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1. Similar efficacy outcomes with peripheral blood stem cell versus bone marrow for autologous stem cell transplantation in acute myeloid leukemia: Long-term follow-up of the EORTC-GIMEMA randomized AML-10 trial

Author

Baron, F., Efficace, F., Cannella, L., Stevens-Kroef, M.J.P.L., Amadori, S., Witte, T.J. de, Lübbert, M., Venditti, A., Suciu, S., Baron, F., Efficace, F., Cannella, L., Stevens-Kroef, M.J.P.L., Amadori, S., Witte, T.J. de, Lübbert, M., Venditti, A., and Suciu, S.

Abstract

Contains fulltext : 304916.pdf (Publisher’s version ) (Closed access), We report here the long-term follow-up of the only prospective randomized trial of autologous hematopoietic stem cell transplantation (auto-HSCT) with peripheral blood stem cells (APBSCT) versus auto-HSCT with bone marrow (ABMT) in acute myeloid leukemia (AML) patients in first remission (CR). We observed that among patients alive and still in CR 5 years after planned auto-HSCT, approximately 10% of the patients died in the following 10 years. This stresses the need for long-term close surveillance of AML patients after auto-HSCT. Further, long-term follow-up of the trial confirms that APBSCT was comparable to ABMT in term of disease-free-survival and overall survival.

Published
2024

2. 10-day decitabine versus 3 + 7 chemotherapy followed by allografting in older patients with acute myeloid leukaemia: an open-label, randomised, controlled, phase 3 trial.

Author

Lübbert, M., Wijermans, P.W., Kicinski, M., Chantepie, S., Velden, W.J.F.M. van der, Noppeney, R., Griškevičius, L., Neubauer, A., Crysandt, M., Vrhovac, R., Luppi, M., Fuhrmann, S., Audisio, E., Candoni, A., Legrand, O., Foà, R., Gaidano, G., Lammeren-Venema, D. van, Posthuma, E.F.M., Hoogendoorn, M., Giraut, A., Stevens-Kroef, M.J.P.L., Jansen, J.H., Graaf, A.O. de, Efficace, F., Ammatuna, E., Vilque, J.P., Wäsch, R., Becker, H., Blijlevens, N., Dührsen, U., Baron, F., Suciu, S., Amadori, S., Venditti, A., Huls, G., Lübbert, M., Wijermans, P.W., Kicinski, M., Chantepie, S., Velden, W.J.F.M. van der, Noppeney, R., Griškevičius, L., Neubauer, A., Crysandt, M., Vrhovac, R., Luppi, M., Fuhrmann, S., Audisio, E., Candoni, A., Legrand, O., Foà, R., Gaidano, G., Lammeren-Venema, D. van, Posthuma, E.F.M., Hoogendoorn, M., Giraut, A., Stevens-Kroef, M.J.P.L., Jansen, J.H., Graaf, A.O. de, Efficace, F., Ammatuna, E., Vilque, J.P., Wäsch, R., Becker, H., Blijlevens, N., Dührsen, U., Baron, F., Suciu, S., Amadori, S., Venditti, A., and Huls, G.

Abstract

Contains fulltext : 299611.pdf (Publisher’s version ) (Closed access), BACKGROUND: Many older patients with acute myeloid leukaemia die or cannot undergo allogeneic haematopoietic stem-cell transplantation (HSCT) due to toxicity caused by intensive chemotherapy. We hypothesised that replacing intensive chemotherapy with decitabine monotherapy could improve outcomes. METHODS: This open-label, randomised, controlled, phase 3 trial was conducted at 54 hospitals in nine European countries. Patients aged 60 years and older who were newly diagnosed with acute myeloid leukaemia and had not yet been treated were enrolled if they had an Eastern Cooperative Oncology Group performance status of 2 or less and were eligible for intensive chemotherapy. Patients were randomly assigned (1:1) to receive decitabine or standard chemotherapy (known as 3 + 7). For the decitabine group, decitabine (20 mg/m(2)) was administered for the first 10 days in the first 28-day cycle, followed by 28-day cycles consisting of 5 days or 10 days of decitabine. For the 3 + 7 group, daunorubicin (60 mg/m(2)) was administered over the first 3 days and cytarabine (200 mg/m(2)) over the first 7 days, followed by 1-3 additional chemotherapy cycles. Allogeneic HSCT was strongly encouraged. Overall survival in the intention-to-treat population was the primary endpoint. Safety was assessed in all patients who received the allocated treatment. This trial is registered at ClinicalTrials.gov, NCT02172872, and is closed to new participants. FINDINGS: Between Dec 1, 2014, and Aug 20, 2019, 606 patients were randomly assigned to the decitabine (n=303) or 3 + 7 (n=303) group. Following an interim analysis which showed futility, the IDMC recommended on May 22, 2019, that the study continued as planned considering the risks and benefits for the patients participating in the study. The cutoff date for the final analysis presented here was June 30, 2021. At a median follow-up of 4·0 years (IQR 2·9-4·8), 4-year overall survival was 26% (95% CI 21-32) in the decitabine group versus 30% (24-35, 01 november 2023

