CTNI-14. RADIOTHERAPY VERSUS TMZ FOR HIGH-RISK LOW-GRADE GLIOMA. FINAL RESULTS AFTER MEDIAN FOLLOW-UP OF 13 YEARS OF PHASE III EORTC/NCIC-CTG/TROG/MRC-CTU (EORTC 22033-26033) STUDY

Abstract BACKGROUND We previously reported on progression-free survival of our randomized phase 3 trial [Lancet Oncol. 2016;17:1521-1532]. Here we report results of long-term follow-up (FU) including overall survival (OS) and molecular subgroup analyses. METHODS 487 patients were randomized between 2005-2012 to either standard radiotherapy (RT, 50.4 Gy/ 28 fractions) or primary dose-dense temozolomide [TMZ] chemotherapy (75 mg/m² daily x 21/28 days, up to 12 cycles). Treatment at progression was at investigators discretion and commonly included cross-over to the alternative treatment modality. RESULTS At a median follow-up of 13 years, 68% of patients had died. Median age at inclusion was 45 years (range 18-75), 96% had a performance status of 0-1. There was no significant difference in PFS nor OS: PFS was 3.6 years (95% CI: 3.0-4.1) and 3.1 years (95% CI: 2.7-3.6), HR 1.12 (95% CI: 0.92-1.36); OS 6.6 years (95% CI: 5.8-7.5) and 8.0 years (95% CI: 6.9-9.1), HR 0.87 (95% CI: 0.69-1.09), for RT or TMZ, respectively. Subgroup analyses were performed for patients when available tissue allowed for molecular analyses (n=351/487,73%). In astrocytoma, IDHmt/1p/19q non-codeleted (n = 178), median OS with RT was 6.6 years (95% CI: 5.3-7.6) and with TMZ was 6.7 years (95% CI: 5.7-8.0); HR 0.98 (95% CI: 0.67-1.44). For oligodendroglioma, IDHmt/codeleted (n = 109) median OS with RT was 12.9 years (95% CI: 9.4 - NE) and with TMZ 14.9 years (95% CI: 10.1 - NE); HR 1.01 (95% CI: 0.56-1.81). For a heterogenous group of IDHwt tumors (n = 64), median OS with RT was 2.5 years (95% CI: 1.8-3.3) and with TMZ 4.7 years (95% CI: 2.2-7.2); HR 0.37 (95% CI: 0.18-0.77). CONCLUSIONS Primary treatment with RT or TMZ provided comparable PFS and OS. Choice of primary treatment can be tailored to individual tumor characteristics and patient preference.

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Publication Details

Journal
Neuro-Oncology
Published
2024-11-01
DOI
https://doi.org/10.1093/neuonc/noae165.0381
Citations
3
Primary Topic
Glioma Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
1.31
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article

CTNI-14. RADIOTHERAPY VERSUS TMZ FOR HIGH-RISK LOW-GRADE GLIOMA. FINAL RESULTS AFTER MEDIAN FOLLOW-UP OF 13 YEARS OF PHASE III EORTC/NCIC-CTG/TROG/MRC-CTU (EORTC 22033-26033) STUDY

Paul M. Clément, Michele Reni, Anja Gijtenbeek, Warren Mason et al.
3 citations
Neuro-Oncology
Glioma Diagnosis and Treatment
1.31
article

CTNI-14. RADIOTHERAPY VERSUS TMZ FOR HIGH-RISK LOW-GRADE GLIOMA. FINAL RESULTS AFTER MEDIAN FOLLOW-UP OF 13 YEARS OF PHASE III EORTC/NCIC-CTG/TROG/MRC-CTU (EORTC 22033-26033) STUDY

Paul M. Clément, Michele Reni, Anja Gijtenbeek, Warren Mason, Martin J. van den Bent, Khê Hoang‐Xuan, Jaap C. Reijneveld, Jeremy Rees, Michael Weller, Wolfgang Wick, Jacoline E. C. Bromberg, Paul Sargos, Anna Sophie Berghoff, Élodie Vauléon, Brian Thiessen, Thierry Gorlia, Roelien H. Enting, Claire Phillips, Alexandre de Freitas Azevedo, Tzahala Tzuk, Monika E. Hegi, Andreas von Deimling, Roger Stupp, Martin Taphoorn, Carmen Balañá, Robert Nordal, Pierre Bady, Johan M. Kros, Olivier Chinot, Brigitta G. Baumert, Alba A. Brandes, F. Dhermain, Denis Lacombe, John P. Rossiter, M.A. Lentz, Julian Jacob
article en
3 citations

