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1. Diagnosis and Management of Cardiovascular Risk in Patients with Polycythemia Vera

Author

Benevolo G, Marchetti M, Melchio R, Beggiato E, Sartori C, Biolé CA, Rapezzi D, Bruno B, and Milan A

Subjects
cardiovascular risk, myeloproliferative neoplasms, polycythemia vera, thrombosis, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Giulia Benevolo,1 Monia Marchetti,2 Remo Melchio,3 Eloise Beggiato,1 Chiara Sartori,4 Carlo Alberto Biolé,5 Davide Rapezzi,6 Benedetto Bruno,1,7 Alberto Milan8 1University Hematology Division, Città della Salute e della Scienza di Torino, Turin, Italy; 2Hematology and Transplant Unit, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 3Division of Internal Medicine, A.O. S. Croce E Carle, Cuneo, Italy; 4Cardiology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; 5SCDO Cardiology, AOU San Luigi Gonzaga Orbassano, Turin, Italy; 6Hematology Division A.O. S. Croce e Carle, Cuneo, Italy; 7Department of Molecular Biotechnolgies and Medical Sciences, University of Turin, Turin, Italy; 8Department of Medical Sciences, University of Turin, Città della Salute e della Scienza di Torino, Turin, ItalyCorrespondence: Giulia Benevolo, University Hematology Division, Città della Salute e della Scienza di Torino, via Genova 3, Turin, 10126, Italy, Tel +39 011 633 4301, Fax +39 011 633 4187, Email gbenevolo@cittadellasalute.to.itAbstract: Polycythemia vera (PV) is a myeloproliferative neoplasm characterized by aberrant myeloid lineage hematopoiesis with excessive red blood cell and pro-inflammatory cytokine production. Patients with PV present with a range of thrombotic and hemorrhagic symptoms that affect quality of life and reduce overall survival expectancy. Thrombotic events, transformation into acute myeloid leukemia, and myelofibrosis are largely responsible for the observed mortality. Treatment of PV is thus primarily focused on symptom control and survival extension through the prevention of thrombosis and leukemic transformation. Patients with PV frequently experience thrombotic events and have elevated cardiovascular risk, including hypertension, dyslipidemias, obesity, and smoking, all of which negatively affect survival. To reduce the risk of thrombotic complications, PV therapy should aim to normalize hemoglobin, hematocrit, and leukocytosis and, in addition, identify and modify cardiovascular risk factors. Herein, we review what is currently known about the associated cardiovascular risk and propose strategies for diagnosing and managing patients with PV.Plain Language Summary: Patients with the myeloproliferative neoplasm (MPN) polycythemia vera (PV) are at increased risk of cardiovascular (CV) events, including stroke, heart attacks, and peripheral arterial disease. High blood pressure, smoking, and dyslipidemia are common in MPN and contribute to the increased cardiovascular risk. Effectively controlling cardiovascular risk factors in PV, along with appropriate hematological therapy such as direct-acting oral anticoagulants alone or in combination with aspirin, may improve the outcomes of patients with PV, but further research is needed.Keywords: cardiovascular risk, myeloproliferative neoplasms, polycythemia vera, thrombosis

Published
2023

2. High-dose chemotherapy and autologous stem cell transplant as first salvage treatment for relapsed or refractory Hodgkin Lymphoma in the era of PET-adapted strategies

Author

Viviani, S, Vanazzi, A, Frassoni, S, Rusconi, C, Rossi, A, Romano, A, Patti, C, Schiavotto, C, Sorasio, R, Marasco, V, Lissandrini, L, Rapezzi, D, Gottardi, D, Cocito, F, Mule, A, Leotta, S, Gini, G, Sorio, M, Derenzini, E, Rambaldi, A, Bagnardi, V, Tarella, C, Viviani S., Vanazzi A., Frassoni S., Rusconi C., Rossi A., Romano A., Patti C., Schiavotto C., Sorasio R., Marasco V., Lissandrini L., Rapezzi D., Gottardi D., Cocito F., Mule A., Leotta S., Gini G., Sorio M., Derenzini E., Rambaldi A., Bagnardi V., Tarella C., Viviani, S, Vanazzi, A, Frassoni, S, Rusconi, C, Rossi, A, Romano, A, Patti, C, Schiavotto, C, Sorasio, R, Marasco, V, Lissandrini, L, Rapezzi, D, Gottardi, D, Cocito, F, Mule, A, Leotta, S, Gini, G, Sorio, M, Derenzini, E, Rambaldi, A, Bagnardi, V, Tarella, C, Viviani S., Vanazzi A., Frassoni S., Rusconi C., Rossi A., Romano A., Patti C., Schiavotto C., Sorasio R., Marasco V., Lissandrini L., Rapezzi D., Gottardi D., Cocito F., Mule A., Leotta S., Gini G., Sorio M., Derenzini E., Rambaldi A., Bagnardi V., and Tarella C.

