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1. Skin lesions in chronic myeloid leukemia patients during dasatinib treatment

Author

Tarantini F, Anelli L, Ingravallo G, Attolico I, Zagaria A, Russo Rossi A, Lospalluti L, Bufano T, Zanframundo G, Maiorano E, Specchia G, and Albano F

Subjects
inhibitor tyrosine kinase, skin lesions, chronic myeloid leukemia, CD8+ lymphocytes, dasatinib, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Francesco Tarantini,1 Luisa Anelli,1 Giuseppe Ingravallo,1 Immacolata Attolico,1 Antonella Zagaria,1 Antonella Russo Rossi,1 Lucia Lospalluti,2 Tamara Bufano,2 Giovanni Zanframundo,2 Eugenio Maiorano,1 Giorgina Specchia,1 Francesco Albano11Department of Emergency and Organ Transplantation (D.E.T.O.), Hematology Section, University of Bari “Aldo Moro”, Bari, Italy; 2Department of Biomedical Sciences and Clinical Oncology, Dermatology Section, University of Bari “Aldo Moro”, Bari, ItalyCorrespondence: Francesco AlbanoDepartment of Emergency and Organ Transplantation (D.E.T.O.), Hematology Section, University of Bari “Aldo Moro”, P.zza G. Cesare, 11, Bari 70124, ItalyTel +39 080 547 8031Email francesco.albano@uniba.itPurpose: In our work we sought to define the prevalence rates of cutaneous events during dasatinib therapy in chronic myeloid leukemia (CML) patients and to investigate the clinical and pathological characteristics of these reactions.Patients and methods: In our institution, 67 CML patients were treated with dasatinib. it was given as first line treatment in 26 (39%) and subsequent treatment in 41 (61%) CML patients. Flow cytometry analysis of peripheral blood and cutaneous biopsy was done on all CML patients with dermatological lesions appearing during dasatinib treatment.Results: Among 67 CML patients, 4 (5.9%) showed skin lesions during dasatinib treatment. The cutaneous manifestations were not generalized but mainly located on the back, abdomen, thorax or leg regions. The patients did not show peripheral lymphocytosis at the time when skin lesions appeared. Overall, histological analysis showed that the skin lesions were characterized by a mild perivascular small CD8+ T lymphocytes infiltrate with minimal epidermotropism.Conclusion: The unusual T cytotoxic cutaneous infiltrate demonstrated in our CML cases could be the expression of a dasatinib-promoted lymphocyte expansion. However, the heterogeneity of the dermatologic manifestations reported in our CML patients could also be related to unknown factors specific to each CML patient. Our work highlights the finding that skin lesions may be associated with dasatinib treatment and that they should not be confused with viral or bacterial infections but rather interpreted as the clinical expression of lymphocytosis promoted by this TKI.Keywords: inhibitor tyrosine kinase, skin lesions, chronic myeloid leukemia, CD8+ lymphocytes, dasatinib

Published
2019

2. Determinants of frontline tyrosine kinase inhibitor choice for patients with chronic-phase chronic myeloid leukemia: A study from the Registro Italiano LMC and Campus CML

Author

Tiribelli, M., Latagliata, R., Breccia, M., Capodanno, I., Miggiano, M. C., Cavazzini, F., Bucelli, C., Attolico, I., Crescenzi, S. L., Russo, S., Annunziata, M., Sora', Federica, Bonifacio, M., Mulas, O., Loglisci, G., Maggi, A., Binotto, G., Crisa, E., Scortechini, A. R., Leporace, A. P., Sancetta, R., Murgano, P., Abruzzese, E., Stagno, F., Rapezzi, D., Luzi, D., Vincelli, I., Bocchia, M., Fava, C., Malato, A., Crugnola, M., Pizzuti, M., Lunghi, F., Galimberti, S., Dalmazzo, M., Fanin, R., Scalzulli, E., Foa, R., Iurlo, A., Saglio, G., Specchia, G., Sora' F. (ORCID:0000-0002-9607-5298), Tiribelli, M., Latagliata, R., Breccia, M., Capodanno, I., Miggiano, M. C., Cavazzini, F., Bucelli, C., Attolico, I., Crescenzi, S. L., Russo, S., Annunziata, M., Sora', Federica, Bonifacio, M., Mulas, O., Loglisci, G., Maggi, A., Binotto, G., Crisa, E., Scortechini, A. R., Leporace, A. P., Sancetta, R., Murgano, P., Abruzzese, E., Stagno, F., Rapezzi, D., Luzi, D., Vincelli, I., Bocchia, M., Fava, C., Malato, A., Crugnola, M., Pizzuti, M., Lunghi, F., Galimberti, S., Dalmazzo, M., Fanin, R., Scalzulli, E., Foa, R., Iurlo, A., Saglio, G., Specchia, G., and Sora' F. (ORCID:0000-0002-9607-5298)

Abstract

Background: Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic-phase chronic myeloid leukemia (CP-CML). The choice of TKI is based on a combined evaluation of the patient’s and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP-CML to correlate the choice with the patient’s features. Methods: A total of 1967 patients with CP-CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second-generation (2G) TKI. Results: Second-generation TKIs were chosen for most patients aged <45 years (69.2%), whereas imatinib was used in 76.7% of patients aged >65 years (p <.001). There was a predominant use of imatinib in intermediate/high European long–term survival risk patients (60.0%/66.0% vs. 49.7% in low-risk patients) and a limited use of 2G-TKIs in patients with comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, or stroke and in those with >3 concomitant drugs. We observed a greater use of imatinib (61.1%) in patients diagnosed in 2018–2019 compared to 2012–2017 (53.2%; p =.002). In multivariable analysis, factors correlated with imatinib use were age > 65 years, spleen size, the presence of comorbidities, and ≥3 concomitant medications. Conclusions: This observational study of almost 2000 cases of CML shows that imatinib is the frontline drug of choice in 55% of Italian patients with CP-CML, with 2G-TKIs prevalently used in younger patients and in those with no concomitant clinical conditions. Introduction of the generic formulation in 2018 seems to have fostered imatinib use.

Published
2023

3. P1319: T AND B LYMPHOCYTES SUBSETS AFTER BNT162B2 ANTI-SARS-COV-2 M-RNA VACCINATION: A COMPARISON BETWEEN HEMATOPOIETIC STEM CELL TRANSPLANTATION PATIENTS AND HEALTHY CONTROLS.

Author

Attolico, I., primary, Tarantini, F., additional, Schifone, C. P., additional, Mestice, A., additional, De Tullio, G., additional, Derosa, C., additional, Carbone, F., additional, Negri, A., additional, Carluccio, P., additional, Delia, M., additional, Albano, F., additional, Larocca, A. M. V., additional, Stefanizzi, P., additional, Vimercati, L., additional, Tafuri, S., additional, and Musto, P., additional

Published
2022
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4. Extramedullar Acute Promyelocytic Leukemia

Author

Specchia, G., Pogliani, E. M., Pastore, D., Mininni, D., Rossi, V., Mestice, A., Attolico, I., Liso, V., 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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5. COVID-19 infection in chronic myeloid leukemia after one year of the pandemic in Italy Campus CML report

Author

Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, Sora, Federica (ORCID:0000-0002-9607-5298), Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, and Sora, Federica (ORCID:0000-0002-9607-5298)

Abstract

Limited information is available on the impact of the COVID-19 pandemic on the management of chronic myeloid leukaemia (CML). The Campus CML network collected retrospective information on 8 665 CML patients followed at 46 centres throughout Italy during the pandemic between February 2020 and January 2021. Within this cohort, we recorded 217 SARS-CoV-2-positive patients (2·5%). Most patients (57%) were diagnosed as having SARS-CoV-2 infection during the second peak of the pandemic (September 2020 to January 2021). The majority (35%) was aged between 50 and 65 years with a male prevalence (73%). Fifty-six percent of patients presented concomitant comorbidities. The median time from CML diagnosis to SARS-CoV-2 infection was six years (three months to 18 years). Twenty-one patients (9·6%) required hospitalization without the need of respiratory assistance, 18 (8·2%) were hospitalized for respiratory assistance, 8 (3·6%) were admitted to an intensive care unit, while 170 (78%) were only quarantined. Twenty-three percent of patients discontinued tyrosine kinase inhibitor (TKI) therapy during the infection. Twelve patients died due to COVID-19 with a mortality rate of 5·5% in the positive cohort and of 0·13% in the whole cohort. We could also document sequelae caused by the SARS-CoV-2 infection and an impact of the pandemic on the overall management of CML patients.