Published
2023

3. Psychiatric comorbidity in patients with chronic migraine

Author

Ricciardulli, S., primary, D'Alessandro, G., additional, Giovannuzzi, I., additional, Tidona, S., additional, De Rosa, U., additional, Barbuti, M., additional, Amadori, S., additional, Parapetto, E., additional, Baldacci, F., additional, Lattanzi, L., additional, and Perugi, G., additional

Published
2023
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4. LABNET AML: AN EFFICIENT NETWORK THAT CONNECTS HEMATOLOGY CENTERS AND LABORATORIES FOR A HIGH-LEVEL DIAGNOSTIC/PROGNOSTIC WORKUP OF AML

Author

Voso, M, Cucci, R, Messina, M, Santoro, A, Divona, M, Albano, F, Ottaviani, E, Bertorelle, R, Guerrasio, A, Gottardi, E, Izzo, B, Tarantini, G, Scardocci, A, Siragusa, S, Forghieri, F, Cairoli, R, Cambo, B, Vallisa, D, Venditti, A, Ferrara, F, Mannina, D, Cilloni, D, La, S, Piciocchi, A, Falini, B, Pane, F, Saglio, G, Vignetti, M, Amadori, S, Voso MT, Cucci R, Messina M, Santoro A, Divona M, Albano F, Ottaviani E, Bertorelle R, Guerrasio A, Gottardi E, Izzo B, Tarantini G, Scardocci A, Siragusa S, Forghieri F, Cairoli R, Cambo B, Vallisa D, Venditti A, Ferrara F, Mannina D, Cilloni D, La SalaE, Piciocchi A, Falini B, Pane F, Saglio G, Vignetti M, Amadori S, Voso, M, Cucci, R, Messina, M, Santoro, A, Divona, M, Albano, F, Ottaviani, E, Bertorelle, R, Guerrasio, A, Gottardi, E, Izzo, B, Tarantini, G, Scardocci, A, Siragusa, S, Forghieri, F, Cairoli, R, Cambo, B, Vallisa, D, Venditti, A, Ferrara, F, Mannina, D, Cilloni, D, La, S, Piciocchi, A, Falini, B, Pane, F, Saglio, G, Vignetti, M, Amadori, S, Voso MT, Cucci R, Messina M, Santoro A, Divona M, Albano F, Ottaviani E, Bertorelle R, Guerrasio A, Gottardi E, Izzo B, Tarantini G, Scardocci A, Siragusa S, Forghieri F, Cairoli R, Cambo B, Vallisa D, Venditti A, Ferrara F, Mannina D, Cilloni D, La SalaE, Piciocchi A, Falini B, Pane F, Saglio G, Vignetti M, and Amadori S

Published
2021

5. Pre-transplant persistence of minimal residual disease does not contraindicate allogeneic stem cell transplantation for adult patients with acute myeloid leukemia

Author

Buccisano, F, Maurillo, L, Piciocchi, A, Del Principe, M I, Picardi, A, Cerretti, R, Cudillo, L, De Angelis, G, Sarlo, C, Cefalo, M, Ditto, C, Di Veroli, A, Mariotti, B, Nasso, D, De Bellis, E, Del Poeta, G, Voso, M T, Sconocchia, G, Lo Coco, F, Arcese, W, Amadori, S, and Venditti, A

Published
2017
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8. S125: 10-DAY DECITABINE VS. CONVENTIONAL CHEMOTHERAPY (“3 + 7”) FOLLOWED BY ALLOGRAFTING (HSCT) IN AML PATIENTS ≥60 YEARS: A RANDOMIZED PHASE III STUDY OF THE EORTC LEUKEMIA GROUP, GIMEMA, CELG, AND GMDS-SG

