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14 results on '"Giles F. J."'

1. Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study

Author

Rosti, G, Brummendorf, T, Gjertsen, B, Giraldo-Castellano, P, Castagnetti, F, Gambacorti-Passerini, C, Ernst, T, Zhao, H, Kuttschreuter, L, Purcell, S, Giles, F, Hochhaus, A, Rosti G., Brummendorf T. H., Gjertsen B. T., Giraldo-Castellano P., Castagnetti F., Gambacorti-Passerini C., Ernst T., Zhao H., Kuttschreuter L., Purcell S., Giles F. J., Hochhaus A., Rosti, G, Brummendorf, T, Gjertsen, B, Giraldo-Castellano, P, Castagnetti, F, Gambacorti-Passerini, C, Ernst, T, Zhao, H, Kuttschreuter, L, Purcell, S, Giles, F, Hochhaus, A, Rosti G., Brummendorf T. H., Gjertsen B. T., Giraldo-Castellano P., Castagnetti F., Gambacorti-Passerini C., Ernst T., Zhao H., Kuttschreuter L., Purcell S., Giles F. J., and Hochhaus A.

Abstract

In the phase 4 BYOND trial, patients with pretreated chronic myeloid leukemia (CML) received bosutinib (starting dose: 500 mg/day). Efficacy and safety after ≥3 years of follow-up in 156 patients with Philadelphia chromosome–positive chronic phase CML by age and Charlson Comorbidity Index scores (without the age component; mCCI) is reported. Cumulative major molecular response rates at any time on treatment were 73.6%, 64.5%, and 74.1% in patients <65, 65–74, and ≥75 years of age, and 77.9%, 63.0%, and 59.3% in patients with mCCI scores 2, 3, and ≥4, respectively. Patients <65, 65–74, and ≥75 years of age experienced grade 3/4 treatment-emergent adverse events (TEAEs) at rates of 74.7%, 78.8%, and 96.4% and permanent discontinuations due to AEs at rates of 22.1%, 39.4%, and 46.4%, respectively. In patients with mCCI 2, 3, and ≥4, respective rates of grade 3/4 TEAEs were 77.8%, 77.8%, and 86.7%, and permanent discontinuations due to AEs were 25.3%, 33.3%, and 43.3%. In conclusion, a substantial proportion of patients maintained/achieved cytogenetic and molecular responses across age groups and mCCI scores. Older patients (≥75 years) and those with high comorbidity burden (mCCI ≥4) may require more careful monitoring due to the increased risk of TEAEs. Clinicaltrials.gov: NCT02228382.

Published
2024

4. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Author

Hochhaus, A, Rosti, G, Cross, N CP, Steegmann, J L, le Coutre, P, Ossenkoppele, G, Petrov, L, Masszi, T, Hellmann, A, Griskevicius, L, Wiktor-Jedrzejczak, W, Rea, D, Coriu, D, Brümmendorf, T H, Porkka, K, Saglio, G, Gastl, G, Müller, M C, Schuld, P, Di Matteo, P, Pellegrino, A, Dezzani, L, Mahon, F-X, Baccarani, M, and Giles, F J

Published
2016
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6. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study

Author

Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., Stenke L., Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., and Stenke L.

Abstract

Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.

Published
2020

7. Efecto de sobrecargas ligeras sobre el rendimiento del salto vertical con contramovimiento

Author

Gutiérrez Dávila, Marcos, González, C., Giles, F. J., Gallardo, D., and Rojas Ruiz, Francisco Javier

Subjects
Salto vertical, Sobrepeso, Vertical jump, Fuerza, Impulse, Biomechanics, Overweight, Impulso, Biomecánica, Force
Abstract

