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1. Therapeutic Management of Patients with FLT3 + Acute Myeloid Leukemia: Case Reports and Focus on Gilteritinib Monotherapy

Author

Bocchia M, Carella AM, Mulè A, Rizzo L, Turrini M, Abbenante MC, Cairoli R, Calafiore V, Defina M, Gardellini A, Luzi G, Patti C, Pinazzi MB, Riva M, Rossi G, Sammartano V, and Rigacci L

Subjects
acute myeloid leukemia, flt3, midostaurin, gilteritinib, Therapeutics. Pharmacology, RM1-950
Abstract

Monica Bocchia,1 Angelo Michele Carella,2 Antonino Mulè,3 Lorenzo Rizzo,4 Mauro Turrini,5 Maria Chiara Abbenante,2 Roberto Cairoli,4 Valeria Calafiore,3 Marzia Defina,1 Angelo Gardellini,5 Giovanni Luzi,6 Caterina Patti,3 Maria Beatrice Pinazzi,6 Marta Riva,4 Giovanni Rossi,2 Vincenzo Sammartano,1 Luigi Rigacci6 1Hematology Unit, Azienda Ospedaliera Universitaria Senese, University of Siena, Siena, Italy; 2Division of Hematology with Hematologic Intensive Care Unit and Cellular Therapies, Department of Medical Science, Fondazione IRCCS Casa Sollievo Della Sofferenza, Foggia, Italy; 3UOC Hematology and Oncology, Ospedali Riuniti Villa Sofia-Cervello, Palermo, Italy; 4Department of Haematology, Niguarda Cancer Center, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy; 5Division of Hematology, Valduce Hospital, Como, Italy; 6UOC Hematology and Stem Cell Transplant Unit, Ospedale S, Camillo, Rome, ItalyCorrespondence: Angelo Michele Carella, Division of Hematology with Hematologic Intensive Care Unit and Cellular Therapies, Department of Medical Science, Fondazione IRCCS Casa Sollievo della Sofferenza, Viale Cappuccini, San Giovanni Rotondo, Foggia, 71013, Italy, Tel +390882410054, Fax +390882410322, Email am.carella@operapadrepio.itAbstract: Acute myeloid leukemia is a malignant disorder of the bone marrow, characterized by differentiation, clonal expansion, and uncontrolled proliferation of malignant myeloid progenitor cells and by several molecular and genetic abnormalities. A mutation of FMS-like tyrosine kinase 3 gene can be observed in about one-third of cases of acute myeloid leukemia. Two FLT3 inhibitors are actually approved for FLT3 mutated acute myeloid leukemia: midostaurin, a multikinase first generation inhibitor with lower affinity for FLT3 binding, and gilteritinib fumarate, a potent second-generation inhibitor of both FLT3-ITD and TKD. Gilteritinib is a new effective and well-tolerated drug for patients with relapsing or refractory FLT3-positive acute myeloid leukemia. Thanks to its efficacy, low toxicity, its good manageability (oral formulation), this drug is suitable for all the patients, including elderly frail patient with concomitant therapies or pre-existing or underlying diseases, and can be used also in the outpatient setting, reducing risks and costs related to the hospitalization. We report and discuss seven cases of different patients with FLT3 positive acute myeloid leukemia successfully managed with gilteritinib in the real clinical practice.Keywords: acute myeloid leukemia, FLT3, midostaurin, gilteritinib

Published
2022

2. SARS-CoV-2 infection in patients with chronic lymphocytic leukemia: The Italian Hematology Alliance on COVID-19 cohort

Author

Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., Visco C., Merli, M, Ferrarini, I, Merli, F, Busca, A, Mina, R, Falini, B, Bruna, R, Cairoli, R, Marchetti, M, Romano, A, Cavo, M, Arcaini, L, Trentin, L, Cattaneo, C, Derenzini, E, Fracchiolla, N, Marchesi, F, Scattolin, A, Billio, A, Bocchia, M, Massaia, M, Gambacorti-Passerini, C, Mauro, F, Gentile, M, Mohamed, S, Della Porta, M, Coviello, E, Cilloni, D, Visani, G, Federici, A, Tisi, M, Cudillo, L, Galimberti, S, Gherlinzoni, F, Pagano, L, Guidetti, A, Bertu, L, Corradini, P, Passamonti, F, Visco, C, Merli M., Ferrarini I., Merli F., Busca A., Mina R., Falini B., Bruna R., Cairoli R., Marchetti M., Romano A., Cavo M., Arcaini L., Trentin L., Cattaneo C., Derenzini E., Fracchiolla N. S., Marchesi F., Scattolin A., Billio A., Bocchia M., Massaia M., Gambacorti-Passerini C., Mauro F. R., Gentile M., Mohamed S., Della Porta M. G., Coviello E., Cilloni D., Visani G., Federici A. B., Tisi M. C., Cudillo L., Galimberti S., Gherlinzoni F., Pagano L., Guidetti A., Bertu L., Corradini P., Passamonti F., and Visco C.

Abstract

COVID-19, the disease caused by SARS-CoV-2, is still afflicting thousands of people across the globe. Few studies on COVID-19 in chronic lymphocytic leukemia (CLL) are available. Here, we analyzed data from the CLL cohort of the Italian Hematology Alliance on COVID-19 (NCT04352556), which included 256 CLL patients enrolled between 25 February 2020 and 1 February 2021. Median age was 70 years (range 38–94) with male preponderance (60.1%). Approximately half of patients (n = 127) had received at least one line of therapy for CLL, including 108 (83.7%) who were on active treatment at the time of COVID-19 or received their last therapy within 12 months. Most patients (230/256, 89.9%) were symptomatic at COVID-19 diagnosis and the majority required hospitalization (n = 176). Overall, after a median follow-up of 42 days (IQR 24–96), case fatality rate was 30.1%, and it was 37.5% and 24.4% in the first (25 February 2020–22 June 2020) and second wave (23 June 2020–1 February 2021), respectively (p = 0.03). At multivariate analysis, male sex (HR 1.82, 95% CI 1.03–3.24, p = 0.04), age over than 70 years (HR 2.23, 95% CI 1.23–4.05, p = 0.01), any treatment for CLL given in the last 12 months (HR 1.72, 95% CI 1.04–2.84, p = 0.04) and COVID-19 severity (severe: HR 5.66, 95% CI 2.62–12.33, p < 0.0001; critical: HR 15.99, 95% CI 6.93–36.90, p < 0.0001) were independently associated with poor survival. In summary, we report a dismal COVID-related outcome in a significant fraction of CLL patients, that can be nicely predicted by clinical parameters.

Published
2023

3. PB0316 Bortezomib for the Treatment of Multi-Refractory Immune-Mediated Thrombotic Thrombocytopenic Purpura: An Italian Multicenter Survey

Author

Giannotta, J., primary, Artoni, A., additional, Mancini, I., additional, Truma, A., additional, Agosti, P., additional, Carpenedo, M., additional, Mancini, G., additional, Molteni, A., additional, Rinaldi, E., additional, Bocchia, M., additional, Napolitano, M., additional, Prezioso, L., additional, Cuccaro, A., additional, Scarpa, E., additional, Grimaldi, D., additional, Massaia, M., additional, and Peyvandi, F., additional

Published
2023
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4. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, 37, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Coviello E, MC, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, Arcaini L., Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, 37, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Coviello E, MC, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, and Arcaini L.

Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5–36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

5. Therapeutic Management of Patients with FLT3 + Acute Myeloid Leukemia: Case Reports and Focus on Gilteritinib Monotherapy

Author

Bocchia, M, Carella, A, Mule, A, Rizzo, L, Turrini, M, Abbenante, M, Cairoli, R, Calafiore, V, Defina, M, Gardellini, A, Luzi, G, Patti, C, Pinazzi, M, Riva, M, Rossi, G, Sammartano, V, Rigacci, L, Bocchia M, Carella AM, Mule A, Rizzo L, Turrini M, Abbenante MC, Cairoli R, Calafiore V, Defina M, Gardellini A, Luzi G, Patti C, Pinazzi MB, Riva M, Rossi G, Sammartano V, Rigacci L., Bocchia, M, Carella, A, Mule, A, Rizzo, L, Turrini, M, Abbenante, M, Cairoli, R, Calafiore, V, Defina, M, Gardellini, A, Luzi, G, Patti, C, Pinazzi, M, Riva, M, Rossi, G, Sammartano, V, Rigacci, L, Bocchia M, Carella AM, Mule A, Rizzo L, Turrini M, Abbenante MC, Cairoli R, Calafiore V, Defina M, Gardellini A, Luzi G, Patti C, Pinazzi MB, Riva M, Rossi G, Sammartano V, and Rigacci L.

Abstract

Acute myeloid leukemia is a malignant disorder of the bone marrow, characterized by differentiation, clonal expansion, and uncontrolled proliferation of malignant myeloid progenitor cells and by several molecular and genetic abnormalities. A mutation of FMS-like tyrosine kinase 3 gene can be observed in about one-third of cases of acute myeloid leukemia. Two FLT3 inhibitors are actually approved for FLT3 mutated acute myeloid leukemia: midostaurin, a multikinase first generation inhibitor with lower affinity for FLT3 binding, and gilteritinib fumarate, a potent second-generation inhibitor of both FLT3-ITD and TKD. Gilteritinib is a new effective and well-tolerated drug for patients with relapsing or refractory FLT3-positive acute myeloid leukemia. Thanks to its efficacy, low toxicity, its good manageability (oral formulation), this drug is suitable for all the patients, including elderly frail patient with concomitant therapies or pre-existing or underlying diseases, and can be used also in the outpatient setting, reducing risks and costs related to the hospitalization. We report and discuss seven cases of different patients with FLT3 positive acute myeloid leukemia successfully managed with gilteritinib in the real clinical practice.

Published
2022

6. A prognostic model for patients with lymphoma and COVID-19: a multicentre cohort study

Author

Visco, C, Marcheselli, L, Mina, R, Sassone, M, Guidetti, A, Penna, D, Cattaneo, C, Bonuomo, V, Busca, A, Ferreri, A, Bruna, R, Petrucci, L, Cairoli, R, Salvini, M, Bertu, L, Ladetto, M, Pilerci, S, Pinto, A, Ramadan, S, Marchesi, F, Cavo, M, Arcaini, L, Coviello, E, Romano, A, Musto, P, Massaia, M, Fracchiolla, N, Marchetti, M, Scattolin, A, Tisi, M, Cuneo, A, Porta, M, Trentin, L, Turrini, M, Gherlinzoni, F, Tafuri, A, Galimberti, S, Bocchia, M, Cardinali, V, Cilloni, D, Corso, A, Armiento, D, Rigacci, L, La Barbera, E, Gambacorti Passerini, C, Visani, G, Vallisa, D, Venditti, A, Selleri, C, Conconi, A, Tosi, P, Lanza, F, Candoni, A, Krampera, M, Corradini, P, Passamonti, F, Merli, F, Visco C., Marcheselli L., Mina R., Sassone M., Guidetti A., Penna D., Cattaneo C., Bonuomo V., Busca A., Ferreri A. J. M., Bruna R., Petrucci L., Cairoli R., Salvini M., Bertu L., Ladetto M., Pilerci S., Pinto A., Ramadan S., Marchesi F., Cavo M., Arcaini L., Coviello E., Romano A., Musto P., Massaia M., Fracchiolla N., Marchetti M., Scattolin A., Tisi M. C., Cuneo A., Porta M. D., Trentin L., Turrini M., Gherlinzoni F., Tafuri A., Galimberti S., Bocchia M., Cardinali V., Cilloni D., Corso A., Armiento D., Rigacci L., La Barbera E. O., Gambacorti Passerini C., Visani G., Vallisa D., Venditti A., Selleri C., Conconi A., Tosi P., Lanza F., Candoni A., Krampera M., Corradini P., Passamonti F., Merli F., Visco, C, Marcheselli, L, Mina, R, Sassone, M, Guidetti, A, Penna, D, Cattaneo, C, Bonuomo, V, Busca, A, Ferreri, A, Bruna, R, Petrucci, L, Cairoli, R, Salvini, M, Bertu, L, Ladetto, M, Pilerci, S, Pinto, A, Ramadan, S, Marchesi, F, Cavo, M, Arcaini, L, Coviello, E, Romano, A, Musto, P, Massaia, M, Fracchiolla, N, Marchetti, M, Scattolin, A, Tisi, M, Cuneo, A, Porta, M, Trentin, L, Turrini, M, Gherlinzoni, F, Tafuri, A, Galimberti, S, Bocchia, M, Cardinali, V, Cilloni, D, Corso, A, Armiento, D, Rigacci, L, La Barbera, E, Gambacorti Passerini, C, Visani, G, Vallisa, D, Venditti, A, Selleri, C, Conconi, A, Tosi, P, Lanza, F, Candoni, A, Krampera, M, Corradini, P, Passamonti, F, Merli, F, Visco C., Marcheselli L., Mina R., Sassone M., Guidetti A., Penna D., Cattaneo C., Bonuomo V., Busca A., Ferreri A. J. M., Bruna R., Petrucci L., Cairoli R., Salvini M., Bertu L., Ladetto M., Pilerci S., Pinto A., Ramadan S., Marchesi F., Cavo M., Arcaini L., Coviello E., Romano A., Musto P., Massaia M., Fracchiolla N., Marchetti M., Scattolin A., Tisi M. C., Cuneo A., Porta M. D., Trentin L., Turrini M., Gherlinzoni F., Tafuri A., Galimberti S., Bocchia M., Cardinali V., Cilloni D., Corso A., Armiento D., Rigacci L., La Barbera E. O., Gambacorti Passerini C., Visani G., Vallisa D., Venditti A., Selleri C., Conconi A., Tosi P., Lanza F., Candoni A., Krampera M., Corradini P., Passamonti F., and Merli F.

