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30 results on '"Elze, Markus"'

1. CEA-CD3 bispecific antibody cibisatamab with or without atezolizumab in patients with CEA-positive solid tumours: results of two multi-institutional Phase 1 trials

Author

Segal, Neil H., Melero, Ignacio, Moreno, Victor, Steeghs, Neeltje, Marabelle, Aurelien, Rohrberg, Kristoffer, Rodriguez-Ruiz, Maria E., Eder, Joseph P., Eng, Cathy, Manji, Gulam A., Waterkamp, Daniel, Leutgeb, Barbara, Bouseida, Said, Flinn, Nick, Das Thakur, Meghna, Elze, Markus C., Koeppen, Hartmut, Jamois, Candice, Martin-Facklam, Meret, Lieu, Christopher H., Calvo, Emiliano, Paz-Ares, Luis, Tabernero, Josep, and Argilés, Guillem

Published
2024
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4. Advancing drug development in pediatric oncology, a focus on cancer biology and targeted therapies: iMATRIX platform.

Author

Uguen, Marianne, Hilton, Magalie, Farid-Kapadia, Mufiza, Datye, Asim, Chohan, Saibah, Carlucci, Claudia, Dixon, Mark, Elze, Markus, Chen, Yingjia, Cheung, Kit Wun Kathy, Sane, Rucha, Zheng, Maoxia, and Choi, YounJeong

Subjects
PEDIATRIC oncology, DRUG development, DRUG approval, BIOLOGY, DRUG labeling
Abstract

With the development of novel treatment therapies as well as evolving and innovative approaches to conduct clinical trials, the landscape of pediatric oncology drug development has dramatically changed in recent years. Despite this change, approvals for new drugs and labeling updates to ensure availability of proper treatment for pediatric patients with cancer remain slow. The context of drug development in pediatric tumors has also changed with regulatory initiatives in the US and Europe, creating a great need for faster development of novel drugs. Today, conventional study designs have been replaced or complemented by novel clinical trial designs, such as master protocols and platform trials, to optimize cancer drug development and enable faster regulatory approval. The iMATRIX platform is a mechanism-of-action (MOA)–based phase 1/2 trial framework for concurrently studying multiple molecules across a range of relevant pediatric tumor types, taking into account the biology of each pediatric tumor type. Six studies have been conducted, ongoing, or planned on the iMATRIX platform – investigating atezolizumab, cobimetinib, entrectinib, idasanutlin, alectinib, and glofitamab. A brief overview of study designs and characteristics are shared in this article, along with learnings from them. [ABSTRACT FROM AUTHOR]

Published
2023
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5. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study

Author

Schoot, Reineke A., primary, Chisholm, Julia C., additional, Casanova, Michela, additional, Minard-Colin, Veronique, additional, Geoerger, Birgit, additional, Cameron, Alison L., additional, Coppadoro, Beatrice, additional, Zanetti, Ilaria, additional, Orbach, Daniel, additional, Kelsey, Anna, additional, Rogers, Timothy, additional, Guizani, Cecile, additional, Elze, Markus, additional, Ben-Arush, Myriam, additional, McHugh, Kieran, additional, van Rijn, Rick R., additional, Ferman, Sima, additional, Gallego, Soledad, additional, Ferrari, Andrea, additional, Jenney, Meriel, additional, Bisogno, Gianni, additional, and Merks, Johannes H.M., additional

Published
2022
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7. Extension of the Alternative Intravenous Dosing Regimens of Atezolizumab into Combination Settings through Modeling and Simulation

Author

Liu, Stephanie N., primary, Marchand, Mathilde, additional, Liu, Xiaoyan, additional, Ingle, Gladys, additional, Maiya, Vidya, additional, Graupner, Vilma, additional, Elze, Markus C., additional, Chan, Phyllis, additional, Hsu, Joy C., additional, Lin, Alyse, additional, Vadhavkar, Shweta, additional, Wu, Benjamin, additional, and Bruno, Rene, additional

Published
2022
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8. The Impact of Radiation Therapy in Children and Adolescents With Metastatic Rhabdomyosarcoma