Published
2022

6. Deciphering the effects of graft Tregs on chronic graft-versus-host disease: results from a prospective, multicenter study in patients with acute leukemia undergoing allogeneic peripheral blood stem cell transplantation

Author

Delia, M., Carluccio, P., Gagliardi, V. P., Mestice, A., Chiusolo, Patrizia, Arpinati, M., Milone, G. A., Martino, M., Mazza, P., Ingrosso, C., Vacca, A., Saporiti, G., Zallio, F., Attolico, I., Pastore, D., Specchia, G., Albano, F., Musto, P., Chiusolo P. (ORCID:0000-0002-1355-1587), Delia, M., Carluccio, P., Gagliardi, V. P., Mestice, A., Chiusolo, Patrizia, Arpinati, M., Milone, G. A., Martino, M., Mazza, P., Ingrosso, C., Vacca, A., Saporiti, G., Zallio, F., Attolico, I., Pastore, D., Specchia, G., Albano, F., Musto, P., and Chiusolo P. (ORCID:0000-0002-1355-1587)

Abstract

N/A

Published
2022

9. Results of a randomized trial comparing high-dose chemotherapy plus Auto-SCT and R-FC in CLL at diagnosis

Author

Magni, M, Nicola, M Di, Patti, C, Scimè, R, Mulè, A, Rambaldi, A, Intermesoli, T, Viero, P, Tarella, C, Gueli, A, Bergui, L, Trentin, L, Barzan, A, Benedetti, F, Ambrosetti, A, Di Raimondo, F, Chiarenza, A, Parvis, G, Billio, A, Attolico, I, Olivieri, A, Montanari, M, Carlo-Stella, C, Matteucci, P, Devizzi, L, Guidetti, A, Viviani, S, Valagussa, P, and Gianni, A M

Published
2014
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10. The Impact of Graft CD3 Cell/Regulatory T Cell Ratio on Acute Graft-versus-Host Disease and Post-Transplantation Outcome: A Prospective Multicenter Study of Patients with Acute Leukemia Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation

Author

Delia, M., Carluccio, P., Mestice, A., Chiusolo, Patrizia, Metafuni, Elisabetta, Bellesi, Silvia, Arpinati, M., Milone, G. A., Martino, M., Mazza, P., Ingrosso, C., Vacca, A., Saporiti, G., Zallio, F., Attolico, I., Pastore, D., Specchia, G., Albano, F., Musto, P., Chiusolo P. (ORCID:0000-0002-1355-1587), Metafuni E., Bellesi S., Delia, M., Carluccio, P., Mestice, A., Chiusolo, Patrizia, Metafuni, Elisabetta, Bellesi, Silvia, Arpinati, M., Milone, G. A., Martino, M., Mazza, P., Ingrosso, C., Vacca, A., Saporiti, G., Zallio, F., Attolico, I., Pastore, D., Specchia, G., Albano, F., Musto, P., Chiusolo P. (ORCID:0000-0002-1355-1587), Metafuni E., and Bellesi S.

Abstract

Although it is well known that tumor site- or bone marrow-infiltrating regulatory T cells (Tregs) might be correlated with worse outcomes in solid tumors and acute leukemias by promoting immune surveillance escape, their contribution to the immediate post-allogeneic transplantation phase by peripheral blood (PB) allografts remains unclear. Moreover, the Treg content in stem cells harvested from PB has been suggested to be correlated with acute graft versus-host-disease (aGVHD) and immunologic recovery after allogeneic PB stem cell transplantation (allo-PBSCT). This study aimed to investigate the impact of the graft content of Tregs, as graft CD3+/Tregs ratio (gCD3/TregsR), on acute GVHD and post-allo-PBSCT outcomes. We prospectively enrolled 94 consecutive patients at 9 Italian centers of the Gruppo Italiano Trapianto di Midollo Osseo (GITMO) with acute myelogenous (n = 71; 75%) or lymphoblastic (n = 23; 25%) leukemia in complete remission who underwent matched related donor (n = 35; 37%) or unrelated donor (n = 59; 63%) allo-PBSCT. The median graft CD3+ cell, Treg, and gCD3/TregsR values were 196 × 106/kg body weight (range, 17 to 666 × 106/kg), 3 × 106/kg (range, 0.1 to 35 × 106/kg), and 71 (range, 1 to 1883), respectively. The discriminatory power of the gCD3/TregsR value to predict grade ≥II aGVHD was assessed by estimating the area under the receiver operating characteristic (ROC) curve (AUC). Any grade and grade ≥II aGVHD occurred in 24 (26%) and 17 (18%) allo-PBSCT recipients, respectively. By ROC analysis, AUC (0.74; 95% confidence interval [CI], 0.608 to 0.866; P =.002) identified 70 as the optimal gCD3/TregsR cutoff value predicting the appearance of grade ≥II aGVHD with 76% sensitivity and 71% specificity. Patients were subdivided into a high (ROC curve value ≥70) gCD3/TregsR group (HR; n = 48) and a low (ROC curve value <70) gCD3/TregsR group (LR; n = 46). The incidence of grade II-IV aGVHD was lower in the LR group compared with the HR group (9% [4 o

Published
2021

11. Proliferation centers in chronic lymphocytic leukemia: correlation with cytogenetic and clinicobiological features in consecutive patients analyzed on tissue microarrays

Author

Ciccone, M, Agostinelli, C, Rigolin, G M, Piccaluga, P P, Cavazzini, F, Righi, S, Sista, M T, Sofritti, O, Rizzotto, L, Sabattini, E, Fioritoni, G, Falorio, S, Stelitano, C, Olivieri, A, Attolico, I, Brugiatelli, M, Zinzani, P L, Saccenti, E, Capello, D, Negrini, M, Cuneo, A, and Pileri, S

Published
2012
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16. PF653 TARGETED NEXT-GENERATION SEQUENCING IDENTIFIES NOVEL GENE VARIANTS IN JAK2V617F NEGATIVE PATIENTS WITH ERYTHROCYTOSIS AND JAK2 GGCC_46/1 HAPLOTYPE

Author

Anelli, L., primary, Orsini, P., additional, Minervini, A., additional, Zagaria, A., additional, Coccaro, N., additional, Parciante, E., additional, Minervini, C.F., additional, Cumbo, C., additional, Tota, G., additional, Impera, L., additional, Ricco, A., additional, Attolico, I., additional, Mallano, S., additional, Conserva, M.R., additional, Specchia, G., additional, and Albano, F., additional

Published
2019
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17. Predicting failure of hematopoietic stem cell mobilization before it starts: The predicted poor mobilizer (pPM) score

Author

Olivieri, J., Attolico, I., Nuccorini, R., Pascale, S. P., Chiarucci, M., Poiani, M., Corradini, P., Farina, L., Gaidano, G., Nassi, L., Sica, S., Piccirillo, N., Pioltelli, P. E., Martino, M., Moscato, T., Pini, M., Zallio, F., Ciceri, F., Marktel, S., Mengarelli, A., Musto, P., Capria, S., Merli, F., Codeluppi, K., Mele, G., Lanza, F., Specchia, G., Pastore, D., Milone, G., Saraceni, F., Di Nardo, E., Perseghin, P., Olivieri, A., Sica S. (ORCID:0000-0003-2426-3465), Piccirillo N. (ORCID:0000-0002-1688-1987), Olivieri, J., Attolico, I., Nuccorini, R., Pascale, S. P., Chiarucci, M., Poiani, M., Corradini, P., Farina, L., Gaidano, G., Nassi, L., Sica, S., Piccirillo, N., Pioltelli, P. E., Martino, M., Moscato, T., Pini, M., Zallio, F., Ciceri, F., Marktel, S., Mengarelli, A., Musto, P., Capria, S., Merli, F., Codeluppi, K., Mele, G., Lanza, F., Specchia, G., Pastore, D., Milone, G., Saraceni, F., Di Nardo, E., Perseghin, P., Olivieri, A., Sica S. (ORCID:0000-0003-2426-3465), and Piccirillo N. (ORCID:0000-0002-1688-1987)

Abstract

Predicting mobilization failure before it starts may enable patient-tailored strategies. Although consensus criteria for predicted PM (pPM) are available, their predictive performance has never been measured on real data. We retrospectively collected and analyzed 1318 mobilization procedures performed for MM and lymphoma patients in the plerixafor era. In our sample, 180/1318 (13.7%) were PM. The score resulting from published pPM criteria had sufficient performance for predicting PM, as measured by AUC (0.67, 95%CI: 0.63-0.72). We developed a new prediction model from multivariate analysis whose score (pPM-score) resulted in better AUC (0.80, 95%CI: 0.76-0.84, p < 0001). pPM-score included as risk factors: increasing age, diagnosis of NHL, positive bone marrow biopsy or cytopenias before mobilization, previous mobilization failure, priming strategy with G-CSF alone, or without upfront plerixafor. A simplified version of pPM-score was categorized using a cut-off to maximize positive likelihood ratio (15.7, 95%CI: 9.9-24.8); specificity was 98% (95%CI: 97-98.7%), sensitivity 31.7% (95%CI: 24.9-39%); positive predictive value in our sample was 71.3% (95%CI: 60-80.8%). Simplified pPM-score can "rule in" patients at very high risk for PM before starting mobilization, allowing changes in clinical management, such as choice of alternative priming strategies, to avoid highly likely mobilization failure.

Published
2018

20. A refined composite clinical score for the early identification of the predicted Poor Mobilizers (PM): a GITMO analysis

Author

Attolico, I., Olivieri, J., Nuccorini, R., Pascale, S. P., Chiarucci, M., Poiani, M., Gozzer, M., Capria, S., Mele, G., Melpignano, A., Perseghin, P., Pioltelli, P., Massimo Martino, Moscato, T., Musto, P., Pietrantuono, G., Corradini, P., Farina, L., Nassi, L., Casaluci, G. Margiotta, Di Marco, A., Spadaro, A., Gumenyuku, S., Marchesi, F., Lanza, F., Brambilla, P., Pini, M., Zallio, F., Marktel, S., Gattillo, S., Sica, S., Ausoni, G., Merli, F., Codeluppi, K., Specchia, G., Pastore, D., Pizzuti, M., Di Nardo, E., and Olivieri, A.

Published
2015

21. Proliferation centres in chronic lymphocytic leucemia: correlation with cytogenetic and clinicobiological features in 183 patients analyzed on tissue-microarrays

Author

Ciccone M., Rigolin G.M., Cavazzini F., Sista M.T., Sofritti O., Rizzotto L., Fioritoni G., Falorio S., Stelitano C., Olivieri A., Attolico I., Brigiatelli M., Cuneo A., AGOSTINELLI, CLAUDIO, PICCALUGA, PIER PAOLO, RIGHI, SIMONA, SABATTINI, ELENA, ZINZANI, PIER LUIGI, PILERI, STEFANO, Ciccone M., Agostinelli C., Rigolin GM., Piccaluga PP., Cavazzini F., Righi S., Sista MT., Sofritti O., Rizzotto L., Sabattini E., Fioritoni G., Falorio S., Stelitano C., Olivieri A., Attolico I., Brigiatelli M., Zinzani PL., Pileri SA., and Cuneo A.