El propósito de este estudio ha sido determinar el efecto de diferentes sobrecargas ligeras sobre el impulso vertical, la velocidad del centro de masas y el máximo pico de potencia, durante la realización de dos saltos verticales máximos consecutivos. Han participado 28 deportistas practicantes de modalidades deportivas donde el salto vertical constituye una habilidad básica. Se ha utilizado una plataforma de fuerza, operando a 500 Hz, sincronizada temporalmente a una cámara de vídeo, que registraba a 210 Hz el plano sagital de los saltos realizados sobre la plataforma. Los resultados indican que, cuando se utilizan sobrecargas del 7,5% del peso corporal, el tiempo utilizado durante la fase de contramovimiento se incrementa. El impulso vertical y el pico de potencia no varían con el uso de los diferentes niveles de las sobrecargas utilizadas, sin embargo, la velocidad de despegue se reduce un porcentaje similar al incremento de la carga., The purpose of this study was to determine the effect of different light overloads on the vertical impulse, velocity of center of mass and peak power during two consecutive maximum vertical jumps. 28 athletes practicing different sports where vertical jump is a basic skill have participated. A force platform, operating at 500 Hz, temporally synchronized to a video camera, which recorded at 210 Hz the sagittal plane of the jumps were used for the analysis. The results have shown that when overloads of 7,5% of body weight were used , the time used for the counter- phase increased. The vertical impulse and peak power did not vary with the use of different levels of light overloads used in this study, however, the take-off velocity the CM was reduced with a similar percentage that increased the overload.

Published
2016

8. Treatment-free remission following frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the ENESTfreedom study

Author

Hochhaus, A, primary, Masszi, T, additional, Giles, F J, additional, Radich, J P, additional, Ross, D M, additional, Gómez Casares, M T, additional, Hellmann, A, additional, Stentoft, J, additional, Conneally, E, additional, García-Gutiérrez, V, additional, Gattermann, N, additional, Wiktor-Jedrzejczak, W, additional, le Coutre, P D, additional, Martino, B, additional, Saussele, S, additional, Menssen, H D, additional, Deng, W, additional, Krunic, N, additional, Bedoucha, V, additional, and Saglio, G, additional

Published
2017
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9. Expanded safety analysis of pevonedistat, a first-in-class NEDD8-activating enzyme inhibitor, in patients with acute myeloid leukemia and myelodysplastic syndromes

Author

Swords, R T, primary, Watts, J, additional, Erba, H P, additional, Altman, J K, additional, Maris, M, additional, Anwer, F, additional, Hua, Z, additional, Stein, H, additional, Faessel, H, additional, Sedarati, F, additional, Dezube, B J, additional, Giles, F J, additional, Medeiros, B C, additional, and DeAngelo, D J, additional

Published
2017
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10. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Author

Hochhaus, A, primary, Rosti, G, additional, Cross, N C P, additional, Steegmann, J L, additional, le Coutre, P, additional, Ossenkoppele, G, additional, Petrov, L, additional, Masszi, T, additional, Hellmann, A, additional, Griskevicius, L, additional, Wiktor-Jedrzejczak, W, additional, Rea, D, additional, Coriu, D, additional, Brümmendorf, T H, additional, Porkka, K, additional, Saglio, G, additional, Gastl, G, additional, Müller, M C, additional, Schuld, P, additional, Di Matteo, P, additional, Pellegrino, A, additional, Dezzani, L, additional, Mahon, F-X, additional, Baccarani, M, additional, and Giles, F J, additional

Published
2015
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11. EFFECT OF LIGHT OVERLOADS ON COUNTERMOVEMENT VERTICAL JUMP PERFORMANCE.

Author

Gutiérrez-Dávila, M., González, C., Giles, F. J., Gallardo, D., and Rojas, F. J.

Subjects
VERTICAL jump, MECHANICAL loads, CENTER of mass, CAMCORDERS, BODY weight
Abstract

Copyright of International Journal of Medicine & Science of Physical Activity & Sport / Revista Internacional de Medicina y Ciencias de la Actividad Física y del Deporte is the property of Revista Internacional de Medicina y Ciencias de la Actividad Fisica y del Deporte and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2016
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12. Acquired Resistance to Poly (ADP-ribose) Polymerase Inhibitor Olaparib in BRCA2 -Associated Prostate Cancer Resulting From Biallelic BRCA2 Reversion Mutations Restores Both Germline and Somatic Loss-of-Function Mutations.

