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Brian M Alexander, Paul D Brown, Manmeet S Ahluwalia, Hidefumi Aoyama, Brigitta G Baumert, Susan M Chang, Laurie E Gaspar, Steven N Kalkanis, David R Macdonald, Minesh P Mehta, Riccardo Soffietti, John H Suh, Martin J van den Bent, Michael A Vogelbaum, Jeffrey S Wefel, Eudocia Q Lee, Patrick Y Wen
The goals of therapeutic and biomarker development form the foundation of clinical trial design, and change considerably from early-phase to late-phase trials. From these goals, decisions on specific clinical trial design elements, such as endpoint selection and statistical approaches, are formed. Whereas early-phase trials might focus on finding a therapeutic signal to make decisions on further development, late-phase trials focus on the confirmation of therapeutic impact by considering clinically meaningful endpoints...
January 2018: Lancet Oncology
D Ross Camidge, Eudocia Q Lee, Nancy U Lin, Kim Margolin, Manmeet S Ahluwalia, Martin Bendszus, Susan M Chang, Janet Dancey, Elisabeth G E de Vries, Gordon J Harris, F Stephen Hodi, Andrew B Lassman, David R Macdonald, David M Peereboom, David Schiff, Ricardo Soffietti, Martin J van den Bent, Jeffrey S Wefel, Patrick Y Wen
Patients with active CNS disease are often excluded from clinical trials, and data regarding the CNS efficacy of systemic agents are usually obtained late in the drug development process or not at all. In this guideline from the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group, we provide detailed recommendations on when patients with brain metastases from solid tumours should be included or excluded in clinical trials of systemic agents. We also discuss the limitations of retrospective studies in determining the CNS efficacy of systemic drugs...
January 2018: Lancet Oncology
T M Churilla, E Handorf, S Collette, L Collette, Y Dong, A A Aizer, M Kocher, R Soffietti, B M Alexander, S E Weiss
Background: The absence of a survival benefit for whole brain radiotherapy (WBRT) among randomized trials has been attributed to a competing risk of death from extracranial disease. We re-analyzed EORTC 22952 to assess the impact of WBRT on survival for patients with controlled extracranial disease or favorable prognoses. Patients and methods: We utilized Cox regression, landmark analysis, and the Kaplan-Meier method to evaluate the impact of WBRT on survival accounting for (i) extracranial progression as a time-dependent covariate in all patients and (ii) diagnosis-specific graded prognostic assessment (GPA) score in patients with primary non-small-cell lung cancer (NSCLC)...
October 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Lakshmi Nayak, Lisa M DeAngelis, Alba A Brandes, David M Peereboom, Evanthia Galanis, Nancy U Lin, Riccardo Soffietti, David R Macdonald, Marc Chamberlain, James Perry, Kurt Jaeckle, Minesh Mehta, Roger Stupp, Alona Muzikansky, Elena Pentsova, Timothy Cloughesy, Fabio M Iwamoto, Joerg-Christian Tonn, Michael A Vogelbaum, Patrick Y Wen, Martin J van den Bent, David A Reardon
Background: The Macdonald criteria and the Response Assessment in Neuro-Oncology (RANO) criteria define radiologic parameters to classify therapeutic outcome among patients with malignant glioma and specify that clinical status must be incorporated and prioritized for overall assessment. But neither provides specific parameters to do so. We hypothesized that a standardized metric to measure neurologic function will permit more effective overall response assessment in neuro-oncology. Methods: An international group of physicians including neurologists, medical oncologists, radiation oncologists, and neurosurgeons with expertise in neuro-oncology drafted the Neurologic Assessment in Neuro-Oncology (NANO) scale as an objective and quantifiable metric of neurologic function evaluable during a routine office examination...
May 1, 2017: Neuro-oncology
T M Churilla, E Handorf, R Soffietti, M Kocher, A A Aizer, L Collette, S Collette, Y Dong, B M Alexander, S E Weiss
No abstract text is available yet for this article.