Abstract

Abstract BACKGROUND We previously reported on progression-free survival of our randomized phase 3 trial [Lancet Oncol. 2016;17:1521-1532]. Here we report results of long-term follow-up (FU) including overall survival (OS) and molecular subgroup analyses. METHODS 487 patients were randomized between 2005-2012 to either standard radiotherapy (RT, 50.4 Gy/ 28 fractions) or primary dose-dense temozolomide [TMZ] chemotherapy (75 mg/m² daily x 21/28 days, up to 12 cycles). Treatment at progression was at investigators discretion and commonly included cross-over to the alternative treatment modality. RESULTS At a median follow-up of 13 years, 68% of patients had died. Median age at inclusion was 45 years (range 18-75), 96% had a performance status of 0-1. There was no significant difference in PFS nor OS: PFS was 3.6 years (95% CI: 3.0-4.1) and 3.1 years (95% CI: 2.7-3.6), HR 1.12 (95% CI: 0.92-1.36); OS 6.6 years (95% CI: 5.8-7.5) and 8.0 years (95% CI: 6.9-9.1), HR 0.87 (95% CI: 0.69-1.09), for RT or TMZ, respectively. Subgroup analyses were performed for patients when available tissue allowed for molecular analyses (n=351/487,73%). In astrocytoma, IDHmt/1p/19q non-codeleted (n = 178), median OS with RT was 6.6 years (95% CI: 5.3-7.6) and with TMZ was 6.7 years (95% CI: 5.7-8.0); HR 0.98 (95% CI: 0.67-1.44). For oligodendroglioma, IDHmt/codeleted (n = 109) median OS with RT was 12.9 years (95% CI: 9.4 - NE) and with TMZ 14.9 years (95% CI: 10.1 - NE); HR 1.01 (95% CI: 0.56-1.81). For a heterogenous group of IDHwt tumors (n = 64), median OS with RT was 2.5 years (95% CI: 1.8-3.3) and with TMZ 4.7 years (95% CI: 2.2-7.2); HR 0.37 (95% CI: 0.18-0.77). CONCLUSIONS Primary treatment with RT or TMZ provided comparable PFS and OS. Choice of primary treatment can be tailored to individual tumor characteristics and patient preference.

Neuro-OncologyVol. 26(Supplement_8)
BC Cancer Agency (CA), University Medical Center Groningen (NL), Radboud University Nijmegen (NL), Vita-Salute San Raffaele University (IT), University of Calgary (CA), University of Groningen (NL), German Cancer Research Center (DE), University of Zurich (CH), Queen's University (CA), Heidelberg University (DE), Peter MacCallum Cancer Centre (AU), Rambam Health Care Campus (IL), Institut Gustave Roussy (FR), Amsterdam UMC Location University of Amsterdam (NL), Radboud University Medical Center (NL), Maastricht University (NL), Sorbonne Université (FR), Assistance Publique – Hôpitaux de Paris (FR), Medisch Centrum Haaglanden (NL), Centre Eugène Marquis (FR), IPO Porto (PT), Pitié-Salpêtrière Hospital (FR), Istituto delle Scienze Neurologiche di Bologna (IT), European Organisation for Research and Treatment of Cancer (BE), Institut Bergonié (FR), Institut d'Investigació en Ciències de la Salut Germans Trias i Pujol (ES), Kantonsspital Graubünden (CH), Erasmus MC Cancer Institute (NL), National Hospital for Neurology and Neurosurgery (GB), Istituti di Ricovero e Cura a Carattere Scientifico (IT), Maastro Clinic (NL), Hôpital de la Timone (FR), Istituto di Ricovero e Cura a Carattere Scientifico San Raffaele (IT), Robert H. Lurie Comprehensive Cancer Center of Northwestern University, University College London (GB), Medical University of Vienna (AT), Amsterdam UMC Location Vrije Universiteit Amsterdam (NL), University of Lausanne (CH), KU Leuven (BE)
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