Abstract

Lymphoma represents a heterogeneous hematological malignancy (HM), which is characterized by severe immunosuppression. Patients diagnosed of coronavirus disease 2019 (COVID-19) during the course of HM have been described to have poor outcome, with only few reports specifically addressing lymphoma patients. Here, we investigated the clinical behavior and clinical parameters of a large multicenter cohort of adult patients with different lymphoma subtypes, with the aim of identifying predictors of death. The study included 856 patients, of whom 619 were enrolled prospectively in a 1-year frame and were followed-up for a median of 66 days (range 1-395). Patients were managed as outpatient (not-admitted cohort, n 5 388) or required hospitalization (n 5 468), and median age was 63 years (range 19-94). Overall, the 30- and 100-days mortality was 13% (95% confidence interval (CI), 11% to 15%) and 23% (95% CI, 20% to 27%), respectively. Antilymphoma treatment, including anti-CD20 containing regimens, did not impact survival. Patients with Hodgkin’s lymphoma had the more favorable survival, but this was partly related to significantly younger age. The time interval between lymphoma diagnosis and COVID-19 was inversely related to mortality. Multivariable analysis recognized 4 easy-to-use factors (age, gender, lymphocyte, and platelet count) that were associated with risk of death, both in the admitted and in the not-admitted cohort (HR 3.79 and 8.85 for the intermediate- and high-risk group, respectively). Overall, our study shows that patients should not be deprived of the best available treatment of their underlying disease and indicates which patients are at higher risk of death. This study was registered with ClinicalTrials.gov, NCT04352556.

Published
2022

7. Topic: AS01-Diagnosis/AS01c-Molecular aberrations (cytogenetic, genetic, gene expression): A CARTOGRAPHY OF UBA1 GENE TESTING, EPIDEMIOLOGY AND CLINICAL-GENOMIC CHARACTERISTICS: THE VEXAS/MDS ITALIAN EXPERIENCE

Author

Gurnari, C., primary, Pascale, M.R., additional, Vitale, A., additional, Diral, E., additional, Galossi, E., additional, Falconi, G., additional, Bruno, A., additional, Crisafulli, F., additional, Frassi, M., additional, Cattaneo, C., additional, Bertoli, D., additional, Bernardi, M., additional, Condorelli, A., additional, Morsia, E., additional, Crisà, E., additional, Triggianese, P., additional, Brussino, L., additional, Battipaglia, G., additional, Bindoli, S., additional, Sfriso, P., additional, Caroni, F., additional, Olivieri, A., additional, Kordasti, S., additional, Albano, F., additional, Pane, F., additional, Musto, P., additional, Bocchia, M., additional, Lugli, E., additional, Rambaldi, A., additional, Greco, R., additional, Franceschini, F., additional, Ciceri, F., additional, Cantarini, L., additional, and Voso, M.T., additional

Published
2023
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8. P48 CARFILZOMIB, LENALIDOMIDE AND DEXAMETHASONE IN RELAPSED REFRACTORY MULTIPLE MYELOMA: A PROSPECTIVE REAL-LIFE EXPERIENCE OF THE REGIONAL TUSCAN MYELOMA NETWORK (RTM)

Author

Attucci, I., primary, Antonioli, E., additional, Pilerci, S., additional, Buda, G., additional, Gozzetti, A., additional, Candi, V., additional, Simonetti, F., additional, Del Giudice, ML., additional, Ciofini, S., additional, Staderini, M., additional, Grammatico, S., additional, Buzzichelli, A., additional, Messeri, M., additional, Bocchia, M., additional, Galimberti, S., additional, and Vannucchi, AM, additional

Published
2023
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9. Treatment discontinuation following low-dose TKIs in 248 chronic myeloid leukemia patients: Updated results from a campus CML real-life study

Author

Iurlo, A., primary, Cattaneo, D., additional, Consonni, D., additional, Castagnetti, F., additional, Miggiano, M. C., additional, Binotto, G., additional, Bonifacio, M., additional, Rege-Cambrin, G., additional, Tiribelli, M., additional, Lunghi, F., additional, Gozzini, A., additional, Pregno, P., additional, Abruzzese, E., additional, Capodanno, I., additional, Bucelli, C., additional, Pizzuti, M., additional, Artuso, S., additional, Iezza, M., additional, Scalzulli, E., additional, La Barba, G., additional, Maggi, A., additional, Russo, S., additional, Elena, C., additional, Scortechini, A. R., additional, Tafuri, A., additional, Latagliata, R., additional, Caocci, G., additional, Bocchia, M., additional, Galimberti, S., additional, Luciano, L., additional, Fava, C., additional, Foà, R., additional, Saglio, G., additional, Rosti, G., additional, and Breccia, M., additional

Published
2023
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10. Real World Outcome of Unfit Patients with Acute Myeloid Leukemia Treated with the Combination Venetoclax Plus Hypomethylating Agents in the Gimema AML2320 Observational Trial

Author

Venditti, A, Piciocchi, A, Soddu, S, Frigeni, M, Palmieri, R, Borlenghi, E, Fracchiolla, N, Martelli, M, Audisio, E, Gianfaldoni, G, Vetro, C, di Rienzo, N, Esposito, D, Di Veroli, A, Selleri, C, Gigli, F, Curti, A, Mulè, A, Califano, C, Bigliardi, S, Breccia, M, Fozza, C, Bocchia, M, Lico, A, Simonetti, F, Pierdomenico, E, Buccisano, F, Del Principe, M, Maurillo, L, Fazi, P, Vignetti, M, Ferrara, F, Cairoli, R, Rossi, G, Rambaldi, A, Venditti, Adriano, Piciocchi, Alfonso, Soddu, Stefano, Frigeni, Marco, Palmieri, Raffaele, Borlenghi, Erika, Fracchiolla, Nicola, Martelli, Maria Paola, Audisio, Ernesta, Gianfaldoni, Giacomo, Vetro, Calogero, di Rienzo, Nicola, Esposito, Daniela, Di Veroli, Ambra, Selleri, Carmine, Gigli, Federica, Curti, Antonio, Mulè, Antonino, Califano, Catello, Bigliardi, Sara, Breccia, Massimo, Fozza, Claudio, Bocchia, Monica, Lico, Albana, Simonetti, Federico, Pierdomenico, Elisabetta, Buccisano, Francesco, Del Principe, Maria Ilaria, Maurillo, Luca, Fazi, Paola, Vignetti, Marco, Ferrara, Felicetto, Cairoli, Roberto, Rossi, Giuseppe, Rambaldi, Alessandro, Venditti, A, Piciocchi, A, Soddu, S, Frigeni, M, Palmieri, R, Borlenghi, E, Fracchiolla, N, Martelli, M, Audisio, E, Gianfaldoni, G, Vetro, C, di Rienzo, N, Esposito, D, Di Veroli, A, Selleri, C, Gigli, F, Curti, A, Mulè, A, Califano, C, Bigliardi, S, Breccia, M, Fozza, C, Bocchia, M, Lico, A, Simonetti, F, Pierdomenico, E, Buccisano, F, Del Principe, M, Maurillo, L, Fazi, P, Vignetti, M, Ferrara, F, Cairoli, R, Rossi, G, Rambaldi, A, Venditti, Adriano, Piciocchi, Alfonso, Soddu, Stefano, Frigeni, Marco, Palmieri, Raffaele, Borlenghi, Erika, Fracchiolla, Nicola, Martelli, Maria Paola, Audisio, Ernesta, Gianfaldoni, Giacomo, Vetro, Calogero, di Rienzo, Nicola, Esposito, Daniela, Di Veroli, Ambra, Selleri, Carmine, Gigli, Federica, Curti, Antonio, Mulè, Antonino, Califano, Catello, Bigliardi, Sara, Breccia, Massimo, Fozza, Claudio, Bocchia, Monica, Lico, Albana, Simonetti, Federico, Pierdomenico, Elisabetta, Buccisano, Francesco, Del Principe, Maria Ilaria, Maurillo, Luca, Fazi, Paola, Vignetti, Marco, Ferrara, Felicetto, Cairoli, Roberto, Rossi, Giuseppe, and Rambaldi, Alessandro

Published
2023

11. Optimal Duration of CPX-351 Treatment and Best Timing for Consolidation with Allogeneic Stem Cell Transplantation: Evidence from a Large Real-World Italian Study

Author

Guolo, F, Fianchi, L, Martelli, M, Chiusolo, P, Lussana, F, Grimaldi, F, Pilo, F, Rondoni, M, Fili, C, Capelli, D, Breccia, M, Mastaglio, S, Bocchia, M, Fumagalli, M, Galimberti, S, Mancini, V, Piccioni, A, Maurillo, L, Palmieri, R, Corbingi, A, Vetro, C, Sperotto, A, Gigli, F, Zappasodi, P, Mulé, A, Borlenghi, E, Dargenio, M, Lessi, F, Cerrano, M, Isidori, A, Brunetti, L, Papayannidis, C, Lunghi, M, Alati, C, Gatani, S, Mannelli, F, Fracchiolla, N, Gottardi, M, Cairoli, R, Ferrara, F, Lemoli, R, Venditti, A, Pagano, L, Todisco, E, Guolo, Fabio, Fianchi, Luana, Martelli, Maria Paola, Chiusolo, Patrizia, Lussana, Federico, Grimaldi, Francesco, Pilo, Federica, Rondoni, Michela, Fili, Carla, Capelli, Debora, Breccia, Massimo, Mastaglio, Sara, Bocchia, Monica, Fumagalli, Monica, Galimberti, Sara, Mancini, Valentina, Piccioni, Anna Lina, Maurillo, Luca, Palmieri, Raffaele, Corbingi, Andrea, Vetro, Calogero, Sperotto, Alessandra, Gigli, Federica, Zappasodi, Patrizia, Mulé, Antonio, Borlenghi, Erika, Dargenio, Michelina, Lessi, Federica, Cerrano, Marco, Isidori, Alessandro, Brunetti, Lorenzo, Papayannidis, Cristina, Lunghi, Monia, Alati, Caterina, Gatani, Samuele, Mannelli, Francesco, Fracchiolla, Nicola, Gottardi, Michele, Cairoli, Roberto, Ferrara, Felicetto, Lemoli, Roberto Massimo, Venditti, Adriano, Pagano, Livio, Todisco, Elisabetta, Guolo, F, Fianchi, L, Martelli, M, Chiusolo, P, Lussana, F, Grimaldi, F, Pilo, F, Rondoni, M, Fili, C, Capelli, D, Breccia, M, Mastaglio, S, Bocchia, M, Fumagalli, M, Galimberti, S, Mancini, V, Piccioni, A, Maurillo, L, Palmieri, R, Corbingi, A, Vetro, C, Sperotto, A, Gigli, F, Zappasodi, P, Mulé, A, Borlenghi, E, Dargenio, M, Lessi, F, Cerrano, M, Isidori, A, Brunetti, L, Papayannidis, C, Lunghi, M, Alati, C, Gatani, S, Mannelli, F, Fracchiolla, N, Gottardi, M, Cairoli, R, Ferrara, F, Lemoli, R, Venditti, A, Pagano, L, Todisco, E, Guolo, Fabio, Fianchi, Luana, Martelli, Maria Paola, Chiusolo, Patrizia, Lussana, Federico, Grimaldi, Francesco, Pilo, Federica, Rondoni, Michela, Fili, Carla, Capelli, Debora, Breccia, Massimo, Mastaglio, Sara, Bocchia, Monica, Fumagalli, Monica, Galimberti, Sara, Mancini, Valentina, Piccioni, Anna Lina, Maurillo, Luca, Palmieri, Raffaele, Corbingi, Andrea, Vetro, Calogero, Sperotto, Alessandra, Gigli, Federica, Zappasodi, Patrizia, Mulé, Antonio, Borlenghi, Erika, Dargenio, Michelina, Lessi, Federica, Cerrano, Marco, Isidori, Alessandro, Brunetti, Lorenzo, Papayannidis, Cristina, Lunghi, Monia, Alati, Caterina, Gatani, Samuele, Mannelli, Francesco, Fracchiolla, Nicola, Gottardi, Michele, Cairoli, Roberto, Ferrara, Felicetto, Lemoli, Roberto Massimo, Venditti, Adriano, Pagano, Livio, and Todisco, Elisabetta