Subjects
FISH, tissue-microarray, CLL
Published
2011

24. IN CHRONIC LYMPHOCYTIC LEUKEMIA THE AMOUNT OF PROLIFERATION CENTERS IN TISSUE-BIOPSIES CORRELATES WITH UNFAVORABLE CYTOGENETIC ABNORMALITIES

Author

Ciccone, M., Agostinelli, C., Rigolin, G., Rizzotto, L., Cavazzini, F., Righi, S., Sista, M. T., Elena Sabattini, Sofritti, O., Piccaluga, P., Cuneo, A., Pileri, S., Zinzani, P. L., Brugiatelli, M., Attolico, I., Fioritono, G., Stilitano, C., M. Ciccone, C. Agostinelli, G. Rigolin, L. Rizzotto, F. Cavazzini, S. Righi, M.T. Sista, E. Sabattini, O. Sofritti, P.P. Piccaluga, A. Cuneo, S. Pileri, P.L. Zinzani, M. Brugiatelli, I. Attolico, G. Fioritono, and C. Stilitano

Subjects
FISH, proliferation centre, CLL
Published
2010

27. Efficacy and tolerability of bendamustine, bortezomib and dexamethasone in patients with relapsed-refractory multiple myeloma: a phase II study

Author

Offidani, M, primary, Corvatta, L, additional, Maracci, L, additional, Liberati, A M, additional, Ballanti, S, additional, Attolico, I, additional, Caraffa, P, additional, Alesiani, F, additional, Caravita di Toritto, T, additional, Gentili, S, additional, Tosi, P, additional, Brunori, M, additional, Derudas, D, additional, Ledda, A, additional, Gozzetti, A, additional, Cellini, C, additional, Malerba, L, additional, Mele, A, additional, Andriani, A, additional, Galimberti, S, additional, Mondello, P, additional, Pulini, S, additional, Coppetelli, U, additional, Fraticelli, P, additional, Olivieri, A, additional, and Leoni, P, additional

Published
2013
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28. Proliferation centers in chronic lymphocytic leukemia: correlation with cytogenetic and clinicobiological features in consecutive patients analyzed on tissue microarrays

Author

Ciccone, M, primary, Agostinelli, C, additional, Rigolin, G M, additional, Piccaluga, P P, additional, Cavazzini, F, additional, Righi, S, additional, Sista, M T, additional, Sofritti, O, additional, Rizzotto, L, additional, Sabattini, E, additional, Fioritoni, G, additional, Falorio, S, additional, Stelitano, C, additional, Olivieri, A, additional, Attolico, I, additional, Brugiatelli, M, additional, Zinzani, P L, additional, Saccenti, E, additional, Capello, D, additional, Negrini, M, additional, Cuneo, A, additional, and Pileri, S, additional

Published
2011
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29. Choice of Frontline Tyrosine‐Kinase Inhibitor and Early Events in Very Elderly Patients With Chronic Myeloid Leukemia in Chronic Phase: A “Campus CML” Study.

Author

Bucelli, C., Capodanno, I., Miggiano, M. C., Cavazzini, F., Crescenzi, S. Leonetti, Russo, S., Carmosino, I., Annunziata, M., Sorà, F., Bonifacio, M., Luciano, L., Caocci, G., Loglisci, G., Elena, C., Lunghi, F., Mullai, R., Attolico, I., Binotto, G., Crisà, E., and Sportoletti, P.

Subjects
*CHRONIC myeloid leukemia, *OLDER patients, *PROTEIN-tyrosine kinase inhibitors, *DASATINIB, *OLDER people
Abstract

ABSTRACT Objectives Methods Results Conclusions The study aimed to evaluate the utilization of frontline TKI therapy in a large cohort of elderly CP‐CML patients.A retrospective analysis was conducted on 332 CP‐CML patients aged 75 years or older among 1929 diagnosed from January 2012 to December 2019 followed at 36 participating Hematology Centers involved in the “Campus CML” project.Among the patients analyzed, 85.8% received imatinib (IM) while 14.2% received second‐generation TKIs (2G‐TKI), 59.5% dasatinib, and 40.5% nilotinib. Most patients initiated IM at standard dose (67.3%) while 32.7% at reduced dose. A similar trend was observed with 2G‐TKIs. The cumulative incidence of permanent TKI discontinuation at 12 months was 28.4%, primarily due to primary resistance (10.1%) and extra‐hematologic toxicity (9.5%), with no significant difference between IM and 2G‐TKI groups. Following the introduction of generic IM in Italy in 2018, IM usage increased significantly compared with 2G‐TKIs.IM was in our Centers the preferred frontline therapy for older CP‐CML patients, with increasing utilization after the introduction of generic formulations. However, 2G‐TKIs are still used in a substantial proportion of patients, suggesting individualized physician assessments regarding patient suitability and expectations. Further investigation is needed to assess efficacy and safety of reduced TKI doses in this patient population. [ABSTRACT FROM AUTHOR]

Published
2024
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31. COVID-19 infection in chronic myeloid leukaemia after oneyear of the pandemic in Italy. A Campus CML report

Author

Elisabetta Abruzzese, Sabina Russo, Carmen Fava, Francesca Lunghi, Sabrina Leonetti Crescenzi, Chiara Elena, Vincenzo Accurso, Fausto Castagnetti, Debora Luzi, Giovanni Caocci, Elena Crisà, Maria Cristina Miggiano, Massimo Breccia, Antonella Gozzini, Giuseppina Loglisci, Giovanna Rege-Cambrin, Monica Bocchia, Immacolata Attolico, Massimiliano Bonifacio, Luigiana Luciano, Gaetano La Barba, Gianantonio Rosti, Maria Stella De Candia, Roberto Latagliata, Gabriele Gugliotta, Francesco Cavazzini, Rosaria Sancetta, Micaela Bergamaschi, Anna Rita Scortechini, Sara Galimberti, Tamara Intermesoli, Federica Sorà, Luciano Levato, Paolo Sportoletti, Monica Crugnola, Mario Tiribelli, Isabella Capodanno, Giuseppe Saglio, Davide Rapezzi, Robin Foà, Alessandra Iurlo, Alessandro Lucchesi, Michele Pizzuti, Sara Barulli, Fabio Stagno, Patrizia Pregno, Alessandra Malato, Gianni Binotto, Agostino Tafuri, Breccia M., Abruzzese E., Accurso V., Attolico I., Barulli S., Bergamaschi M., Binotto G., Bocchia M., Bonifacio M., Caocci G., Capodanno I., Castagnetti F., Cavazzini F., Crisa E., Crugnola M., Stella De Candia M., Elena C., Fava C., Galimberti S., Gozzini A., Gugliotta G., Intermesoli T., Iurlo A., La Barba G., Latagliata R., Leonetti Crescenzi S., Levato L., Loglisci G., Lucchesi A., Luciano L., Lunghi F., Luzi D., Malato A., Cristina Miggiano M., Pizzuti M., Pregno P., Rapezzi D., Rege-Cambrin G., Rosti G., Russo S., Sancetta R., Rita Scortechini A., Sora F., Sportoletti P., Stagno F., Tafuri A., Tiribelli M., Foa R., and Saglio G.

Subjects
Male, Tyrosine-kinase inhibitor, law.invention, law, Retrospective Studie, Pandemic, Chronic, Covid‐19, Leukemia, Mortality rate, Hematology, Middle Aged, Intensive care unit, Research Papers, Survival Rate, Italy, covid-19, Hematologic Neoplasms, Cohort, Female, prognosi, Human, Research Paper, chronic myeloid leukemia, Covid-19, prognosis, mortality, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), medicine.drug_class, chronic myeloid leukemia, prognosis, mortality, Chronic myeloid leukaemia, Disease-Free Survival, NO, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Covid-19, mortality, prognosis, Aged, Humans, Retrospective Studies, COVID-19, Pandemics, SARS-CoV-2, medicine, business.industry, Concomitant, Commentary, BCR-ABL Positive, business, Myelogenous
Abstract

Limited information is available on the impact of the COVID-19 pandemic on the management of chronic myeloid leukaemia (CML). The Campus CML network collected retrospective information on 8665 CML patients followed at 46 centres throughout Italy during the pandemic between February 2020 and January 2021. Within this cohort, we recorded 217 SARS-CoV-2-positive patients (2·5%). Most patients (57%) were diagnosed as having SARS-CoV-2 infection during the second peak of the pandemic (September 2020 to January 2021). The majority (35%) was aged between 50 and 65years with a male prevalence (73%). Fifty-six percent of patients presented concomitant comorbidities. The median time from CML diagnosis to SARS-CoV-2 infection was six years (three months to 18years). Twenty-one patients (9·6%) required hospitalization without the need of respiratory assistance, 18 (8·2%) were hospitalized for respiratory assistance, 8 (3·6%) were admitted to an intensive care unit, while 170 (78%) were only quarantined. Twenty-three percent of patients discontinued tyrosine kinase inhibitor (TKI) therapy during the infection. Twelve patients died due to COVID-19 with a mortality rate of 5·5% in the positive cohort and of 0·13% in the whole cohort. We could also document sequelae caused by the SARS-CoV-2 infection and an impact of the pandemic on the overall management of CML patients.