Abstract

Data on the efficacy of high-dose chemotherapy and autologous stem cell transplantation (ASCT) for classical Hodgkin lymphoma (cHL) patients who failed a PET-driven first-line therapy are limited. We retrospectively evaluated 220 adult cHL patients who underwent ASCT from 2009 to 2021 at 11 centers in Italy. Overall, 49.5% had refractory disease, 23.2% relapsed < 12 and 27.3% ≥12 months from the end of first-line chemotherapy. The 3-year progression-free survival (PFS) and overall survival (OS) were 73.8% and 89.4%. In univariable analysis for PFS events PET-2+ (HR 2.69, p =.001), anemia (HR 2.22, p =.019), refractory disease (HR 1.76, p =.045), less than CR before ASCT (HR 3.24, p <.001) and >2 lines of salvage therapy (HR 2.52; p =.004) were associated with a higher risk of failure after ASCT. In multivariable analysis, >2 lines of salvage therapy (HR 3.28, p =.004) and RT before ASCT (HR 3.00, p = 0.041) retained significance. ASCT is an effective salvage approach for cHL patients treated in the era of PET-adapted therapies.

Published
2024

4. 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

5. The clinical experience of compassionate use program for avapritinib: implications for drug positioning in the therapeutic scenario of systemic mastocytosis

Author

Mannelli, F., Crupi, F., Zanotti, R., Pagano, Livio, Rapezzi, D., Tanasi, I., Criscuolo, Marianna, Bonifacio, M., Fresa, Alberto, Guglielmelli, P., Vannucchi, A. M., Pagano L. (ORCID:0000-0001-8287-928X), Criscuolo M., Fresa A., Mannelli, F., Crupi, F., Zanotti, R., Pagano, Livio, Rapezzi, D., Tanasi, I., Criscuolo, Marianna, Bonifacio, M., Fresa, Alberto, Guglielmelli, P., Vannucchi, A. M., Pagano L. (ORCID:0000-0001-8287-928X), Criscuolo M., and Fresa A.

Abstract

In systemic mastocytosis, cytoreductive treatment is indicated for advanced systemic mastocytosis (AdvSM) variants. The treatment scenario is rapidly diversifying especially with the introduction of KIT tyrosine kinase inhibitors. Avapritinib is a second-generation potent and selective inhibitor of the mutant KIT D816V that, based on the results of pivotal clinical trials, was approved for the treatment of adults with AdvSM by the regulatory agencies US FDA and EMA. The present article reports the experience of treating SM patients with avapritinib in an Italian compassionate use program. The data from our case series confirm the drug as being active after multiple lines of treatment allowing rapid achievement of profound responses, making it also an effective bridging strategy to allogeneic transplant in eligible patients. However, the anticipated wider use of avapritinib in the near future will require careful monitoring of side effects, especially in heavily pretreated patients.

Published
2023

6. 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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7. High rate of recurrent venous thromboembolism in patients with myeloproliferative neoplasms and effect of prophylaxis with vitamin K antagonists

Author

De Stefano, V, Ruggeri, M, Cervantes, F, Alvarez-Larrán, A, Iurlo, A, Randi, M L, Elli, E, Finazzi, M C, Finazzi, G, Zetterberg, E, Vianelli, N, Gaidano, G, Rossi, E, Betti, S, Nichele, I, Cattaneo, D, Palova, M, Ellis, M H, Cacciola, R, Tieghi, A, Hernandez-Boluda, J C, Pungolino, E, Specchia, G, Rapezzi, D, Forcina, A, Musolino, C, Carobbio, A, Griesshammer, M, Sant’Antonio, E, Vannucchi, A M, and Barbui, T

