, Reifenberger G, von Deimling A, Weller M. J Clin Oncol. 2009;27: 5874-5880

The NOA-04 study prospectively and randomly investigated whether chemotherapy can be used instead of radiotherapy in the primary treatment of anaplastic gliomas after surgery. Between October 1999 and February 2005, 318 patients were randomized at 36 German centers. The primary endpoint was time to treatment failure. Treatment failure is defined as time to second progression or a time point before second progression at which further therapy is not possible.

Long-term results were presented at ASCO 2015.