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26 results on '"de Fabritiis, P."'

1. Vortices in a parity-invariant Maxwell-Chern-Simons model

Author

De Lima, W. B. and De Fabritiis, P.

Subjects
High Energy Physics - Theory, Condensed Matter - Other Condensed Matter, High Energy Physics - Theory (hep-th), FOS: Physical sciences, Other Condensed Matter (cond-mat.other)
Abstract

In this work we propose a parity-invariant Maxwell-Chern-Simons $U(1) \times U(1)$ model coupled with two charged scalar fields in $2+1$ dimensions, and show that it admits finite-energy topological vortices. We describe the main features of the model and find explicit numerical solutions for the equations of motion, considering different sets of parameters and analyzing some interesting particular regimes. We remark that the structure of the theory follows naturally from the requirement of parity invariance, a symmetry that is rarely envisaged in the context of Chern-Simons theories. Another distinctive aspect is that the vortices found here are characterized by two integer numbers., Comment: 15 pages, 18 figures. References added, improved text, results unchanged

Published
2022
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2. Epidemiological surveillance of SARSCov2 in β-Thalassemia Patients in the last two years: reinfection rate, insights and future challenges

Author

Torti, L, Sorrentino, F, Maffei, L, De Fabritiis, P, and Abruzzese, E

Subjects
Infectious Diseases, Reinfection, SARSCov2, Vaccination, Immunity, Thalassemia, Monoclonal antibodies, Hematology, Settore MED/15
Abstract

Background: Although the association between comorbidities and the severity of COVID-19 infection has been extensively discussed, data on COVID-19 and hemoglobinopathies are still limited. SARS-Cov2 reinfections with severe acute respiratory syndrome have been described in the general population, usually with a milder outcome compared to the primary infection. The aim of our study was to determine the rate of reinfection and clinical features in a population of β-thalassemia patients. Results: Following the first infection, patients showed an adequate humoral immune response, however, all four patients are considered immune impaired owing to chronic transfusional support coupled with iron chelating treatment and splenectomy in three of the four.

Published
2023
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3. Daratumumab combined with dexamethasone and lenalidomide or bortezomib in relapsed/refractory multiple myeloma (RRMM) patients: Report from the multiple myeloma GIMEMA Lazio group

Author

Fazio, F, Franceschini, L, Tomarchio, V, Rago, A, Garzia, Mg, Cupelli, L, Bongarzoni, V, Andriani, A, Gumenyuk, S, Tafuri, A, Siniscalchi, A, Piciocchi, A, De Fabritiis, P, De Rosa, L, Caravita di Toritto, T, Annibali, O, Cantonetti, M, and Petrucci, Mt

Subjects
multiple myeloma, immunotherapy, relapsed refractory, Settore MED/15
Abstract

The multiple myeloma (MM) treatment has changed over the last years due to the introduction of novel drugs. Despite improvements in the MM outcome, MM remains an incurable disease. Daratumumab is a human IgGK monoclonal antibody targeting CD38 with tumor activity associated with immunomodulatory mechanism. In combination with standard of care regimens, including bortezomib (Vd) or lenalidomide (Rd), daratumumab prolonged progression-free survival (PFS) in patients (pts) with relapsed/refractory multiple myeloma (RRMM) and in new diagnosis MM. We report the data of the MM GIMEMA Lazio group in 171 heavily treated pts who received daratumumab, lenalidomide and dexamethasone (DRd) or daratumumab, velcade and dexamethasone (DVd). The overall response rate was 80%, and the overall survival (OS) and PFS were 84% and 77%, respectively. In addition, pts treated with DRd showed a better median PFS compared to pts treated with DVd, at 12 and 24 months, respectively. The most common hematologic treatment-emergent adverse events (TAEs) were neutropenia, thrombocytopenia, and anemia. The most common nonhematologic TAEs were peripheral sensory neuropathy and infections. Our data confirmed that DRd or DVd therapy is effective and safe in RRMM pts, and our real-life analysis could support the physicians regarding the choice of optimal therapy in this setting of pts.

Published
2021

4. Phenomenology of a Born-Infeld extension of the $U(1)_{\rm Y}$ sector at lepton colliders

Author

De Fabritiis, P., Malta, P. C., and Helayël-Neto, J. A.

Subjects
High Energy Physics - Theory, High Energy Physics - Phenomenology, High Energy Physics - Phenomenology (hep-ph), High Energy Physics - Theory (hep-th), High Energy Physics::Phenomenology, FOS: Physical sciences
Abstract

In this work we perform a non-linear extension of the $U(1)_{\rm Y}$ sector of the Standard Model leading to novel quartic effective interactions between the neutral gauge bosons. We study the induced effects through high-energy processes resulting in three photons, namely, Z-boson decay and electron-positron annihilation. Available experimental data on these processes do not yield viable lower bounds on the mass parameter $\sqrt{\beta}$, but we estimate that the range $\sqrt{\beta} \lesssim m_Z$ could be reliably excluded with better statistics in future $e^- e^+$ colliders. We also discuss neutral gauge-boson scatterings, contextualizing our findings with recent results on anomalous quartic gauge couplings., Comment: 16 pages, 5 figures. The title has been changed, section 3C improved, results unchanged. Matches published version

Published
2021
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6. Monoclonal Gammopathy Responsive to Decitabine Given for Acute Myeloid Leukemia in a Frail Patient

Author

Pasquale Niscola, de Fabritiis P, Benedetta Neri, and Morino L

Subjects
Myeloid, Male, 0301 basic medicine, Antimetabolites, Decitabine, Acute, Monoclonal Gammopathy of Undetermined Significance, 03 medical and health sciences, medicine, Humans, Aged, Leukemia, business.industry, Myeloid leukemia, Hematology, General Medicine, Antimetabolites, Antineoplastic, Leukemia, Myeloid, Acute, Treatment Outcome, Antineoplastic, Settore MED/01, Monoclonal gammopathy, 030104 developmental biology, Cancer research, medicine.symptom, business, medicine.drug
Published
2018
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7. Diagnosis of acute foetal distress does not preclude banking of umbilical cord blood units

Author

Picardi, A, Tamburini, A, Caravita, T, De Angelis, C, Ballatore, Spagnoli, G, A, Malerba, C, Calugi, A, DE FABRITIIS, P, and Amadori, S

Subjects
Meconium, Blood Donors, Umbilical cord, Fetal Distress, Donor Selection, Pregnancy, Humans, Settore MED/05 - Patologia Clinica, Medicine, reproductive and urinary physiology, Cryopreservation, Asphyxia, Asphyxia Neonatorum, Blood Specimen Collection, Donor criteria, business.industry, Contraindications, Infant, Newborn, Pregnancy Outcome, Cord blood banking, Foetal distress, Hematology, Fetal Blood, Distress, medicine.anatomical_structure, Blood Preservation, Cord blood, Anesthesia, embryonic structures, Apgar Score, Blood units, Female, Apgar score, medicine.symptom, Abnormality, business, Settore MED/15 - Malattie del Sangue
Abstract