Published
2016
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8. 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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9. 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

10. 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

11. 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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12. Arterial thrombosis in Philadelphia-negative myeloproliferative neoplasms predicts second cancer: A case-control study

Author

De Stefano, V., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, E., Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Finazzi, G., Bonifacio, M., Scaffidi, L., Patriarca, A., Rumi, E., Casetti, I. C., Stephenson, C., Guglielmelli, P., Elli, E. M., Palova, M., Rapezzi, D., Erez, D., Gomez, M., Wille, K., Perez-Encinas, M., Lunghi, F., Angona, A., Fox, M. L., Beggiato, E., Benevolo, G., Carli, G., Cacciola, R., McMullin, M. F., Tieghi, A., Recasens, V., Isfort, S., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., De Stefano V. (ORCID:0000-0002-5178-5827), Rossi E. (ORCID:0000-0002-7572-9379), De Stefano, V., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, E., Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Finazzi, G., Bonifacio, M., Scaffidi, L., Patriarca, A., Rumi, E., Casetti, I. C., Stephenson, C., Guglielmelli, P., Elli, E. M., Palova, M., Rapezzi, D., Erez, D., Gomez, M., Wille, K., Perez-Encinas, M., Lunghi, F., Angona, A., Fox, M. L., Beggiato, E., Benevolo, G., Carli, G., Cacciola, R., McMullin, M. F., Tieghi, A., Recasens, V., Isfort, S., Marchetti, M., Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., De Stefano V. (ORCID:0000-0002-5178-5827), and Rossi E. (ORCID:0000-0002-7572-9379)

Abstract

Patients with Philadelphia-negative myeloproliferative neoplasm (MPN) are prone to the development of second cancers, but the factors associated with these events have been poorly explored. In an international nested case-control study, we recruited 647 patients with carcinoma, nonmelanoma skin cancer, hematological second cancer, and melanoma diagnosed concurrently or after MPN diagnosis. Up to 3 control patients without a history of cancer and matched with each case for center, sex, age at MPN diagnosis, date of diagnosis, and MPN disease duration were included (n 5 1234). Cases were comparable to controls for MPN type, driver mutations and cardiovascular risk factors. The frequency of thrombosis preceding MPN was similar for cases and controls (P 5 .462). Thrombotic events after MPN and before second cancer were higher in cases than in controls (11.6% vs 8.1%; P 5 .013), because of a higher proportion of arterial thromboses (6.2% vs 3.7%; P 5 .015). After adjustment for confounders, the occurrence of arterial thrombosis remained independently associated with the risk of carcinoma (odds ratio, 1.97; 95% confidence interval, 1.14-3.41), suggesting that MPN patients experiencing arterial events after MPN diagnosis deserve careful clinical surveillance for early detection of carcinoma.

Published
2020

13. Second cancers in MPN: Survival analysis from an international study

Author

Marchetti, M., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, Elena, Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Finazzi, G., Bonifacio, M., Scaffidi, L., Patriarca, A., Rumi, E., Casetti, I. C., Stephenson, C., Guglielmelli, P., Elli, E. M., Palova, M., Rapezzi, D., Erez, D., Gomez, M., Wille, K., Perez-Encinas, M., Lunghi, F., Angona, A., Fox, M. L., Beggiato, E., Benevolo, G., Carli, G., Cacciola, R., Mcmullin, M. F., Tieghi, A., Recasens, V., Isfort, S., Pane, F., De Stefano, Valerio, Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., Rossi E. (ORCID:0000-0002-7572-9379), De Stefano V. (ORCID:0000-0002-5178-5827), Marchetti, M., Ghirardi, A., Masciulli, A., Carobbio, A., Palandri, F., Vianelli, N., Rossi, Elena, Betti, S., Di Veroli, A., Iurlo, A., Cattaneo, D., Finazzi, G., Bonifacio, M., Scaffidi, L., Patriarca, A., Rumi, E., Casetti, I. C., Stephenson, C., Guglielmelli, P., Elli, E. M., Palova, M., Rapezzi, D., Erez, D., Gomez, M., Wille, K., Perez-Encinas, M., Lunghi, F., Angona, A., Fox, M. L., Beggiato, E., Benevolo, G., Carli, G., Cacciola, R., Mcmullin, M. F., Tieghi, A., Recasens, V., Isfort, S., Pane, F., De Stefano, Valerio, Griesshammer, M., Alvarez-Larran, A., Vannucchi, A. M., Rambaldi, A., Barbui, T., Rossi E. (ORCID:0000-0002-7572-9379), and De Stefano V. (ORCID:0000-0002-5178-5827)