Author

Lübbert, M., primary, Wijermans, P., additional, Kicinski, M., additional, Chantepie, S., additional, van der Velden, W., additional, Noppeney, R., additional, Griskevicius, L., additional, Neubauer, A., additional, Crysandt, M., additional, Vrhovac, R., additional, Luppi, M., additional, Fuhrmann, S., additional, Audisio, E., additional, Candoni, A., additional, Legrand, O., additional, Foà, R., additional, Gaidano, G., additional, van Lammeren-Venema, D., additional, Posthuma, E. F., additional, Hoogendoorn, M., additional, Giraut, A., additional, Stevens-Kroef, M., additional, Jansen, J. H., additional, Ammatuna, E., additional, Vilque, J.-P., additional, Wäsch, R., additional, Becker, H., additional, Blijlevens, N., additional, Dührsen, U., additional, Baron, F., additional, Suciu, S., additional, Amadori, S., additional, Venditti, A., additional, and Huls, G., additional

Published
2022
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9. S100: QUIZARTINIB PROLONGED SURVIVAL VS PLACEBO PLUS INTENSIVE INDUCTION AND CONSOLIDATION THERAPY FOLLOWED BY SINGLE-AGENT CONTINUATION IN PATIENTS AGED 18-75 YEARS WITH NEWLY DIAGNOSED FLT3-ITD+ AML

Author

Erba, H., primary, Montesinos, P., additional, Vrhovac, R., additional, Patkowska, E., additional, Kim, H.-J., additional, Zak, P., additional, Wang, P.-N., additional, Mitov, T., additional, Hanyok, J., additional, Liu, L., additional, Benzohra, A., additional, Lesegretain, A., additional, Cortes, J., additional, Perl, A., additional, Sekeres, M., additional, Dombret, H., additional, Amadori, S., additional, Wang, J., additional, Levis, M., additional, and Schlenk, R., additional

Published
2022
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10. Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2020

11. Intensive Chemotherapy Followed by Stem Cell Transplantation for the Treatment of Myelodysplastic Syndromes

Author

De Witte, T., Suciu, S., Verhoef, G., Labar, B., Archimbaud, E., Aul, C., Selleslag, D., Ferrant, A., Wijermans, P., Mandelli, F., Amadori, S., Jehn, U., Muus, P., Demuynck, H., Dardenne, M., Zittoun, R., Willemze, R., Gratwohl, A., Apperley, J., Büchner, T., editor, Hiddemann, W., editor, Wörmann, B., editor, Schellong, G., editor, Ritter, J., editor, and Creutzig, U., editor

Published
2001
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16. A procedure for the identification of the SLS material model from dynamical experimental measurements

Author

Amadori S., Catania G., Sriram Sundararajan, Martin Dienwiebel, and Amadori, S., Catania, G.

Subjects
Identification, vibration, material modeling
Abstract

Dynamic Mechanical Analysis tests are an established experimental technique that can be used to obtain the material stress-strain relationship by means of forced sinusoidal excitation measurements made on beam specimens. A procedure for the experimental identification of the material standard linear solid (SLS) frequency dependent constitutive equation by means of the DMA estimated material stress-strain relationship is presented. The proposed approach is an extension of an identification technique for the constitutive stress-strain relationship presented by the authors previous works. Uniform and homogeneous beams in clamped-double pendulum boundary conditions, with a sinusoidal flexural force applied at the mobile beam end are considered. Frequency dependent force and displacement test results from reference known specimens are processed in order to estimate the 2-DOFs model frame contribution to the measurement data. The model frame and the material SLS model are both mathematically defined by polynomial rational functions, polynomial order and parameters are to be identified by means of an algebraic numerical technique. The rational function model of the instrument frame is obtained by means of an approach based on the least square error technique and making use of different polynomial bases such as the Forsythe, Legendre, and Chebyshev ones. Unphysical model zeros and poles are eliminated to obtain a minimum order optimal model. A multi-step algorithm is adopted to obtain a n-order SLS material model, where a rational polynomial, n+1-degree numerator and a n-degree denominator polynomial, is assumed. The optimal SLS model order is automatically obtained by eliminating non-physical poles. To minimize computational errors, the influence of the choice of the different polynomial functional bases on the effectiveness of the model results is investigated, and numerical results are discussed. Some application examples, concerning the identification of the SLS material model of viscoelastic standard and non-standard materials, are shown and discussed as well.