Published
2022

32. Low-density lipoprotein (LDL) levels and risk of arterial occlusive events in chronic myeloid leukemia patients treated with nilotinib

Author

Fabio Stagno, Patrizia Pregno, Giovanni Caocci, Gianni Binotto, Robin Foà, Anna Sicuranza, Emilia Scalzulli, Francesca Pirillo, Mario Tiribelli, Isabella Capodanno, Antonella Gozzini, Massimiliano Bonifacio, Rossella Stella, Elisabetta Abruzzese, Massimo Breccia, Claudio Fozza, Gabriele Gugliotta, Giorgio La Nasa, Luigiana Luciano, Olga Mulas, Maria Pina Simula, Daniele Cattaneo, Mario Annunziata, Francesco Albano, Luigi Scaffidi, Fiorenza De Gregorio, Debora Luzi, Claudia Baratè, Malgorzata Monika Trawinska, Immacolata Attolico, Fabio Efficace, Sara Galimberti, Fausto Castagnetti, Monica Bocchia, Bruno Martino, Alessandra Iurlo, Caocci G., Mulas O., Capodanno I., Bonifacio M., Annunziata M., Galimberti S., Luciano L., Tiribelli M., Martino B., Castagnetti F., Binotto G., Pregno P., Stagno F., Abruzzese E., Bocchia M., Gozzini A., Albano F., Fozza C., Luzi D., Efficace F., Simula M.P., Scaffidi L., Barate C., De Gregorio F., Stella R., Gugliotta G., Pirillo F., Trawinska M.M., Sicuranza A., Cattaneo D., Attolico I., Scalzulli E., Iurlo A., Foa R., Breccia M., and La Nasa G.

Subjects
Male, Arterial Occlusive Disease, Triglyceride, Gastroenterology, Antineoplastic Agent, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, 80 and over, Cumulative incidence, Chronic, Aged, 80 and over, Leukemia, Incidence (epidemiology), Chronic myeloid leukemia, Hematology, General Medicine, Middle Aged, Lipoproteins, LDL, Cholesterol, 030220 oncology & carcinogenesis, Low-density lipoprotein, Female, Human, medicine.drug, Adult, medicine.medical_specialty, Lipoproteins, Arterial occlusive event, Antineoplastic Agents, Arterial Occlusive Diseases, Lower risk, High cholesterol, LDL, 03 medical and health sciences, Young Adult, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, medicine, Humans, Triglycerides, Aged, Dyslipidemias, business.industry, Risk Factor, Nilotinib, medicine.disease, Pyrimidines, Dyslipidemia, Pyrimidine, chemistry, BCR-ABL Positive, business, 030215 immunology, Myelogenous
Abstract

Recommendations for dyslipidemia management aimed at reducing arterial occlusive events (AOEs) have been recently published. So far, no data have been reported on the management of dyslipidemia in chronic myeloid leukemia (CML) patients treated with nilotinib. We investigated 369 CML adult patients, stratified according to the new Systematic Coronary Risk Evaluation (SCORE) scoring system. Plasma levels of cholesterol, HDL, LDL, and triglycerides were measured prior to the start of nilotinib and after 3, 6, and 12months. The 5-year cumulative incidence of AOEs was 15.9%. Patients with cholesterol levels > 200mg/dL and LDL > 70mg/dL 3months after treatment showed a significantly higher incidence of AOEs (21.9 ± 4.6% vs 6.2 ± 2.5, P= 0.003). Patients belonging to the high and very high SCORE risk group showed a significant increase of AOEs (34.4 ± 6% vs 10 ± 2.1%, P< 0.001). In multivariate analysis, both high cholesterol and LDL levels and a high and very high SCORE risk remained significantly associated with the risk of AOEs (P= 0.008; HR = 3.5; 95% CI = 1.4–8.7 and P < 0.001; HR = 4.4; 95% CI = 2–9.8, respectively). Overall, 78 patients (21.1%) presented dyslipidemia at the time of CML diagnosis and 88 (23.3%) after starting nilotinib, but only 26 of them (29.5%) were treated with statins. Low LDL and cholesterol plasma levels are associated with a significant lower risk of AOEs in CML patients treated with nilotinib in the real life.

Published
2020

33. Renin angiotensin system inhibitors reduce the incidence of arterial thrombotic events in patients with hypertension and chronic myeloid leukemia treated with second- or third-generation tyrosine kinase inhibitors

Author

Chiara Elena, Alessandra Iurlo, Antonella Gozzini, Giorgio La Nasa, Claudia Baratè, Gabriele Gugliotta, Bruno Martino, Francesca Pirillo, Fiorenza De Gregorio, Fabio Efficace, Monica Bocchia, Massimo Breccia, Claudio Fozza, Elisabetta Abruzzese, Mario Annunziata, Sara Galimberti, Gianni Binotto, Fabio Stagno, Isabella Capodanno, Malgorzata Monika Trawinska, Anna Sicuranza, Maria Pina Simula, Robin Foà, Debora Luzi, Patrizia Pregno, Rossella Stella, Imma Attolico, Luigiana Luciano, Francesco Albano, Giovanni Caocci, Ester Orlandi, Daniele Cattaneo, Olga Mulas, Nicola Sgherza, Luigi Scaffidi, Massimiliano Bonifacio, Emilia Scalzulli, Mario Tiribelli, Fausto Castagnetti, Mulas O., Caocci G., Stagno F., Bonifacio M., Annunziata M., Luciano L., Orlandi E.M., Abruzzese E., Sgherza N., Martino B., Albano F., Galimberti S., Pregno P., Bocchia M., Castagnetti F., Tiribelli M., Binotto G., Gozzini A., Capodanno I., Fozza C., Luzi D., Efficace F., Simula M.P., Scaffidi L., De Gregorio F., Elena C., Trawinska M.M., Cattaneo D., Attolico I., Barate C., Pirillo F., Sicuranza A., Gugliotta G., Stella R., Scalzulli E., Iurlo A., Foa R., Breccia M., and La Nasa G.

Subjects
Male, Myeloid, Angiotensin-Converting Enzyme Inhibitors, Gastroenterology, Cohort Studies, Renin-Angiotensin System, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, 80 and over, Cumulative incidence, Chronic, Aged, 80 and over, Leukemia, Arterial occlusive events, Incidence, Ponatinib, Angiotensin Receptor Antagonist, Chronic myeloid leukemia, Myeloid leukemia, Hematology, General Medicine, Middle Aged, TKI, Dasatinib, medicine.anatomical_structure, 030220 oncology & carcinogenesis, Combination, Hypertension, Drug Therapy, Combination, Female, Survival Analysi, medicine.drug, Human, Renin angiotensin system inhibitors, Adult, medicine.medical_specialty, Arterial occlusive event, Protein Kinase Inhibitor, 03 medical and health sciences, Angiotensin Receptor Antagonists, Drug Therapy, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, medicine, Humans, Artery occlusion, Protein Kinase Inhibitors, Aged, business.industry, Risk Factor, Angiotensin-Converting Enzyme Inhibitor, Thrombosis, Renin angiotensin system inhibitor, Survival Analysis, Blood pressure, chemistry, Nilotinib, BCR-ABL Positive, Cohort Studie, business, 030215 immunology, Myelogenous
Abstract

Hypertension is a commonly reported comorbidity in patients diagnosed with chronic myeloid leukemia (CML), and its management represents a challenge in patients treated with 2nd- or 3rd-generation tyrosine kinase inhibitors (TKIs), considering their additional cardiovascular (CV) toxicity. The renin angiotensin system (RAS) contributes to hypertension genesis and plays an important role in atherosclerosis development, proliferation, and differentiation of myeloid hematopoietic cells. We analyzed a cohort of 192 patients with hypertension at CML diagnosis, who were treated with 2nd- or 3rd-generation TKIs, and evaluated the efficacy of RAS inhibitors (angiotensin-converting enzyme inhibitors (ACEi) and angiotensin-II receptor blockers (ARBs)) in the prevention of arterial occlusive events (AOEs), as compared with other drug classes. The 5-year cumulative incidence of AOEs was 32.7 ± 4.2%. Patients with SCORE ≥ 5% (high-very-high) showed a significantly higher incidence of AOEs (33.7 ± 7.6% vs 13.6 ± 4.8%, p = 0.006). The AOE incidence was significantly lower in patients treated with RAS inhibitors (14.8 ± 4.2% vs 44 ± 1%, p < 0.001, HR = 0.283). The difference in the low and intermediate Sokal risk group was confirmed but not in the high-risk group, where a lower RAS expression has been reported. Our data suggest that RAS inhibitors may represent an optimal treatment in patients with hypertension and CML, treated with 2nd or 3rdG TKIs.

Published
2020

34. Favorable outcome of chronic myeloid leukemia co-expressing e13a2 and e14a2 transcripts, treated with nilotinib

Author

Sara Galimberti, Giovanni Caocci, Ester Orlandi, Mario Annunziata, Gabriele Gugliotta, Emilia Scalzulli, Alessandra Iurlo, Chiara Elena, Elisabetta Abruzzese, Daniele Cattaneo, Bruno Martino, Malgorzata Monika Trawinska, Giorgio La Nasa, Luigi Scaffidi, Francesca Pirillo, Anna Sicuranza, Luigiana Luciano, Fausto Castagnetti, Patrizia Pregno, Monica Bocchia, Nicola Sgherza, Francesco Albano, Robin Foà, Massimo Breccia, Fiorenza De Gregorio, Antonella Gozzini, Massimiliano Bonifacio, Claudia Baratè, Imma Attolico, Maria Pina Simula, Gianni Binotto, Claudio Fozza, Olga Mulas, Mulas O., Caocci G., Annunziata M., Martino B., Luciano L., Castagnetti F., Pregno P., Galimberti S., Albano F., Orlandi E.M., Sgherza N., Iurlo A., Bonifacio M., Binotto G., Gozzini A., Bocchia M., Abruzzese E., Fozza C., Simula M.P., De Gregorio F., Gugliotta G., Pirillo F., Barate C., Attolico I., Elena C., Cattaneo D., Scaffidi L., Sicuranza A., Trawinska M.M., Scalzulli E., Foa R., Breccia M., and La Nasa G.