Abstract

One out of ten patients with Philadelphia-negative myeloproliferative neoplasms (MPN) develop a second cancer (SC): in such patients we aimed at assessing the survival impact of SC itself and of MPN-specific therapies. Data were therefore extracted from an international nested case-control study, recruiting 798 patients with SC diagnosed concurrently or after the MPN. Overall, 2995 person-years (PYs) were accumulated and mortality rate (MR) since SC diagnosis was 5.9 (5.1-6.9) deaths for every 100 PYs. A “poor prognosis” SC (stomach, esophagus, liver, pancreas, lung, ovary, head-and-neck or nervous system, osteosarcomas, multiple myeloma, aggressive lymphoma, acute leukemia) was reported in 26.3% of the patients and was the cause of death in 65% of them (MR 11.0/100 PYs). In contrast, patients with a “non-poor prognosis” SC (NPPSC) incurred a MR of 4.6/100 PYs: 31% of the deaths were attributed to SC and 15% to MPN evolution. At multivariable analysis, death after SC diagnosis was independently predicted (HR and 95% CI) by patient age greater than 70 years (2.68; 1.88-3.81), the SC prognostic group (2.57; 1.86-3.55), SC relapse (1.53; 10.6-2.21), MPN evolution (2.72; 1.84-4.02), anemia at SC diagnosis (2.32; 1.49-3.59), exposure to hydroxyurea (1.89; 1.26-2.85) and to ruxolitinib (3.63; 1.97-6.71). Aspirin was protective for patients with a NPPSC (0.60; 0.38-0.95). In conclusion, SC is a relevant cause of death competing with MPN evolution. Prospective data are awaited to confirm the role of cytoreductive and anti-platelet drugs in modulating patient survival after the occurrence of a SC.

Published
2020

21. Observational Study of CML Italian Patients Who Discontinued TKIs

Author

Fava, C, Rege-Carmbrin, G, Dogliotti, I, Cerrano, M, Berchialla, P, Rosti, G, Castagnetti, F, Gugliotta, G, Martino, B, Gambacorti-Passerini, C, Abruzzese, E, Orlandi, Em, Elena, C, Pregno, P, Gozzini, A, Avanzini, P, 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, Baccarani, M, Ferrero, D, and Saglio, G

Published
2017

22. Tyrosine Kinase Inhibitors Discontinuation in Chronic Myeloid Leukemia: a Retrospective Analysis of 208 Italian Patients

Author

Fava, C, Rege Cambrin, G, Dogliotti, I., Berchialla, P., Abruzzese, E, Annunziata, M., Avanzini, P., Bergamaschi, M., Bocchia, M., Caocci, G, Catania, G., Cattaneo, D., Cavazzini, F., Cerrano, M, Chiara, E, Crugnola, M, Galimberti, Sara, Gambacorti Passerini, C, Iuliano, F, Iurlo, A, Levato, L, Luciano, L, Musto, P., Orlandi, E, Pregno, P., Rapezzi, D, Russo, S, Santoro, Sora, M., F, Baccarani, M., Ferrero, D., and Saglio, G.

Published
2016

23. TYROSINE KINASE INHIBITORS DISCONTINUATION IN CHRONIC MYELOID LEUKEMIA: A RETROSPECTIVE ANALYSIS OF 208 ITALIAN PATIENTS

Author

Fava, C., Rege Cambrin, G., Dogliotti, I., Berchialla, P., Abruzzese, E., Annunziata, M., Avanzini, P., Bergamaschi, M., Bocchia, M., Caocci, G., Catania, G., Cattaneo, D., Cavazzini, Francesco, Cerrano, M., Chiara, E., Crugnola, M., Galimberti, S., Gambacorti Passerini, C., Iuliano, F., Iurlo, A., Levato, L., Luciano, L., Musto, P., Orlandi, E., Pregno, P., Rapezzi, D., Russo, S., Santoro, M., Sorà, F., Baccarani, M., Ferrero, D., and Saglio, G.