Published
2021

18. Therapy of Adult Acute Lymphoblastic Leukemia. Preliminary Results of the GIMEMA ALL/0288 Study

Author

Amadori, S., Annino, L., Ferrari, A., Vegna, M. L., Camera, A., Ciolli, S., Deplano, W., Fabiano, F., Ferrara, F., Ladogana, S., Muti, G., Peta, A., Recchia, A., Sica, S., Stasi, R., Tabilio, A., Visani, G., Baccarani, M., Mandelli, F., Büchner, T., editor, Hiddemann, W., editor, Wörmann, B., editor, Schellong, G., editor, and Ritter, J., editor

Published
1994
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19. Clofarabine in combination with a standard remission induction regimen (cytosine arabinoside and idarubicin) in patients with previously untreated intermediate and bad-risk acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): phase I results of an ongoing phase I/II study of the leukemia groups of EORTC and GIMEMA (EORTC GIMEMA 06061/AML-14A trial)

Author

Willemze, R., Suciu, S., Muus, P., Halkes, C. J. M., Meloni, G., Meert, L., Karrasch, M., Rapion, J., Vignetti, M., Amadori, S., de Witte, T., and Marie, J. P.

Published
2014
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20. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2019

21. IN ADULT ACUTE MYELOID LEUKEMIA (AML) PERIPHERAL BLOOD MEASURABLE RESIDUAL DISEASE (MRD) BY FLOW CYTOMETRY (FC) IS FEASIBLE AND IS PROGNOSTICALLY RELEVANT

Author

Maurillo, L, Buccisano, F, Piciocchi, A, Del Principe, M, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Mazza, P, Martelli, M, Cuneo, A, Albano, F, Fabbiano, F, Tafuri, A, Chierichini, A, Tieghi, A, Fracchiolla, N, Capelli, D, Foa, R, Alati, C, La Sala, E, Voso, M, Fazi, P, Vignetti, M, Consalvo, M, Ottone, T, Lavorgna, S, Arcese, W, Lo Coco, F, Amadori, S, Venditti, A, Maurillo L, Buccisano F, Piciocchi A, Del Principe MI, Candoni A, Melillo L, Calafiore V, Cairoli R, De Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Mazza P, Martelli MP, Cuneo A, Albano F, Fabbiano F, Tafuri A, Chierichini A, Tieghi A, Fracchiolla NS, Capelli D, Foa R, Alati C, La Sala E, Voso MT, Fazi P, Vignetti M, Consalvo MI, Ottone T, Lavorgna S, Arcese W, Lo Coco F, Amadori S, Venditti a., Maurillo, L, Buccisano, F, Piciocchi, A, Del Principe, M, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Mazza, P, Martelli, M, Cuneo, A, Albano, F, Fabbiano, F, Tafuri, A, Chierichini, A, Tieghi, A, Fracchiolla, N, Capelli, D, Foa, R, Alati, C, La Sala, E, Voso, M, Fazi, P, Vignetti, M, Consalvo, M, Ottone, T, Lavorgna, S, Arcese, W, Lo Coco, F, Amadori, S, Venditti, A, Maurillo L, Buccisano F, Piciocchi A, Del Principe MI, Candoni A, Melillo L, Calafiore V, Cairoli R, De Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Mazza P, Martelli MP, Cuneo A, Albano F, Fabbiano F, Tafuri A, Chierichini A, Tieghi A, Fracchiolla NS, Capelli D, Foa R, Alati C, La Sala E, Voso MT, Fazi P, Vignetti M, Consalvo MI, Ottone T, Lavorgna S, Arcese W, Lo Coco F, Amadori S, and Venditti a.