Published
2023

12. 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

13. Efficacy and safety of nilotinib as frontline treatment in elderly (> 65 years) chronic myeloid leukemia patients outside clinical trials

Author

Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

Here, we report real-world evidence on the safety and efficacy of nilotinib as a first-line treatment in elderly patients with chronic phase CML, treated in 18 Italian centers. Sixty patients aged > 65 years (median age 72 years (65–84)) were reported: 13 patients were older than 75 years. Comorbidities were recorded at baseline in 56/60 patients. At 3 months of treatment, all patients obtained complete hematological response (CHR), 43 (71.6%) an early molecular response (EMR), while 47 (78%) reached a complete cytogenetic response (CCyR). At last follow-up, 63.4% of patients still had a deep molecular response (MR4 or better), 21.6% reached MR3 as best response and 11.6% persisted without MR. Most patients (85%) started the treatment at the standard dose (300 mg BID), maintained at 3 months in 80% of patients and at 6 months in 89% of them. At the last median follow-up of 46.3 months, 15 patients discontinued definitively the treatment (8 due to side effects, 4 died for unrelated CML causes, 1 for failure, 2 were lost to follow-up). One patient entered in treatment-free remission. As to safety, 6 patients (10%) experienced cardiovascular events after a median time of 20.9 months from the start. Our data showed that nilotinib could be, as first-line treatment, effective and relatively safe even in elderly CML patients. In this setting, more data in the long term are needed about possible dose reduction to improve the tolerability, while maintaining the optimal molecular response.

Published
2023

14. Prospective monitoring of chronic myeloid leukemia patients from the time of TKI discontinuation: the fate of peripheral blood CD26+ leukemia stem cells

Author

Pacelli, P., Santoni, A., Sicuranza, A., Abruzzese, E., Giai, V., Crugnola, M., Annunziata, M., Galimberti, S., Iurlo, A., Luciano, L., Sora', Federica, Fava, C., Bestoso, E., Marzano, C., Cartocci, A., Defina, M., Sammartano, V., Cencini, E., Raspadori, D., Bocchia, M., Sora' F. (ORCID:0000-0002-9607-5298), Pacelli, P., Santoni, A., Sicuranza, A., Abruzzese, E., Giai, V., Crugnola, M., Annunziata, M., Galimberti, S., Iurlo, A., Luciano, L., Sora', Federica, Fava, C., Bestoso, E., Marzano, C., Cartocci, A., Defina, M., Sammartano, V., Cencini, E., Raspadori, D., Bocchia, M., and Sora' F. (ORCID:0000-0002-9607-5298)

Abstract

Introduction: In chronic myeloid leukemia (CML), about half of the patients achieving a deep and stable molecular response with tyrosine kinase inhibitors (TKIs) may discontinue TKI treatment without disease recurrence. As such, treatment-free remission (TFR) has become an ambitious goal of treatment. Given the evidence that deepness and duration of molecular response are necessary but not sufficient requisites for a successful TFR, additional biological criteria are needed to identify CML patients suitable for efficacious discontinuation. Leukemia stem cells (LSCs) are supposed to be the reservoir of the disease. Previously, we demonstrated that residual circulating CD34+/CD38-/CD26+ LSCs were still detectable in a consistent number of CML patients during TFR. Methods: CML LSCs could be easily identified by flow-cytometry as they express the CD34+/CD38-/CD26+ phenotype. In this study, we explored the role of these cells and their correlation with molecular response in a cohort of 109 consecutive chronic phase CML patients prospectively monitored from the time of TKI discontinuation. Results: After a median observation time of 33 months from TKI discontinuation, 38/109 (35%) patients failed TFR after a median time of 4 months, while 71/109 (65%) patients are still in TFR. At TKI discontinuation, peripheral blood CD26+LSCs were undetectable in 48/109 (44%) patients and detectable in 61/109 (56%). No statistically significant correlation between detectable/undetectable CD26+LSCs and the rate of TFR loss was found (p = 0.616). The incidence of TFR loss based on the type of TKI treatment was statistically significant for imatinib treatment compared to that of nilotinib (p = 0.039). Exploring the behavior of CD26+LSCs during TFR, we observed fluctuating values that were very variable between patients, and they were not predictive of TFR loss. Discussion: Up to date, our results confirm that CD26+LSCs are detectable at the time of TKI discontinuation and during

Published
2023

15. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, S.F., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, A.M., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, E.M., Luppi, M., Marasca, R., Pogliani, E.M., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, M.C., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, A.M., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., D'Emilio, A., Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., and Rosti, G.

Published
2015
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16. P013 - Topic: AS01-Diagnosis/AS01c-Molecular aberrations (cytogenetic, genetic, gene expression): A CARTOGRAPHY OF UBA1 GENE TESTING, EPIDEMIOLOGY AND CLINICAL-GENOMIC CHARACTERISTICS: THE VEXAS/MDS ITALIAN EXPERIENCE

Author

Gurnari, C., Pascale, M.R., Vitale, A., Diral, E., Galossi, E., Falconi, G., Bruno, A., Crisafulli, F., Frassi, M., Cattaneo, C., Bertoli, D., Bernardi, M., Condorelli, A., Morsia, E., Crisà, E., Triggianese, P., Brussino, L., Battipaglia, G., Bindoli, S., Sfriso, P., Caroni, F., Olivieri, A., Kordasti, S., Albano, F., Pane, F., Musto, P., Bocchia, M., Lugli, E., Rambaldi, A., Greco, R., Franceschini, F., Ciceri, F., Cantarini, L., and Voso, M.T.

Published
2023
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17. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi P, Cattaneo C, Ferretti V, Mina R, Ferreri AJ, Merli F, Oberti M, Krampera M, Romano A, Zerbi C, Ferrari J, Cavo M, Marco Salvini M, Bertù L, Fracchiolla N, Marchesi F, Massaia M, Marasco V, Cairoli R, Scattolin AM, Vannucchi AM, Gambacorti-Passerini C, Musto P, Gherlinzoni F, Cuneo A, Pinto A, Trentin L, Bocchia M, Galimberti, Coviello E, Morotti A, Falini B, Turrin M, Tafuri A, Billio A, Gentile M, Lemoli M, Venditti A, Della Porta M, Lanza F, Rigacci L, Tosi P, Mohamed S, Corso A, Luppi M, Giuliani N, Busca A, Pagano L, Bruno R, Grossi P, Corradini P, Passamonti F, Arcaini L., Zappasodi, P, Cattaneo, C, Ferretti, V, Mina, R, Ferreri, A, Merli, F, Oberti, M, Krampera, M, Romano, A, Zerbi, C, Ferrari, J, Cavo, M, Marco Salvini, M, Bertù, L, Fracchiolla, N, Marchesi, F, Massaia, M, Marasco, V, Cairoli, R, Scattolin, A, Vannucchi, A, Gambacorti-Passerini, C, Musto, P, Gherlinzoni, F, Cuneo, A, Pinto, A, Trentin, L, Bocchia, M, Galimberti, Coviello, E, Mc, Morotti, A, Falini, B, Turrin, M, Tafuri, A, Billio, A, Gentile, M, Lemoli, M, Venditti, A, Della Porta, M, Lanza, F, Rigacci, L, Tosi, P, Mohamed, S, Corso, A, Luppi, M, Giuliani, N, Busca, A, Pagano, L, Bruno, R, Grossi, P, Corradini, P, Passamonti, F, Arcaini, L, Zappasodi, Patrizia, Cattaneo, Chiara, Ferretti, Virginia Valeria, Mina, Roberto, Ferreri, Andrés José María, Merli, Francesco, Oberti, Margherita, Krampera, Mauro, Romano, Alessandra, Zerbi, Caterina, Ferrari, Jacqueline, Cavo, Michele, Salvini, Marco, Bertù, Lorenza, Fracchiolla, Nicola Stefano, Marchesi, Francesco, Massaia, Massimo, Marasco, Vincenzo, Cairoli, Roberto, Scattolin, Anna Maria, Vannucchi, Alessandro Maria, Gambacorti-Passerini, Carlo, Musto, Pellegrino, Gherlinzoni, Filippo, Cuneo, Antonio, Pinto, Antonello, Trentin, Livio, Bocchia, Monica, Galimberti, Sara, Coviello, Elisa, Tisi, Maria Chiara, Morotti, Alessandro, Falini, Brunangelo, Turrini, Mauro, Tafuri, Agostino, Billio, Atto, Gentile, Massimo, Lemoli, Roberto Massimo, Venditti, Adriano, Della Porta, Matteo Giovanni, Lanza, Francesco, Rigacci, Luigi, Tosi, Patrizia, Mohamed, Sara, Corso, Alessandro, Luppi, Mario, Giuliani, Nicola, Busca, Alessandro, Pagano, Livio, Bruno, Raffaele, Grossi, Paolo Antonio, Corradini, Paolo, Passamonti, Francesco, and Arcaini, Luca

Subjects
Cancer Research, Lymphoma, Coinfection, COVID-19, Hematology, General Medicine, Settore MED/15, hematological malignancie, secondary infections, Settore MED/15 - MALATTIE DEL SANGUE, COVID-19 Testing, Oncology, Hematologic Neoplasms, secondary infection, outcome, Humans, hematological malignancies, Aged
Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5-36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

18. COVID-19 elicits an impaired antibody response against SARS-CoV-2 in patients with haematological malignancies

Author

Passamonti, F, Romano, A, Salvini, M, Merli, F, Porta, M, Bruna, R, Coviello, E, Romano, I, Cairoli, R, Lemoli, R, Farina, F, Venditti, A, Busca, A, Ladetto, M, Massaia, M, Pinto, A, Arcaini, L, Tafuri, A, Marchesi, F, Fracchiolla, N, Bocchia, M, Armiento, D, Candoni, A, Krampera, M, Luppi, M, Cardinali, V, Galimberti, S, Cattaneo, C, La Barbera, E, Mina, R, Lanza, F, Visani, G, Musto, P, Petrucci, L, Zaja, F, Grossi, P, Bertu, L, Pagano, L, Corradini, P, Derenzini, E, Marchetti, M, Scattolin, A, Corso, A, Tosi, P, Gherlinzoni, F, Gambacorti Passerini, C, Cavo, M, Fava, C, Turrini, M, Visco, C, Zappasodi, P, Merli, M, Mora, B, Vannucchi, A, Passamonti F., Romano A., Salvini M., Merli F., Porta M. G. D., Bruna R., Coviello E., Romano I., Cairoli R., Lemoli R., Farina F., Venditti A., Busca A., Ladetto M., Massaia M., Pinto A., Arcaini L., Tafuri A., Marchesi F., Fracchiolla N., Bocchia M., Armiento D., Candoni A., Krampera M., Luppi M., Cardinali V., Galimberti S., Cattaneo C., La Barbera E. O., Mina R., Lanza F., Visani G., Musto P., Petrucci L., Zaja F., Grossi P. A., Bertu L., Pagano L., Corradini P., Derenzini E., Marchetti M., Scattolin A. M., Corso A., Tosi P., Gherlinzoni F., Gambacorti Passerini C., Cavo M., Fava C., Turrini M., Visco C., Zappasodi P., Merli M., Mora B., Vannucchi A. M., Passamonti, F, Romano, A, Salvini, M, Merli, F, Porta, M, Bruna, R, Coviello, E, Romano, I, Cairoli, R, Lemoli, R, Farina, F, Venditti, A, Busca, A, Ladetto, M, Massaia, M, Pinto, A, Arcaini, L, Tafuri, A, Marchesi, F, Fracchiolla, N, Bocchia, M, Armiento, D, Candoni, A, Krampera, M, Luppi, M, Cardinali, V, Galimberti, S, Cattaneo, C, La Barbera, E, Mina, R, Lanza, F, Visani, G, Musto, P, Petrucci, L, Zaja, F, Grossi, P, Bertu, L, Pagano, L, Corradini, P, Derenzini, E, Marchetti, M, Scattolin, A, Corso, A, Tosi, P, Gherlinzoni, F, Gambacorti Passerini, C, Cavo, M, Fava, C, Turrini, M, Visco, C, Zappasodi, P, Merli, M, Mora, B, Vannucchi, A, Passamonti F., Romano A., Salvini M., Merli F., Porta M. G. D., Bruna R., Coviello E., Romano I., Cairoli R., Lemoli R., Farina F., Venditti A., Busca A., Ladetto M., Massaia M., Pinto A., Arcaini L., Tafuri A., Marchesi F., Fracchiolla N., Bocchia M., Armiento D., Candoni A., Krampera M., Luppi M., Cardinali V., Galimberti S., Cattaneo C., La Barbera E. O., Mina R., Lanza F., Visani G., Musto P., Petrucci L., Zaja F., Grossi P. A., Bertu L., Pagano L., Corradini P., Derenzini E., Marchetti M., Scattolin A. M., Corso A., Tosi P., Gherlinzoni F., Gambacorti Passerini C., Cavo M., Fava C., Turrini M., Visco C., Zappasodi P., Merli M., Mora B., and Vannucchi A. M.