Subjects
Socio-culturale
Published
2016

25. Cardiovascular events and intensity of treatment in polycythemia vera

Author

Marchioli, R, Finazzi, G, Specchia, G, Cacciola, R, Cavazzina, R, Cilloni, D, De Stefano, V, Elli, E, Iurlo, A, Latagliata, R, Lunghi, F, Lunghi, M, Marfisi, Rm, Musto, P, Masciulli, A, Musolino, C, Cascavilla, N, Quarta, G, Randi, M. L., Rapezzi, D, Ruggeri, M, Rumi, E, Scortechini, Ar, Santini, S, Scarano, M, Siragusa, S, Spadea, A, Tieghi, A, Angelucci, E, Visani, G, Vannucchi, Am, Specchia G, Barbui T., D'Amico, A, Ferri, B, Guido, C, Marfisi, L, Pera, C, Polidoro, A, Sacco, M, Levantesi, G, Tognoni, G, Barosi, G, Carobbio, A, Leoni, P, Mulattieri, S, Tomassetti, S, Honorati, E, Ricco, A, Albano, F, Pastore, D, Carluccio, P, Mazzone, Am, Rossi, Ar, Finazzi, Mc, Delaini, F, Falanga, A, Rambaldi, A, Guaragna, G, Giannotta, A, Usala, E, Simula, Mp, Pilo, F, Cacciola, E, Pezzella, F, Seria, E, Di Francesco, E, Gallamini, A, Bertolotti, L, Antonioli, E, Guglielmelli, P, Pieri, L, Susini, Mc, Bartalucci, N, Bosi, A, D'Angelo, A, Centorrino, R, Gerace, D, Allegra, A, Cortelezzi, A, De Philippis, C, Ferretti, E, Ciceri, F, Claudiani, S, Malato, S, Trinca, S, Pogliani, Em, Belotti, A, Lanzi, E, Elli, Em, Gaidano, G, Deambrogi, C, Rossi, D, Saglio, G, Rotolo, A, Zanone, C, Bertozzi, I, Tezza, F, Aneloni, V, Quintini, G, Saccullo, G, Caracciolo, C, Cazzola, M, Casetti, I, Elena, C, Landini, B, Barulli, S, Guiducci, B, Lucesole, M, Malerba, L, Isidori, A, Grossi, A, De Stefanis, M, Biagioni, C, Merli, F, Imovilli, A, Codeluppi, K, Rubagotti, S, Romano, N, Bonini, A, Bellesia, E, Martorelli, Mc, Villani, O, Zifarone, E, Zonno, A, Santopietro, V, Za, T, Rossi, E, Ciminello, Am, Betti, S, Alimena, G, Tafuri, A, Breccia, M, Carmosino, I, Pisani, F, Romano, A, D'Andrea, M, Nobile, M, Mantuano, Fs, Rossi, G, Tricarico, M, Rodeghiero, F, Bedin, F, Lissandrini, L, Finotto, S., Marchioli, R, Finazzi, G, Specchia, G, Cacciola, R, Cavazzina, R, Cilloni, D, De Stefano, V, Elli, E, Iurlo, A, Latagliata, R, Lunghi, F, Lunghi, M, Marfisi, RM, Musto, P, Masciulli, A, Musolino, C, Cascavilla, N, Quarta, G, Randi, ML, Rapezzi, D, Ruggeri, M, Rumi, E, Scortechini, AR, Santini, S, Scarano, M, Siragusa, S, Spadea, A, Tieghi, A, Angelucci, E, Visani, G, Vannucchi, AM, Barbui, T, and CYTO-PV Collaborative Group.