Clinical diagnosis of acute foetal distress (AFD) is based on several parameters such as abnormal foetal heart rate (FHR) pattern and/or meconium liquid staining (MLS). Standards for cord blood (CB) banking indicate that AFD should be considered as exclusion criteria for CB collection, but precise guidelines on how to proceed with CB collection in the presence of AFD signs during labour are not available. We evaluated whether the presence of FHR abnormality and/or MLS during labour 1) reduced the CB collection activity; 2) were associated with the infant's acidaemia or asphyxia and 3) deteriorated the biological characteristics of CB units. Thirty-three units of CB were evaluated for biological parameters, gas values and newborn's Apgar score. The results were compared with a control group of 33 consecutive units previously banked. No differences were observed between the two groups and all but one newborn showed normal Apgar score and absence of metabolic acidaemia. The results showed that 1) AFD reduced the CB collection activity by 10% each year; 2) the majority of CB units collected in the presence of abnormal FHR and/or meconium have biological characteristics eligible for banking; 3) FHR alterations or meconium in the presence of normal gas analysis do not represent certain diagnosis of AFD.

Published
2006
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8. Retrospective comparison of transplant from matched unrelated donor or identical sibling in adult MDS: evidence for a graft-versus-myelodysplasia effect in unrelated donor transplant

Author

Alessandrino E, Bacigalupo A, Falda M, Deliliers GL, Arcese W, Benedetti F, Di Bartolomeo P, La Nasa G, Rambaldi A, Pioltelli P, De Fabritiis P, Marenco P, Pascutto C, Bandini G, Fanin R, Bosi A., CICERI , FABIO, Alessandrino, E, Bacigalupo, A, Falda, M, Deliliers, Gl, Arcese, W, Benedetti, F, Ciceri, Fabio, Di Bartolomeo, P, La Nasa, G, Rambaldi, A, Pioltelli, P, De Fabritiis, P, Marenco, P, Pascutto, C, Bandini, G, Fanin, R, and Bosi, A.

Published
2007

9. Updating Long-Term Outcome of Intermittent Imatinib (INTERIM) Treatment in Elderly Patients with Ph plus -CML

Author

Russo, D, Martinelli, G, Malagola, M, Cancelli, V, Skert, C, Soverini, S, Iacobucci, I, Turri, D, Mirto, S, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Fogli, M, Testoni, N, De Vivo, A, Castagnetti, F, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, A, Intermesoli, T, Saglio, G, Cambrin, Gr, Visani, G, Nicolini, G, de Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D'Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, Di Lorenzo, R, Cesana, Bm, and Rosti, G

Published
2014

10. Venetoclax: Bcl-2 inhibition for the treatment of chronic lymphocytic leukemia

Author

Maria Cantonetti, Francesco Buccisano, Sergio Amadori, Livio Pupo, Del Poeta G, Iannella E, Massimiliano Postorino, Luca Maurillo, Del Principe Mi, Benedetta Mariotti, Tamara Bittolo, de Fabritiis P, Adriano Venditti, Dal Bo M, and Gattei

Subjects
0301 basic medicine, Programmed cell death, Chronic lymphocytic leukemia, Antineoplastic Agents, Pharmacology, Venetoclax, Bridged Bicyclo Compounds, 03 medical and health sciences, chemistry.chemical_compound, 17p deletion/TP53 mutation, ABT-199, Bcl-2, Novel tyrosine kinase inhibitors, Antineoplastic Combined Chemotherapy Protocols, Bridged Bicyclo Compounds, Heterocyclic, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Proto-Oncogene Proteins c-bcl-2, Sulfonamides, medicine, Chronic, Leukemia, business.industry, Heterocyclic, B-Cell, medicine.disease, Lymphocytic, 030104 developmental biology, Prior Therapy, Mechanism of action, chemistry, Ibrutinib, Cancer research, medicine.symptom, Idelalisib, business, Settore MED/15 - Malattie del Sangue, Tyrosine kinase
Abstract

Venetoclax (ABT-199) is a small-molecule selective oral inhibitor of the antiapoptotic protein Bcl-2 that promotes programmed cell death of chronic lymphocytic leukemia (CLL) cells regulating the release of proapoptotic factors, such as Smac/Diablo, apoptosis-inducing factor (AIF) and cytochrome c. In April 2016, the U.S. Food and Drug Administration (FDA) granted accelerated approval to venetoclax for patients diagnosed with CLL with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy. This review will focus on the mechanism of action, preclinical studies and clinical development of venetoclax both as a monotherapy and in combination with other drugs for CLL in the current milieu of therapy dominated by novel tyrosine kinase inhibitors such as ibrutinib and idelalisib.

Published
2016
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14. Multiple Myeloma and Paget’s disease with abnormal skull lesions and intracranial hypertension

Author

Caravita, T, Siniscalchi, A, Montinaro, E, Bove, R, Zaccagnini, M, De Pascalis, D, Morocutti, A, Brusa, L, Arciprete, F, Cupini, M, Perrotti, A, Palma, E, Fratoni, S, De Simone, R, Iani, C, and de Fabritiis, P

Subjects
Pathology, medicine.medical_specialty, biology, lcsh:RC633-647.5, business.industry, lcsh:Diseases of the blood and blood-forming organs, Case Reports, Hematology, Settore MED/15, medicine.disease, Skull, Infectious Diseases, medicine.anatomical_structure, Osteoprotegerin, RANKL, Paget Disease, biology.protein, medicine, Molecular mechanism, Differential diagnosis, business, Multiple myeloma
Abstract

We report a 73 years old man with a diagnosis of Paget Disease (PD) and symptomatic Multiple Myeloma (MM). Coexistence of MM and PD has rarely been described. PD mimics many of the features of bone destructive process in MM, making differential diagnosis more complicated. In addition, the presence of serious muscolo-skeletal and metabolic complications in both diseases makes management of patients difficult, worsening the prognosis. The comparison of these two diseases has led to the characterization of a common molecular mechanism represented by the receptor activator of nuclear factor-kB ligand (RANKL)/Osteoprotegerin signaling pathway. The improved comprehension of these mechanisms led to the development of new pharmacologic agents (bisphosphonates, cytokines inhibitors) effective for the treatment of these bone diseases.

