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2. Phase I study of FOLFIRI plus pimasertib as second-line treatment for KRAS-mutated metastatic colorectal cancer

Author

Macarulla Mercadé, Teresa, Cervantes, Andrés, Tabernero, Josep, Roselló, Susana, Van Cutsem, E., Tejpar, S., Prenen, H., Martinelli, E., Troiani, T., Laffranchi, B., Jego, V, von Richter, O., Ciardiello, Fortunato, Universitat Autònoma de Barcelona, Macarulla, T, Cervantes, A., Tabernero, J., Roselló, S., Van Cutsem, E., Tejpar, S., Prenen, H., Martinelli, Erika, Troiani, Teresa, Laffranchi, B., Jego, V., Von Richter, O., and Ciardiello, Fortunato

Subjects
Male, Cancer Research, Colorectal cancer, medicine.medical_treatment, Leucovorin, Colorectal Neoplasm, Pharmacology, medicine.disease_cause, pimasertib, combination therapy, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Metastasis, combination therapy second-line treatment, Aged, 80 and over, Proto-Oncogene Protein, Cetuximab, KRAS-mutated metastatic colorectal cancer, Medicine (all), MEK inhibitor, Middle Aged, Neoplasm Metastasi, Treatment Outcome, Oncology, Fluorouracil, FOLFIRI, Second-line treatment, Female, KRAS, Colorectal Neoplasms, Pimasertib, Human, medicine.drug, Niacinamide, Proto-Oncogene Proteins p21(ras), Proto-Oncogene Proteins, medicine, Humans, Combination therapy, neoplasms, Aged, Chemotherapy, Antineoplastic Combined Chemotherapy Protocol, business.industry, KRAS -mutated metastatic colorectal cancer, Genes, ra, ras Protein, medicine.disease, digestive system diseases, Genes, ras, second-line treatment, Mutation, ras Proteins, Clinical Study, Cancer research, Camptothecin, Human medicine, business
Abstract

BACKGROUND: The mitogen-activated protein kinase (MAPK) pathway has been implicated in the molecular pathogenesis of human cancers, including metastatic colorectal cancer (mCRC). This provides a rationale for the development of MAPK-targeted agents such as pimasertib. METHODS: Patients with KRAS mutant mCRC were treated in the second-line setting with FOLFIRI (5-fluorouracil/folinic acid/irinotecan) plus pimasertib. The primary objective of the safety run-in phase was to determine the maximum-tolerated dose (MTD) and the recommended phase II dose of pimasertib combined with FOLFIRI. RESULTS: Sixteen patients were enrolled in the trial. Ten and six patients were treated daily with 45 and 60 mg of pimasertib plus FOLFIRI, respectively. The MTD was considered to be 45 mg per day. The most common treatment-emergent adverse events were diarrhoea, nausea, vomiting, asthenia and skin/rash event. Of the 15 patients in the efficacy analysis group, two patients had partial response, nine patients had stable disease, three patients had progressive disease as their best overall response and one patient could not be evaluated. CONCLUSIONS: Dose escalation of pimasertib in combination with FOLFIRI was limited by toxicity. At the MTD of 45 mg per day, pimasertib was adequately tolerated in patients with mCRC and no unexpected or new safety signals or concerns were identified. ispartof: British Journal of Cancer vol:112 issue:12 pages:1874-1881 ispartof: location:England status: published

Published
2015

3. A phase I schedule dependency study of the aurora kinase inhibitor MSC1992371A in combination with gemcitabine in patients with solid tumors

Author

Raymond, Éric E., Faivre, Sandrine, Alexandre, Jérôme, Goldwasser, François, Besse-Hammer, Tatiana, Awada, Ahmad, Gianella-Borradori, Athos, Jego, V., Trandafir, Lucia, Rejeb, Narmyn, Raymond, Éric E., Faivre, Sandrine, Alexandre, Jérôme, Goldwasser, François, Besse-Hammer, Tatiana, Awada, Ahmad, Gianella-Borradori, Athos, Jego, V., Trandafir, Lucia, and Rejeb, Narmyn

Abstract

Introduction: MSC1992371A is an aurora kinase inhibitor with potential antitumor activity. Methods: This trial established the maximum tolerated dose (MTD) and dose-limiting toxicities (DLTs) of oral MSC1992371A given before or after gemcitabine (1,000 mg/m2) in a 21-day cycle in patients with advanced malignancies. In schedule 1 (n = 31), gemcitabine was administered on days 1 and 8 followed by escalating doses of MSC1992371A on days 2 and 9. In schedule 2 (n = 35), MSC1992371A was given on days 1 and 8 followed by gemcitabine on days 2 and 9. Patients had a range of solid tumors, the most frequent of which was colorectal (n = 19). Results: In both schedules, the 37 mg/m2 dose level was defined as the MTD. The main DLT was grade 4 neutropenia. Adverse events consisted of neutropenia, thrombocytopenia, asthenia, fatigue, nausea, vomiting, anorexia, and diarrhea. Administration of MSC1992371A prior to gemcitabine had no effect on the metabolism or elimination of gemcitabine. Time to reach maximum plasma concentration and area under the plasma concentration-time curve for MSC1992371A increased proportionally with dose. Exploration of drug-target-related and tumor biomarkers did not identify predictors of biologic activity or response. Two patients (1 with lung carcinoma and 1 with hepatocellular carcinoma) had durable partial responses in schedule 2, and 5 patients had stable disease (SD) lasting 6-14 months. Conclusion: Oral MSC1992371A can be administered at a MTD of 37 mg/m2 in combination with the standard 1,000 mg/m2 dose of gemcitabine, but hematologic toxicity requires careful monitoring. Preliminary signs of efficacy were indicated by durable responses and SD. © Springer Science+Business Media 2013., SCOPUS: ar.j, info:eu-repo/semantics/published