Subjects
Male, Hematocrit, RECURRENT THROMBOSIS, law.invention, Aged, Antineoplastic Agents, Cardiovascular Diseases, Combined Modality Therapy, Female, Follow-Up Studies, Humans, Hydroxyurea, Janus Kinase 2, Middle Aged, Polycythemia Vera, Thrombosis, Phlebotomy, Medicine (all), LEUKOCYTOSIS, Polycythemia vera, Randomized controlled trial, law, hemic and lymphatic diseases, ESSENTIAL THROMBOCYTHEMIA, Clinical endpoint, Polycythemia Vera, Secondary Prophylaxis, ESSENTIAL THROMBOCYTHEMIA, RECURRENT THROMBOSIS, RISK-FACTOR, HEMATOCRIT, MANAGEMENT, LEUKOCYTOSIS, PREVENTION, DIAGNOSIS, EFFICACY, WARFARIN, medicine.diagnostic_test, Hazard ratio, General Medicine, medicine.medical_specialty, randomized trial, polycythemia vera, Cardiovascular event, DIAGNOSIS, WARFARIN, RISK-FACTOR, Internal medicine, MANAGEMENT, medicine, Myelofibrosis, Adverse effect, business.industry, EFFICACY, medicine.disease, PREVENTION, Surgery, Polycythemia Vera, Cardiovascular event, hematocrit, Settore MED/15 - MALATTIE DEL SANGUE, business
Abstract

A b s t r ac t Background Current treatment recommendations for patients with polycythemia vera call for maintaining a hematocrit of less than 45%, but this therapeutic strategy has not been tested in a randomized clinical trial. Methods We randomly assigned 365 adults with JAK2-positive polycythemia vera who were being treated with phlebotomy, hydroxyurea, or both to receive either more intensive treatment (target hematocrit

Published
2013

26. Long-term outcome of chronic myeloid leukemia patients treated frontline with imatinib

Author

Castagnetti, F, Gugliotta, G., Breccia, M., Stagno, F., Iurlo, A., Albano, F., Abruzzese, E., Martino, B., Levato, L., Intermesoli, T., Pregno, P., Rossi, G., Gherlinzoni, F., Leoni, P., Cavazzini, F., Venturi, C., Soverini, S., Testoni, N., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Baccarani, M., on behalf of the GIMEMA CML Working Party (Lucarelli, G., Polimeno, G., Ladetto, M., Pini, M., Rupoli, S., Scortechini, A. R., Galieni, P., Bigazzi, C., Cantore, N., Palmieri, F., Specchia, G., Russo, Rossi., Rambaldi, A., Ferrari, M. L., Palandri, F., Luatti, S., Iacobucci, I., Bochicchio, M. T., Apolinari, M., Fogli, M., Cervello, I., Capucci, A., Giuliani, G., Malpignano, A., Girasoli, M., Angelucci, E., Usala, E., De Biasi, E., Tagariello, G., Sartori, R., Di Raimondo, F., Vigneri, P., Molica, S., Lentini, M., Lanza, F., Viganò, C., Grasso, M., Rapezzi, D., Cuneo, A., Ciccone, M., Bosi, A., Gozzini, A., Gobbi, M., Pierri, I., Chianese, R., De Blasio, A., Ciccone, F., Capochiani, E., Pelosini, M., Musolino, C., Russo, S., Cortelezzi, A., Luppi, M., Marasca, R., Pogliani, E. M., Gambacorti-Passerini, C., Luciano, L., Izzo, B., Ferrara, F., Annunziata, M., Mettivier, V., Sessa, U., 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., Cazzola, M., Orlandi, E., Falini, B., Falzetti, F., Visani, G., Isidor, I., Di Bartolomeo, P., Di Lorenzo, R., Vallisa, D., Trabacch, I., Pizzuti, M., Zuffa, E., Salvucci, M., Ronco, F., Lelo, D., Merli, F., Avanzini, P., Tosi, P., Merli, A., Sica, S., Sorà, F., Latagliata, R., De Fabritiis, P., Trawiska, M., Amadori, S., Cantonetti, M., Majolino, I., Pacilli, L., Ronci, B., Cedrone, M., Mengarelli, A., Romano, A., Tafuri, A., Montefusc, O., Iuliano, F., Infusino, S., Dore, F., Fozza, C., Bocchia, M., Defina, M., Liberati, Am., Luzi, D., Boccadoro, M., Ferrero, D., Vitolo, U., Nicolosi, M., Gottardi, M., Calistri, E., Fanin, R., Tiribelli, M., Pizzolo, G., Bonifacio, M., Rodeghiero, F., Di Bona, E. )., Castagnetti, F, Gugliotta, G., Breccia, M., Stagno, F., Iurlo, A., Albano, F., Abruzzese, E., Martino, B., Levato, L., Intermesoli, T., Pregno, P., Rossi, G., Gherlinzoni, F., Leoni, P., Cavazzini, F., Venturi, C., Soverini, S., Testoni, N., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Rosti, G., Baccarani, M., and on behalf of the GIMEMA CML Working Party [, Palandri F.], Pane, Fabrizio, Gugliotta, G, Breccia, M, Stagno, F, Iurlo, A, Albano, F, Abruzzese, E, Martino, B, Levato, L, Intermesoli, T, Pregno, P, Rossi, G, Gherlinzoni, F, Leoni, P, Cavazzini, F, Venturi, C, Soverini, S, Testoni, N, Alimena, G, Cavo, M, Martinelli, G, Pane, F, Saglio, G, Rosti, G, Baccarani, M, and GAMBACORTI PASSERINI, C