October 1, 2016: International Journal of Radiation Oncology, Biology, Physics
Vijay Ramaswamy, Thomas Hielscher, Stephen C Mack, Alvaro Lassaletta, Tong Lin, Kristian W Pajtler, David T W Jones, Betty Luu, Florence M G Cavalli, Kenneth Aldape, Marc Remke, Martin Mynarek, Stefan Rutkowski, Sridharan Gururangan, Roger E McLendon, Eric S Lipp, Christopher Dunham, Juliette Hukin, David D Eisenstat, Dorcas Fulton, Frank K H van Landeghem, Mariarita Santi, Marie-Lise C van Veelen, Erwin G Van Meir, Satoru Osuka, Xing Fan, Karin M Muraszko, Daniela P C Tirapelli, Sueli M Oba-Shinjo, Suely K N Marie, Carlos G Carlotti, Ji Yeoun Lee, Amulya A Nageswara Rao, Caterina Giannini, Claudia C Faria, Sofia Nunes, Jaume Mora, Ronald L Hamilton, Peter Hauser, Nada Jabado, Kevin Petrecca, Shin Jung, Luca Massimi, Massimo Zollo, Giuseppe Cinalli, László Bognár, Almos Klekner, Tibor Hortobágyi, Sarah Leary, Ralph P Ermoian, James M Olson, Jeffrey R Leonard, Corrine Gardner, Wieslawa A Grajkowska, Lola B Chambless, Jason Cain, Charles G Eberhart, Sama Ahsan, Maura Massimino, Felice Giangaspero, Francesca R Buttarelli, Roger J Packer, Lyndsey Emery, William H Yong, Horacio Soto, Linda M Liau, Richard Everson, Andrew Grossbach, Tarek Shalaby, Michael Grotzer, Matthias A Karajannis, David Zagzag, Helen Wheeler, Katja von Hoff, Marta M Alonso, Teresa Tuñon, Ulrich Schüller, Karel Zitterbart, Jaroslav Sterba, Jennifer A Chan, Miguel Guzman, Samer K Elbabaa, Howard Colman, Girish Dhall, Paul G Fisher, Maryam Fouladi, Amar Gajjar, Stewart Goldman, Eugene Hwang, Marcel Kool, Harshad Ladha, Elizabeth Vera-Bolanos, Khalida Wani, Frank Lieberman, Tom Mikkelsen, Antonio M Omuro, Ian F Pollack, Michael Prados, H Ian Robins, Riccardo Soffietti, Jing Wu, Phillipe Metellus, Uri Tabori, Ute Bartels, Eric Bouffet, Cynthia E Hawkins, James T Rutka, Peter Dirks, Stefan M Pfister, Thomas E Merchant, Mark R Gilbert, Terri S Armstrong, Andrey Korshunov, David W Ellison, Michael D Taylor
PURPOSE: Posterior fossa ependymoma comprises two distinct molecular variants termed EPN_PFA and EPN_PFB that have a distinct biology and natural history. The therapeutic value of cytoreductive surgery and radiation therapy for posterior fossa ependymoma after accounting for molecular subgroup is not known. METHODS: Four independent nonoverlapping retrospective cohorts of posterior fossa ependymomas (n = 820) were profiled using genome-wide methylation arrays. Risk stratification models were designed based on known clinical and newly described molecular biomarkers identified by multivariable Cox proportional hazards analyses...
July 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Antonella Castellano, Marina Donativi, Roberta Rudà, Giorgio De Nunzio, Marco Riva, Antonella Iadanza, Luca Bertero, Matteo Rucco, Lorenzo Bello, Riccardo Soffietti, Andrea Falini
OBJECTIVES: To explore the role of diffusion tensor imaging (DTI)-based histogram analysis and functional diffusion maps (fDMs) in evaluating structural changes of low-grade gliomas (LGGs) receiving temozolomide (TMZ) chemotherapy. METHODS: Twenty-one LGG patients underwent 3T-MR examinations before and after three and six cycles of dose-dense TMZ, including 3D-fluid-attenuated inversion recovery (FLAIR) sequences and DTI (b = 1000 s/mm(2), 32 directions). Mean diffusivity (MD), fractional anisotropy (FA), and tensor-decomposition DTI maps (p and q) were obtained...
May 2016: European Radiology
L Barault, A Amatu, F E Bleeker, C Moutinho, C Falcomatà, V Fiano, A Cassingena, G Siravegna, M Milione, P Cassoni, F De Braud, R Rudà, R Soffietti, T Venesio, A Bardelli, P Wesseling, P de Witt Hamer, F Pietrantonio, S Siena, M Esteller, A Sartore-Bianchi, F Di Nicolantonio
BACKGROUND: O(6)-methyl-guanine-methyl-transferase (MGMT) silencing by promoter methylation may identify cancer patients responding to the alkylating agents dacarbazine or temozolomide. PATIENTS AND METHODS: We evaluated the prognostic and predictive value of MGMT methylation testing both in tumor and cell-free circulating DNA (cfDNA) from plasma samples using an ultra-sensitive two-step digital PCR technique (methyl-BEAMing). Results were compared with two established techniques, methylation-specific PCR (MSP) and Bs-pyrosequencing...