Subjects
Oncology, Male, Cancer Research, Chromosomes, Human, Pair 22, bcr-abl, Messenger, Fusion Proteins, bcr-abl, Translocation, Genetic, 80 and over, Favorable outcome, RNA, Neoplasm, Chronic, Aged, 80 and over, Leukemia, Follow up studies, Myeloid leukemia, molecular response, Hematology, General Medicine, Middle Aged, Survival Rate, outcome, Female, Chromosomes, Human, Pair 9, medicine.drug, Human, Pair 9, Adult, medicine.medical_specialty, Disease free survival, transcript type, MEDLINE, Translocation, Disease-Free Survival, Chromosomes, Follow-Up Studie, Text mining, Genetic, chronic myeloid leukemia, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, medicine, Humans, RNA, Messenger, Survival rate, nilotinib, Aged, Follow-Up Studies, Pyrimidines, business.industry, chronic myeloid leukemia, nilotinib, transcript type, molecular response, outcome, Fusion Proteins, Nilotinib, Pyrimidine, RNA, Neoplasm, BCR-ABL Positive, Pair 22, business, Myelogenous
Abstract

No abstract available.

Published
2020

35. Low low-density lipoprotein (LDL), cholesterol and triglycerides plasma levels are associated with reduced risk of arterial occlusive events in chronic myeloid leukemia patients treated with ponatinib in the real-life. A Campus CML study

Author

Emilia Scalzulli, Fabio Efficace, Giovanni Caocci, Ester Orlandi, Sara Galimberti, Mario Tiribelli, Daniele Cattaneo, Elisabetta Abruzzese, Luigi Scaffidi, Olga Mulas, Immacolata Attolico, Debora Luzi, Massimiliano Bonifacio, Robin Foà, Chiara Elena, Rossella Stella, Fausto Castagnetti, Massimo Breccia, Maria Pina Simula, Claudia Baratè, Luigiana Luciano, Malgorzata Monika Trawinska, Francesco Albano, Fabio Stagno, Patrizia Pregno, Antonella Gozzini, Gianni Binotto, Gabriele Gugliotta, Giorgio La Nasa, Francesca Pirillo, Nicola Sgherza, Mario Annunziata, Alessandra Iurlo, Claudio Fozza, Isabella Capodanno, Fiorenza De Gregorio, Caocci G., Mulas O., Capodanno I., Abruzzese E., Iurlo A., Luciano L., Albano F., Annunziata M., Tiribelli M., Bonifacio M., Galimberti S., Castagnetti F., Sgherza N., Stagno F., Gozzini A., Orlandi E.M., Luzi D., Binotto G., Pregno P., Fozza C., Efficace F., Simula M.P., Trawinska M.M., Cattaneo D., De Gregorio F., Attolico I., Stella R., Scaffidi L., Barate C., Gugliotta G., Scalzulli E., Elena C., Pirillo F., Foa R., Breccia M., and Nasa G.L.

Subjects
Adult, Male, medicine.medical_specialty, Antineoplastic Agents, Arterial Occlusive Diseases, Gastroenterology, lcsh:RC254-282, chronic myeloid leukemia, TKI, ponatinib, arterial occlusive events, Article, chemistry.chemical_compound, Young Adult, Myeloproliferative disease, High-density lipoprotein, Low low-density lipoprotein, LDL, cholesterol, triglycerides, arterial occlusive events, chronic myeloid leukemia, ponatinib, CML, Campus, chronic myeloid leukemia, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Medicine, Humans, ponatinib, Artery occlusion, arterial occlusive events, Triglycerides, Aged, Aged, 80 and over, business.industry, Cholesterol, Ponatinib, Imidazoles, Myeloid leukemia, Hematology, Middle Aged, Protective Factors, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, TKI, Lipoproteins, LDL, Pyridazines, Leukemia, Oncology, chemistry, Risk factors, Low-density lipoprotein, Female, business, Dyslipidemia
Abstract

Not available.

Published
2020

36. Prospective assessment of NGS-detectable mutations in CML patients with nonoptimal response: The NEXT-in-CML study

Author

Anna Serra, Antonio Percesepe, Gabriele Gugliotta, Caterina Musolino, Gianni Binotto, Elisabetta Abruzzese, Immacolata Attolico, Gianantonio Rosti, Mario Annunziata, Rosaria Sancetta, Mariella Girasoli, Fabrizio Pane, Maria Antonella Laginestra, Sara Galimberti, Alessandra Iurlo, Stefania Stella, Sabrina Coluzzi, Simona Sica, Monica Bocchia, Marzia Salvucci, Francesca Lunghi, Fabio Stagno, Nicola Orofino, Stefano Pileri, Federica Sorà, Santa Errichiello, Elisabetta Calistri, Paolo Vigneri, Fausto Castagnetti, Michele Baccarani, Luana Bavaro, Michele Cavo, Eros Di Bona, Francesco Di Raimondo, Claudia Baratè, Margherita Martelli, Simona Soverini, Antonella Russo Rossi, Francesco Albano, Mariella D'Adda, Fabio Ciceri, Flavio Mignone, Elena Tenti, Caterina De Benedittis, Giuseppe Saglio, Isabella Capodanno, Giovanni Martinelli, Massimiliano Bonifacio, Luigi Scaffidi, Soverini, S., Bavaro, L., de Benedittis, C., Martelli, M., Iurlo, A., Orofino, N., Sica, S., Sora, F., Lunghi, F., Ciceri, F., Galimberti, S., Barate, C., Bonifacio, M., Scaffidi, L., Castagnetti, F., Gugliotta, G., Albano, F., Rossi, A. V. R., Stagno, F., di Raimondo, F., D'Adda, M., di Bona, E., Abruzzese, E., Binotto, G., Sancetta, R., Salvucci, M., Capodanno, I., Girasoli, M., Coluzzi, S., Attolico, I., Musolino, C., Calistri, E., Annunziata, M., Bocchia, M., Stella, S., Serra, A., Errichiello, S., Saglio, G., Pane, F., Vigneri, P., Mignone, F., Laginestra, M. A., Pileri, S. A., Percesepe, A., Tenti, E., Rosti, G., Baccarani, M., Cavo, M., Martinelli, G., Soverini, Simona, Bavaro, Luana, De Benedittis, Caterina, Martelli, Margherita, Iurlo, Alessandra, Orofino, Nicola, Sica, Simona, Sora, Federica, Lunghi, Francesca, Ciceri, Fabio, Galimberti, Sara, Baratè, Claudia, Bonifacio, Massimiliano, Scaffidi, Luigi, Castagnetti, Fausto, Gugliotta, Gabriele, Albano, Francesco, Russo Rossi, Antonella Vita, Stagno, Fabio, Di Raimondo, Francesco, D'Adda, Mariella, Di Bona, Ero, Abruzzese, Elisabetta, Binotto, Gianni, Sancetta, Rosaria, Salvucci, Marzia, Capodanno, Isabella, Girasoli, Mariella, Coluzzi, Sabrina, Attolico, Immacolata, Musolino, Caterina, Calistri, Elisabetta, Annunziata, Mario, Bocchia, Monica, Stella, Stefania, Serra, Anna, Errichiello, Santa, Saglio, Giuseppe, Pane, Fabrizio, Vigneri, Paolo G, Mignone, Flavio, Laginestra, Maria Antonella, Pileri, Stefano A, Percesepe, Antonio, Tenti, Elena, Rosti, Gianantonio, Baccarani, Michele, Cavo, Michele, and Martinelli, Giovanni

Subjects
Oncology, Male, Mutation rate, bcr-abl, Drug Resistance, Fusion Proteins, bcr-abl, Gene mutation, medicine.disease_cause, Settore MED/01 - STATISTICA MEDICA, Biochemistry, Adult, Aged, Aged, 80 and over, Drug Resistance, Neoplasm, Female, High-Throughput Nucleotide Sequencing, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Middle Aged, Mutation, Mutation Rate, Prospective Studies, Protein Kinase Inhibitors, hemic and lymphatic diseases, 80 and over, cml mutation, BCR-ABL mutations, Chronic, Prospective cohort study, Sanger sequencing, Leukemia, Chronic myeloid leukemia, Myeloid leukemia, Hematology, TKI, NGS, symbols, Human, medicine.medical_specialty, Immunology, symbols.namesake, CML, TKIs, BCR-ABL1, Chronic myeloid leukemia,TKI,BCR-ABL mutations,Sanger Sequencing,NGS, Internal medicine, medicine, business.industry, Fusion Proteins, Cell Biology, medicine.disease, Clinical trial, Prospective Studie, Sanger Sequencing, Neoplasm, BCR-ABL Positive, business, Myelogenous
Abstract

In chronic myeloid leukemia (CML) patients, tyrosine kinase inhibitors (TKIs) may select for drug-resistant BCR-ABL1 kinase domain (KD) mutants. Although Sanger sequencing (SS) is considered the gold standard for BCR-ABL1 KD mutation screening, next-generation sequencing (NGS) has recently been assessed in retrospective studies. We conducted a prospective, multicenter study (NEXT-in-CML) to assess the frequency and clinical relevance of low-level mutations and the feasibility, cost, and turnaround times of NGS-based BCR-ABL1 mutation screening in a routine setting. A series of 236 consecutive CML patients with failure (n = 124) or warning (n = 112) response to TKI therapy were analyzed in parallel by SS and NGS in 1 of 4 reference laboratories. Fifty-one patients (22 failure, 29 warning) who were negative for mutations by SS had low-level mutations detectable by NGS. Moreover, 29 (27 failure, 2 warning) of 60 patients who were positive for mutations by SS showed additional low-level mutations. Thus, mutations undetectable by SS were identified in 80 out of 236 patients (34%), of whom 42 (18% of the total) had low-level mutations somehow relevant for clinical decision making. Prospective monitoring of mutation kinetics demonstrated that TKI-resistant low-level mutations are invariably selected if the patients are not switched to another TKI or if they are switched to a inappropriate TKI or TKI dose. The NEXT-in-CML study provides for the first time robust demonstration of the clinical relevance of low-level mutations, supporting the incorporation of NGS-based BCR-ABL1 KD mutation screening results in the clinical decision algorithms.