Published
2019

28. Molecular landscape and prognostic impact of FLT3-ITD insertion site in acute myeloid leukemia: RATIFY study results

Author

Rücker, F.G., Du, L., Luck, T.J., Benner, A., Krzykalla, J., Gathmann, I., Voso, M.T., Amadori, S., Prior, T.W., Brandwein, J.M., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Savoie, L., Sierra, J., Pallaud, C., Sanz, Mariano, Jansen, J.H., Niederwieser, D., Fischer, T., Ehninger, G., Heuser, M., Ganser, A., Bullinger, L., Larson, R.A., Bloomfield, C.D., Stone, R.M., Döhner, H., Thiede, C., Döhner, K., Rücker, F.G., Du, L., Luck, T.J., Benner, A., Krzykalla, J., Gathmann, I., Voso, M.T., Amadori, S., Prior, T.W., Brandwein, J.M., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Savoie, L., Sierra, J., Pallaud, C., Sanz, Mariano, Jansen, J.H., Niederwieser, D., Fischer, T., Ehninger, G., Heuser, M., Ganser, A., Bullinger, L., Larson, R.A., Bloomfield, C.D., Stone, R.M., Döhner, H., Thiede, C., and Döhner, K.

Abstract

Item does not contain fulltext

Published
2021

29. Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial

Author

Larson, R.A., Mandrekar, S.J., Huebner, L.J., Sanford, B.L., Laumann, K., Geyer, S., Bloomfield, C.D., Thiede, C., Prior, T.W., Döhner, K., Marcucci, G., Voso, M.T., Klisovic, R.B., Galinsky, I., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Krauter, J., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Döhner, H., Stone, R.M., Larson, R.A., Mandrekar, S.J., Huebner, L.J., Sanford, B.L., Laumann, K., Geyer, S., Bloomfield, C.D., Thiede, C., Prior, T.W., Döhner, K., Marcucci, G., Voso, M.T., Klisovic, R.B., Galinsky, I., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Krauter, J., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Döhner, H., and Stone, R.M.

Abstract

Item does not contain fulltext, The prospective randomized, placebo-controlled CALGB 10603/RATIFY trial (Alliance) demonstrated a statistically significant overall survival benefit from the addition of midostaurin to standard frontline chemotherapy in a genotypically-defined subgroup of 717 patients with FLT3-mutant acute myeloid leukemia (AML). The risk of death was reduced by 22% on the midostaurin-containing arm. In this post hoc analysis, we analyzed the cumulative incidence of relapse (CIR) on this study and also evaluated the impact of 12 4-week cycles of maintenance therapy. CIR analyses treated relapses and AML deaths as events, deaths from other causes as competing risks, and survivors in remission were censored. CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events. However, when transplantation was considered as a competing risk, there was overall no significant difference between the risks of relapse on the two randomized arms. Patients still in remission after consolidation with high-dose cytarabine entered the maintenance phase, continuing with either midostaurin or placebo. Analyses were inconclusive in quantifying the impact of the maintenance phase on the overall outcome. In summary, midostaurin reduces the CIR.

Published
2021

30. Midostaurin reduces relapse in FLT3-mutant acute myeloid leukemia: the Alliance CALGB 10603/RATIFY trial

Author

Larson, RA, Mandrekar, SJ, Huebner, LJ, Sanford, BL, Laumann, K, Geyer, S, Bloomfield, CD, Thiede, C, Prior, TW, Dohner, K, Marcucci, G, Voso, MT, Klisovic, RB, Galinsky, I, Wei, AH, Sierra, J, Sanz, MA, Brandwein, JM, de Witte, T, Niederwieser, D, Appelbaum, FR, Medeiros, BC, Tallman, MS, Krauter, J, Schlenk, RF, Ganser, A, Serve, H, Ehninger, G, Amadori, S, Gathmann, I, Dohner, H, Stone, RM, Larson, RA, Mandrekar, SJ, Huebner, LJ, Sanford, BL, Laumann, K, Geyer, S, Bloomfield, CD, Thiede, C, Prior, TW, Dohner, K, Marcucci, G, Voso, MT, Klisovic, RB, Galinsky, I, Wei, AH, Sierra, J, Sanz, MA, Brandwein, JM, de Witte, T, Niederwieser, D, Appelbaum, FR, Medeiros, BC, Tallman, MS, Krauter, J, Schlenk, RF, Ganser, A, Serve, H, Ehninger, G, Amadori, S, Gathmann, I, Dohner, H, and Stone, RM