Abstract

COVID-19 is associated with high mortality in patients with haematological malignancies (HM) and rate of seroconversion is unknown. The ITA-HEMA-COV project (NCT04352556) investigated patterns of seroconversion for SARS-CoV-2 IgG in patients with HMs. A total of 237 patients, SARS-CoV-2 PCR-positive with at least one SARS-CoV-2 IgG test performed during their care, entered the analysis. Among these, 62 (26·2%) had myeloid, 121 (51·1%) lymphoid and 54 (22·8%) plasma cell neoplasms. Overall, 69% of patients (164 of 237) had detectable IgG SARS-CoV-2 serum antibodies. Serologically negative patients (31%, 73 of 237) were evenly distributed across patients with myeloid, lymphoid and plasma cell neoplasms. In the multivariable logistic regression, chemoimmunotherapy [odds ratio (OR), 3·42; 95% confidence interval (CI), 1·04–11·21; P = 0·04] was associated with a lower rate of seroconversion. This effect did not decline after 180 days from treatment withdrawal (OR, 0·35; 95% CI: 0·11–1·13; P = 0·08). This study demonstrates a low rate of seroconversion in HM patients and indicates that treatment-mediated immune dysfunction is the main driver. As a consequence, we expect a low rate of seroconversion after vaccination and thus we suggest testing the efficacy of seroconversion in HM patients.

Published
2021

19. Fludarabine, high-dose cytarabine and idarubicin-based induction may overcome the negative prognostic impact of flt3-itd in npm1 mutated aml, irrespectively of flt3-itd allelic Burden

Author

Minetto, P, Candoni, A, Guolo, F, Clavio, M, Zannier, M, Miglino, M, Dubbini, M, Carminati, E, Sicuranza, A, Ciofini, S, Colombo, N, Pugliese, G, Marcolin, R, Santoni, A, Ballerini, F, Lanino, L, Cea, M, Gobbi, M, Bocchia, M, Fanin, R, Lemoli, R, Minetto P., Candoni A., Guolo F., Clavio M., Zannier M. E., Miglino M., Dubbini M. V., Carminati E., Sicuranza A., Ciofini S., Colombo N., Pugliese G., Marcolin R., Santoni A., Ballerini F., Lanino L., Cea M., Gobbi M., Bocchia M., Fanin R., Lemoli R. M., Minetto, P, Candoni, A, Guolo, F, Clavio, M, Zannier, M, Miglino, M, Dubbini, M, Carminati, E, Sicuranza, A, Ciofini, S, Colombo, N, Pugliese, G, Marcolin, R, Santoni, A, Ballerini, F, Lanino, L, Cea, M, Gobbi, M, Bocchia, M, Fanin, R, Lemoli, R, Minetto P., Candoni A., Guolo F., Clavio M., Zannier M. E., Miglino M., Dubbini M. V., Carminati E., Sicuranza A., Ciofini S., Colombo N., Pugliese G., Marcolin R., Santoni A., Ballerini F., Lanino L., Cea M., Gobbi M., Bocchia M., Fanin R., and Lemoli R. M.

Abstract

The mutations of NPM1 and FLT3-ITD represent the most frequent genetic aberration in acute myeloid leukemia. Indeed, the presence of an NPM1 mutation reduces the negative prognostic impact of FLT3-ITD in patients treated with conventional “3+7” induction. However, little information is available on their prognostic role with intensified regimens. Here, we investigated the efficacy of a fludarabine, high-dose cytarabine and idarubicin induction (FLAI) in 149 consecutive fit AML patients (median age 52) carrying the NPM1 and/or FLT3-ITD mutation, treated from 2008 to 2018. One-hundred-and-twenty-nine patients achieved CR (86.6%). After a median follow up of 68 months, 3-year overall survival was 58.6%. Multivariate analysis disclosed that both NPM1mut (p < 0.05) and ELN 2017 risk score (p < 0.05) were significant predictors of survival. NPM1-mutated patients had a favorable outcome, with no significant differences between patients with or without concomitant FLT3-ITD (p = 0.372), irrespective of FLT3-ITD allelic burden. Moreover, in landmark analysis, performing allogeneic transplantation (HSCT) in first CR proved to be beneficial only in ELN 2017 high-risk patients. Our data indicate that FLAI exerts a strong anti-leukemic effect in younger AML patients with NPM1mut and question the role of HSCT in 1st CR in NPM1mut patients with concomitant FLT3-ITD.

Published
2021

20. S113: NATIONAL PEGASPARGASE-MODIFIED RISK-ORIENTED PROGRAM FOR PHILADELPHIA-NEGATIVE ADULT ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (PH− ALL/LL). GIMEMA LAL 1913 FINAL RESULTS.

Author

Bassan, R., primary, Chiaretti, S., additional, Della Starza, I., additional, Spinelli, O., additional, Santoro, A., additional, Elia, L., additional, De Propris, M. S., additional, Scattolin, A. M., additional, Paoloni, F., additional, Messina, M., additional, Audisio, E., additional, Marbello, L., additional, Borlenghi, E., additional, Zappasodi, P., additional, Vetro, C., additional, Martinelli, G., additional, Mattei, D., additional, Fracchiolla, N., additional, Bocchia, M., additional, De Fabritiis, P., additional, Bonifacio, M., additional, Candoni, A., additional, Cassibba, V., additional, Di Bartolomeo, P., additional, Latte, G., additional, Trappolini, S., additional, Guarini, A., additional, Vitale, A., additional, Fazi, P., additional, Vignetti, M., additional, Rambaldi, A., additional, and Foà, R., additional

Published
2022
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21. S244: EFFECT OF ANTI-SPIKE NEUTRALIZING MONOCLONAL ANTIBODIES ON COVID-19 PROGRESSION AND TIME TO VIRAL CLEARANCE IN PATIENTS WITH HEMATOLOGICAL MALIGNANCIES AND SARS-COV-2 INFECTION: THE GIMEMA EXPERIENCE

Author

Marasco, V., primary, Guidetti, A., additional, Piciocchi, A., additional, Candoni, A., additional, Bocchia, M., additional, Bruna, R., additional, Musto, P., additional, Visentin, A., additional, Turrini, M., additional, Tucci, A., additional, Selleri, C., additional, Crea, E., additional, Fazi, P., additional, Passamonti, F., additional, and Corradini, P., additional

Published
2022
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22. P1010: RUXOLITINIB IN MYELODEPLETIVE MYELOFIBROSIS: RESPONSE, TOXICITY, AND OUTCOME

Author

Palandri, F., primary, Bartoletti, D., additional, Breccia, M., additional, Auteri, G., additional, Elli, E. M., additional, Trawinska, M. M., additional, Polverelli, N., additional, Tiribelli, M., additional, Benevolo, G., additional, Iurlo, A., additional, Tieghi, A., additional, Heidel, F. H., additional, Caocci, G., additional, Beggiato, E., additional, Binotto, G., additional, Cavazzini, F., additional, Miglino, M., additional, Bosi, C., additional, Crugnola, M., additional, Bocchia, M., additional, Martino, B., additional, Pugliese, N., additional, Romagnoli, A. D., additional, Mazzoni, C., additional, Scaffidi, L., additional, Isidori, A., additional, Cattaneo, D., additional, Krampera, M., additional, Pane, F., additional, Cilloni, D., additional, Semenzato, G., additional, Lemoli, R. M., additional, Cuneo, A., additional, Abruzzese, E., additional, Vianelli, N., additional, Cavo, M., additional, Bonifacio, M., additional, and Palumbo, G. A., additional

Published
2022
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23. P698: BOSUTINIB DOSE OPTIMIZATION IN THE SECOND-LINE TREATMENT OF ELDERLY CML PATIENTS: EXTENDED 3-YEAR FOLLOW-UP AND FINAL RESULTS OF THE BEST STUDY

Author

Castagnetti, F., primary, Bocchia, M., additional, Abruzzese, E., additional, Capodanno, I., additional, Bonifacio, M., additional, Rege Cambrin, G., additional, Crugnola, M., additional, Binotto, G., additional, Elena, C., additional, Lucchesi, A., additional, Bergamaschi, M., additional, Albano, F., additional, Luciano, L., additional, Sorà, F., additional, Lunghi, F., additional, Stagno, F., additional, Cerrano, M., additional, Iurlo, A., additional, Scortechini, A. R., additional, Leonetti Crescenzi, S., additional, Spadano, R., additional, Trabacchi, E., additional, Lunghi, M., additional, Spinosa, G., additional, Ferrero, D., additional, Rapezzi, D., additional, Ladetto, M., additional, Nocilli, L., additional, Gugliotta, G., additional, Iezza, M., additional, Cavo, M., additional, Saglio, G., additional, Pane, F., additional, and Rosti, G., additional

Published
2022
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24. P1011: PREDICTORS OF COVID-19 DISEASE AND SURVIVAL TO COVID-19 IN MPN PATIENTS TREATED WITH RUXOLITINIB

Author

Palandri, F., primary, Bartoletti, D., additional, Elli, E. M., additional, Auteri, G., additional, Bonifacio, M., additional, Benevolo, G., additional, Heidel, F., additional, Trawinska, M. M., additional, Rossi, E., additional, Bosi, C., additional, Tieghi, A., additional, Tiribelli, M., additional, Iurlo, A., additional, Polverelli, N., additional, Caocci, G., additional, Binotto, G., additional, Cavazzini, F., additional, Beggiato, E., additional, Cilloni, D., additional, Tatarelli, C., additional, Mendicino, F., additional, Miglino, M., additional, Bocchia, M., additional, Crugnola, M., additional, Mazzoni, C., additional, Romagnoli, A. D., additional, Rindone, G., additional, Ceglie, S., additional, D’Addio, A., additional, Santoni, E., additional, Cattaneo, D., additional, Lemoli, R. M., additional, Krampera, M., additional, Cuneo, A., additional, Semenzato, G., additional, Latagliata, R., additional, Abruzzese, E., additional, Vianelli, N., additional, Cavo, M., additional, Andriani, A., additional, De Stefano, V., additional, Palumbo, G., additional, and Breccia, M., additional

Published
2022
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25. A retrospective analysis about frequency of monitoring in italian chronic myeloid leukemia patients after discontinuation

Author

Dragani, M, Cambrin, G, Berchialla, P, Dogliotti, I, Rosti, G, Castagnetti, F, Capodanno, I, Martino, B, Cerrano, M, Ferrero, D, Gambacorti Passerini, C, Crugnola, M, Elena, C, Breccia, M, Iurlo, A, Cattaneo, D, Galimberti, S, Gozzini, A, Bocchia, M, Lunghi, F, Cedrone, M, Sgherza, N, Luciano, L, Russo, S, Santoro, M, Giai, V, Caocci, G, Levato, L, Abruzzese, E, Sora, F, Saglio, G, Fava, C, Dragani M., Cambrin G. R., Berchialla P., Dogliotti I., Rosti G., Castagnetti F., Capodanno I., Martino B., Cerrano M., Ferrero D., Gambacorti Passerini C., Crugnola M., Elena C., Breccia M., Iurlo A., Cattaneo D., Galimberti S., Gozzini A., Bocchia M., Lunghi F., Cedrone M., Sgherza N., Luciano L., Russo S., Santoro M., Giai V., Caocci G., Levato L., Abruzzese E., Sora F., Saglio G., Fava C., Dragani, M, Cambrin, G, Berchialla, P, Dogliotti, I, Rosti, G, Castagnetti, F, Capodanno, I, Martino, B, Cerrano, M, Ferrero, D, Gambacorti Passerini, C, Crugnola, M, Elena, C, Breccia, M, Iurlo, A, Cattaneo, D, Galimberti, S, Gozzini, A, Bocchia, M, Lunghi, F, Cedrone, M, Sgherza, N, Luciano, L, Russo, S, Santoro, M, Giai, V, Caocci, G, Levato, L, Abruzzese, E, Sora, F, Saglio, G, Fava, C, Dragani M., Cambrin G. R., Berchialla P., Dogliotti I., Rosti G., Castagnetti F., Capodanno I., Martino B., Cerrano M., Ferrero D., Gambacorti Passerini C., Crugnola M., Elena C., Breccia M., Iurlo A., Cattaneo D., Galimberti S., Gozzini A., Bocchia M., Lunghi F., Cedrone M., Sgherza N., Luciano L., Russo S., Santoro M., Giai V., Caocci G., Levato L., Abruzzese E., Sora F., Saglio G., and Fava C.