Published
2012
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17. Home care management of patients affected by hematologic malignancies: A review

Author

Niscola P, de Fabritiis P, Cartoni C, Romani C, francesco sorrentino, Dentamaro T, Piccioni D, Scaramucci L, Giovannini M, Amadori S, and Mandelli F

Subjects
Early discharge, Hematologic malignancies, Hematopoietic stem cell transplantation (HSCT), Home care, Managed care, Palliative care, Hematologic Neoplasms, Palliative Care, Disease Management, Humans, Settore MED/15 - Malattie del Sangue, Home Care Services
Abstract

Home care (HC) has an increasingly expanding role in the global management of patients affected by hematologic malignancies. Integrated strategies, including causal-targeted and supportive treatments according to hematologic expertise and a holistic approach inspired by the philosophy and practice of palliative medicine, may allow suitable management and the possibility for most patients to stay at home. Physical, social and psychological needs of patients are likely to vary according to the course of their disease and the treatments they are receiving. Therefore, consideration should be given to different models of care and how to tackle patients' diverse needs, as outlined by reported experiences which claimed that HC can provide appropriate solutions not only for terminally and chronically ill patients but also for those in other phases of disease. According to these studies and to our own experience, when appropriate measures and structured operating models are adopted, HC results in a safe, effective and economically realistic alternative to traditional in-hospital treatment. Therefore, all efforts should be made to overcome budget and administrative barriers and to ensure a more widespread use of this model of care.

18. Hema e-Chart: Italian Registry for prospective analysis of epidemiology, management and outcome of febrile events in patients with hematological malignancies

Author

Pagano, L, Caira, M, Nosari, A, Rossi, G, Locatelli, F, Viale, P, Aversa, F, Chart Group Italy:CollaboratorsLevis A, Hema E., Leoni, P, Liso, V, Baccarani, M, Cortellazzo, S, Russo, D, La Nasa, G, Storti, S, Giustolisi, R, Morabito, F, Cuneo, Antonio, Bosi, A, Capalbo, Sf, Cascavilla, N, Ghio, R, Carella, A, Brugiatelli, M, Ciceri, F, Martinelli, G, Morra, E, Pogliani, E, Mettivier, V, Carli, M, Abbadessa, V, Musso, M, Aricò, M, Lazzarino, M, Visani, G, Fioritoni, G, Di Bartolomeo, P, Vallisa, D, Petrini, M, Favre, C, Olivieri, A, Gugliotta, L, Leone, G, Amadori, S, De Rossi, G, De Fabritiis, P, Majolino, I, D'Arco, A, Lauria, F, Mazza, P, Fagioli, F, Gherlinzoni, F, Chesesi, T, Rodeghiero, F., Pagano L, Caira M, Nosari A, Rossi G, Locatelli F, Viale P, Aversa F, Baccarani M, and Hema E-Chart Group Italy.

Subjects
medicine.medical_specialty, Pediatrics, Myeloid, Fever, medicine.medical_treatment, Hematopoietic stem cell transplantation, hemic and lymphatic diseases, Epidemiology, medicine, Humans, Pharmacology (medical), Prospective Studies, Registries, Medical diagnosis, Prospective cohort study, Multiple myeloma, Pharmacology, HAEMATOLOGY, business.industry, Incidence, Incidence (epidemiology), Hematopoietic Stem Cell Transplantation, FUNGI, Fungal infection, Hematological malignancies, medicine.disease, Surgery, Lymphoma, Settore MED/15 - MALATTIE DEL SANGUE, Infectious Diseases, medicine.anatomical_structure, Italy, Mycoses, Oncology, Hematologic Neoplasms, business
Abstract

The aim of the study was to create a prospective computerized registry to collect and analyze febrile events, particularly due to fungal infections, in patients with hematological malignancies. A systematic approach that starts from the registration of new diagnosis and complete follow-up can be of help for the study of treatment and evolution of these complications. The software allows several concurrent users to create and manage medical information in a website. Its aim is to improve the speed, quality and integration of information related to subjects with febrile event, ultimately resulting in improving patients' care.Patients included adults and children with acute and chronic myeloid or lymphoid leukemia, Hodgkin's and non-Hodgkin's lymphoma, myelodysplastic syndrome, or multiple myeloma. The registry also included data regarding event onset in hematopoietic stem cell transplants (HSCTs). In order to evaluate the incidence of febrile events, all new diagnoses of hematological malignancy and all HSCTs were reported.The Hema e-Chart can be a very useful network collecting information about febrile events in patients with hematological malignancy and HSCTs. Significant trends and treatment practices are expected to be observed. As enrollment continues, data will be analyzed and published, which will provide valuable information concerning the epidemiology, therapy, and outcome of infectious complications.

19. Case reports: zoster pain in haematological malignancies: effective pain relief with oxycodone in patients unresponsive to other analgesic measures

Author

Niscola P, Ap, Perrotti, del Poeta G, Romani C, Palombi M, Piccioni D, Scaramucci L, Tolu B, Tendas A, Cupelli L, elisabetta abruzzese, Elia Gm, D., Ga, Brunetti, Maurillo L, Giovannini M, Cartoni C, and de Fabritiis P

Subjects
Male, Analgesics, Cyclohexanecarboxylic Acids, Pain, Middle Aged, Herpes Zoster, Antiviral Agents, Neuralgia, Postherpetic, Acute Disease, Hematologic Neoplasms, Humans, Oxycodone, Aged, Amines, Drug Therapy, Combination, gamma-Aminobutyric Acid, Aged, 80 and over, Treatment Outcome, Female, Drug Therapy, Combination, 80 and over, Neuralgia, Postherpetic, Settore MED/15 - Malattie del Sangue

20. Primary pulmonary hodgkin lymphoma simulating a mediastinal tumour: An uncommon occurrence

Author

Fratoni, S, Abruzzese, E, Niscola, P, Trawinska, M, Mercadante, E, Casullo, A, DE FABRITIIS, P, P, Perrotti, A, and Santeusanio, G

Subjects
Pediatrics, medicine.medical_specialty, Pathology, Hodgkin’s lymphoma, business.industry, lcsh:RC633-647.5, Case Report, Hematology, lcsh:Diseases of the blood and blood-forming organs, Settore MED/08 - Anatomia Patologica, mediastinum, frozen section, lung, Infectious Diseases, thoracoscopy, immune system diseases, hemic and lymphatic diseases, medicine, Hodgkin lymphoma, business, Mediastinal tumour
Abstract

The case of a patient with p rimary pulmonary Hodgkin Lymphoma simulating a mediastinal tumour i s r e p o r t e d f o r i t s r a r i t y a n d t h e d i a g n o s t i c c o n c e r n s e n c o u n t e r e d b y u s .