Abstract

The prospective randomized, placebo-controlled CALGB 10603/RATIFY trial (Alliance) demonstrated a statistically significant overall survival benefit from the addition of midostaurin to standard frontline chemotherapy in a genotypically-defined subgroup of 717 patients with FLT3-mutant acute myeloid leukemia (AML). The risk of death was reduced by 22% on the midostaurin-containing arm. In this post hoc analysis, we analyzed the cumulative incidence of relapse (CIR) on this study and also evaluated the impact of 12 4-week cycles of maintenance therapy. CIR analyses treated relapses and AML deaths as events, deaths from other causes as competing risks, and survivors in remission were censored. CIR was improved on the midostaurin arm (HR = 0.71 (95% CI, 0.54-0.93); p = 0.01), both overall and within European LeukemiaNet 2017 risk classification subsets when post-transplant events were considered in the analysis as events. However, when transplantation was considered as a competing risk, there was overall no significant difference between the risks of relapse on the two randomized arms. Patients still in remission after consolidation with high-dose cytarabine entered the maintenance phase, continuing with either midostaurin or placebo. Analyses were inconclusive in quantifying the impact of the maintenance phase on the overall outcome. In summary, midostaurin reduces the CIR.

Published
2021

32. Experimental identification of the parameters of a multilayer coating architecture

Author

Amadori, S., Catania, G., Amadori, S., and Catania, G.

Subjects
multilayer beam model, damping, coating, parameter identification
Abstract

Composite components with specifically designed and optimized vibration damping behaviour can be obtained by means of multilayered coating technology solutions [1-3], and these authors presented a multilayer beam model that takes into account of the dissipative actions at the interface between different layers [3], modeled by means of a complex interlaminar impedance. This model can be used as a virtual prototyping tool in order to find and optimize innovative multilayer coating solutions. Since the model needs laminar parameters as input, i.e. the density and modulus of the layer materials and the interface parameters values that define the complex impedance between different coating materials, dynamic mechanical measurements and an optimization based numerical technique are used to find these laminar and interlaminar parameters. An identification procedure is applied to measurement data from three-layer and five-layer beam specimens in order to identify the unknown interface parameters modeling the interlaminar impedance. Normalized estimator z [3] is used to evaluate the damping behaviour. Error vector e, function of the unknown parameters, is defined as the difference between z calculated from the model and z measured at the same frequency values. The objective function Ψ=0.5·e·eT is obtained. A multi-step optimization algorithm based on a quadratic, constrained non-linear optimisation technique is employed to identify the interface parameter values that minimize Ψ. Fig. (1a) shows examples of identification, i.e. measurements and the resulting model fit for five-layer beams, adopting Al and E1, E2 epoxy based layers. Identified parameter values are then used as input to the multilayer beam virtual prototype model in order to simulate the damping behaviour of different multilayer composite architectures. Fig. (1b) shows the z model estimate from the C1 (E2-E1-Al-E1-E2) five-layer beam virtual prototype model, and the z experimental validation. Some different coating solutions are then applied to gear pump Al casings to be tested and compared, by means of sound pressure measurements, in a real industrial application with real operating conditions, i.e. revolution speed n [1000-2000] rpm, fluid (oil) pressure p [50-230] bar. Results concerning the application of the E1-E2 coating architecture are reported in Fig. (2). A discussion and a critical analysis of the results is presented.

Published
2019

33. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, and Lo-Coco, F

Subjects
Hematology
Published
2019

36. Impact of NPM1/FLT3-ITD genotypes defined by the 2017 European LeukemiaNet in patients with acute myeloid leukemia

Author

Dohner, K., Thiede, C., Jahn, N., Panina, E., Gambietz, A., Larson, R.A., Prior, T.W., Marcucci, G., Jones, Dan, Krauter, J., Heuser, M., Voso, M.T., Ottone, T., Nomdedeu, J.F., Mandrekar, S.J., Klisovic, R.B., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Jansen, J.H., Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Benner, A., Pallaud, C., Stone, R.M., Dohner, H., Bloomfield, C.D., Dohner, K., Thiede, C., Jahn, N., Panina, E., Gambietz, A., Larson, R.A., Prior, T.W., Marcucci, G., Jones, Dan, Krauter, J., Heuser, M., Voso, M.T., Ottone, T., Nomdedeu, J.F., Mandrekar, S.J., Klisovic, R.B., Wei, A.H., Sierra, J., Sanz, Mariano, Brandwein, J.M., Witte, T.J. de, Jansen, J.H., Niederwieser, D., Appelbaum, F.R., Medeiros, B.C., Tallman, M.S., Schlenk, R.F., Ganser, A., Serve, H., Ehninger, G., Amadori, S., Gathmann, I., Benner, A., Pallaud, C., Stone, R.M., Dohner, H., and Bloomfield, C.D.