Author

Cameron, Alison L., primary, Elze, Markus C., additional, Casanova, Michela, additional, Geoerger, Birgit, additional, Gaze, Mark N., additional, Minard-Colin, Veronique, additional, McHugh, Kieran, additional, van Rijn, Rick R., additional, Kelsey, Anna, additional, Martelli, Hélène, additional, Mandeville, Henry, additional, Bisogno, Gianni, additional, Lowis, Stephen, additional, Ronghe, Milind, additional, Orbach, Daniel, additional, Guizani, Cecile, additional, Fürst-Recktenwald, Sabine, additional, Chisholm, Julia C., additional, and Merks, Johannes H.M., additional

Published
2021
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9. Metastatic Rhabdomyosarcoma: Results of the European Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study.

Author

Schoot, Reineke A., Chisholm, Julia C., Casanova, Michela, Minard-Colin, Veronique, Geoerger, Birgit, Cameron, Alison L., Coppadoro, Beatrice, Zanetti, Ilaria, Orbach, Daniel, Kelsey, Anna, Rogers, Timothy, Guizani, Cecile, Elze, Markus, Ben-Arush, Myriam, McHugh, Kieran, van Rijn, Rick R., Ferman, Sima, Gallego, Soledad, Ferrari, Andrea, and Jenney, Meriel

Published
2022
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11. Selective Phenotyping, Entropy Reduction, and the Mastermind game

Author

Gagneur Julien, Elze Markus C, and Tresch Achim

Subjects
Computer applications to medicine. Medical informatics, R858-859.7, Biology (General), QH301-705.5
Abstract

Abstract Background With the advance of genome sequencing technologies, phenotyping, rather than genotyping, is becoming the most expensive task when mapping genetic traits. The need for efficient selective phenotyping strategies, i.e. methods to select a subset of genotyped individuals for phenotyping, therefore increases. Current methods have focused either on improving the detection of causative genetic variants or their precise genomic location separately. Results Here we recognize selective phenotyping as a Bayesian model discrimination problem and introduce SPARE (Selective Phenotyping Approach by Reduction of Entropy). Unlike previous methods, SPARE can integrate the information of previously phenotyped individuals, thereby enabling an efficient incremental strategy. The effective performance of SPARE is demonstrated on simulated data as well as on an experimental yeast dataset. Conclusions Using entropy reduction as an objective criterion gives a natural way to tackle both issues of detection and localization simultaneously and to integrate intermediate phenotypic data. We foresee entropy-based strategies as a fruitful research direction for selective phenotyping.

Published
2011
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12. Somatosensory Evoked Potentials and Central Motor Conduction Times in children with dystonia and their correlation with outcomes from Deep Brain Stimulation of the Globus pallidus internus

Author

McClelland, Verity M., Fialho, Doreen, Flexney-Briscoe, Denise, Holder, Graham.E., Elze, Markus C., Gimeno, Hortensia, Siddiqui, Ata, Mills, Kerry, Selway, Richard, and Lin, Jean-Pierre

Subjects
Male, congenital, hereditary, and neonatal diseases and abnormalities, Secondary, SEP, Somatosensory Evoked Potential, Adolescent, Deep Brain Stimulation, Neural Conduction, Dystonic Cerebral Palsy, Neurophysiology, TMS, Transcranial Magnetic Stimulation, Globus Pallidus, behavioral disciplines and activities, COPM-p, Canadian Occupational Performance Measure-performance, Article, MRI, Magnetic Resonance Imaging, CP, Cerebral Palsy, Young Adult, MEP, Motor Evoked Potential, Dystonic cerebral palsy, Evoked Potentials, Somatosensory, Humans, Child, Children, HIE, Hypoxic Ischemic Encephalopathy, CMCT, Central Motor Conduction Time, Patient Selection, DBS, Deep Brain Stimulation, Motor Cortex, Somatosensory Cortex, Transcranial Magnetic Stimulation, nervous system diseases, CST, Corticospinal Tract, Central Motor Conduction Time, Dystonia, Treatment Outcome, Somatosensory Evoked Potentials, Child, Preschool, BFMDRS-m, Burke-Fahn-Marsden Dystonia Rating Scale motor score, Female
Abstract