Subjects
DIAGNOSED CHRONIC-PHASE, Oncology, Male, Cancer Research, Time Factors, bcr-abl, Fusion Proteins, bcr-abl, Antineoplastic Agent, Hematology, Anesthesiology and Pain Medicine, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Cumulative incidence, Young adult, Chronic, Aged, 80 and over, Leukemia, PATIENTS RECEIVING IMATINIB, CHRONIC MYELOGENOUS LEUKEMIA, TYROSINE KINASE INHIBITORS, BCR-ABL1 TRANSCRIPT LEVELS, EARLY MOLECULAR RESPONSE, CML WORKING PARTY, 3-YEAR FOLLOW-UP, EUROPEAN LEUKEMIANET, 400 MG, Myeloid leukemia, Middle Aged, Prognosis, Treatment Outcome, Retreatment, Imatinib Mesylate, Female, Tyrosine kinase, Human, medicine.drug, Adult, medicine.medical_specialty, Time Factor, Adolescent, Prognosi, Protein Kinase Inhibitor, Socio-culturale, Antineoplastic Agents, Treatment results, Follow-Up Studie, Young Adult, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, medicine, Humans, Protein Kinase Inhibitors, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Fusion Proteins, Imatinib, Follow-Up Studies, Surgery, Imatinib mesylate, BCR-ABL Positive, business, Myelogenous
Abstract

For almost 10 years imatinib has been the therapeutic standard of chronic myeloid leukemia. The introduction of other tyrosine kinase inhibitors (TKIs) raised a debate on treatment optimization. The debate is still heated: some studies have protocol restrictions or limited follow-up; in other studies, some relevant data are missing. The aim of this report is to provide a comprehensive, long-term, intention-to-treat, analysis of 559 newly diagnosed, chronic-phase, patients treated frontline with imatinib. With a minimum follow-up of 66 months, 65% of patients were still on imatinib, 19% were on alternative treatment, 12% died and 4% were lost to follow-up. The prognostic value of BCR-ABL1 ratio at 3 months (⩽10% in 81% of patients) was confirmed. The prognostic value of complete cytogenetic response and major molecular response at 1 year was confirmed. The 6-year overall survival was 89%, but as 50% of deaths occurred in remission, the 6-year cumulative incidence of leukemia-related death was 5%. The long-term outcome of first-line imatinib was excellent, also because of second-line treatment with other TKIs, but all responses and outcomes were inferior in high-risk patients, suggesting that to optimize treatment results, a specific risk-adapted treatment is needed for such patients.

Published
2015

27. Personal history and quality of life in chronic myeloid leukemia patients: a cross-sectional study using narrative medicine and quantitative analysis

Author

Breccia, M, Graffigna, G, Galimberti, S, Iurlo, A, Pungolino, E, Pizzuti, M, Maggi, A, Falzetti, F, Capalbo, S, Intermesoli, T, Maffioli, M, Elena, C, Melosi, A, Simonetti, F, Capochiani, E, Seta, R, Pacilli, M, Luppi, M, Di Renzo, N, Mastrullo, L, Trabacchi, E, Vallisa, D, Rapezzi, D, Orlandi, E, GAMBACORTI PASSERINI, C, Efficace, F, Alimena, G, GAMBACORTI PASSERINI, CARLO, Alimena, G., Breccia, M, Graffigna, G, Galimberti, S, Iurlo, A, Pungolino, E, Pizzuti, M, Maggi, A, Falzetti, F, Capalbo, S, Intermesoli, T, Maffioli, M, Elena, C, Melosi, A, Simonetti, F, Capochiani, E, Seta, R, Pacilli, M, Luppi, M, Di Renzo, N, Mastrullo, L, Trabacchi, E, Vallisa, D, Rapezzi, D, Orlandi, E, GAMBACORTI PASSERINI, C, Efficace, F, Alimena, G, GAMBACORTI PASSERINI, CARLO, and Alimena, G.