Published
2014

7. Episodic Memory Impairments in Primary Brain Tumor Patients

Author

Flavie Bompaire, Damien Ricard, Hervé Taillia, Sabine Hoffmann, Dimitri Psimaras, Daniel Delgadillo, Isabelle Léger, Giulia Berzero, Virginie Jego, Thomas Durand, Marie Baruteau, Durand, T., Berzero, G., Bompaire, F., Hoffmann, S., Leger, I., Jego, V., Baruteau, M., Delgadillo, D., Taillia, H., Psimaras, D., Ricard, D., University of Paris Descartes, University of Pavia, Service de Santé des Armées, PRPHOM, SRBE, LEPID, Institut de Radioprotection et de Sûreté Nucléaire (IRSN), and American Hospital of Paris

Subjects
Adult, Male, 050103 clinical psychology, medicine.medical_specialty, Memory, Episodic, [SDV]Life Sciences [q-bio], Brain tumor, Neuropsychological Tests, Audiology, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Cognitive assessment, Memory decay, Encoding (memory), Neurotoxicity, Humans, Medicine, Memory impairment, 0501 psychology and cognitive sciences, Young adult, Episodic memory, Aged, Retrospective Studies, Aged, 80 and over, Cued speech, Memory Disorders, Brain Neoplasms, business.industry, 05 social sciences, Neuropsychology, Cognition, General Medicine, Middle Aged, medicine.disease, 3. Good health, Psychiatry and Mental health, Clinical Psychology, Neuropsychology and Physiological Psychology, Brain neoplasms, Regression Analysis, Female, business, 030217 neurology & neurosurgery
Abstract

International audience; Objective Cognitive investigations in brain tumor patients have mostly explored episodic memory without differentiating between encoding, storage, and retrieval deficits. The aim of this study is to offer insight into the memory sub-processes affected in primary brain tumor patients and propose an appropriate assessment method. Method We retrospectively reviewed the clinical and memory assessments of 158 patients with primary brain tumors who had presented to our departments with cognitive complaints and were investigated using the Free and Cued Selective Reminding Test. Results Retrieval was the process of episodic memory most frequently affected, with deficits in this domain detected in 92% of patients with episodic memory impairments. Storage and encoding deficits were less prevalent, with impairments, respectively, detected in 41% and 23% of memory-impaired patients. The pattern of episodic memory impairment was similar across different tumor histologies and treatment modalities. Conclusion Although all processes of episodic memory were found to be impaired, retrieval was by far the most widely affected function. A thorough assessment of all three components of episodic memory should be part of the regular neuropsychological evaluation in patients with primary brain tumors. © 2018 The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail journals.permissions@oup.com.

Published
2017
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8. Clinical outcomes in idursulfase-treated patients with mucopolysaccharidosis type II: 3-year data from the hunter outcome survey (HOS).

Author

Muenzer J, Giugliani R, Scarpa M, Tylki-Szymańska A, Jego V, and Beck M

Subjects
Adolescent, Adult, Child, Child, Preschool, Enzyme Replacement Therapy methods, Humans, Infant, Male, Mucopolysaccharidosis II drug therapy, Retrospective Studies, Young Adult, Iduronate Sulfatase therapeutic use
Abstract

Background: Mucopolysaccharidosis type II (MPS II; Hunter syndrome) is a rare, X-linked disorder caused by deficient activity of the enzyme iduronate-2-sulfatase (I2S). Treatment is available in the form of enzyme replacement therapy (ERT) with recombinant I2S. Clinical outcomes following ≥3 years of ERT with idursulfase were investigated in a broad population of patients with MPS II enrolled in the Hunter Outcome Survey (HOS)., Methods: As of January 2016, 639 patients (excluding female patients, individuals who had received a bone marrow transplant and those enrolled in the phase 1/2 [TKT018] or phase 2/3 [TKT024] clinical trial) followed prospectively in the registry had received idursulfase for ≥6 months. These individuals all had data available for ≥1 clinical parameter at baseline and ≥1 additional time point following treatment initiation. Changes in clinical parameters were assessed in the subcohorts of patients with a measurement at baseline and at year 1, 2 or 3 of treatment. Safety data from patients who started treatment at or after enrollment in HOS (n = 233) were also assessed., Results: Median (10th, 90th percentiles) age at first treatment was 6.2 (2.1, 18.2) years and median treatment duration was 56.3 (18.2, 97.6) months. Urinary glycosaminoglycan (uGAG) levels decreased from baseline to year 3 in patients with data available at this time point (median change from baseline: -201.0 [-591.4, -21.9] μg/mg creatinine [n = 121]). Improvements in the following parameters were observed at year 3 in the subcohorts: 6-min walking test (6MWT) distance, 10.6 (-33.6, 50.8)% (n = 26); left ventricular mass index (LVMI), -9.3 (-31.5, 19.7)% (n = 52); absolute forced vital capacity (FVC), 29.7 (-13.4, 66.7)% (n = 23); absolute forced expiratory volume in 1 s (FEV 1 ), 22.8 (-15.2, 62.1)% (n = 22); palpable liver size, -54.5 (-85.7, 50.0)% (n = 53); palpable spleen size, -33.3 (-80.0, 33.3)% (n = 17). No new or unexpected safety concerns were identified in this analysis., Conclusions: These findings suggest that idursulfase has a positive effect on uGAG levels, 6MWT results, LVMI, FVC, FEV 1 and hepatosplenomegaly after 1, 2 and 3 years treatment.

Published
2017
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