Abstract

Contains fulltext : 218279.pdf (Publisher’s version ) (Open Access), Patients with acute myeloid leukemia (AML) harboring FLT3 internal tandem duplications (ITDs) have poor outcomes, in particular AML with a high (>/=0.5) mutant/wild-type allelic ratio (AR). The 2017 European LeukemiaNet (ELN) recommendations defined 4 distinct FLT3-ITD genotypes based on the ITD AR and the NPM1 mutational status. In this retrospective exploratory study, we investigated the prognostic and predictive impact of the NPM1/FLT3-ITD genotypes categorized according to the 2017 ELN risk groups in patients randomized within the RATIFY trial, which evaluated the addition of midostaurin to standard chemotherapy. The 4 NPM1/FLT3-ITD genotypes differed significantly with regard to clinical and concurrent genetic features. Complete ELN risk categorization could be done in 318 of 549 trial patients with FLT3-ITD AML. Significant factors for response after 1 or 2 induction cycles were ELN risk group and white blood cell (WBC) counts; treatment with midostaurin had no influence. Overall survival (OS) differed significantly among ELN risk groups, with estimated 5-year OS probabilities of 0.63, 0.43, and 0.33 for favorable-, intermediate-, and adverse-risk groups, respectively (P < .001). A multivariate Cox model for OS using allogeneic hematopoietic cell transplantation (HCT) in first complete remission as a time-dependent variable revealed treatment with midostaurin, allogeneic HCT, ELN favorable-risk group, and lower WBC counts as significant favorable factors. In this model, there was a consistent beneficial effect of midostaurin across ELN risk groups.

Published
2020

37. Survival Improvement over Time of 960 s-AML Patients Included in 13 EORTC-GIMEMA-HOVON Trials

Author

Ramadan, S.M., Suciu, Stefan, Stevens-Kroef, M.J.P.L., Willemze, Roelof, Amadori, S., Witte, T.J.M. de, Muus, P., Lubbert, Michael, Baron, Frederic, Ramadan, S.M., Suciu, Stefan, Stevens-Kroef, M.J.P.L., Willemze, Roelof, Amadori, S., Witte, T.J.M. de, Muus, P., Lubbert, Michael, and Baron, Frederic

Abstract

Contains fulltext : 228575.pdf (publisher's version ) (Open Access)

Published
2020

38. Impact of the type of anthracycline and of stem cell transplantation in younger patients with acute myeloid leukaemia: Long-term follow up of a phase III study

Author

Baron, F., Efficace, F., Cannella, L., Muus, P., Trisolini, S., Halkes, C.J., Fazi, P., Vignetti, M., Marie, J.P., Chiusolo, P., Velden, W.J. van der, La Sala, E., Vitolo, U., Thomas, X., Lefrere, F., Raimondo, F. Di, Bourhis, J.H., Specchia, G., Guimaraes, J.E., Allione, B., Vrhovac, R., Ferrara, F., Stevens-Kroef, M.J., Meert, L., Witte, T.J. de, Willemze, R., Amadori, S., Suciu, S., Baron, F., Efficace, F., Cannella, L., Muus, P., Trisolini, S., Halkes, C.J., Fazi, P., Vignetti, M., Marie, J.P., Chiusolo, P., Velden, W.J. van der, La Sala, E., Vitolo, U., Thomas, X., Lefrere, F., Raimondo, F. Di, Bourhis, J.H., Specchia, G., Guimaraes, J.E., Allione, B., Vrhovac, R., Ferrara, F., Stevens-Kroef, M.J., Meert, L., Witte, T.J. de, Willemze, R., Amadori, S., and Suciu, S.

Abstract

Item does not contain fulltext, We provide a long-term evaluation of patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60 years old, randomized to receive either daunorubicin (DNR, 50 mg/m(2) ), mitoxantrone (MXR, 12 mg/m(2) ), or idarubicin (IDA, 10 mg/m(2) ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine for consolidation. Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery were then scheduled to receive an allogeneic hematopoietic stem cell transplantation (HSCT). That was if they had a HLA-identical sibling donor; in all other cases, an autologous HSCT had to be administered. At an 11-year median follow-up, the 5-year, 10-year and 15-year overall survival (OS) rates were 33.2%, 30.1% and 28.0%, respectively. No significant difference between the three randomized groups regarding OS was observed (P = .38). In young patients, 15-45 years old, no treatment difference (P = .89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P = .029). Among younger patients without a favorable MRC cytogenetic risk subgroup who achieved a CR/CRi after induction chemotherapy, those with a HLA-identical sibling donor had higher 10-year and 15-year OS rates than those without. In older patients who reached CR/CRi, the long-term outcomes of those with or without a donor was similar. In conclusion, long-term outcomes of the study confirmed similar OS in the three randomized groups in the whole cohort of patients.