September 2015: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Nancy U Lin, Eudocia Q Lee, Hidefumi Aoyama, Igor J Barani, Daniel P Barboriak, Brigitta G Baumert, Martin Bendszus, Paul D Brown, D Ross Camidge, Susan M Chang, Janet Dancey, Elisabeth G E de Vries, Laurie E Gaspar, Gordon J Harris, F Stephen Hodi, Steven N Kalkanis, Mark E Linskey, David R Macdonald, Kim Margolin, Minesh P Mehta, David Schiff, Riccardo Soffietti, John H Suh, Martin J van den Bent, Michael A Vogelbaum, Patrick Y Wen
CNS metastases are the most common cause of malignant brain tumours in adults. Historically, patients with brain metastases have been excluded from most clinical trials, but their inclusion is now becoming more common. The medical literature is difficult to interpret because of substantial variation in the response and progression criteria used across clinical trials. The Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) working group is an international, multidisciplinary effort to develop standard response and progression criteria for use in clinical trials of treatment for brain metastases...
June 2015: Lancet Oncology
Elizabeth Vera-Bolanos, Kenneth Aldape, Ying Yuan, Jimin Wu, Khalida Wani, Mary Jo Necesito-Reyes, Howard Colman, Girish Dhall, Frank S Lieberman, Philippe Metellus, Tom Mikkelsen, Antonio Omuro, Sonia Partap, Michael Prados, H Ian Robins, Riccardo Soffietti, Jing Wu, Mark R Gilbert, Terri S Armstrong
BACKGROUND: Ependymomas are rare CNS tumors. Previous studies describing the clinical course of ependymoma patients were restricted to small sample sizes, often with patients at a specific institution. METHODS: Clinically annotated ependymoma tissue samples from 19 institutions were centrally reviewed. Patients were all adults aged 18 years or older at the time of diagnosis. Potential prognostic clinical factors identified on univariate analysis were included in a multivariate Cox proportional hazards model with backwards selection to model progression-free survival...
March 2015: Neuro-oncology
Jason T Huse, Max Wallace, Kenneth D Aldape, Mitchel S Berger, Chetan Bettegowda, Daniel J Brat, Daniel P Cahill, Timothy Cloughesy, Daphne A Haas-Kogan, Marco Marra, C Ryan Miller, Sarah J Nelson, Sofie R Salama, Riccardo Soffietti, Patrick Y Wen, Stephen Yip, Katharine Yen, Joseph F Costello, Susan Chang
Diffuse gliomas consist of both low- and high-grade varieties, each with distinct morphological and biological features. The often extended periods of relative indolence exhibited by low-grade gliomas (LGG; WHO grade II) differ sharply from the aggressive, rapidly fatal clinical course of primary glioblastoma (GBM; WHO grade IV). Nevertheless, until recently, the molecular foundations underlying this stark biological contrast between glioma variants remained largely unknown. The discoveries of distinctive and highly recurrent genomic and epigenomic abnormalities in LGG have both informed a more accurate classification scheme and pointed to viable avenues for therapeutic development...
January 2014: Neuro-oncology
S Greco Crasto, R Soffietti, R Rudà, P Cassoni, A Ducati, O Davini, R De Lucchi, L Rizzo
This study evaluated the usefulness of diffusion-weighted (DW) magnetic resonance imaging (MRI) and ADC maps in the differential diagnosis of brain abscesses from cystic or necrotic neoplasms. MR images of 49 patients with 54 lesions were examined retrospectively. All patients underwent conventional MRI and DWI, and ADC values were calculated by placing ROIs of 30 mm(2) manually over the cystic part of the lesions. On DWI, all cystic portions of abscesses were hyperintense. Mean ADC values were 0.48×10 mm(2)/s (range 0...
December 31, 2007: Neuroradiology Journal
Nancy U Lin, Jeffrey S Wefel, Eudocia Q Lee, David Schiff, Martin J van den Bent, Riccardo Soffietti, John H Suh, Michael A Vogelbaum, Minesh P Mehta, Janet Dancey, Mark E Linskey, D Ross Camidge, Hidefumi Aoyama, Paul D Brown, Susan M Chang, Steven N Kalkanis, Igor J Barani, Brigitta G Baumert, Laurie E Gaspar, F Stephen Hodi, David R Macdonald, Patrick Y Wen
Neurocognitive function, neurological symptoms, functional independence, and health-related quality of life are major concerns for patients with brain metastases. The inclusion of these endpoints in trials of brain metastases and the methods by which these measures are assessed vary substantially. If functional independence or health-related quality of life are planned as key study outcomes, then the reliability and validity of these endpoints can be crucial because methodological issues might affect the interpretation and acceptance of findings...