21. Bortezomib, thalidomide, and dexamethasone followed by double autologous haematopoietic stem-cell transplantation for newly diagnosed multiple myeloma (GIMEMA-MMY-3006): long-term follow-up analysis of a randomised phase 3, open-label study

Author

Paola Tacchetti, Lucia Pantani, Francesca Patriarca, Maria Teresa Petrucci, Elena Zamagni, Luca Dozza, Monica Galli, Francesco Di Raimondo, Claudia Crippa, Mario Boccadoro, Simona Barbato, Patrizia Tosi, Franco Narni, Vittorio Montefusco, Nicoletta Testoni, Antonio Spadano, Carolina Terragna, Norbert Pescosta, Giulia Marzocchi, Claudia Cellini, Piero Galieni, Sonia Ronconi, Marco Gobbi, Lucio Catalano, Antonio Lazzaro, Giovanni De Sabbata, Clotilde Cangialosi, Fabrizio Ciambelli, Pellegrino Musto, Francesca Elice, Michele Cavo, Renato Fanin, Roberto Foa', Alessandro Rambaldi, Giuseppe Rossi, Pietro Leoni, Paolo Corradini, Giuseppe Torelli, Giuseppe Fioritoni, Sergio Cortelazzo, Giorgio Lambertenghi Deliliers, Giorgio La Nasa, Alfonso Zaccaria, Paolo De Fabritiis, Nicola Cascavilla, Alberto Bosi, Gianpietro Semenzato, Luigi Gugliotta, Filippo Gherlinzoni, Emanuele Angelucci, Massimo Fabrizio Martelli, Maria Concetta Petti, Giuseppe Leone, Angelo Michele Carella, Fabio Ciceri, Armando Santoro, Felicetto Ferrara, Francesco Nobile, Alfonso Maria D'Arco, Alessandro Levis, Luciano Guardigni, Andrea Gallamini, Pier Paolo Fattori, Sergio Morandi, Dino Amadori, Bruno Rotoli, Salvatore Mirto, Giorgio Paladini, Ruggero Mozzana, Graziella Pinotti, Francesco Rodeghiero, Nicola Cantore, Vincenzo Pavone, Enrico Maria Pogliani, Anna Marina Liberati, Ignazio Majolino, Sergio Amadori, Francesco Lauria, Massimo Aglietta, Giovanni Quarta, Sergio Storti, Fortunato Morabito, Silvana Franca Capalbo, Alessandro Massimo Gianni, Vincenzo Mettivier, Vittorio Rizzoli, Carlo Bernasconi, Giuseppe Visani, Michele Pizzuti, Giacinto La Verde, Giuseppe Avvisati, Maurizio Longinotti, Eugenio Gallo, Franco Dammacco, Domenico Russo, Andrea Bacigalupo, Caterina Musolino, Tacchetti P., Pantani L., Patriarca F., Petrucci M.T., Zamagni E., Dozza L., Galli M., Di Raimondo F., Crippa C., Boccadoro M., Barbato S., Tosi P., Narni F., Montefusco V., Testoni N., Spadano A., Terragna C., Pescosta N., Marzocchi G., Cellini C., Galieni P., Ronconi S., Gobbi M., Catalano L., Lazzaro A., De Sabbata G., Cangialosi C., Ciambelli F., Musto P., Elice F., Cavo M., Fanin R., Foa' R., Rambaldi A., Rossi G., Leoni P., Corradini P., Torelli G., Fioritoni G., Cortelazzo S., Lambertenghi Deliliers G., La Nasa G., Zaccaria A., De Fabritiis P., Cascavilla N., Bosi A., Semenzato G., Gugliotta L., Gherlinzoni F., Angelucci E., Martelli M.F., Petti M.C., Leone G., Carella A.M., Ciceri F., Santoro A., Ferrara F., Nobile F., D'Arco A.M., Levis A., Guardigni L., Gallamini A., Fattori P.P., Morandi S., Amadori D., Rotoli B., Mirto S., Paladini G., Mozzana R., Pinotti G., Rodeghiero F., Cantore N., Pavone V., Pogliani E.M., Liberati A.M., Majolino I., Amadori S., Lauria F., Aglietta M., Quarta G., Storti S., Morabito F., Capalbo S.F., Gianni A.M., Mettivier V., Rizzoli V., Bernasconi C., Visani G., Pizzuti M., La Verde G., Avvisati G., Longinotti M., Gallo E., Dammacco F., Russo D., Bacigalupo A., and Musolino C.

Subjects
Adult, Male, medicine.medical_specialty, Transplantation Conditioning, Adolescent, Phases of clinical research, Transplantation, Autologous, Dexamethasone, Bortezomib, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, GIMEMA-MMY-3006 trial, bortezomib, thalidomide, dexamethasone, VTD, double autologous haematopoietic stem-cell transplantation, multiple myeloma, Multiple myeloma, Aged, Intention-to-treat analysis, business.industry, Hazard ratio, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, medicine.disease, Thalidomide, Transplantation, Regimen, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, business, Follow-Up Studies, 030215 immunology, medicine.drug
Abstract

Background: The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study. Methods: In this randomised, open-label, phase 3 study, patients aged 18–65 years with previously untreated symptomatic multiple myeloma and a Karnofsky Performance Status of 60% or higher were enrolled at 73 centres in Italy. Patients were randomised (1:1) by a web-based system to receive three 21-day cycles of thalidomide (100 mg daily orally for the first 14 days and 200 mg daily thereafter) plus dexamethasone (total 320 mg per cycle; 40 mg on days 1–2, 4–5, 8–9, and 11–12 in the VTD regimen, and 40 mg on days 1–4 and 9–12 in the TD regimen), either alone (TD group) or with bortezomib (1·3 mg/m2 intravenously on days 1, 4, 8, and 11; VTD group). After double autologous HSCT, patients received two 35-day cycles of either the VTD or TD regimen, according to random assignment, as consolidation therapy. The primary outcome was the rate of complete response and near complete response after induction (already reported). In this updated analysis we assessed long-term progression-free survival and overall survival (secondary endpoints of the study) with an extended 10-year median follow-up, and analysed the variables influencing survival. Analysis was by intention to treat. The study is registered with ClinicalTrials.gov, NCT01134484. Findings: Between May 10, 2006, and April 30, 2008, 480 patients were enrolled and randomly assigned to receive VTD (241 patients) or TD (239 patients). Six patients withdrew consent before start of treatment. 236 (99 [42%] women) in the VTD group and 238 (102 [43%] women) in the TD group were included in the intention-to-treat analysis. The data cutoff date for this analysis was May 31, 2018. Median follow-up for surviving patients was 124·1 months (IQR 117·2–131·7). The 10-year progression-free survival estimate for patients in the VTD group was 34% (95% CI 28–41) compared with 17% (13–23) for the TD group (hazard ratio [HR] 0·62 [95% CI 0·50–0·77]; p

Published
2020
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22. ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol

Author

Luca Maurillo, Adriano Venditti, Maria Teresa Voso, Paolo de Fabritiis, Giovanni Martinelli, Marco Vignetti, Gabriella Storti, Mario Luppi, Francesco Buccisano, Francesco Lanza, Valentina Arena, Giovangiacinto Paterno, Lorella Melillo, Prassede Salutari, Roberto Cairoli, Serena Lavorgna, Paola Fazi, Anna Candoni, Tiziana Ottone, Alfonso Piciocchi, Maria Antonietta Irno Consalvo, Saveria Capria, Raffaele Palmieri, Maria Ilaria Del Principe, William Arcese, Valeria Calafiore, Buccisano, F, Palmieri, R, Piciocchi, A, Arena, V, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, de Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Capria, S, Maurillo, L, Del Principe, M, Paterno, G, Consalvo, M, Ottone, T, Lavorgna, S, Voso, M, Fazi, P, Vignetti, M, Arcese, W, Venditti, A, Buccisano, Francesco, Palmieri, Raffaele, Piciocchi, Alfonso, Arena, Valentina, Candoni, Anna, Melillo, Lorella, Calafiore, Valeria, Cairoli, Roberto, de Fabritiis, Paolo, Storti, Gabriella, Salutari, Prassede, Lanza, Francesco, Martinelli, Giovanni, Luppi, Mario, Capria, Saveria, Maurillo, Luca, Del Principe, Maria Ilaria, Paterno, Giovangiacinto, Irno Consalvo, Maria Antonietta, Ottone, Tiziana, Lavorgna, Serena, Voso, Maria Teresa, Fazi, Paola, Vignetti, Marco, Arcese, William, and Venditti, Adriano

Subjects
medicine.medical_specialty, Humans, Neoplasm, Residual, Prognosis, Prospective Studies, Risk Assessment, Transplantation, Homologous, autologous stem cell transplantation, post hoc analysi, overall survival, Article, remission, male, allogeneic stem cell transplantation, MED/15 - MALATTIE DEL SANGUE, Internal medicine, medicine, Overall survival, Mutational status, human, outcome assessment, business.industry, cytogenetic, adult, flow cytometry, Complete remission, Myeloid leukemia, Hematology, prediction, Settore MED/15, major clinical study, female, Acute myeloid leukemia, gimema aml1310, outcome prediction, risk stratification, Risk stratification, survival analysi, minimal residual disease, treatment outcome, Population study, Risk categorization, business, Outcome prediction, intermediate risk patient, prospective study
Abstract

The 2017 version of the European LeukemiaNet (ELN) recommendations, by integrating cytogenetics and mutational status of specific genes, divides patients with acute myeloid leukemia into 3 prognostically distinct risk categories: favorable (ELN2017-FR), intermediate (ELN2017-IR), and adverse (ELN2017-AR). We performed a post hoc analysis of the GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto) AML1310 trial to investigate the applicability of the ELN2017 risk stratification to our study population. In this trial, after induction and consolidation, patients in complete remission were to receive an autologous stem cell transplant (auto-SCT) if categorized as favorable risk or an allogeneic stem cell transplant (allo-SCT) if adverse risk. Intermediate-risk patients were to receive auto-SCT or allo-SCT based on the postconsolidation levels of measurable residual disease as measured by using flow cytometry. Risk categorization was originally conducted according to the 2009 National Comprehensive Cancer Network recommendations. Among 500 patients, 445 (89%) were reclassified according to the ELN2017 criteria: ELN2017-FR, 186 (41.8%) of 455; ELN2017-IR, 179 (40.2%) of 445; and ELN2017-AR, 80 (18%) of 455. In 55 patients (11%), ELN2017 was not applicable. Two-year overall survival (OS) was 68.8%, 51.3%, 45.8%, and 42.8% for the ELN2017-FR, ELN2017-IR, ELN2017-not classifiable, and ELN2017-AR groups, respectively (P < .001). When comparing the 2 different transplant strategies in each ELN2017 risk category, a significant benefit of auto-SCT over allo-SCT was observed among ELN2017-FR patients (2-year OS of 83.3% vs 66.7%; P = .0421). The 2 transplant procedures performed almost equally in the ELN2017-IR group (2-year OS of 73.9% vs 70.8%; P = .5552). This post hoc analysis of the GIMEMA AML1310 trial confirms that the ELN2017 classification is able to accurately discriminate patients with different outcomes and who may benefit from different transplant strategies. This trial was registered as EudraCT number 2010-023809-36 and at www.clinicaltrials.gov as #NCT01452646.

Published
2021

23. Validation of ELN2017 Risk Stratification in a Post-Hoc Analysis of the Prospective Biomarker-Based Gimema AML1310 Protocol

Author

Giovangiacinto Paterno, Luca Maurillo, Prassede Salutari, Mario Luppi, Francesco Lanza, Francesco Buccisano, Tiziana Ottone, Alfonso Piciocchi, Adriano Venditti, Marco Vignetti, Serena Lavorgna, Paola Fazi, Paolo de Fabritiis, Gabriella Storti, Valeria Calafiore, L. Melillo, Roberto Cairoli, Valentina Arena, Anna Candoni, Maria Teresa Voso, Saveria Capria, Raffaele Palmieri, Maria Ilaria Del Principe, Giovanni Martinelli, William Arcese, Palmieri, R, Buccisano, F, Piciocchi, A, Arena, V, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Capria, S, Maurillo, L, Del Principe, M, Paterno, G, Voso, M, Ottone, T, Lavorgna, S, Fazi, P, Vignetti, M, Arcese, W, and Venditti, A

Subjects
Oncology, Protocol (science), medicine.medical_specialty, business.industry, Immunology, Cell Biology, Hematology, Biochemistry, Internal medicine, Post-hoc analysis, Risk stratification, medicine, Biomarker (medicine), business
Abstract