Published
2020

37. The multi-tyrosine kinase inhibitor ponatinib for chronic myeloid leukemia: Real-world data

Author

Bruno Martino, Alessandra Malato, Nicola Sgherza, Immacolata Attolico, Luigia Luciano, Mario Annunziata, Fabrizio Pane, Francesco Di Raimondo, Fausto Palmieri, Giorgina Specchia, Alessandro Maggi, Luciano, L., Annunziata, M., Attolico, I., Di Raimondo, F., Maggi, A., Malato, A., Martino, B., Palmieri, F., Pane, F., Sgherza, N., and Specchia, G.

Subjects
Oncology, Male, Disease, Tyrosine-kinase inhibitor, chronic myeloid leukemia, elderly, frail, intolerant, ponatinib, resistant, tyrosine kinase inhibitors, chemistry.chemical_compound, 0302 clinical medicine, Antineoplastic Agents, Immunological, Quality of life, hemic and lymphatic diseases, Medicine, Molecular Targeted Therapy, Clinical Trials as Topic, Ponatinib, Age Factors, Imidazoles, Myeloid leukemia, Disease Management, Hematology, General Medicine, Middle Aged, Protein-Tyrosine Kinases, Pyridazines, Treatment Outcome, 030220 oncology & carcinogenesis, Retreatment, Female, Disease Susceptibility, Real world data, Tyrosine kinase, Adult, medicine.medical_specialty, medicine.drug_class, Clinical Decision-Making, 03 medical and health sciences, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Biomarkers, Tumor, Humans, Adverse effect, Protein Kinase Inhibitors, Aged, business.industry, respiratory tract diseases, chemistry, business, 030215 immunology
Abstract

Development of the highly selective targeted tyrosine kinase inhibitors (TKIs) has expanded the therapeutic options for chronic myeloid leukemia (CML). Patients undergoing TKI therapy should be closely monitored to ensure that the best therapeutic response and quality of life are achieved, and to control suboptimal responses and adverse events. Despite the high rate of response using current first-line TKIs, treatment failure may still occur, and resistance is considered a challenge in the treatment of patients with CML. The third-generation TKI, ponatinib, is a potent orally bioavailable pan BCR-ABL inhibitor that inhibits both wild-type and mutant BCR-ABL1 kinase, including the "gatekeeper" T315I mutation, which is resistant to all other currently available TKIs. This paper reviews the effectiveness, feasibility, and safety of ponatinib in the real-life clinical management of CML. Potential prognostic factors in identifying patients most likely to benefit from ponatinib treatment will be discussed, and case presentations illustrating situations encountered in real-life clinical practice are described. Ponatinib is effective in patients who have received prior TKIs in clinical studies as well as under real-life conditions. Nevertheless, the risk/benefit balance must be evaluated for each patient, particularly considering disease state, mutational status, treatment line, intolerance/resistance to prior TKIs, age, frailty, and specific comorbidities.

Published
2020

38. Long-term mortality rate for cardiovascular disease in 656 chronic myeloid leukaemia patients treated with second- and third-generation tyrosine kinase inhibitors

Author

Gabriele Gugliotta, Francesca Pirillo, Bruno Martino, Fausto Castagnetti, Chiara Elena, Antonella Gozzini, Giorgio La Nasa, Massimiliano Bonifacio, Claudia Baratè, Gianni Binotto, Robin Foà, Daniele Cattaneo, Nicola Sgherza, Alessandra Iurlo, Monica Bocchia, Elisabetta Abruzzese, Mario Annunziata, Claudio Fozza, Fiorenza De Gregorio, Matteo Molica, Luigi Scaffidi, Sara Galimberti, Olga Mulas, Giovanni Caocci, Imma Attolico, Ester Orlandi, Maria Pina Simula, Luigiana Luciano, Massimo Breccia, Francesco Albano, Fabio Stagno, Patrizia Pregno, Anna Sicuranza, Malgorzata Monika Trawinska, Caocci G., Mulas O., Annunziata M., Luciano L., Abruzzese E., Bonifacio M., Orlandi E.M., Albano F., Galimberti S., Iurlo A., Pregno P., Sgherza N., Martino B., Binotto G., Castagnetti F., Gozzini A., Bocchia M., Fozza C., Stagno F., Simula M.P., De Gregorio F., Trawinska M.M., Scaffidi L., Elena C., Attolico I., Barate C., Cattaneo D., Pirillo F., Gugliotta G., Sicuranza A., Molica M., La Nasa G., Foa R., and Breccia M.

Subjects
Male, Chronic myeloid leuk, Dasatinib, emia, Long Term Adverse Effects, Long Term Adverse Effect, 030204 cardiovascular system & hematology, Antineoplastic Agent, chemistry.chemical_compound, 0302 clinical medicine, Cardiovascular Disease, Cardiovascular toxicity, Ischemic heart disease, TKI, Aged, Antineoplastic Agents, Female, Humans, Italy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Life Expectancy, Mortality, Protein Kinase Inhibitors, Risk Adjustment, Aniline Compounds, Cardiotoxicity, Cardiovascular Diseases, Imidazoles, Nitriles, Pyridazines, Pyrimidines, Quinolines, 030212 general & internal medicine, Chronic, education.field_of_study, Leukemia, Mortality rate, Ponatinib, Aniline Compound, a, Pyridazine, Cardiology and Cardiovascular Medicine, Nitrile, Bosutinib, Human, medicine.drug, medicine.medical_specialty, Population, Protein Kinase Inhibitor, 03 medical and health sciences, Internal medicine, medicine, education, Imidazole, Survival rate, business.industry, Standardized mortality ratio, Pyrimidine, Nilotinib, chemistry, BCR-ABL Positive, business, Myelogenous
Abstract

Background Limited information is available regarding the rate of long-term cardiovascular (CV) mortality in chronic myeloid leukaemia (CML) patients treated with second- and third-generation tyrosine kinase inhibitors (2ndG/3rdG TKIs) in the real-life practice. Methods We identified 656 consecutive CML patients treated with nilotinib, dasatinib, bosutinib and ponatinib. Results The 15-year CV-mortality free survival was 93 ± 2.8%. Age ≥65 years (p = 0.005) and a positive history of CV disease (p = 0.04) were significantly associated with a lower CV-mortality free survival. CV disease accounted for 16.5% and 5% of potential years of life lost (PYLL) in male and female patients, respectively. The standard mortality ratio (SMR) following ischemic heart disease (IHD) was 3.9 in males and 3.8 in female patients, meaning an excess of IHD deaths observed, in comparison with the population of control. Conclusion. Prevention strategies based on CV risk factors, in particular in those patients with a previous history of CV disease, should be considered.

Published
2019

39. Arterial occlusive events in chronic myeloid leukemia patients treated with ponatinib in the real-life practice are predicted by the Systematic Coronary Risk Evaluation (SCORE) chart

Author

Giovanni Caocci, Massimo Breccia, Ester Orlandi, Antonella Gozzini, Robin Foà, Luigiana Luciano, Nicola Sgherza, Francesco Albano, Sara Galimberti, Massimiliano Bonifacio, Elisabetta Abruzzese, Gabriele Gugliotta, Olga Mulas, Daniele Cattaneo, Gianni Binotto, Chiara Elena, Luigi Scaffidi, Claudia Baratè, Fabio Stagno, Patrizia Pregno, Immacolata Attolico, Fiorenza De Gregorio, Emilia Scalzulli, Fausto Castagnetti, Mario Annunziata, Giorgio La Nasa, Alessandra Iurlo, Francesca Pirillo, Malgorzata Monika Trawinska, Claudio Fozza, Caocci G., Mulas O., Abruzzese E., Luciano L., Iurlo A., Attolico I., Castagnetti F., Galimberti S., Sgherza N., Bonifacio M., Annunziata M., Gozzini A., Orlandi E.M., Stagno F., Binotto G., Pregno P., Fozza C., Trawinska M.M., De Gregorio F., Cattaneo D., Albano F., Gugliotta G., Barate C., Scaffidi L., Elena C., Pirillo F., Scalzulli E., La Nasa G., Foa R., and Breccia M.

Subjects
Male, Cancer Research, Decision Support Systems, Medical Oncology, chemistry.chemical_compound, 0302 clinical medicine, Risk Factors, Retrospective Studie, Original Research Articles, Epidemiology, 80 and over, Medicine, Cumulative incidence, ponatinib, Original Research Article, arterial occlusive event, Chronic, Aged, 80 and over, Aspirin, Leukemia, Incidence (epidemiology), Incidence, Ponatinib, Imidazoles, Hematology, General Medicine, Middle Aged, Pyridazines, Treatment Outcome, Oncology, Italy, 030220 oncology & carcinogenesis, Hypertension, Female, prophylaxis, Pyridazine, medicine.drug, Human, Adult, medicine.medical_specialty, Chronic myeloid leukemia, Cardiology, 03 medical and health sciences, Clinical, Young Adult, chronic myeloid leukemia, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Humans, Risk factor, Imidazole, Retrospective Studies, Aged, business.industry, prophylaxi, Risk Factor, Coronary Occlusion, Decision Support Systems, Clinical, Retrospective cohort study, Blood pressure, chemistry, BCR-ABL Positive, business, 030215 immunology, Myelogenous
Abstract

Arterial occlusive events (AOEs) represent emerging complications in chronic myeloid leukemia (CML) patients treated with ponatinib. We identified 85 consecutive CML adult patients who were treated with ponatinib in 17 Italian centers. Patients were stratified according to the Systematic Coronary Risk Evaluation (SCORE) assessment, based on sex, age, smoking habits, systolic blood pressure, and total cholesterol levels. The 60-month cumulative incidence rate of AOEs excluding hypertension was 25.7%. Hypertension was reported in 14.1% of patients. The median time of exposure to ponatinib was 28months (range, 3-69months). Patients with a high to very high SCORE risk showed a significantly higher incidence rate of AOEs (74.3% vs 15.2%, P&nbsp

Published
2019

40. Proliferation centers in chronic lymphocytic leukemia: correlation with cytogenetic and clinicobiological features in consecutive patients analyzed on tissue microarrays

Author

Claudio Agostinelli, S Falorio, Maria Ciccone, G. Fioritoni, Lara Rizzotto, Immacolata Attolico, Olga Sofritti, Massimo Negrini, Pier Luigi Zinzani, Maura Brugiatelli, Elena Sabattini, Stefano Pileri, Antonio Cuneo, Simona Righi, Maria Teresa Sista, Francesco Cavazzini, Daniela Capello, Pier Paolo Piccaluga, Gian Matteo Rigolin, Elena Saccenti, Attilio Olivieri, Caterina Stelitano, Ciccone M., Agostinelli C., Rigolin G.M., Piccaluga P.P., Cavazzini F., Righi S., Sista M.T., Sofritti O., Rizzotto L., Sabattini E., Fioritoni G., Falorio S., Stelitano C., Olivieri A., Attolico I., Brugiatelli M., Zinzani P.L., Saccenti E., Capello D., Negrini M., Cuneo A., and Pileri S.