Highlights • A high proportion (47%) of children with dystonia have evidence of abnormal sensory pathway function. • Central motor conduction times (CMCTs) and somatosensory evoked potentials (SEPs) show a significant relationship with deep brain stimulation (DBS) outcome, independent of aetiology or cranial MRI. • CMCTs and SEPs can guide patient selection and help counsel families about potential benefit of DBS., Objectives To report Somatosensory Evoked Potentials (SEPs) and Central Motor Conduction Times (CMCT) in children with dystonia and to test the hypothesis that these parameters predict outcome from Deep Brain Stimulation (DBS). Methods 180 children with dystonia underwent assessment for Globus pallidus internus (GPi) DBS, mean age 10 years (range 2.5–19). CMCT to each limb was calculated using Transcranial Magnetic Stimulation. Median and posterior tibial nerve SEPs were recorded over contralateral and midline centro-parietal scalp. Structural abnormalities were assessed with cranial MRI. One-year outcome from DBS was assessed as percentage improvement in Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS-m). Results Abnormal CMCTs and SEPs were found in 19% and 47% of children respectively and were observed more frequently in secondary than primary dystonia. Of children proceeding to DBS, better outcome was seen in those with normal (n = 78/89) versus abnormal CMCT (n = 11/89) (p = 0.002) and those with normal (n = 35/51) versus abnormal SEPs (n = 16/51) (p = 0.001). These relationships were independent of dystonia aetiology and cranial MRI findings. Conclusions CMCTs and SEPs provide objective evidence of motor and sensory pathway dysfunction in children with dystonia and relate to DBS outcome. Significance CMCTs and SEPs can contribute to patient selection and counselling of families about potential benefit from neuromodulation for dystonia.

Published
2017
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13. Integrated analysis of long-term growth and bone development in pediatric and adolescent patients receiving bevacizumab

Author

Müller, Hermann L., primary, Merks, Johannes H.M., additional, Geoerger, Birgit, additional, Grill, Jacques, additional, Hargrave, Darren, additional, Glade Bender, Julia, additional, Gururangan, Sridharan, additional, Navid, Fariba, additional, Johnston, Michael, additional, Bachir, Jeanette, additional, Elze, Markus C., additional, and Fürst-Recktenwald, Sabine, additional

Published
2018
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14. Platform Session – Evoked potentials & NIOM: Somatosensory evoked potentials and central motor conduction times help predict outcomes from deep brain stimulation (DBS) in children with dystonia

Author

McClelland, Verity M., primary, Fialho, Doreen, additional, Flexney-Briscoe, Denise, additional, Holder, Graham, additional, Elze, Markus, additional, Gimeno, Hortensia, additional, Siddiqui, Ata, additional, Mills, Kerry, additional, Selway, Richard, additional, and Lin, Jean-Pierre, additional

Published
2018
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15. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma

Author

Grill, Jacques, primary, Massimino, Maura, additional, Bouffet, Eric, additional, Azizi, Amedeo A., additional, McCowage, Geoffrey, additional, Cañete, Adela, additional, Saran, Frank, additional, Le Deley, Marie-Cécile, additional, Varlet, Pascale, additional, Morgan, Paul S., additional, Jaspan, Tim, additional, Jones, Chris, additional, Giangaspero, Felice, additional, Smith, Helen, additional, Garcia, Josep, additional, Elze, Markus C., additional, Rousseau, Raphaël F., additional, Abrey, Lauren, additional, Hargrave, Darren, additional, and Vassal, Gilles, additional

Published
2018
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16. Somatosensory Evoked Potentials and Central Motor Conduction Times in children with dystonia and their correlation with outcomes from Deep Brain Stimulation of the Globus pallidus internus

Author

McClelland, Verity M., primary, Fialho, Doreen, additional, Flexney-Briscoe, Denise, additional, Holder, Graham E., additional, Elze, Markus C., additional, Gimeno, Hortensia, additional, Siddiqui, Ata, additional, Mills, Kerry, additional, Selway, Richard, additional, and Lin, Jean-Pierre, additional

Published
2018
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17. Comparison of Propensity Score Methods and Covariate Adjustment: Evaluation in 4 Cardiovascular Studies