Background: In the 2017 version of the ELN recommendations (ELN2017), a comprehensive evaluation of karyotype and mutational status of specific genes (e.g. FLT3 and NPM1) allows to classify patients (pts) with Acute Myeloid Leukemia (AML) into 3 prognostically distinct risk groups (favorable, intermediate and adverse-risk). Before the publication of the ELN2017 guidelines, the Gruppo Italiano Malattie Ematologiche MAligne (GIMEMA) conducted a prospective trial (AML1310) in which prognostic classification relied on the risk assessment criteria (NCCN2009) at that time available. In this post-hoc analysis, we investigated the applicability of the ELN2017 risk stratification to the AML1310 study population. Methods: After induction and consolidation, pts in complete remission (CR) were to receive autologous stem cell transplant (AuSCT) if categorized as favorable-risk (FR) (CBF-AML, NPM1-mutated) or allogeneic stem cell transplant (ASCT) if adverse-risk (AR) (FLT3-ITD, complex karyotype). Intermediate-risk pts (IR) were to receive AuSCT or ASCT based on the post-consolidation levels of MRD as measured by flow-cytometry. Baseline genetic/cytogenetic, together with RUNX1/RUNX1T1, CBFb/MYH11, NPM1, FLT3 mutational status (including the FLT3 allelic ratio for those positive) were used to retrospectively classify pts according to the ELN2017. Results: All 500 pts, enrolled in the AML1310 trial, were included in the present analysis. Retrospective allocation was feasible in 445/500 (89%) cases and pts lacking crucial information for a proper ELN2017 assignment, defined a control group (ELN2017-NC). Median age was 49 (range 18-61). The re-assignmentaccording to the ELN2017, resulted in 186 pts (41.8%) belonging to the FR category (ELN2017-FR), 179 (40.2%) to the IR (ELN2017-IR) and 80 (18%) to the AR (ELN2017-AR) ones. Moreover, 55 (11%) pts were considered ELN2017-NC. Based on this process of re-assignment, 173 pts were reclassified according to ELN2017: 6 from NCCN FR (1 ELN2017-NC, 4 ELN2017-IR, 1 ELN2017-AR), 54 from NCCN IR (34 ELN2017-NC, 4 ELN2017-IR, 1 ELN2017-AR), and 113 from NCCN AR (20 ELN2017-NC, 38 ELN2017-FR, 55 ELN2017-AR) groups. After 1-2 cycles of induction, 361 (72%) pts obtained CR or CR incomplete (CRi): 163 (88.1%), 114 (65%), 45 (56.2%) and 39 (70%) in the ELN2017-FR, ELN2017-IR, ELN2017-AR and ELN2017-NC groups, respectively (p Summary/Conclusion: In this GIMEMA AML1310 post-hoc analysis, we confirmed that the ELN2017 classification is able to accurately define pts that can benefit from different post-remission strategies. Specifically, AuSCT granted longer survival in FR pts, while for IR pts AuSCT and ASCT performed equally when minimal residual disease was used as a driver for opting between one of the two. In conclusion, ELN classification is a reliable grouping system that, combined with MRD assessment, helps addressing pts to the most appropriate treatment. Such an hypothesis will be prospectively challenged in the next GIMEMA trial AML1819. Disclosures Luppi: Abbvie: Consultancy; Novartis: Consultancy, Speakers Bureau; Gilead Sci: Consultancy, Speakers Bureau; Sanofi: Consultancy; Daiichi-Sankyo: Consultancy; MSD: Consultancy. Voso:Bristol Myers Squibb: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding. Venditti:Pfizer: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company), Speakers Bureau; Amgen: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); Jazz: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company); AbbVie: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company); Janssen: Consultancy, Honoraria, Other: TRAVEL, ACCOMODATIONS, EXPENSES (paid by any for-profit health care company); Novartis: Consultancy, Honoraria, Other: TRAVEL, ACCOMMODATIONS, EXPENSES (paid by any for-profit health care company).