Abstract

Successful discontinuation of tyrosine kinase inhibitors has been achieved in patients with chronic-phase chronic myeloid leukemia (CML). Careful molecular monitoring after discontinuation warrants safe and prompt resumption of therapy. We retrospectively evaluated how molecular monitoring has been conducted in Italy in a cohort of patients who discontinued tyrosine kinase inhibitor (TKI) treatment per clinical practice. The outcome of these patients has recently been reported—281 chronic-phase CML patients were included in this subanalysis. Median follow-up since discontinuation was 2 years. Overall, 2203 analyses were performed, 17.9% in the first three months and 38.4% in the first six months. Eighty-six patients lost major molecular response (MMR) in a mean time of 5.7 months—65 pts (75.6%) during the first six months. We evaluated the number of patients who would experience a delay in diagnosis of MMR loss if a three-month monitoring schedule was adopted. In the first 6 months, 19 pts (29.2%) would have a one-month delay, 26 (40%) a 2-month delay. Very few patients would experience a delay in the following months. A less intense frequency of monitoring, particularly after the first 6 months off treatment, would not have affected the success of treatment-free remission (TFR) nor put patients at risk of progression.

Published
2020

26. Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study

Author

Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta, M, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, M, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, A, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, A, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, P, Bertu, L, Corrao, G, Pagano, L, Corradini, P, Passamonti F., Cattaneo C., Arcaini L., Bruna R., Cavo M., Merli F., Angelucci E., Krampera M., Cairoli R., Della Porta M. G., Fracchiolla N., Ladetto M., Gambacorti Passerini C., Salvini M., Marchetti M., Lemoli R., Molteni A., Busca A., Cuneo A., Romano A., Giuliani N., Galimberti S., Corso A., Morotti A., Falini B., Billio A., Gherlinzoni F., Visani G., Tisi M. C., Tafuri A., Tosi P., Lanza F., Massaia M., Turrini M., Ferrara F., Gurrieri C., Vallisa D., Martelli M., Derenzini E., Guarini A., Conconi A., Cuccaro A., Cudillo L., Russo D., Ciambelli F., Scattolin A. M., Luppi M., Selleri C., Ortu La Barbera E., Ferrandina C., Di Renzo N., Olivieri A., Bocchia M., Gentile M., Marchesi F., Musto P., Federici A. B., Candoni A., Venditti A., Fava C., Pinto A., Galieni P., Rigacci L., Armiento D., Pane F., Oberti M., Zappasodi P., Visco C., Franchi M., Grossi P. A., Bertu L., Corrao G., Pagano L., Corradini P., Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta, M, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, M, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, A, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, A, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, P, Bertu, L, Corrao, G, Pagano, L, Corradini, P, Passamonti F., Cattaneo C., Arcaini L., Bruna R., Cavo M., Merli F., Angelucci E., Krampera M., Cairoli R., Della Porta M. G., Fracchiolla N., Ladetto M., Gambacorti Passerini C., Salvini M., Marchetti M., Lemoli R., Molteni A., Busca A., Cuneo A., Romano A., Giuliani N., Galimberti S., Corso A., Morotti A., Falini B., Billio A., Gherlinzoni F., Visani G., Tisi M. C., Tafuri A., Tosi P., Lanza F., Massaia M., Turrini M., Ferrara F., Gurrieri C., Vallisa D., Martelli M., Derenzini E., Guarini A., Conconi A., Cuccaro A., Cudillo L., Russo D., Ciambelli F., Scattolin A. M., Luppi M., Selleri C., Ortu La Barbera E., Ferrandina C., Di Renzo N., Olivieri A., Bocchia M., Gentile M., Marchesi F., Musto P., Federici A. B., Candoni A., Venditti A., Fava C., Pinto A., Galieni P., Rigacci L., Armiento D., Pane F., Oberti M., Zappasodi P., Visco C., Franchi M., Grossi P. A., Bertu L., Corrao G., Pagano L., and Corradini P.

Abstract

Background: Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. Methods: This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. Findings: We enrolled 536 patients with a median follow-up of 20 days (IQR 10–34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77–2·34) in our whole study cohort and 3·72 (2·86–4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1–44·9). Older age (hazard ratio 1·03, 95% CI 1·01–1·05); progressive disease status (2·10, 1·41–3·12); diagnosis of

Published
2020

27. Secondary infections worsen the outcome of COVID-19 in patients with hematological malignancies: A report from the ITA-HEMA-COV

Author

Zappasodi, P., Cattaneo, C., Valeria Ferretti, V., Mina, R., Jose Maria Ferreri, A., Merli, F., Oberti, M., Krampera, M., Romano, A., Zerbi, C., Ferrari, J., Cavo, M., Salvini, M., Bertu, L., Stefano Fracchiolla, N., Marchesi, F., Massaia, M., Marasco, V., Cairoli, R., Maria Scattolin, A., Maria Vannucchi, A., Gambacorti-Passerini, C., Musto, P., Gherlinzoni, F., Cuneo, A., Pinto, A., Trentin, L., Bocchia, M., Galimberti, S., Coviello, E., Chiara Tisi, M., Morotti, A., Falini, B., Turrini, M., Tafuri, A., Billio, A., Gentile, M., Massimo Lemoli, R., Venditti, A., Giovanni Della Porta, M., Lanza, F., Rigacci, L., Tosi, P., Mohamed, S., Corso, A., Luppi, M., Giuliani, N., Busca, A., Pagano, Livio, Bruno, R., Antonio Grossi, P., Corradini, P., Passamonti, F., Arcaini, L., Pagano L. (ORCID:0000-0001-8287-928X), Zappasodi, P., Cattaneo, C., Valeria Ferretti, V., Mina, R., Jose Maria Ferreri, A., Merli, F., Oberti, M., Krampera, M., Romano, A., Zerbi, C., Ferrari, J., Cavo, M., Salvini, M., Bertu, L., Stefano Fracchiolla, N., Marchesi, F., Massaia, M., Marasco, V., Cairoli, R., Maria Scattolin, A., Maria Vannucchi, A., Gambacorti-Passerini, C., Musto, P., Gherlinzoni, F., Cuneo, A., Pinto, A., Trentin, L., Bocchia, M., Galimberti, S., Coviello, E., Chiara Tisi, M., Morotti, A., Falini, B., Turrini, M., Tafuri, A., Billio, A., Gentile, M., Massimo Lemoli, R., Venditti, A., Giovanni Della Porta, M., Lanza, F., Rigacci, L., Tosi, P., Mohamed, S., Corso, A., Luppi, M., Giuliani, N., Busca, A., Pagano, Livio, Bruno, R., Antonio Grossi, P., Corradini, P., Passamonti, F., Arcaini, L., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

The impact of secondary infections (SI) on COVID-19 outcome in patients with hematological malignancies (HM) is scarcely documented. To evaluate incidence, clinical characteristics, and outcome of SI, we analyzed the microbiologically documented SI in a large multicenter cohort of adult HM patients with COVID-19. Among 1741 HM patients with COVID-19, 134 (7.7%) had 185 SI, with a 1-month cumulative incidence of 5%. Median time between COVID-19 diagnosis and SI was 16 days (IQR: 5–36). Acute myeloid leukemia (AML) and lymphoma/plasma cell neoplasms (PCN) were more frequent diagnoses in SI patients compared to patients without SI (AML: 14.9% vs. 7.1%; lymphoma/PCN 71.7% vs. 65.3%). Patients with SI were older (median age 70 vs. 66 years, p = 0.002), with more comorbidities (median Charlson Comorbidity Index 5 vs. 4, p < 0.001), higher frequency of critical COVID-19 (19.5% vs. 11.5%, p = 0.046), and more frequently not in complete remission (75% vs. 64.7% p = 0.024). Blood and bronchoalveolar lavage were the main sites of isolation for SI. Etiology of infections was bacterial in 80% (n = 148) of cases, mycotic in 9.7% (n = 18) and viral in 10.3% (n = 19); polymicrobial infections were observed in 24 patients (18%). Escherichia coli represented most of Gram-negative isolates (18.9%), while coagulase-negative Staphylococci were the most frequent among Gram-positive (14.2%). The 30-day mortality of patients with SI was higher when compared to patients without SI (69% vs. 15%, p < 0.001). The occurrence of SI worsened COVID-19 outcome in HM patients. Timely diagnosis and adequate management should be considered to improve their prognosis.

Published
2022

28. Neutralizing monoclonal antibodies in haematological patients paucisymptomatic for COVID-19: The GIMEMA EMATO-0321 study

Author

Marasco, V., Piciocchi, A., Candoni, A., Pagano, Livio, Guidetti, A., Musto, P., Bruna, R., Bocchia, M., Visentin, A., Turrini, M., Tucci, A., Pilerci, S., Fianchi, Luana, Salvini, M., Galimberti, S., Coviello, E., Selleri, C., Luppi, M., Crea, E., Fazi, P., Passamonti, F., Corradini, P., Pagano L. (ORCID:0000-0001-8287-928X), Fianchi L., Marasco, V., Piciocchi, A., Candoni, A., Pagano, Livio, Guidetti, A., Musto, P., Bruna, R., Bocchia, M., Visentin, A., Turrini, M., Tucci, A., Pilerci, S., Fianchi, Luana, Salvini, M., Galimberti, S., Coviello, E., Selleri, C., Luppi, M., Crea, E., Fazi, P., Passamonti, F., Corradini, P., Pagano L. (ORCID:0000-0001-8287-928X), and Fianchi L.

Abstract

COVID-19 continues to be a relevant issue among patients with haematological malignancies (HM). Vaccines are frequently not effective in subjects on active treatment. In this multicentre retrospective study of Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), we collected data from 91 paucisymptomatic HM patients treated with anti-spike neutralizing monoclonal antibodies (nMoAbs) to determine time to viral clearance, referencing it to the expected value of 28 days from an historical group of untreated paucisymptomatic patients. Secondary endpoints included rate of hospitalization, intensive care unit (ICU) admission, COVID-19 related death and safety. SARS-CoV-2 molecular swab negativity was obtained in 86 patients (95%), with a median time of 18 days (IQR 13–26; p < 0.0001). We did not find significant variations according to age, diagnosis, treatment type, vaccination status or nMoAbs type. Rate of hospitalization due to COVID-19 progression was 12% (11/91), with 2 patients (2.2%) requiring ICU admission. With a median follow-up of 2.33 months, the overall mortality was 5.5% (5/91), with 3 deaths due to COVID-19. Side effects were rare and self-limiting. Our data suggest that nMoAbs can limit the detrimental effect of immunosuppressive treatments on COVID-19 clinical progression and time to viral clearance. The original trial was registered at www.clinicaltrials.gov as #NCT04932967.