September 2013: Lancet Oncology
Nancy U Lin, Eudocia Q Lee, Hidefumi Aoyama, Igor J Barani, Brigitta G Baumert, Paul D Brown, D Ross Camidge, Susan M Chang, Janet Dancey, Laurie E Gaspar, Gordon J Harris, F Stephen Hodi, Steven N Kalkanis, Kathleen R Lamborn, Mark E Linskey, David R Macdonald, Kim Margolin, Minesh P Mehta, David Schiff, Riccardo Soffietti, John H Suh, Martin J van den Bent, Michael A Vogelbaum, Jeffrey S Wefel, Patrick Y Wen
Therapeutic outcomes for patients with brain metastases need to improve. A critical review of trials specifically addressing brain metastases shows key issues that could prevent acceptance of results by regulatory agencies, including enrolment of heterogeneous groups of patients and varying definitions of clinical endpoints. Considerations specific to disease, modality, and treatment are not consistently addressed. Additionally, the schedule of CNS imaging and consequences of detection of new or progressive brain metastases in trials mainly exploring the extra-CNS activity of systemic drugs are highly variable...
September 2013: Lancet Oncology
Aditya Raghunathan, Khalida Wani, Terri S Armstrong, Elizabeth Vera-Bolanos, Maryam Fouladi, Richard Gilbertson, Amar Gajjar, Stewart Goldman, Norman L Lehman, Phillipe Metellus, Tom Mikkelsen, Mary Jo T Necesito-Reyes, Antonio Omuro, Roger J Packer, Sonia Partap, Ian F Pollack, Michael D Prados, H Ian Robins, Riccardo Soffietti, Jing Wu, C Ryan Miller, Mark R Gilbert, Kenneth D Aldape
Ependymomas originate in posterior fossa (PF), supratentorial (ST) or spinal cord (SC) compartments. At present, grading schemes are applied independent of anatomic site. We performed detailed histological examination on 238 World Health Organization grade II and III ependymomas. Among PF ependymomas, the presence of hypercellular areas, necrosis, microvascular proliferation and elevated mitotic rate (all P < 0.01) were significantly associated with worse progression-free survival (PFS), while extensive ependymal canal formation was not (P = 0...
September 2013: Brain Pathology
Khalida Wani, Terri S Armstrong, Elizabeth Vera-Bolanos, Aditya Raghunathan, David Ellison, Richard Gilbertson, Brian Vaillant, Stewart Goldman, Roger J Packer, Maryam Fouladi, Ian Pollack, Tom Mikkelsen, Michael Prados, Antonio Omuro, Riccardo Soffietti, Alicia Ledoux, Charmaine Wilson, Lihong Long, Mark R Gilbert, Ken Aldape
Patients with ependymoma exhibit a wide range of clinical outcomes that are currently unexplained by clinical or histological factors. Little is known regarding molecular biomarkers that could predict clinical behavior. Since recent data suggest that these tumors display biological characteristics according to their location (cerebral vs. infratentorial vs. spinal cord), rather than explore a broad spectrum of ependymoma, we focused on molecular alterations in ependymomas arising in the infratentorial compartment...
May 2012: Acta Neuropathologica
R Soffietti, A Ducati, R Rudà
No abstract text is available yet for this article.
2012: Handbook of Clinical Neurology
R Rudà, E Trevisan, R Soffietti
No abstract text is available yet for this article.
2012: Handbook of Clinical Neurology
R Soffietti, E Trevisan, L Bertero, C Bosa, R Ruda
Despite advances in multidisciplinary approaches, the prognosis for most patients with malignant gliomas is poor. Malignant gliomas are highly vascularized tumors with elevated expression of vascular endothelial growth factor (VEGF), an important mediator of angiogenesis. Recent studies of bevacizumab, an anti-VEGF monoclonal antibody, alone or associated with chemotherapy, have demonstrated high response rates and prolongation of median and 6-month progression-free survival. Clinical evaluation of several multitarget small molecule tyrosine kinase inhibitors is ongoing...
March 2012: Current Cancer Drug Targets
M J Titulaer, R Soffietti, J Dalmau, N E Gilhus, B Giometto, F Graus, W Grisold, J Honnorat, P A E Sillevis Smitt, R Tanasescu, C A Vedeler, R Voltz, J J G M Verschuuren
BACKGROUND: paraneoplastic neurological syndromes (PNS) almost invariably predate detection of the malignancy. Screening for tumours is important in PNS as the tumour directly affects prognosis and treatment and should be performed as soon as possible. OBJECTIVES: an overview of the screening of tumours related to classical PNS is given. Small cell lung cancer, thymoma, breast cancer, ovarian carcinoma and teratoma and testicular tumours are described in relation to paraneoplastic limbic encephalitis, subacute sensory neuronopathy, subacute autonomic neuropathy, paraneoplastic cerebellar degeneration, paraneoplastic opsoclonus-myoclonus, Lambert-Eaton myasthenic syndrome (LEMS), myasthenia gravis and paraneoplastic peripheral nerve hyperexcitability...
January 2011: European Journal of Neurology: the Official Journal of the European Federation of Neurological Societies
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