Published
2020
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24. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Mohamad Mohty, Evangelos Terpos, Maria-Victoria Mateos, Michele Cavo, Sandra Lejniece, Meral Beksac, Mohamed Amine Bekadja, Wojciech Legiec, Meletios Dimopoulos, Svetlana Stankovic, Maria Soledad Durán, Valerio De Stefano, Alessandro Corso, Yulia Kochkareva, Edward Laane, Christian Berthou, Hans Salwender, Zvenyslava Masliak, Valdas Pečeliūnas, Wolfgang Willenbacher, João Silva, Vernon Louw, Damir Nemet, Zita Borbényi, Uri Abadi, Robert Schou Pedersen, Peter Černelč, Anna Potamianou, Catherine Couturier, Caroline Feys, Florence Thoret-Bauchet, Mario Boccadoro, Mohamed Bekadja, Rose-Marie Hamladji, Hocine Ait Ali, Selma Hamdi, Hadj Touhami, Nourredine Sidi Mansour, Werner Linkesch, Robert Shou Pedersen, Niels Abildgaard, Marju Hein, Jean Richard Eveillard, Abderrazak el Yamani, Philippe Moreau, Laurence Sanhes, Gérard Lepeu, Kamel Laribi, Eric Jourdan, Olivier Fitoussi, Olivier Allangba, Joël Fleury, Martine Escoffre, Riad Benramdane, Guillaume Cartron, Gérard Dine, Eric Legouffe, Hanns-Detlev Harich, Thomas Illmer, Steffen Dörfel, Carla Verena Hannig, Michael Koenigsmann, Gabriele Prange-Krex, Ingo Tamm, Wolfgang Zeller, Michael Maasberg, Rudolf Schlag, Martine Klausmann, Jens Uhlig, Burkhard Alkemper, Stefan Schütz, Hans-Werner Tessen, Benno Mohr, Peter Schmidt, Bernhard Heinrich, Holger Hebart, Gernot Seipelt, Thomas Zoeller, Frank Heits, Clemens Müller-Naendrup, Richard Hansen, Roland Repp, Ludwig Fischer Von Weikersthal, Rudolf Schmits, Jörg Heßling, B. Krammer-Steiner, Viktor Janzen, Michael Schauer, Marcus W. Grüner, Jens Kisro, Claudio Denzlinger, Werner Freier, Christian Junghanss, Martin Görner, Katharina Laichinger, Helmut Ostermann, Heinz Dürk, Georg Hess, Gernot Reich, Panagiota Matsouka, Anastasia Pouli, Achilles Anagnostopoulos, Tamas Masszi, Janos Ivanyi, Arpad Szomor, Arnon Nagler, Hila Magen, Irit Avivi, Miriam Quitt, Antonio Palumbo, Tommaso Za, Daniele Vallisa, Roberto Foa, Alberto Bosi, Angelo Vacca, Francesco Lanza, Giulia Palazzo, Giuseppe Avvisati, Felicetto Ferrara, Ugo Consoli, Maria Cantonetti, Emanuele Angelucci, Catello Califano, Francesco Di Raimondo, Attilio Guarini, Maurizio Musso, Michele Pizzuti, Nicola Giuliani, Antonio Ardizzoia, Nicola Di Renzo, Gianluca Gaidano, Alessandro Gozzetti, Vincenzo Pitini, Gabriella Farina, Riccardo Centurioni, Paolo De Fabritiis, Francesco Iuliano, Giorgio La Nasa, Giacinto La Verde, Fabrizio Pane, Umberto Recine, Maria La Targia, Giuseppe Mineo, Clotilde Cangialosi, Daniele Fagnani, Augusto Federici, Atelda Romano, Giorgina Specchia, Sergio Storti, Velia Bongarzoni, Andrea Bacigalupo, Marco Gobbi, Giancarlo Latte, Donato Mannina, Silvana Capalbo, Mindaugas Jurgutis, Dariusz Woszczyk, Jadwiga Hołojda, Slawomir Gornik, Andrzej Pluta, Elzbieta Morawiec-Szymonik, Slawomira Kyrcz-Krzemien, Wojciech Homenda, Sebastian Grosicki, Kazimierz Sulek, Andrzej Lange, Janusz Kloczko, Jolanta Starzak-Gwozdz, Andrzej Hellmann, Mieczyslaw Komarnicki, Kazimierz Kuliczkowski, Carolina Viveiros, Cristina Gonçalves, Natalia Esefyeva, Julia Kochkareva, Kamil Kaplanov, Elena Volodicheva, Elena Laricheva, Valentina Dergacheva, Marina Chukavina, Natalia Volchenko, Irina Nazarova, Ludmila Anchukova, Elena Ovanesova, Taras Gritsenko, Galina Salogub, Ludmila Magomedova, Irina Kuznetsova, Svetlana Osyunikhina, Olga Serdyuk, Elena Karyagina, Valentina Ivanova, Slovenia Peter Černelč, Corlia Coetzee, Karen Gunther, Dhayanithi Moodley, Soledad Duran, Asunción Echeveste Gutiérrez, Jaime Perez De Oteyza, Francisco Javier Capote, Maria Casanova, Jesus Martin Sanchez, Eduardo Rios-Herranz, Jeronima Ibañez-Garcia, Maria Jose Herranz, Belen Hernandez, Sara Sanchez Sanchez, Fernando Escalante, Fernando Carnicero, Joan Bargay Lleonart, Mercedes Gironella, Rafael Martínez, Ana Lopez De La Guia, Luis Palomera, Rebeca Iglesias, Fernando Solano Ramos, Javier De La Serna, Pedro Garcia Sanchez, Juan Besalduch Vidal, Miguel Diaz Morfa, Turkey – Meral Beksac, Filiz Vural, Yildiz Aydin, Ali Unal, Hakan Goker, Oktay Bilgir, Birol Guvenc, Mehmet Turgut, Gulsum Gulistan Ozet, Ridvan Ali, Maryna Kyselyova, Nataliia Glushko, Renata Vybyrana, Igor Skrypnyk, Natalya Tretyak, Tetiana Kharchevska, Iryna Dyagil, Tetiana Popovs'ka, Vadim Shimanskiy, Tamila Lysa, Hanna Oliynyk, Kateryna Vilchevskaya, Iryna Kryachok, Yuriy Popovych, Natalia Romanyuk, Natalia Yushchenko, Polina Kaplan, Grygoriy Rekhtman, Halyna Pylypenko, Viktor Kozlov, Johannes Drach, Jean-Luc Harousseau, Hermann Einsele, Hartmut Goldschmidt, Thierry Facon, Mauricette Michalet, Valery G. Savchenko, Javier De la Rubia, Gordon Cook, Ulf-Henrik Mellqvist, Heinz Ludwig, Millennium Pharmaceuticals, Janssen Research and Development, Mohty, Mohamad, Terpos, Evangelo, Mateos, Maria-Victoria, Cavo, Michele, Lejniece, Sandra, Beksac, Meral, Bekadja, Mohamed Amine, Legiec, Wojciech, Dimopoulos, Meletio, Stankovic, Svetlana, Durán, Maria Soledad, De Stefano, Valerio, Corso, Alessandro, Kochkareva, Yulia, Laane, Edward, Berthou, Christian, Salwender, Han, Masliak, Zvenyslava, Pečeliūnas, Valda, Willenbacher, Wolfgang, Silva, João, Louw, Vernon, Nemet, Damir, Borbényi, Zita, Abadi, Uri, Pedersen, Robert Schou, Černelč, Peter, Potamianou, Anna, Couturier, Catherine, Feys, Caroline, Thoret-Bauchet, Florence, Boccadoro, Mario, Mohty, M., Terpos, E., Mateos, M. -V., Cavo, M., Lejniece, S., Beksac, M., Bekadja, M. A., Legiec, W., Dimopoulos, M., Stankovic, S., Duran, M. S., De Stefano, V., Corso, A., Kochkareva, Y., Laane, E., Berthou, C., Salwender, H., Masliak, Z., Peceliunas, V., Willenbacher, W., Silva, J., Louw, V., Nemet, D., Borbenyi, Z., Abadi, U., Pedersen, R. S., Cernelc, P., Potamianou, A., Couturier, C., Feys, C., Thoret-Bauchet, F., Boccadoro, M., Bekadja, M., Hamladji, R. -M., Ali, H. A., Hamdi, S., Touhami, H., Mansour, N. S., Linkesch, W., Abildgaard, N., Hein, M., Eveillard, J. R., Yamani, A. E., Moreau, P., Sanhes, L., Lepeu, G., Laribi, K., Jourdan, E., Fitoussi, O., Allangba, O., Fleury, J., Escoffre, M., Benramdane, R., Cartron, G., Dine, G., Legouffe, E., Harich, H. -D., Illmer, T., Dorfel, S., Hannig, C. V., Koenigsmann, M., Prange-Krex, G., Tamm, I., Zeller, W., Maasberg, M., Schlag, R., Klausmann, M., Uhlig, J., Alkemper, B., Schutz, S., Tessen, H. -W., Mohr, B., Schmidt, P., Heinrich, B., Hebart, H., Seipelt, G., Zoeller, T., Heits, F., Muller-Naendrup, C., Hansen, R., Repp, R., Von Weikersthal, L. F., Schmits, R., Hessling, J., Krammer-Steiner, B., Janzen, V., Schauer, M., Gruner, M. W., Kisro, J., Denzlinger, C., Freier, W., Junghanss, C., Gorner, M., Laichinger, K., Ostermann, H., Durk, H., Hess, G., Reich, G., Matsouka, P., Pouli, A., Anagnostopoulos, A., Masszi, T., Ivanyi, J., Szomor, A., Nagler, A., Magen, H., Avivi, I., Quitt, M., Palumbo, A., Za, T., Vallisa, D., Foa, R., Bosi, A., Vacca, A., Lanza, F., Palazzo, G., Avvisati, G., Ferrara, F., Consoli, U., Cantonetti, M., Angelucci, E., Califano, C., Di Raimondo, F., Guarini, A., Musso, M., Pizzuti, M., Giuliani, N., Ardizzoia, A., Di Renzo, N., Gaidano, G., Gozzetti, A., Pitini, V., Farina, G., Centurioni, R., De Fabritiis, P., Iuliano, F., La Nasa, G., La Verde, G., Pane, F., Recine, U., La Targia, M., Mineo, G., Cangialosi, C., Fagnani, D., Federici, A., Romano, A., Specchia, G., Storti, S., Bongarzoni, V., Bacigalupo, A., Gobbi, M., Latte, G., Mannina, D., Capalbo, S., Jurgutis, M., Woszczyk, D., Holojda, J., Gornik, S., Pluta, A., Morawiec-Szymonik, E., Kyrcz-Krzemien, S., Homenda, W., Grosicki, S., Sulek, K., Lange, A., Kloczko, J., Starzak-Gwozdz, J., Hellmann, A., Komarnicki, M., Kuliczkowski, K., Viveiros, C., Goncalves, C., Esefyeva, N., Kaplanov, K., Volodicheva, E., Laricheva, E., Dergacheva, V., Chukavina, M., Volchenko, N., Nazarova, I., Anchukova, L., Ovanesova, E., Salogub, G., Magomedova, L., Kuznetsova, I., Osyunikhina, S., Serdyuk, O., Karyagina, E., Ivanova, V., Cernelc, S. P., Coetzee, C., Gunther, K., Moodley, D., Duran, S., Gutierrez, A. E., De Oteyza, J. P., Capote, F. J., Casanova, M., Sanchez, J. M., Rios-Herranz, E., Ibanez-Garcia, J., Herranz, M. J., Hernandez, B., Sanchez, S. S., Escalante, F., Carnicero, F., Lleonart, J. B., Gironella, M., Martinez, R., De La Guia, A. L., Palomera, L., Iglesias, R., Ramos, F. S., De La Serna, J., Sanchez, P. G., Vidal, J. B., Morfa, M. D., Beksac, T. -M., Vural, F., Aydin, Y., Unal, A., Goker, H., Bilgir, O., Guvenc, B., Turgut, M., Ozet, G. G., Ali, R., Kyselyova, M., Glushko, N., Vybyrana, R., Skrypnyk, I., Tretyak, N., Kharchevska, T., Dyagil, I., Popovs'Ka, T., Shimanskiy, V., Lysa, T., Oliynyk, H., Vilchevskaya, K., Kryachok, I., Popovych, Y., Romanyuk, N., Yushchenko, N., Kaplan, P., Rekhtman, G., Pylypenko, H., Kozlov, V., Drach, J., Harousseau, J. -L., Einsele, H., Goldschmidt, H., Facon, T., Michalet, M., Savchenko, V. G., De la Rubia, J., Cook, G., Mellqvist, U. -H., Ludwig, H., Service d'hématologie clinique et de thérapie cellulaire [CHU Saint-Antoine], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-CHU Saint-Antoine [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU)-Sorbonne Université (SU), Department of Clinical Therapeutics, Univesrity of Athens, Universidad de Salamanca- CSIC, The Institute of Hematology and Oncology L. and A. Seràgnoli, Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), Riga Stradins University (RSU), Ankara University, University of Oran Es-Senia [Oran] | Université d'Oran Es-Senia [Oran], Medical University of Lublin, Department of Clinical Therapeutics [Athens, Greece], National and Kapodistrian University of Athens (NKUA), University Clinic of Hematology, Skopje, Complejo Hospitalario de Jaén, Institute of Hematology, Catholic University, Division of Hematology, Foundation IRCCS Policlinico San Matteo, Università degli Studi di Pavia, State Budget Healthcare Insititution of Moscow, North Estonia Medical Centre, Service d'hématologie, Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Lymphocyte B et Auto-immunité (LBAI), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO), Asklepios Klinik Altona, Institute of Blood Pathology and Transfusion Medicine, Lviv, Vilnius University Hospital Santariskiu Clinics, Universitätsklinik Innsbruck Innere Medizin V (Innsbruck Austria & Oncotyrol), Instituto de Engenharia de Sistemas e Computadores Investigação e Desenvolvimento em Lisboa (INESC-ID), Instituto Superior Técnico, Universidade Técnica de Lisboa (IST)-Instituto de Engenharia de Sistemas e Computadores (INESC), University Health Network, University of the Free State [South Africa], Clinical Hospital Centre Zagreb, Szegedi Tudományegyetem, Meir Medical Center, Regionshospitalet i Holstebro, Medicinsk Afdeling, University Medical Centre Ljubljana [Ljubljana, Slovenia] (UMCL), Janssen-Cilag, Neuss, Janssen-Cilag [Issy-les-Moulineaux], Janssen Research & Development, Divisione di Ematologia dell' Università di Torino, and Azienda Ospedaliera S. Giovanni Battista di Torino