Author

Elze, Markus C, Gregson, John, Baber, Usman, Williamson, Elizabeth, Sartori, Samantha, Mehran, Roxana, Nichols, Melissa, Stone, Gregg W, and Pocock, Stuart J

Abstract

Propensity scores (PS) are an increasingly popular method to adjust for confounding in observational studies. Propensity score methods have theoretical advantages over conventional covariate adjustment, but their relative performance in real-word scenarios is poorly characterized. We used datasets from 4 large-scale cardiovascular observational studies (PROMETHEUS, ADAPT-DES [the Assessment of Dual AntiPlatelet Therapy with Drug-Eluting Stents], THIN [The Health Improvement Network], and CHARM [Candesartan in Heart Failure-Assessment of Reduction in Mortality and Morbidity]) to compare the performance of conventional covariate adjustment with 4 common PS methods: matching, stratification, inverse probability weighting, and use of PS as a covariate. We found that stratification performed poorly with few outcome events, and inverse probability weighting gave imprecise estimates of treatment effect and undue influence to a small number of observations when substantial confounding was present. Covariate adjustment and matching performed well in all of our examples, although matching tended to give less precise estimates in some cases. PS methods are not necessarily superior to conventional covariate adjustment, and care should be taken to select the most suitable method.

Published
2017

20. Reply

Author

Elze, Markus C., primary, Gregson, John, additional, Baber, Usman, additional, Williamson, Elizabeth, additional, Sartori, Samantha, additional, Mehran, Roxana, additional, Stone, Gregg W., additional, and Pocock, Stuart J., additional

Published
2017
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21. Burke-Fahn-Marsden dystonia severity, Gross Motor, Manual Ability, and Communication Function Classification scales in childhood hyperkinetic movement disorders including cerebral palsy: a 'Rosetta Stone' study

Author

Elze, Markus C, Gimeno, Hortensia, Tustin, Kylee, Baker, Lesley, Lumsden, Daniel E, Hutton, Jane L, and Lin, Jean-Pierre S-M

Abstract

AIM: Hyperkinetic movement disorders (HMDs) can be assessed using impairment-based scales or functional classifications. The Burke-Fahn-Marsden Dystonia Rating Scale-movement (BFM-M) evaluates dystonia impairment, but may not reflect functional ability. The Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS) are widely used in the literature on cerebral palsy to classify functional ability, but not in childhood movement disorders. We explore the concordance of these three functional scales in a large sample of paediatric HMDs and the impact of dystonia severity on these scales. METHOD: Children with HMDs (n=161; median age 10y 3mo, range 2y 6mo-21y) were assessed using the BFM-M, GMFCS, MACS, and CFCS from 2007 to 2013. This cross-sectional study contrasts the information provided by these scales. RESULTS: All four scales were strongly associated (all Spearman's rank correlation coefficient rs >0.72, p

Published
2015

26. Burke-Fahn-Marsden dystonia severity, Gross Motor, Manual Ability, and Communication Function Classification scales in childhood hyperkinetic movement disorders including cerebral palsy: a 'Rosetta Stone' study.

Author

Elze, Markus C, Gimeno, Hortensia, Tustin, Kylee, Baker, Lesley, Lumsden, Daniel E, Hutton, Jane L, Lin, Jean‐Pierre S‐M, and Lin, Jean-Pierre S-M

Subjects
*CEREBRAL palsy, *SPASTIC paralysis, *DISABILITIES, *MOTOR ability, *MOVEMENT disorders, *COMMUNICATION, *DYSTONIA, *HYPERKINESIA, *RESEARCH funding, *SEVERITY of illness index, *DIAGNOSIS
Abstract