Published
2022

29. 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

30. Development and implementation of the AIDA International Registry for patients with VEXAS syndrome

Author

Vitale, A, Caggiano, V, Della Casa, F, Hernández-Rodríguez, J, Frassi, M, Monti, S, Tufan, A, Telesca, S, Conticini, E, Ragab, G, Lopalco, G, Almaghlouth, I, Pereira, Rmr, Yildirim, D, Cattalini, M, Marino, A, Giani, T, La Torre, F, Ruscitti, P, Aragona, E, Wiesik-Szewczyk, E, Del Giudice, E, Sfikakis, Pp, Govoni, M, Emmi, G, Maggio, Mc, Giacomelli, R, Ciccia, F, Conti, Giorgio, Ait-Idir, D, Lomater, C, Sabato, V, Piga, M, Sahin, A, Opris-Belinski, D, Ionescu, R, Bartoloni, E, Franceschini, F, Parronchi, P, de Paulis, A, Espinosa, G, Maier, A, Sebastiani, Gd, Insalaco, A, Shahram, F, Sfriso, P, Minoia, F, Alessio, M, Makowska, J, Hatemi, G, Akkoç, N, Li Gobbi, F, Gidaro, A, Olivieri, An, Al-Mayouf, Sm, Erten, S, Gentileschi, S, Vasi, I, Tarsia, M, Mahmoud, Aaa, Frediani, B, Fares Alzahrani, M, Laymouna, Ah, Ricci, F, Cardinale, F, Jahnz-Rózyk, K, Tosi, Gm, Crisafulli, F, Balistreri, A, Dagostin, Ma, Ghanema, M, Gaggiano, C, Sota, J, Di Cola, I, Fabiani, C, Giardini, Ham, Renieri, A, Fabbiani, A, Carrer, A, Bocchia, M, Caroni, F, Rigante, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), Rigante D (ORCID:0000-0001-7032-7779), Vitale, A, Caggiano, V, Della Casa, F, Hernández-Rodríguez, J, Frassi, M, Monti, S, Tufan, A, Telesca, S, Conticini, E, Ragab, G, Lopalco, G, Almaghlouth, I, Pereira, Rmr, Yildirim, D, Cattalini, M, Marino, A, Giani, T, La Torre, F, Ruscitti, P, Aragona, E, Wiesik-Szewczyk, E, Del Giudice, E, Sfikakis, Pp, Govoni, M, Emmi, G, Maggio, Mc, Giacomelli, R, Ciccia, F, Conti, Giorgio, Ait-Idir, D, Lomater, C, Sabato, V, Piga, M, Sahin, A, Opris-Belinski, D, Ionescu, R, Bartoloni, E, Franceschini, F, Parronchi, P, de Paulis, A, Espinosa, G, Maier, A, Sebastiani, Gd, Insalaco, A, Shahram, F, Sfriso, P, Minoia, F, Alessio, M, Makowska, J, Hatemi, G, Akkoç, N, Li Gobbi, F, Gidaro, A, Olivieri, An, Al-Mayouf, Sm, Erten, S, Gentileschi, S, Vasi, I, Tarsia, M, Mahmoud, Aaa, Frediani, B, Fares Alzahrani, M, Laymouna, Ah, Ricci, F, Cardinale, F, Jahnz-Rózyk, K, Tosi, Gm, Crisafulli, F, Balistreri, A, Dagostin, Ma, Ghanema, M, Gaggiano, C, Sota, J, Di Cola, I, Fabiani, C, Giardini, Ham, Renieri, A, Fabbiani, A, Carrer, A, Bocchia, M, Caroni, F, Rigante, Donato, Cantarini, L, Conti G (ORCID:0000-0002-8566-9365), and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: The aim of this paper is to present the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic (VEXAS) syndrome, describing its design, construction, and modalities of dissemination. Methods: The present registry is a clinical, physician-driven, population- and electronic-based instrument designed for the retrospective and prospective collection of real-life data. Data gathering is based on the Research Electronic Data Capture (REDCap) tool and is intended to obtain real-world evidence for daily patients’ management; the registry may potentially communicate with other on-line tools dedicated to VEXAS syndrome, enhancing international collaboration and data sharing for research purposes. The registry is handy enough to be easily modified to meet future needs regarding VEXAS syndrome. Results: To date (April 2022), 105 Centers from 23 Countries in 4 continents have been involved; 287 users (106 Principal Investigators, 177 Site Investigators, 2 Lead Investigators, and 2 data managers) may already enter the registry for data collection and sharing. The registry includes 4950 fields organised into 18 instruments designed to fully describe patient’s details about demographics, clinical manifestations, symptoms, histologic details about skin and bone marrow biopsies and aspirate, laboratory features, complications, comorbidities, therapies, and healthcare access. Conclusions: This international Registry for patients with VEXAS syndrome will allow the achievement of a comprehensive knowledge about this new disease in a relatively short time with the final goal to obtain real-world evidence data for daily clinical practice. This project can be found on https://clinicaltrials.gov NCT 05200715

Published
2022

31. Development and implementation of the AIDA International Registry for patients with Schnitzler’s syndrome

Author

Sota, J, Vitale, A, Więsik-Szewczyk, E, Frassi, M, Lopalco, G, Emmi, G, Govoni, M, de Paulis, A, Marino, A, Gidaro, A, Monti, S, Opris-Belinski, D, Pereira, Rmr, Jahnz-Rózyk, K, Gaggiano, C, Crisafulli, F, Iannone, F, Mattioli, I, Ruffilli, F, Mormile, I, Rybak, K, Caggiano, V, Airò, P, Tufan, A, Gentileschi, S, Ragab, G, Almaghlouth, Ia, Aboul-Fotouh Khalil, A, Cattalini, M, La Torre, F, Tarsia, M, Giardini, Ham, Ali Saad, M, Bocchia, M, Caroni, F, Giani, T, Cinotti, E, Ruscitti, P, Rubegni, P, Dagostin, Ma, Frediani, B, Guler, Aa, Della Casa, F, Maggio, Mc, Recke, A, von Bubnoff, D, Krause, K, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, Rigante D (ORCID:0000-0001-7032-7779), Sota, J, Vitale, A, Więsik-Szewczyk, E, Frassi, M, Lopalco, G, Emmi, G, Govoni, M, de Paulis, A, Marino, A, Gidaro, A, Monti, S, Opris-Belinski, D, Pereira, Rmr, Jahnz-Rózyk, K, Gaggiano, C, Crisafulli, F, Iannone, F, Mattioli, I, Ruffilli, F, Mormile, I, Rybak, K, Caggiano, V, Airò, P, Tufan, A, Gentileschi, S, Ragab, G, Almaghlouth, Ia, Aboul-Fotouh Khalil, A, Cattalini, M, La Torre, F, Tarsia, M, Giardini, Ham, Ali Saad, M, Bocchia, M, Caroni, F, Giani, T, Cinotti, E, Ruscitti, P, Rubegni, P, Dagostin, Ma, Frediani, B, Guler, Aa, Della Casa, F, Maggio, Mc, Recke, A, von Bubnoff, D, Krause, K, Balistreri, A, Fabiani, C, Rigante, Donato, Cantarini, L, and Rigante D (ORCID:0000-0001-7032-7779)

Abstract

Objective: The present paper describes the design, development, and implementation of the AutoInflammatory Disease Alliance (AIDA) International Registry specifically dedicated to patients with Schnitzler syndrome. Methods: This is a clinical physician-driven, population- and electronic-based registry implemented for the retrospective and prospective collection of real-life data from patients with Schnitzler’s syndrome; the registry is based on the Research Electronic Data Capture (REDCap) tool, which is thought to collect standardised information for clinical research, and has been realised to change over time according to future scientific acquisitions and potentially communicate with other existing or future similar registries. Results: Since its launch, 112 centres from 23 countries in 4 continents have been involved. Fifty-four have already obtained the approval from their local Ethics Committees. The platform counts 303 users (113 Principal Investigators, 186 Site Investigators, 2 Lead Investigators, and 2 data managers) at current (April 12th 2022). The registry collects baseline and follow-up data using 3922 fields organised into 25 instruments, including patient’s demographics, history, clinical manifestations and symptoms, trigger/risk factors, laboratory, instrumental exams, therapies, socioeconomic information, and healthcare access. Conclusions: This International Registry for patients with Schnitzler syndrome facilitates standardised data collection, enabling international collaborative projects through data sharing and dissemination of knowledge; in turn, it will shed light into many blind spots characterizing this complex autoinflammatory disorder

Published
2022

32. INCB84344-201: Ponatinib and steroids in frontline therapy for unfit patients with Ph1 acute lymphoblastic leukemia

Author

Martinelli, G., Papayannidis, C., Piciocchi, A., Robustelli, V., Soverini, S., Terragna, C., Marconi, G., Lemoli, R. M., Guolo, F., Fornaro, A., Lunghi, M., de Fabritiis, P., Candoni, A., Selleri, C., Simonetti, F., Bocchia, M., Vitale, A., Frison, L., Tedeschi, A., Cuneo, A., Bonifacio, M., Martelli, M. P., D'Ardia, S., Trappolini, S., Tosi, P., Galieni, P., Fabbiano, F., Abbenante, M. C., Granier, M., Zhu, Z., Wang, M., Sartor, C., Paolini, S., Cavo, M., Foa, R., Fazi, P., Vignetti, M., and Baccarani, M.

Published
2022

33. Observational study of chronic myeloid leukemia italian patients who discontinued tyrosine kinase inhibitors in clinical practice

Author

Fava, C, Rege-Cambrin, G, Dogliotti, I, Cerrano, M, Berchialla, P, Dragani, M, Rosti, G, Castagnetti, F, Gugliotta, G, Martino, B, Gambacorti-Passerini, C, Abruzzese, E, Elena, C, Pregno, P, Gozzini, A, Capodanno, I, Bergamaschi, M, Crugnola, M, Bocchia, M, Galimberti, S, Rapezzi, D, Iurlo, A, Cattaneo, D, Latagliata, R, Breccia, M, Cedrone, M, Santoro, M, Annunziata, M, Levato, L, Stagno, F, Cavazzini, F, Sgherza, N, Giai, V, Luciano, L, Russo, S, Musto, P, Caocci, G, Sora, F, Iuliano, F, Lunghi, F, Specchia, G, Pane, F, Ferrero, D, Baccarani, M, Saglio, G, Fava C., Rege-Cambrin G., Dogliotti I., Cerrano M., Berchialla P., Dragani M., Rosti G., Castagnetti F., Gugliotta G., Martino B., Gambacorti-Passerini C., Abruzzese E., Elena C., Pregno P., Gozzini A., Capodanno I., Bergamaschi M., Crugnola M., Bocchia M., Galimberti S., Rapezzi D., Iurlo A., Cattaneo D., Latagliata R., Breccia M., Cedrone M., Santoro M., Annunziata M., Levato L., Stagno F., Cavazzini F., Sgherza N., Giai V., Luciano L., Russo S., Musto P., Caocci G., Sora F., Iuliano F., Lunghi F., Specchia G., Pane F., Ferrero D., Baccarani M., Saglio G., Fava, C, Rege-Cambrin, G, Dogliotti, I, Cerrano, M, Berchialla, P, Dragani, M, Rosti, G, Castagnetti, F, Gugliotta, G, Martino, B, Gambacorti-Passerini, C, Abruzzese, E, Elena, C, Pregno, P, Gozzini, A, Capodanno, I, Bergamaschi, M, Crugnola, M, Bocchia, M, Galimberti, S, Rapezzi, D, Iurlo, A, Cattaneo, D, Latagliata, R, Breccia, M, Cedrone, M, Santoro, M, Annunziata, M, Levato, L, Stagno, F, Cavazzini, F, Sgherza, N, Giai, V, Luciano, L, Russo, S, Musto, P, Caocci, G, Sora, F, Iuliano, F, Lunghi, F, Specchia, G, Pane, F, Ferrero, D, Baccarani, M, Saglio, G, Fava C., Rege-Cambrin G., Dogliotti I., Cerrano M., Berchialla P., Dragani M., Rosti G., Castagnetti F., Gugliotta G., Martino B., Gambacorti-Passerini C., Abruzzese E., Elena C., Pregno P., Gozzini A., Capodanno I., Bergamaschi M., Crugnola M., Bocchia M., Galimberti S., Rapezzi D., Iurlo A., Cattaneo D., Latagliata R., Breccia M., Cedrone M., Santoro M., Annunziata M., Levato L., Stagno F., Cavazzini F., Sgherza N., Giai V., Luciano L., Russo S., Musto P., Caocci G., Sora F., Iuliano F., Lunghi F., Specchia G., Pane F., Ferrero D., Baccarani M., and Saglio G.