Subjects
Male, Cancer Research, Boronic Acid, [SDV]Life Sciences [q-bio], bortezomib, global, observational study, routine practice, stem cell transplantation, Salvage therapy, Practice Patterns, Dexamethasone, Bortezomib, Routine practice, 0302 clinical medicine, Global, Observational study, Stem cell transplantation, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Prospective Studies, Practice Patterns, Physicians', Prospective cohort study, Lenalidomide, ComputingMilieux_MISCELLANEOUS, Multiple myeloma, Aged, 80 and over, Hematology, Middle Aged, Boronic Acids, 3. Good health, Thalidomide, Survival Rate, Treatment Outcome, Local, Oncology, 030220 oncology & carcinogenesis, Female, Multiple Myeloma, Adult, Aged, Follow-Up Studies, Humans, Neoplasm Recurrence, Local, Salvage Therapy, medicine.drug, Human, medicine.medical_specialty, NO, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Survival rate, Physicians', Antineoplastic Combined Chemotherapy Protocol, business.industry, Settore MED/15, medicine.disease, Transplantation, Settore MED/15 - MALATTIE DEL SANGUE, Prospective Studie, Neoplasm Recurrence, business, 030215 immunology
Abstract

© 2018 The Authors., [Background]: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. [Patients and Methods]: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months., [Results]: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide., [Conclusion]: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits., Writing support during the development of our report was provided by Laura Mulcahy and Catherine Crookes of FireKite, an Ashfield company, a part of UDG Healthcare plc, which was funded by Millennium Pharmaceuticals, Inc, and Janssen Global Services, LLC. The EMMOS study was supported by research funding from Janssen Pharmaceutical NV and Millennium Pharmaceuticals, Inc.

Published
2018
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25. 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. I., Candoni, A., Melillo, L., Calafiore, V., Cairoli, R., Fabritiis, P., Storti, G., Salutari, P., Lanza, F., Martinelli, G., Luppi, M., Mazza, P., Maria Paola MARTELLI, Cuneo, A., Albano, F., Fabbiano, F., Tafuri, A., Chierichini, A., Tieghi, A., Fracchiolla, N. S., Capelli, D., Foa, R., Alati, C., La Sala, E., Voso, M. T., Fazi, P., Vignetti, M., Consalvo, M. Irno, 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, and Venditti, A

Subjects
Hematology

26. RISK-ADAPTED, MRD-DIRECTED THERAPY FOR YOUNG ADULTS WITH NEWLY DIAGNOSED ACUTE MYELOID LEUKEMIA: RESULTS OF THE AML1310 TRIAL OF THE GIMEMA GROUP

Author

Venditti, A., Piciocchi, A., Candoni, A., Melillo, L., Calafiore, V., Cairoli, R., Fabritiis, P., Storti, G., Salutari, P., Lanza, F., Martinelli, G., Luppi, M., Mazza, P., Falini, B., Cuneo, A., Specchia, G., Fabbiano, F., agostino tafuri, Ronci, B., Tieghi, A., Fracchiolla, N. S., Capelli, D., Foa, R., Ronco, F., La Sala, E., Fazi, P., Maurillo, L., Buccisano, F., Del Principe, M. I., Lo Coco, F., Arcese, W., Amadori, S., Venditti, A, Piciocchi, A, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Mazza, P, Falini, B, Cuneo, A, Specchia, G, Fabbiano, F, Tafuri, A, Ronci, B, Tieghi, A, Fracchiolla, N, Capelli, D, Foa, R, Ronco, F, La Sala, E, Fazi, P, Maurillo, L, Buccisano, F, Del Principe, M, Lo Coco, F, Arcese, W, and Amadori, S

Subjects
Hematology

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