Subscribe to RSS
DOI: 10.1055/s-0039-1693650
Multicentric Registry Study on Epidemiological and Biological Disease Profile as Well as Clinical Outcome in Patients with Low-Grade Gliomas: The LoG-Glio Project
Trial registration NCT02686229 Clinical trials.Publication History
02 June 2018
03 April 2019
Publication Date:
24 September 2019 (online)
![](https://www.thieme-connect.de/media/jnlsa/202001/lookinside/thumbnails/10-1055-s-0039-1693650_182155oa-1.jpg)
Abstract
Background World Health Organization (WHO) grade II low-grade gliomas (LGGs) in adults are rare, and patients' mean overall survival (OS) is relatively long. Epidemiological data on factors influencing tumor genesis and progression are scarce, and prospective data on surgical management are still lacking. Because of the molecular heterogeneity of LGG, a comprehensive molecular characterization is required for any clinical and epidemiological research. Further, a detailed radiologic assessment is needed as the only established objective criterion for progressive disease. Both radiologic and molecular assessments have to be standardized to produce comparable data. The aim of the registry is to improve the evidence for surgical management of LGG patients by establishing a multicenter registry with a strong surgical and clinical focus including mandatory biobanking.
Methods The LoG-Glio project is a prospective national observational multicenter registry that began on November 1, 2015. Inclusion criteria encompass all patients > 18 years of age with a radiologic suspicion of LGG. Patients with severe neurologic or psychiatric disorders that may interfere with their informed consent or if there is no possibility for further follow-up are excluded. Diagnosis of glioblastoma WHO grade IV isocitrate dehydrogenase (IDH) wild type leads to a secondary exclusion of patients. In addition to demographic data, results of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, add-on for patients with brain tumors, and National Health Institute Stroke Scale before and after surgery and during regular follow-ups are collected. At each time point a detailed recording of surgical and adjuvant treatment is performed. Radiologic assessment involves three-dimensional (3D) acquisition of T1, fluid-attenuated inversion recovery, and T2 sequences. For the final evaluation, a central detailed neuropathologic and molecular assessment of tumor samples and a radiologic evaluation of imaging sets are part of the study protocol.
Results We report the first 100 consecutively registered patients for LoG-Glio. Three patients dropped out due to loss of follow-up. Of the remaining recruited patients, 8 were classified as wait and scan; 89 had surgery. Using the inclusion criteria described previously, 70 patients had an IDH-mutated glioma, 10 had miscellaneous rare LGGs, and 8 patients had an IDH wild-type WHO grade II or III glioma.
Conclusion The LoG-Glio registry has been successfully implemented. Applied selection criteria result in an appropriately balanced patient cohort. Short-term outcome data on epidemiology as well as the influence of current surgical techniques and adjuvant treatment on patient outcomes are expected. In the long run, the aim of the registry is to validate the new molecular-based WHO classification and the influence of the extent of resection on progression-free survival and OS. The registry provides an open platform for future research projects benefiting patients with LGG.
-
References
- 1 Bradley S, Sherwood PR, Donovan HS. , et al. I could lose everything: understanding the cost of a brain tumor. J Neurooncol 2007; 85 (03) 329-338
- 2 Ho VKY, Reijneveld JC, Enting RH. , et al; Dutch Society for Neuro-Oncology (LWNO). Changing incidence and improved survival of gliomas. Eur J Cancer 2014; 50 (13) 2309-2318
- 3 Rees J, Watt H, Jäger HR. , et al. Volumes and growth rates of untreated adult low-grade gliomas indicate risk of early malignant transformation. Eur J Radiol 2009; 72 (01) 54-64
- 4 Ostrom QT, Bauchet L, Davis FG. , et al. The epidemiology of glioma in adults: a “state of the science” review. Neuro Oncol 2014; 16 (07) 896-913
- 5 Bondy ML, Scheurer ME, Malmer B. , et al; Brain Tumor Epidemiology Consortium. Brain tumor epidemiology: consensus from the Brain Tumor Epidemiology Consortium. Cancer 2008; 113 (7, Suppl): 1953-1968
- 6 Sadetzki S, Chetrit A, Freedman L, Stovall M, Modan B, Novikov I. Long-term follow-up for brain tumor development after childhood exposure to ionizing radiation for tinea capitis. Radiat Res 2005; 163 (04) 424-432
- 7 McCarthy BJ, Rankin KM, Aldape K. , et al. Risk factors for oligodendroglial tumors: a pooled international study. Neuro Oncol 2011; 13 (02) 242-250
- 8 Linos E, Raine T, Alonso A, Michaud D. Atopy and risk of brain tumors: a meta-analysis. J Natl Cancer Inst 2007; 99 (20) 1544-1550
- 9 McGirt MJ, Chaichana KL, Attenello FJ. , et al. Extent of surgical resection is independently associated with survival in patients with hemispheric infiltrating low-grade gliomas. Neurosurgery 2008; 63 (04) 700-707 ; author reply 707–708
- 10 Coburger J, Merkel A, Scherer M. , et al. Low-grade glioma surgery in intraoperative magnetic resonance imaging: results of a multicenter retrospective assessment of the German Study Group for Intraoperative Magnetic Resonance Imaging. Neurosurgery 2016; 78 (06) 775-786