Abstract

It is judged safe to discontinue treatment with tyrosine kinase inhibitors (TKI) for chronic myeloid leukemia (CML) in experimental trials on treatment-free remission (TFR). We collected a total of 293 Italian patients with chronic phase CML who discontinued TKI in deep molecular response. Seventy-two percent of patients were on treatment with imatinib, and 28% with second generation TKI at the time of discontinuation. Median duration of treatment with the last TKI was 77 months [Interquartile Range (IQR) 54;111], median duration of deep molecular response was 46 months (IQR 31;74). Duration of treatment with TKI and duration of deep molecular response were shorter with second generation TKI than with imatinib (P<0.001). Eighty-eight percent of patients discontinued as per clinical practice, and reasons for stopping treatment were: toxicity (20%), pregnancy (6%), and shared decision between treating physician and patient (62%). After a median follow up of 34 months (range, 12-161) overall estimated TFR was 62% (95%CI: 56;68). At 12 months, TFR was 68% (95%CI: 62;74) for imatinib, 73% (95%CI: 64;83) for second generation TKI. Overall median time to restart treatment was six months (IQR 4;11). No progressions occurred. Although our study has the limitation of a retrospective study, our experience within the Italian population confirms that discontinuation of imatinib and second generation TKI is feasible and safe in clinical practice

Published
2019

34. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

Castagnetti, F., Gugliotta, G., Baccarani, M., Breccia, M., Specchia, G., Levato, L., Abruzzese, E., Rossi, G., Iurlo, A., Martino, B., Pregno, P., Stagno, F., Cuneo, A., Bonifacio, M., Gobbi, M., Russo, D., Gozzini, A., Tiribelli, M., de Vivo, A., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Salvi, F., Pini, M., Leoni, P., Rupoli, S., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Albano, F., Russo Rossi, A., Rambaldi, A., Intermesoli, T., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, MT., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Malagola, M., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., Storti, S., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Impera, S., Molica, S., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cavazzini, F., Bosi, A., Santini, V., Capalbo, SF., Spinosa, G., Pierri, I., Bergamaschi, M., Carella, AM., Bacigalupo, A., De Blasio, A., Ciccone, F., Di Renzo, N., Musolino, C., Russo, S., Cortelezzi, A., Morra, E., Pungolino, EM., Luppi, M., Marasca, R., Pogliani, EM., Gambacorti-Passerini, C., Luciano, L., Ferrara, F., Annunziata, M., Latte, G., Noli, D., Rege-Cambrin, G., Fava, C., Semenzato, G., Binotto, G., Fabbiano, F., Turri, D., Siragusa, S., Caracciolo, C., Musso, M., Porretto, F., Aversa, F., Crugnola, M., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidori, A., Fioritoni, G., Di Lorenzo, R., Vallisa, D., Trabacchi, E., Petrini, M., Galimberti, S., Pizzuti, M., Zaccaria, A., Salvucci, M., Ronco, F., Ielo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Musto, P., De Stefano, V., Sica, S., Latagliata, R., De Fabritiis, P., Trawiska, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Petti, MC., Pisani, F., Tafuri, A., Montefusco, E., Iuliano, F., Dore, F., Pardini, S., Bocchia, M., Defina, M., Liberati, AM., Luzzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Gherlinzoni, F., Calistri, E., Fanin, R., Pizzolo, G., Meneghini, V., Rodighiero, F., and DʼEmilio, A.

Published
2015
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35. A case of bone lesion in a patient with relapsed chronic lymphocytic leukemia and review of the literature

Author

Bocchia M, Alessandro Gozzetti, Mondanelli N, Lazzi S, and F. Bacchiarri

Subjects
Pathology, medicine.medical_specialty, Text mining, business.industry, Bone lesion, Medicine, Relapsed chronic lymphocytic leukemia, business
Abstract

Skeletal involvement in CLL is very rare. We present a case of ileum bone lesion during in a patient receiving 5th line of therapy. Despite radiotherapy and salvage therapies, subsequent bone lesions led to a fatal outcome. Further studies on the mechanism by which bone disease develops are currently needed.

Published
2021

36. COVID-19 elicits an impaired antibody response against SARS-CoV-2 in patients with haematological malignancies

Author

Passamonti, F., Romano, A., Salvini, M., Merli, F., Porta, M. G. D., Bruna, R., Coviello, E., Romano, I., Cairoli, R., Lemoli, R., Farina, F., Venditti, A., Busca, A., Ladetto, M., Massaia, M., Pinto, A., Arcaini, L., Tafuri, A., Marchesi, F., Fracchiolla, N., Bocchia, M., Armiento, D., Candoni, A., Krampera, M., Luppi, M., Cardinali, V., Galimberti, S., Cattaneo, C., La Barbera, E. O., Mina, R., Lanza, F., Visani, G., Musto, P., Petrucci, L., Zaja, F., Grossi, P. A., Bertu, L., Pagano, Livio, Corradini, P., Derenzini, E., Marchetti, M., Scattolin, A. M., Corso, A., Tosi, P., Gherlinzoni, F., Passerini, C. G., Cavo, M., Fava, C., Turrini, M., Visco, C., Zappasodi, P., Merli, M., Mora, B., Vannucchi, A. M., Pagano L. (ORCID:0000-0001-8287-928X), Passamonti, F., Romano, A., Salvini, M., Merli, F., Porta, M. G. D., Bruna, R., Coviello, E., Romano, I., Cairoli, R., Lemoli, R., Farina, F., Venditti, A., Busca, A., Ladetto, M., Massaia, M., Pinto, A., Arcaini, L., Tafuri, A., Marchesi, F., Fracchiolla, N., Bocchia, M., Armiento, D., Candoni, A., Krampera, M., Luppi, M., Cardinali, V., Galimberti, S., Cattaneo, C., La Barbera, E. O., Mina, R., Lanza, F., Visani, G., Musto, P., Petrucci, L., Zaja, F., Grossi, P. A., Bertu, L., Pagano, Livio, Corradini, P., Derenzini, E., Marchetti, M., Scattolin, A. M., Corso, A., Tosi, P., Gherlinzoni, F., Passerini, C. G., Cavo, M., Fava, C., Turrini, M., Visco, C., Zappasodi, P., Merli, M., Mora, B., Vannucchi, A. M., and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

COVID-19 is associated with high mortality in patients with haematological malignancies (HM) and rate of seroconversion is unknown. The ITA-HEMA-COV project (NCT04352556) investigated patterns of seroconversion for SARS-CoV-2 IgG in patients with HMs. A total of 237 patients, SARS-CoV-2 PCR-positive with at least one SARS-CoV-2 IgG test performed during their care, entered the analysis. Among these, 62 (26·2%) had myeloid, 121 (51·1%) lymphoid and 54 (22·8%) plasma cell neoplasms. Overall, 69% of patients (164 of 237) had detectable IgG SARS-CoV-2 serum antibodies. Serologically negative patients (31%, 73 of 237) were evenly distributed across patients with myeloid, lymphoid and plasma cell neoplasms. In the multivariable logistic regression, chemoimmunotherapy [odds ratio (OR), 3·42; 95% confidence interval (CI), 1·04–11·21; P = 0·04] was associated with a lower rate of seroconversion. This effect did not decline after 180 days from treatment withdrawal (OR, 0·35; 95% CI: 0·11–1·13; P = 0·08). This study demonstrates a low rate of seroconversion in HM patients and indicates that treatment-mediated immune dysfunction is the main driver. As a consequence, we expect a low rate of seroconversion after vaccination and thus we suggest testing the efficacy of seroconversion in HM patients.

Published
2021

37. Chronic myeloid leukemia management at the time of the COVID-19 pandemic in Italy. A campus CML survey

Author

Breccia, M., Abruzzese, E., Bocchia, M., Bonifacio, M., Castagnetti, F., Fava, C., Galimberti, S., Gozzini, A., Gugliotta, G., Iurlo, A., Latagliata, R., Luciano, L., Pregno, P., Rege-Cambrin, G., Rosti, G., Stagno, F., Tiribelli, M., Foa, R., Saglio, G., Mariacristina, M. M., Isabella, C., Vincenzo, A., Federica, S., Debora, L., Mario, A., Immacolata, A., Alessandra, M., Rosaria, S., Chiara, E., Sara, B., Rita, S. A., Sabrina, L. -C., Agostino, T., Francesco, C., Giovanni, C., Alessandro, L., Davide, R., Michele, P., Gianni, B., Tamara, I., Alessandro, M., Elena, C., Monica, C., Mariella, D. A., Germana, B., Francesca, L., Iolanda -Donatella, V., Grazia, S., Luca, F., Sabina, R., Gaetano, L. B., Breccia M., Abruzzese E., Bocchia M., Bonifacio M., Castagnetti F., Fava C., Galimberti S., Gozzini A., Gugliotta G., Iurlo A., Latagliata R., Luciano L., Pregno P., Rege-Cambrin G., Rosti G., Stagno F., Tiribelli M., Foa R., Saglio G., MariaCristina M.M., Isabella C., Vincenzo A., Federica S., Debora L., Mario A., Immacolata A., Alessandra M., Rosaria S., Chiara E., Sara B., Rita S.A., Sabrina L.-C., Agostino T., Francesco C., Giovanni C., Alessandro L., Davide R., Michele P., Gianni B., Tamara I., Alessandro M., Elena C., Monica C., Mariella D.A., Germana B., Francesca L., Iolanda -Donatella V., Grazia S., Luca F., Sabina R., and Gaetano L.B.

Subjects
Cancer Research, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Protein Kinase Inhibitor, Time-to-Treatment, Betacoronavirus, Myelogenous, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Surveys and Questionnaires, Correspondence, Pandemic, Surveys and Questionnaire, COVID-19, Coronavirus Infections, Disease Management, Humans, Infection Control, Italy, Pandemics, Practice Guidelines as Topic, Protein Kinase Inhibitors, SARS-CoV-2, Telemedicine, Medicine, Viral, Chronic, Disease management (health), Chronic myeloid leukaemia, Leukemia, Betacoronaviru, Coronavirus Infection, business.industry, Myeloid leukemia, Pneumonia, Hematology, medicine.disease, Oncology, Family medicine, BCR-ABL Positive, business, Haematological diseases, Human
Abstract

No abstract available.

Published
2020

39. The features of acquired thrombotic thrombocytopenic purpura occurring at advanced age

Author

Agosti, P, Mancini, I, Artoni, A, Ferrari, B, Pontiggia, S, Trisolini, Sm, Facchini, L, Peyvandi, F, Capria, S, Codeluppi, K, Rinaldi, E, Pastore, D, Campus, S, Podda, Ra, Caria, C, Caddori, A, Nicolosi, D, Giuffrida, G, Agostini, V, Roncarati, U, Mannarella, C, Fragasso, A, Podda, Gm, Birocchi, S, Cerbone, Am, Tufano, A, Loffredo, G, Menna, G, Pizzuti, M, Ronchi, M, De Fanti, A, Amarri, S, Defina, M, Bocchia, M, Ceru, S, Gattillo, S, Agosti, P., Mancini I., Artoni A., Ferrari B., Pontiggia S., Trisolini S. M., Facchini L., Peyvandi F., and Tufano, A.

Subjects
medicine.medical_specialty, Thrombotic microangiopathy, ADAMTS13 Protein, Hemorrhage, Disease, 030204 cardiovascular system & hematology, Kidney, Adamts13 activity, 03 medical and health sciences, 0302 clinical medicine, Elderly, Older patients, Internal medicine, medicine, Humans, Registries, Acute thrombotic thrombocytopenic purpura management, ADAMTS13, Rare disease, Aged, Acquired Thrombotic Thrombocytopenic Purpura, Purpura, Thrombotic Thrombocytopenic, business.industry, Hematology, Microangiopathic hemolytic anemia, medicine.disease, Cross-Sectional Studies, 030220 oncology & carcinogenesis, Female, business
Abstract

Introduction: Acquired thrombotic thrombocytopenic purpura (aTTP) is a rare life-threatening thrombotic microangiopathy (TMA) affecting more frequently women of 30–50 years of age. There is scarce information on the clinical features of aTTP occurring in the elderly. Our goal was to evaluate the impact of an elderly-onset disease on the expression, severity and management of aTTP. Materials and methods: We performed a cross-sectional study of patients enrolled in the Milan TTP Registry (www.ttpdatabase.org) after a first acute episode of aTTP from January 2002 to March 2018. The aTTP diagnosis was suspected on the basis of the presence of thrombocytopenia and microangiopathic hemolytic anemia with no alternative causes, and was confirmed centrally by a severe plasma deficiency of ADAMTS13 activity (

Published
2020

42. Real-life experience of edoxaban treatment for venous thromboembolism (VTE)/pulmonary embolism (PE) in patients with isolated positive Lupus Anticoagulant (LAC) during the COVID-19 pandemic lockdown in Italy.