Aim: Hyperkinetic movement disorders (HMDs) can be assessed using impairment-based scales or functional classifications. The Burke-Fahn-Marsden Dystonia Rating Scale-movement (BFM-M) evaluates dystonia impairment, but may not reflect functional ability. The Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS), and Communication Function Classification System (CFCS) are widely used in the literature on cerebral palsy to classify functional ability, but not in childhood movement disorders. We explore the concordance of these three functional scales in a large sample of paediatric HMDs and the impact of dystonia severity on these scales.Method: Children with HMDs (n=161; median age 10y 3mo, range 2y 6mo-21y) were assessed using the BFM-M, GMFCS, MACS, and CFCS from 2007 to 2013. This cross-sectional study contrasts the information provided by these scales.Results: All four scales were strongly associated (all Spearman's rank correlation coefficient rs >0.72, p<0.001), with worse dystonia severity implying worse function. Secondary dystonias had worse dystonia and less function than primary dystonias (p<0.001). A longer proportion of life lived with dystonia is associated with more severe dystonia (rs =0.42, p<0.001).Interpretation: The BFM-M is strongly linked with the GMFCS, MACS, and CFCS, irrespective of aetiology. Each scale offers interrelated but complementary information and is applicable to all aetiologies. Movement disorders including cerebral palsy can be effectively evaluated using these scales. [ABSTRACT FROM AUTHOR]

Published
2016
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29. Phase II, open-label, randomized, multicenter trial (HERBY) of Bevacizumab in pediatric patients with newly diagnosed high-grade glioma

Author

Grill, Jacques, Massimino, Maura, Bouffet, Eric, Azizi, Amedeo A., McCowage, Geoffrey, Cañete, Adela, Saran, Frank, Le Deley, Marie-Cécile, Varlet, Pascale, Morgan, Paul S., Jaspan, Tim, Jones, Chris, Giangaspero, Felice, Smith, Helen, Garcia, Josep, Elze, Markus C., Rousseau, Raphaël F., Abrey, Lauren, Hargrave, Darren, Vassal, Gilles, Grill, Jacques, Massimino, Maura, Bouffet, Eric, Azizi, Amedeo A., McCowage, Geoffrey, Cañete, Adela, Saran, Frank, Le Deley, Marie-Cécile, Varlet, Pascale, Morgan, Paul S., Jaspan, Tim, Jones, Chris, Giangaspero, Felice, Smith, Helen, Garcia, Josep, Elze, Markus C., Rousseau, Raphaël F., Abrey, Lauren, Hargrave, Darren, and Vassal, Gilles

Abstract

Purpose Bevacizumab (BEV) is approved in more than 60 countries for use in adults with recurrent glioblastoma. We evaluated the addition of BEV to radiotherapy plus temozolomide (RT+TMZ) in pediatric patients with newly diagnosed high-grade glioma (HGG). Methods The randomized, parallel group, multicenter, open-label HERBY trial (ClinicalTrials.gov identifier: NCT01390948) enrolled patients age ≥ 3 years to ≤ 18 years with localized, centrally neuropathology-confirmed, nonbrainstem HGG. Eligible patients were randomly assigned to receive RT + TMZ (RT: 1.8 Gy, 5 days per week, and TMZ: 75 mg/m² per day for 6 weeks; 4-week treatment break; then up to 12 3 28-day cycles of TMZ [cycle 1: 150 mg/m² per day, days 1 to 5; cycles 2 to 12: 200 mg/m² per day, days 1 to 5]) with or without BEV (10 mg/kg every 2 weeks). The primary end point was event-free survival (EFS) as assessed by a central radiology review committee that was blinded to treatment. We report findings of EFS at 12 months after the enrollment of the last patient. Results One hundred twenty-one patients were enrolled (RT+TMZ [n = 59]; BEV plus RT+TMZ [n = 62]). Central radiology review committee–assessed median EFS did not differ significantly between treatment groups (RT+TMZ, 11.8 months; 95% CI, 7.9 to 16.4 months; BEV plus RT+TMZ, 8.2 months; 95% CI, 7.8 to 12.7 months; hazard ratio, 1.44; P = .13 [stratified log-rank test]). In the overall survival analysis, the addition of BEV did not reduce the risk of death (hazard ratio, 1.23; 95% CI, 0.72 to 2.09). More patients in the BEV plus RT+TMZ group versus the RT+TMZ group experienced one or more serious adverse events (n = 35 [58%] v n = 27 [48%]), and more patients who received BEV discontinued study treatment as a result of adverse events (n = 13 [22%] v n = 3 [5%]). Conclusion Adding BEV to RT+TMZ did not improve EFS in pediatric patients with newly diagnosed HGG. Our findings were not comparable to those of previous adult trials, which highlights the impo

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