Subjects
Male, Cancer Research, Pathology, medicine.medical_specialty, Chronic lymphocytic leukemia, small lymphocytic lymphoma, Chromosomal translocation, proliferation centers, Biology, NO, FISH, Risk Factors, cytogenetic and clinicobiological features, medicine, Humans, 14q32 translocation, Lymph node, In Situ Hybridization, Fluorescence, Chromosome Aberrations, Tissue microarray, medicine.diagnostic_test, Incidence (epidemiology), Hematology, medicine.disease, Prognosis, Leukemia, Lymphocytic, Chronic, B-Cell, Leukemia, medicine.anatomical_structure, Oncology, Tissue Array Analysis, Mutation, Proliferation center, chronic lymphocytic leukemia, Female, Trisomy, Immunoglobulin Heavy Chains, Fluorescence in situ hybridization
Abstract

To better define the significance of proliferation centers (PCs), the morphological hallmark of chronic lymphocytic leukemia (CLL), lymph node biopsies taken from 183 patients were submitted to histopathologic and fluorescence in situ hybridization (FISH) studies using a 5-probe panel on tissue microarrays. Seventy-five cases (40.9%) with confluent PCs were classified as 'PCs-rich' and 108 cases (59.1%) with scattered PCs were classified as 'typical'. Complete FISH data were obtained in 101 cases (55.1%), 79 of which (78.2%) displayed at least one chromosomal aberration. The incidence of each aberration was: 13q- 36,7%, 14q32 translocations 30.8%, 11q- 24.7%, trisomy 12 19.5% and 17p- 15.6%. Five cases showed extra copies of the 14q32 region. The 'PCs-rich' group was associated with 17p-, 14q32/IgH translocation, +12, Ki-67>30%. The median survival from the time of tissue biopsy for PCs-rich and typical groups was 11 and 64 months, respectively (P=0.00001). The PCs-rich pattern was the only predictive factor of an inferior survival at multivariate analysis (P=0.022). These findings establish an association between cytogenetic profile and the amount of PC in CLL, and show that this histopathologic characteristic is of value for risk assessment in patients with clinically significant adenopathy.

Published
2012

41. Effects of daratumumab on hematopoietic stem cell collection and engraftment in multiple myeloma patients eligible for autologous transplantation: results of the real-life PRIMULA study comparing bortezomib, thalidomide and dexamethasone (VTd) with VTd plus daratumumab (D-VTd) as induction therapy.

Author

Strafella V, Attolico I, Carluccio P, Tarantini F, Curci P, Sgherza N, Rizzi R, Ostuni A, Buda G, Del Giudice ML, Marasco V, Mele A, Margiotta-Casaluci G, Valli VB, Mele G, Germano CR, Quinto AM, Palazzo G, Febbo MA, Ciuffreda L, Reddiconto G, Di Renzo N, Cimminiello M, Albano F, and Musto P

Published
2024
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42. The new Systematic Coronary Risk Evaluation (SCORE2 and SCORE2-OP) estimates the risk of arterial occlusive events in chronic myeloid leukemia patients treated with nilotinib or ponatinib.

Author

Mulas O, Abruzzese E, Luciano L, Iurlo A, Attolico I, Castagnetti F, Galimberti S, Bonifacio M, Annunziata M, Gozzini A, Orlandi EM, Stagno F, Binotto G, Pregno P, Fozza C, Loi M, Trawinska MM, De Gregorio F, Cattaneo D, Albano F, Iezza M, Baratè C, Scaffidi L, Elena C, Giai V, Scalzulli E, Breccia M, La Nasa G, and Caocci G

Subjects
Adult, Humans, Aged, Aged, 80 and over, Imidazoles adverse effects, Pyrimidines therapeutic use, Protein Kinase Inhibitors adverse effects, Cardiovascular Diseases chemically induced, Cardiovascular Diseases epidemiology, Cardiovascular Diseases drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive epidemiology, Leukemia, Myelogenous, Chronic, BCR-ABL Positive chemically induced, Pyridazines
Abstract

Patients with chronic myeloid leukemia (CML) treated with nilotinib or ponatinib may experience arterial occlusive events (AOEs). It is currently recommended to thoroughly assess cardiovascular risk factors before treating CML. We identified 455 consecutive CML adult patients, 335 treated with nilotinib and 120 with ponatinib; 380 patients without previous cardiovascular diseases or diabetes were stratified according to the Systematic Coronary Risk Evaluation (SCORE2) and SCORE2-Older Persons (SCORE2-OP). This updated algorithm from the European Society of Cardiology (ESC) estimates a 10-year risk of fatal and non-fatal cardiovascular diseases. It is based on sex, age, smoking habits, systolic blood pressure, non-high-density lipoprotein cholesterol, and European geographical region of cardiovascular risk. The SCORE2/SCORE2-OP algorithm translated more patients (50.2%) to the high-very high cardiovascular risk category than the previous SCORE (25.3%). Patients with a high to very high SCORE2/SCORE2-OP risk showed a significantly higher incidence rate of AOEs (69.2% vs. 46.5%, p < 0.001). The older SCORE was less specific in estimating AOEs in patients classified as low-intermediate risk (69.8 vs. 54.2%). In multivariate analysis, no associations were found between AOEs and gender, age, and type or dose of tyrosine kinase inhibitor. Only the SCORE2/SCORE2-OP risk was confirmed as a significant predictive factor (p = 0.028; hazard ratio = 2.2; 95% confidence interval = 1.1-4.5). Patients with AOEs required, in most cases, imaging diagnostic tests, additional drugs, and sometimes invasive procedures, increasing access to visits and hospital management. This real-life study suggested that the SCORE2 and SCORE2-OP charts could help identify cardiovascular fragility in CML patients providing them with more attention and a proper TKI selection., (© 2023. The Author(s).)

Published
2024
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43. TNFRSF13B gene mutation in familial acute myeloid leukemia: A new piece in the complex scenario of hereditary predisposition?

Author

Cumbo C, Orsini P, Tarantini F, Anelli L, Zagaria A, Tragni V, Coccaro N, Tota G, Parciante E, Conserva MR, Redavid I, Minervini CF, Minervini A, Attolico I, Gentile M, Pierri CL, Specchia G, Musto P, and Albano F

Subjects
Humans, Child, Mutation, Genetic Predisposition to Disease, Transmembrane Activator and CAML Interactor Protein genetics, Hematologic Neoplasms genetics, Leukemia, Myeloid, Acute genetics
Abstract

TNFRSF13B mutations are widely associated with common variable immunodeficiency. TNFRSF13B was recently counted among relevant genes associated with childhood-onset of hematological malignancies; nonetheless, its role in acute myeloid leukemia (AML) remains unexplored. We report the study of a family with two cases of AML, sharing a germline TNFRSF13B mutation favoring the formation of a more stable complex with its ligand TNFSF13: a positive regulator of AML-initiating cells. Our data turn the spotlight onto the TNFRSF13B role in AML onset, inserting a new fragment into the complex scenario of a hereditary predisposition to myeloid neoplasms., (© 2023 The Authors. Hematological Oncology published by John Wiley & Sons Ltd.)

Published
2023
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44. Oral anti-viral therapy for early COVID-19 infection in patients with haematological malignancies: A multicentre prospective cohort.

Author

Minoia C, Diella L, Perrone T, Loseto G, Pelligrino C, Attolico I, Pasciolla C, Totaro V, De Candia MS, Spada V, Clemente F, Camporeale M, Di Gennaro F, Guarini A, Musto P, Saracino A, and Bavaro DF

Subjects
Humans, Prospective Studies, RNA, Viral, SARS-CoV-2, Antiviral Agents therapeutic use, COVID-19, Hematologic Neoplasms complications, Hematologic Neoplasms drug therapy
Abstract

High rates of lung failure have been reported in haematological patients after SARS-CoV2 infection. An early administration of monoclonal antibodies or anti-virals may improve the prognosis. Oral anti-virals may have a wider use independently of the genetic variations of the virus. Prospective data on anti-virals in haematological malignancies (HMs) are still lacking. Outpatients diagnosed with HM and early COVID-19 infection were prospectively treated with the oral anti-virals nirmatrelvir/ritonavir and molnupiravir. Incidence of lung failure, deaths and adverse events was analysed. Long-term outcome at third month was evaluated. Eighty-two outpatients were evaluable for the study objectives. All patients had been treated for their HM within 12 months. COVID-19-related lung failure was 23.1%. Active HM (aOR = 4.42; p = 0.038) and prolonged viral shedding (aOR = 1.04; p = 0.022) resulted independent predictors of severe infection. The vaccination with three to four doses (aOR = 0.02; p = 0.001) and with two doses (aOR = 0.06; p = 0.006) resulted protective. COVID-19-related deaths at 28 days were 6.1%. All-cause mortality at 90-day follow-up was 13.4% (n. 11) and included opportunistic infections and cardiovascular events. In conclusion, this approach reduced the incidence of lung failure and specific mortality compared to previous cohorts, but patients remain at high risk of further complications., (© 2023 British Society for Haematology and John Wiley & Sons Ltd.)