Author

PUCCETTI, L., SAMMARTANO, V., CALZONI, P., BACCHIARRI, F., SANTONI, A., FINESCHI, D., and BOCCHIA, M.

Abstract

OBJECTIVE: Direct-acting oral anticoagulants (DOACs) have established indications, according to recent guidelines for the treatment and prevention of venous thromboembolism (VTE), including pulmonary embolism (PE), with a safer profile compared to vitamin K antagonist (VKA) in terms of a lower risk for major bleeding and no need of blood coagulation tests. However, DOACs are not indicated in the treatment of patients with triple-positive antiphospholipid syndrome (APS). This limitation is often extended in clinical practice to patients with isolated positivity. The COVID-19 pandemic has sometimes made it difficult to maintain a safe VKA treatment, due to the practical difficulties of performing INR. PATIENTS AND METHODS: We evaluated 39 patients with a previous unprovoked VTE/PE, who were no longer eligible for VKA treatment due to the difficulty of performing INR during the COVID-19 pandemic lockdown, in Italy. All patients had a positive LAC and refused a longterm anticoagulation with low molecular weight heparin. They were shifted to edoxaban. RESULTS: Any recurrence of VTE/PE occurred during the observation period (up to eight months of treatment), while only one minor bleeding event was recorded (Hazard ratio=0.06, 95% confidence interval 0.03-0.11, p=0.094). No arterial events occurred during the observation period. Hemoglobin, platelets, and creatinine were unchanged during the observation period. CONCLUSIONS: Edoxaban treatment may be safe and effective in preventing the recurrence of VTE/PE in patients with isolated LAC positivity, without the occurrence of arterial events. [ABSTRACT FROM AUTHOR]

Published
2022

47. outcome of very elderly chronic myeloid leukemia patients treated with imatinib frontline

Author

Crugnola, M, Castagnetti, F, Breccia, M, Ferrero, D, Trawinska, Mm, Abruzzese, E, Annunziata, M, Stagno, F, Tiribelli, M, Binotto, G, Bonifacio, M, Fava, C, Iurlo, A, Bucelli, C, Mansueto, G, Gozzini, A, Falzetti, F, Montefusco, E, Crisà, E, Gugliotta, G, Russo, S, Cedrone, M, Russorossi, A, Pregno, P, Isidori, A, Mauro, E, Atelda, R, Giglio, G, Celesti, F, Sora', Federica, Storti, S, D'Addosio, A, Galimberti, S, Orlandi, E, Calistri, E, Bocchia, M, Cavazzini, F, Cambrin, Gr, Orofino, N, Luciano, L, Sgherza, N, Rosti, G, Latagliata, R, Capodanno, I, Sora, Federica (ORCID:0000-0002-9607-5298), Crugnola, M, Castagnetti, F, Breccia, M, Ferrero, D, Trawinska, Mm, Abruzzese, E, Annunziata, M, Stagno, F, Tiribelli, M, Binotto, G, Bonifacio, M, Fava, C, Iurlo, A, Bucelli, C, Mansueto, G, Gozzini, A, Falzetti, F, Montefusco, E, Crisà, E, Gugliotta, G, Russo, S, Cedrone, M, Russorossi, A, Pregno, P, Isidori, A, Mauro, E, Atelda, R, Giglio, G, Celesti, F, Sora', Federica, Storti, S, D'Addosio, A, Galimberti, S, Orlandi, E, Calistri, E, Bocchia, M, Cavazzini, F, Cambrin, Gr, Orofino, N, Luciano, L, Sgherza, N, Rosti, G, Latagliata, R, Capodanno, I, and Sora, Federica (ORCID:0000-0002-9607-5298)

Abstract

Very elderly (> 75 years) chronic myeloid leukaemia (CML) patients at diagnosis are sometimes treated with different doses of imatinib (IM) based on concomitant diseases and physicians' judgement. However, data on long-term follow-up of these patients are still lacking. To investigate treatment response and outcome, we retrospectively revised an Italian database of 263 very elderly CML patients receiving IM from the time of diagnosis. Median age at diagnosis was 78.5 years and 56% of patients had 2 or 3 comorbidities. A complete haematological and cytogenetic response were achieved in 244 (92.8%) and 184 (69.9%) patients, respectively. In 148 cases (56.2%), a major molecular response was observed, which was deep in 63 cases (24%). A blastic phase occurred in 11 patients (4.2%). After a median follow-up of 45.0 months, 93 patients have died (9 from disease progression) and 104 (39.5%) are still in treatment with IM. Incidence of grades 3-4 haematological and non-haematological toxicity was similar to those reported in younger patients. Five-year event-free survival was 54.5% and 45.2% in patients ≤ 80 years and > 80 years, respectively (p = 0.098). Five years OS was 75.7% and 61.6% in patients ≤80 years and > 80 years, respectively (p = 0.003). These findings show that IM plays an important role in frontline treatment of very elderly CML patients without increased toxicity and any effort to treat these patients with standard doses should be made in order to achieve responses as in younger subjects

Published
2019

48. Frontline imatinib treatment of chronic myeloid leukemia: no impact of age on outcome, a survey by the GIMEMA CML Working Party

Author

Gugliotta, G, Castagnetti, F, Palandri, F, Breccia, M, Intermesoli, T, Capucci, A, Martino, B, Pregno, P, Rupoli, S, Ferrero, D, Gherlinzoni, F, Montefusco, E, Bocchia, M, Tiribelli, M, Pierri, Ivana, Grifoni, F, Marzocchi, G, Amabile, M, Testoni, N, Martinelli, G, Alimena, G, Pane, F, Saglio, G, Baccarani, M, Rosti, G, Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party, Gugliotta, G, Castagnetti, F, Palandri, F, Breccia, M, Intermesoli, T, Capucci, A, Martino, B, Pregno, P, Rupoli, S, Ferrero, D, Gherlinzoni, F, Montefusco, E, Bocchia, M, Tiribelli, M, Pierri, I, Grifoni, F, Marzocchi, G, Amabile, M, Testoni, N, Martinelli, G, Alimena, G, Pane, Fabrizio, Saglio, G, Baccarani, M, Rosti, G, Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working, Party, Gugliotta G., Castagnetti F., Palandri F., Breccia M., Intermesoli T., Capucci A., Martino B., Pregno P., Rupoli S., Ferrero D., Gherlinzoni F., Montefusco E., Bocchia M., Tiribelli M., Pierri I., Grifoni F., Marzocchi G., Amabile M., Testoni N., Martinelli G., Alimena G., Pane F., Saglio G., Baccarani M., and Rosti G.

Subjects
Myeloid, Male, chronic myeloid leukemia, imatinib, elderly, Biochemistry, Piperazines, hemic and lymphatic diseases, 80 and over, Young adult, Aged, 80 and over, Leukemia, Mortality rate, Myeloid leukemia, Hematology, Middle Aged, Phase III as Topic, Survival Rate, Treatment Outcome, Benzamides, Leukemia, Myeloid, Chronic-Phase, Disease Progression, Imatinib Mesylate, Female, Complete Hematologic Response, Adult, medicine.medical_specialty, Adolescent, Immunology, Alpha interferon, Antineoplastic Agents, Young Adult, Clinical Trials, Phase II as Topic, Internal medicine, medicine, Humans, Clinical Trials, bone-marrow-transplantation, chronic myelogenous leukemia, complete cytogenetic response, early chronic phase, elderly-patients, european-leukemianet, interferon-alpha, line treatment, mesylate therapy, patients receiving imatinib, Survival rate, Aged, business.industry, Clinical Trials, Phase III as Topic, Health Surveys, Pyrimidines, Phase II as Topic, Cell Biology, medicine.disease, Surgery, Imatinib mesylate, Chronic-Phase, business, CHRONIC MYELOID LEUKEMIA (CML), Chronic myelogenous leukemia
Abstract

The median age of chronic myeloid leukemia (CML) patients is ∼ 60 years, and age is still considered an important prognostic factor, included in Sokal and EURO risk scores. However, few data are available about the long-term outcome of older patients treated with imatinib (IM) frontline. We analyzed the relationship between age and outcome in 559 early chronic-phase CML patients enrolled in 3 prospective clinical trials of Gruppo Italiano Malattie Ematologiche dell'Adulto CML Working Party, treated frontline with IM, with a median follow-up of 60 months. There were 115 older patients (≥ 65 years; 21%). The complete cytogenetic and major molecular response rates were similar in the 2 age groups. In older patients, event-free survival (55% vs 67%), failure-free survival (78% vs 92%), progression-free survival (62% vs 78%), and overall survival (75% vs 89%) were significantly inferior (all P < .01) because of a higher proportion of deaths that occurred in complete hematologic response, therefore unrelated to CML progression (15% vs 3%, P < .0001). The outcome was similar once those deaths were censored. These data show that response to IM was not affected by age and that the mortality rate linked to CML is similar in both age groups. This trial was registered at www.clinicaltrials.gov as #NCT00514488 and #NCT00510926.

Published
2011

49. Evaluation of the prognostic role of tumour-associated macrophages in newly diagnosed classical hodgkin lymphoma and correlation with early FDG-PET assessment

Author

Cencini E, Fabbri A, Rigacci L, Lazzi S, Gini G, Mc, Cox, Mancuso S, elisabetta abruzzese, Kovalchuk S, Goteri G, Di Napoli A, Bono R, Fratoni S, Di Lollo S, Bosi A, Leoncini L, Bocchia M, Cencini, E., Fabbri, A., Rigacci, L., Lazzi, S., Gini, G., Cox, M., Mancuso, S., Abruzzese, E., Kovalchuk, S., Goteri, G., Di Napoli, A., Bono, R., Fratoni, S., Di Lollo, S., Bosi, A., Leoncini, L., and Bocchia, M.

Subjects
Adult, Male, Adolescent, Hodgkin’s lymphoma, Macrophage, Prognosi, Antigens, Differentiation, Myelomonocytic, Vinblastine, Disease-Free Survival, Cohort Studies, Bleomycin, Young Adult, Antigens, CD, Fluorodeoxyglucose F18, Recurrence, Positron Emission Tomography Computed Tomography, Antineoplastic Combined Chemotherapy Protocols, Humans, CD68, Aged, Aged, 80 and over, Hodgkin's lymphoma, hematology, Macrophages, macrophages, PET, prognosis, oncology, cancer research, Antibodies, Monoclonal, Middle Aged, Prognosis, Hodgkin Disease, Immunohistochemistry, Dacarbazine, Treatment Outcome, Doxorubicin, Positron-Emission Tomography, Female, Neoplasm Recurrence, Local, Follow-Up Studies
Abstract

In Hodgkin Lymphoma (HL), about 20% of patients still have relapsed/refractory disease and late toxic effects rate continue to rise with time. 'Early FDG-PET' and tissue macrophage infiltration (TAM) emerged as powerful prognostic predictors. The primary endpoint was to investigate the prognostic role of both early FDG-PET and TAM; the secondary endpoint was to test if early FDG-PET positivity could correlate with high TAM score. A cohort of 200 HL patients was analysed. Induction treatment plan consisted of two to six courses of ABVD and, if indicated, involved field radiation therapy. All patients repeated CT scan and FDG-PET after two cycles and after the completion of therapy. TAM in diagnostic specimens was determined by immunohistochemistry with a monoclonal antibody (anti-CD68 KP1). Overall, early FDG-PET was negative in 163 patients (81.5%) and positive in 37 patients (18.5%), showing a significant correlation with the achievement of CR (p 0.0001). After a median follow-up of 40 months, progression free survival (PFS) was significantly better for PET negative patients (p 0.0001). CD68 expression was low, intermediate or high in 26 (13%), 100 (50%) and 74 (37%) cases, without difference in the distribution between responders and non-responders. PFS analysis showed no significant difference in any score group. TAM score did not show any correlation with early FDG-PET result. This study confirms that early FDG-PET has a high prognostic power, while TAM score does not seem to influence the outcome; in contrast to our original hypothesis, it does not correlate with FDG-PET assessment. Copyright © 2015 John WileySons, Ltd.

Published
2017

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