Author

Carneiro BA, Collier KA, Nagy RJ, Pamarthy S, Sagar V, Fairclough S, Odegaard J, Lanman RB, Costa R, Taxter T, Kuzel TM, Fan A, Chae YK, Cristofanilli M, Hussain MH, Abdulkadir SA, and Giles FJ

Abstract

PARP1/2 inhibitors are effective against BRCA2-deficient tumors. The PARP inhibitor (PARPi) olaparib received FDA breakthrough designation for treatment of metastatic castration-resistant prostate cancers (CRPC) carrying mutations in BRCA1/2 or ATM genes. Emergent resistance to PARPi has been associated with tumor-specific BRCA2 mutations that revert the normal open reading frame rescuing homologous recombination. We describe a case of metastatic CRPC with germline BRCA2 mutation with acquired resistance to olaparib related to biallelic BRCA2 reversion mutations of both the germline and somatic loss of function alleles detected by circulating tumor DNA testing. We also summarize a retrospective analysis of 1,534 prostate cancer cases with ctDNA analysis showing a 1.6% incidence of germline BRCA2 mutations. Within the germline BRCA2 -positive cases exposed to platinum chemotherapy or PARP inhibition, the prevalence of reversion mutations was 40%. This report documents the frequency of reversion mutations in a large cohort of prostate cancer patients carrying of BRCA mutations. It also shows the potential utility of ctDNA analyses for early detection of reversion mutation driving tumor resistance.

Published
2018
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13. Malignancies and ustekinumab: an analysis of the U.S. Food and Drug Administration Adverse Event Reporting System and the European Union Drug Regulating Authorities Pharmacovigilance database.

Author

Florek AG, Nardone B, Thareja S, Tran G, Giles FJ, and West DP

Subjects
Adverse Drug Reaction Reporting Systems standards, Adverse Drug Reaction Reporting Systems statistics & numerical data, Databases, Factual, European Union, Humans, Pharmacovigilance, Product Surveillance, Postmarketing standards, Product Surveillance, Postmarketing statistics & numerical data, United States, United States Food and Drug Administration, Dermatologic Agents adverse effects, Neoplasms chemically induced, Psoriasis drug therapy, Ustekinumab adverse effects
Published
2017
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14. Systematic analysis of early phase clinical studies for patients with breast cancer: Inclusion of patients with brain metastasis.

Author

Costa R, Gill N, Rademaker AW, Carneiro BA, Chae YK, Kumthekar P, Gradishar WJ, Kurzrock R, and Giles FJ

Subjects
Breast Neoplasms chemistry, Female, Humans, Molecular Targeted Therapy, Receptor, ErbB-2 analysis, Brain Neoplasms secondary, Breast Neoplasms pathology, Breast Neoplasms therapy, Clinical Trials, Phase I as Topic, Clinical Trials, Phase II as Topic, Patient Selection
Abstract

Purpose: This systematic review aims to better define the limitations and patterns with which patients with MBC and CNS metastasis are enrolled into early phase developmental therapeutics trials., Methods: In June 2016, PubMed search was conducted using the following keywords: "Breast cancer". Drug-development phase 1, phase 2 or phase 1/2 trials for patients with MBC were included. Multiple-histology trials and trials without an efficacy endpoint were excluded., Results: In total, 1474 studies were included; Inclusion criteria for 423 (29%) allowed for CNS metastasis, 770 (52%) either excluded or did not document eligibility of patients with CNS disease. Trials accruing patients with HER2-positive MBC and including targeted therapies had higher odds of allowing for patients with CNS disease (adjusted OR 1.56, 95% CI 1.08-2.2.6; p=0.019 and 1.49, 95% 1.08-2.06; p=0.014, respectively). There were also higher odds of accrual of patients with CNS involvement into clinical trials over time (odds ratio=1.10, 95% CI 1.07-1.12; p<0.0001)., Conclusion: Most published early phase clinical trials either did not clearly document or did not allow for accrual of patients with CNS disease. Early phase trials with targeted agents or enrolling HER2+ MBC had higher odds of permitting CNS metastases., (Copyright © 2017 Elsevier Ltd. All rights reserved.)

Published
2017
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