Published
2023
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45. Determinants of frontline tyrosine kinase inhibitor choice for patients with chronic-phase chronic myeloid leukemia: A study from the Registro Italiano LMC and Campus CML.

Author

Tiribelli M, Latagliata R, Breccia M, Capodanno I, Miggiano MC, Cavazzini F, Bucelli C, Attolico I, Crescenzi SL, Russo S, Annunziata M, Sorà F, Bonifacio M, Mulas O, Loglisci G, Maggi A, Binotto G, Crisà E, Scortechini AR, Leporace AP, Sancetta R, Murgano P, Abruzzese E, Stagno F, Rapezzi D, Luzi D, Vincelli I, Bocchia M, Fava C, Malato A, Crugnola M, Pizzuti M, Lunghi F, Galimberti S, Dalmazzo M, Fanin R, Scalzulli E, Foà R, Iurlo A, Saglio G, and Specchia G

Subjects
Humans, Imatinib Mesylate, Tyrosine Kinase Inhibitors, Retrospective Studies, Protein Kinase Inhibitors, Dasatinib, Leukemia, Myeloid, Chronic-Phase drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy
Abstract

Background: Imatinib, dasatinib, and nilotinib are tyrosine kinase inhibitors (TKIs) approved in Italy for frontline treatment of chronic-phase chronic myeloid leukemia (CP-CML). The choice of TKI is based on a combined evaluation of the patient's and the disease characteristics. The aim of this study was to analyze the use of frontline TKI therapy in an unselected cohort of Italian patients with CP-CML to correlate the choice with the patient's features., Methods: A total of 1967 patients with CP-CML diagnosed between 2012 and 2019 at 36 centers throughout Italy were retrospectively evaluated; 1089 patients (55.4%) received imatinib and 878 patients (44.6%) received a second-generation (2G) TKI., Results: Second-generation TKIs were chosen for most patients aged <45 years (69.2%), whereas imatinib was used in 76.7% of patients aged >65 years (p < .001). There was a predominant use of imatinib in intermediate/high European long-term survival risk patients (60.0%/66.0% vs. 49.7% in low-risk patients) and a limited use of 2G-TKIs in patients with comorbidities such as hypertension, diabetes, chronic obstructive pulmonary disease, previous neoplasms, ischemic heart disease, or stroke and in those with >3 concomitant drugs. We observed a greater use of imatinib (61.1%) in patients diagnosed in 2018-2019 compared to 2012-2017 (53.2%; p = .002). In multivariable analysis, factors correlated with imatinib use were age > 65 years, spleen size, the presence of comorbidities, and ≥3 concomitant medications., Conclusions: This observational study of almost 2000 cases of CML shows that imatinib is the frontline drug of choice in 55% of Italian patients with CP-CML, with 2G-TKIs prevalently used in younger patients and in those with no concomitant clinical conditions. Introduction of the generic formulation in 2018 seems to have fostered imatinib use., (© 2023 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.)

Published
2023
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46. Long term follow-up of refractory/relapsed acute myeloid leukemia patients treated with the FLAG-Ida regimen as bridge therapy to allotransplantation: 10-year results from a single centre experience.

Author

Delia M, Gagliardi VP, Carluccio P, Attolico I, Contento C, Di Gennaro D, Albano F, and Musto P

Subjects
Humans, Follow-Up Studies, Idarubicin, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cytarabine, Granulocyte Colony-Stimulating Factor, Vidarabine, Recurrence, Bridge Therapy, Leukemia, Myeloid, Acute drug therapy
Abstract

Competing Interests: Conflict of interest There are no conflicts of interest to report.

Published
2023
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47. Efficacy of Remdesivir and Neutralizing Monoclonal Antibodies in Monotherapy or Combination Therapy in Reducing the Risk of Disease Progression in Elderly or Immunocompromised Hosts Hospitalized for COVID-19: A Single Center Retrospective Study.

Author

Bavaro DF, Diella L, Belati A, Metrangolo G, De Santis L, Spada V, Camporeale M, Dargenio A, Brindicci G, Balena F, Fiordelisi D, Signorile F, Loseto G, Pasciolla C, Minoia C, Attolico I, Perrone T, Simone S, Rendina M, Giovine N, Di Gennaro F, Musto P, Guarini A, Di Leo A, Gesualdo L, Dell'Aera M, and Saracino A

Subjects
Aged, Male, Humans, Aged, 80 and over, Female, Retrospective Studies, COVID-19 Drug Treatment, Antibodies, Monoclonal therapeutic use, Antibodies, Neutralizing, Immunocompromised Host, Disease Progression, COVID-19
Abstract

Introduction: Remdesivir (REM) and monoclonal antibodies (mAbs) could alleviate severe COVID-19 in at-risk outpatients. However, data on their use in hospitalized patients, particularly in elderly or immunocompromised hosts, are lacking., Methods: All consecutive patients hospitalized with COVID-19 at our unit from 1 July 2021 to 15 March 2022 were retrospectively enrolled. The primary outcome was the progression to severe COVID-19 (P/F < 200). Descriptive statistics, a Cox univariate-multivariate model, and an inverse probability treatment-weighted (IPTW) analysis were performed., Results: Overall, 331 subjects were included; their median (q1-q3) age was 71 (51-80) years, and they were males in 52% of the cases. Of them, 78 (23%) developed severe COVID-19. All-cause in-hospital mortality was 14%; it was higher in those with disease progression (36% vs. 7%, p < 0.001). REM and mAbs resulted in a 7% (95%CI = 3-11%) and 14% (95%CI = 3-25%) reduction in the risk of severe COVID-19, respectively, after adjusting the analysis with the IPTW. In addition, by evaluating only immunocompromised hosts, the combination of REM and mAbs was associated with a significantly lower incidence of severe COVID-19 (aHR = 0.06, 95%CI = 0.02-0.77) when compared with monotherapy., Conclusions: REM and mAbs may reduce the risk of COVID-19 progression in hospitalized patients. Importantly, in immunocompromised hosts, the combination of mAbs and REM may be beneficial.

Published
2023
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48. Clonal hematopoiesis onset in chronic myeloid leukemia patients developing an adverse cardiovascular event.

Author

Tarantini F, Cumbo C, Zagaria A, Anelli L, Parciante E, Redavid I, Coccaro N, Tota G, Conserva MR, Minervini CF, Minervini A, Attolico I, Russo Rossi A, Specchia G, Musto P, and Albano F

Subjects
Humans, Clonal Hematopoiesis, Hematopoiesis genetics, Mutation, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive genetics, Leukemia, Myelogenous, Chronic, BCR-ABL Positive pathology, Leukemia, Myeloid, Acute therapy, Cardiovascular Diseases genetics
Abstract

Life expectation of chronic myeloid leukemia patients in the tyrosine kinase inhibitors era is almost equal to that of healthy subjects. On the other hand, their long-term management must take into account a higher risk of adverse events, at least partly related to the treatment. Various studies reported a higher incidence of cardiovascular events in these patients. Clonal hematopoiesis is broadly considered a major independent risk factor for cardiovascular events. Of note, the underlying physiopathological mechanisms connect clonal hematopoiesis with a global proinflammatory status, triggering a vicious circle in which the somatic mutations and inflammation feed each other. All this considered, we investigated the occurrence of clonal hematopoiesis in chronic myeloid leukemia patients developing a cardiovascular event under tyrosine kinase inhibitor therapy., Competing Interests: Conflict of Interests The authors declare no conflict of interest., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Published
2023
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50. IRF4 Gene Expression on the Trail of Molecular Response: Looking at Chronic Myeloid Leukemia from Another Perspective.

Author

Tarantini F, Cumbo C, Parciante E, Anelli L, Zagaria A, Coccaro N, Minervini CF, Tota G, Redavid I, Conserva MR, Attolico I, Rossi AR, Specchia G, Musto P, and Albano F

Subjects
Humans, Chronic Disease, Protein Kinase Inhibitors pharmacology, Protein Kinase Inhibitors therapeutic use, Gene Expression, Leukemia, Myelogenous, Chronic, BCR-ABL Positive diagnosis, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive genetics, Leukemia, Myeloid
Abstract

Introduction: Interferon regulatory factor 4 (IRF4) is a transcriptional factor with a key role in the modulation of inflammation and immune surveillance. The IRF4 gene is downregulated in Philadelphia-negative myeloproliferative neoplasms, and its expression is associated with prognosis and response to treatment., Methods: We evaluated the IRF4 expression kinetics during tyrosine kinase inhibitor (TKI) treatment in a cohort of 116 chronic myeloid leukemia (CML) patients to elucidate its role in the disease course., Results: A relationship between the IRF4 expression and the disease burden was observed at various disease stages. A correlation analysis between the International Scale (IS) and IRF4 values confirmed this close association. A significant increase is detected after 3 months of TKI treatment. Patients achieving an early molecular response (EMR) had higher IRF4 values at both diagnosis and after 3 months of therapy as compared to those failing the EMR target. Patients achieving treatment-free remission did not show IRF4 fluctuations during monitoring, while a decreased IRF4 expression emerged at the time of molecular relapse., Conclusion: Our data seem to confirm the relevance of IRF4 in the pathogenesis of CML, suggesting a pivotal role at the disease onset and a predictive value during the CML course., (© 2022 S. Karger AG, Basel.)

Published
2023
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