Published
2020

39. Long-term follow-up of a trial comparing post-remission treatment with autologous or allogeneic bone marrow transplantation or intensive chemotherapy in younger acute myeloid leukemia patients

Author

Baron, F., Efficace, F., Cannella, L., Willemze, R., Vignetti, M., Muus, P., Marie, J.P., Ferrero, D., Fazi, P., La Sala, E., Bourhis, J.H., Fabbiano, F., Bosi, A., Sborgia, M., Martinelli, G., Wittnebel, S., Trisolini, S., Petti, M.C., Halkes, C.J., Velden, W.J.F.M. van der, Witte, T.J. de, Amadori, S., Zittoun, R.A., Suciu, S., Baron, F., Efficace, F., Cannella, L., Willemze, R., Vignetti, M., Muus, P., Marie, J.P., Ferrero, D., Fazi, P., La Sala, E., Bourhis, J.H., Fabbiano, F., Bosi, A., Sborgia, M., Martinelli, G., Wittnebel, S., Trisolini, S., Petti, M.C., Halkes, C.J., Velden, W.J.F.M. van der, Witte, T.J. de, Amadori, S., Zittoun, R.A., and Suciu, S.

Abstract

Contains fulltext : 218286.pdf (publisher's version ) (Open Access)

Published
2020

40. Survival improvement over time of 960 s-AML patients included in 13 EORTC-GIMEMA-HOVON trials

Author

Ramadan, SM, Suciu, S, Stevens-Kroef, MJ, Willemze, R, Amadori, S, Witte, T, Löwenberg, Bob, Muus, P, Labar, B, Meert, L, de Schaetzen, G, Meloni, G, Leone, G, Vignetti, M, Marie, JP, Lübbert, M, Baron, F, Ramadan, SM, Suciu, S, Stevens-Kroef, MJ, Willemze, R, Amadori, S, Witte, T, Löwenberg, Bob, Muus, P, Labar, B, Meert, L, de Schaetzen, G, Meloni, G, Leone, G, Vignetti, M, Marie, JP, Lübbert, M, and Baron, F

Published
2020

42. Low-dose cytosine arabinoside (LD-AraC) vs LD-AraC plus granulocyte/macrophage colony stimulating factor vs LD-AraC plus Interleukin-3 for myelodysplastic syndrome patients with a high risk of developing acute leukemia: final results of a randomized phase III study (06903) of the EORTC Leukemia Cooperative Group

Author

Zwierzina, H, Suciu, S, Loeffler-Ragg, J, Neuwirtova, R, Fenaux, P, Beksac, M, Harousseau, J, Nuessler, V, Cermak, J, Solbu, G, Willemze, R, de Witte, T, and Amadori, S

Published
2005
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43. Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups

Author

Amadori, S, Suciu, S, Stasi, R, Willemze, R, Mandelli, F, Selleslag, D, Denzlinger, C, Muus, P, Stauder, R, Berneman, Z, Pruijt, J, Nobile, F, Cassibba, V, Marie, J-P, Beeldens, F, Baila, L, Vignetti, M, and de Witte, T

Published
2005
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47. The presence of an HLA-identical sibling donor has no impact on outcome of patients with high-risk MDS or secondary AML (sAML) treated with intensive chemotherapy followed by transplantation: results of a prospective study of the EORTC, EBMT, SAKK and GIMEMA Leukemia Groups (EORTC study 06921)

Author

Oosterveld, M, Suciu, S, Verhoef, G, Labar, B, Belhabri, A, Aul, C, Selleslag, D, Ferrant, A, Wijermans, P, Mandelli, F, Amadori, S, Jehn, U, Muus, P, Zittoun, R, Hess, U, Anak, Ö, Beeldens, F, Willemze, R, and de Witte, T

Published
2003
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