- 11 Pala A, König R, Hlavac M, Wirtz CR, Coburger J. Does the routine use of intraoperative MRI prolong progression free survival in low-grade glioma surgery? A retrospective study. Innovative Neurosurg. 2015; 3: 109-8
- 12 Louis DN, Perry A, Reifenberger G. , et al. The 2016 World Health Organization Classification of Tumors of the Central Nervous System: a summary. Acta Neuropathol 2016; 131 (06) 803-820
- 13 Brat DJ, Verhaak RG, Aldape KD. , et al; Cancer Genome Atlas Research Network. Comprehensive, integrative genomic analysis of diffuse lower-grade gliomas. N Engl J Med 2015; 372 (26) 2481-2498
- 14 Schüz J, Elliott P, Auvinen A. , et al. An international prospective cohort study of mobile phone users and health (Cosmos): design considerations and enrolment. Cancer Epidemiol 2011; 35 (01) 37-43
- 15 Goldstein LB, Samsa GP. Reliability of the National Institutes of Health Stroke Scale. Extension to non-neurologists in the context of a clinical trial. Stroke 1997; 28 (02) 307-310
- 16 Olson R, Tyldesley S, Carolan H, Parkinson M, Chhanabhai T, McKenzie M. Prospective comparison of the prognostic utility of the Mini Mental State Examination and the Montreal Cognitive Assessment in patients with brain metastases. Support Care Cancer 2011; 19 (11) 1849-1855
- 17 Nasreddine ZS, Phillips N, Chertkow H. Normative data for the Montreal Cognitive Assessment (MoCA) in a population-based sample. Neurology 2012; 78 (10) 765-766 ; author reply 766
- 18 Olson RA, Chhanabhai T, McKenzie M. Feasibility study of the Montreal Cognitive Assessment (MoCA) in patients with brain metastases. Support Care Cancer 2008; 16 (11) 1273-1278
- 19 Wen PY, Macdonald DR, Reardon DA. , et al. Updated response assessment criteria for high-grade gliomas: response assessment in neuro-oncology working group. J Clin Oncol 2010; 28 (11) 1963-1972
- 20 Dupont WD, Plummer WD. Power and sample size calculations. A review and computer program. Control Clin Trials 1990; 11: 116-28
- 21 Schoenfeld DA, Richter JR. Nomograms for calculating the number of patients needed for a clinical trial with survival as an endpoint. Biometrics 1982; 38: 163-70
- 22 Weller M, van den Bent M, Hopkins K. , et al; European Association for Neuro-Oncology (EANO) Task Force on Malignant Glioma. EANO guideline for the diagnosis and treatment of anaplastic gliomas and glioblastoma. Lancet Oncol 2014; 15 (09) e395-e403
- 23 Marko NF, Weil RJ, Schroeder JL, Lang FF, Suki D, Sawaya RE. Extent of resection of glioblastoma revisited: personalized survival modeling facilitates more accurate survival prediction and supports a maximum-safe-resection approach to surgery. J Clin Oncol 2014; 32 (08) 774-782
- 24 Buckner JC, Shaw EG, Pugh SL. , et al. Radiation plus procarbazine, CCNU, and vincristine in low-grade glioma. N Engl J Med 2016; 374 (14) 1344-1355
- 25 Senft C, Bink A, Franz K, Vatter H, Gasser T, Seifert V. Intraoperative MRI guidance and extent of resection in glioma surgery: a randomised, controlled trial. Lancet Oncol 2011; 12 (11) 997-1003
- 26 Duffau H, Taillandier L. New concepts in the management of diffuse low-grade glioma: proposal of a multistage and individualized therapeutic approach. Neuro Oncol 2015; 17 (03) 332-342
- 27 Duffau H, Capelle L. Preferential brain locations of low-grade gliomas. Cancer 2004; 100 (12) 2622-2626
- 28 Capelle L, Fontaine D, Mandonnet E. , et al; French Réseau d'Étude des Gliomes. Spontaneous and therapeutic prognostic factors in adult hemispheric World Health Organization Grade II gliomas: a series of 1097 cases: clinical article. J Neurosurg 2013; 118 (06) 1157-1168
- 29 Pala A, Brand C, Kapapa T. , et al. The value of intraoperative and early postoperative MRI in low-grade glioma surgery: a retrospective study. World Neurosurg 2016; 93: 191-197
- 30 Hartmann C, Hentschel B, Wick W. , et al. 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 of gliomas. Acta Neuropathol 2010; 120 (06) 707-718
- 31 Cairncross G, Wang M, Shaw E. , et al. Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol 2013; 31 (03) 337-343
- 32 van den Bent MJ, Brandes AA, Taphoorn MJB. , et al. Adjuvant procarbazine, lomustine, and vincristine chemotherapy in newly diagnosed anaplastic oligodendroglioma: long-term follow-up of EORTC brain tumor group study 26951. J Clin Oncol 2013; 31 (03) 344-350
- 33 Weiler M, Wick W. Molecular predictors of outcome in low-grade glioma. Curr Opin Neurol 2012; 25 (06) 767-773
- 34 Woehrer A. Brain tumor epidemiology in Austria and the Austrian Brain Tumor Registry. Clin Neuropathol 2013; 32 (04) 269-285
- 35 Georgakis MK, Karalexi MA, Kalogirou EI. , et al. Incidence, time trends and survival patterns of childhood pilocytic astrocytomas in Southern-Eastern Europe and SEER, US. J Neurooncol 2017; 131 (01) 163-175
- 36 Asklund T, Malmström A, Bergqvist M, Björ O, Henriksson R. Brain tumors in Sweden: data from a population-based registry 1999–2012. Acta Oncol 2015; 54 (03) 377-384
- 37 Jeswani S, Nuño M, Folkerts V, Mukherjee D, Black KL, Patil CG. Comparison of survival between cerebellar and supratentorial glioblastoma patients: surveillance, epidemiology, and end results (SEER) analysis. Neurosurgery 2013; 73 (02) 240-246 ; discussion 246; quiz 246
- 38 Alattar AA, Brandel MG, Hirshman BR. , et al. Oligodendroglioma resection: a Surveillance, Epidemiology, and End Results (SEER) analysis. J Neurosurg 2018; 128 (04) 1076-1083