Abstract

Background: Tyrosine kinase inhibitors (TKIs) drastically changed the outcome of patients diagnosed with chronic myeloid leukemia (CML). Several reports indicated the advantage of continue long-term adherence associated with positive outcome. Therefore, it is important to better understand from the patient’s standpoint the experience of living with the disease and the related treatment. Objectives: In this study, quantitative analysis and narrative medicine were combined to get insights on this issue in a population of 257 patients with CML in chronic phase treated with TKIs (43 % men, with a median age of 58 years, 27 % aged 31–50 years), followed for a median time of 5 years. Sixty-one percent of patients enrolled were treated in first line, whereas 37 % were treated in second line. Results: The results showed more positive perceptions and acceptance in males compared to females, without impact of disease on relationships. Level of positive acceptance was more evident in elderly compared to younger patients, with a close connection with median time from diagnosis. Overall, female patients reported negative perceptions and an impact of disease on family daily living. The majority of patients understood the importance of continue adherence to treatment, with 27 % resulting less adherent (60 % for forgetfulness), even if well informed and supported by his/her physician. Discussion and conclusions: Narrative medicine, in association to quantitative analysis, can help physicians to understand needs of their patients in order to improve communication.

Published
2016

28. High rate of recurrent venous thromboembolism in patients with myeloproliferative neoplasms and effect of prophylaxis with Vitamin K antagonists

Author

De Stefano, Valerio, Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Rossi, Elena, Betti, Silvia, Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, R., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Sant'Antonio, E., Vannucchi, A. M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), Rossi, Elena (ORCID:0000-0002-7572-9379), De Stefano, Valerio, Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Rossi, Elena, Betti, Silvia, Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, R., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Sant'Antonio, E., Vannucchi, A. M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), and Rossi, Elena (ORCID:0000-0002-7572-9379)

Abstract

The optimal duration of treatment with vitamin K antagonists (VKA) after venous thromboembolism (VTE) in patients with Philadelphia-negative myeloproliferative neoplasms (MPNs) is uncertain. To tackle this issue, we retrospectively studied 206 patients with MPN-related VTE (deep venous thrombosis of the legs and/or pulmonary embolism). After this index event, we recorded over 695 pt-years 45 recurrences, venous in 36 cases, with an incidence rate (IR) of 6.5 per 100 pt-years (95% confidence interval (CI): 4.9-8.6). One hundred fifty-five patients received VKA; the IR of recurrent thrombosis per 100 pt-years was 4.7 (95% CI: 2.8-7.3) on VKA and 8.9 (95% CI: 5.7-13.2) off VKA (P=0.03). In patients receiving VKA, the IR of recurrent thrombosis per 100 pt-years was 5.3 (95% CI: 3.2-8.4) among 108 patients on long-term VKA and 12.8 (95% CI: 7.3-20.7) after discontinuation among the 47 who ceased treatment (P=0.008), with a doubled risk of recurrence after stopping VKA (hazard ratio: 2.21, 95% CI: 1.19-5.30). The IR of major bleeding per 100 pt-years was 2.4 (95%: CI: 1.1-4.5) on VKA and 0.7 (95% CI: 0.08-2.5) off VKA (P=0.08). In conclusion, in MPN patients with VTE recurrent thrombosis is significantly reduced by VKA and caution should be adopted in discontinuation; however, the incidence of recurrence on treatment remains high, calling for clinical trials aimed to improve prophylaxis in this setting.

Published
2016

29. Splanchnic vein thrombosis in myeloproliferative neoplasms: Risk factors for recurrences in a cohort of 181 patients

Author

De Stefano, Valerio, Vannucchi, A. M., Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Pieri, L., Rossi, Elena, Guglielmelli, P., Betti, Silvia, Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, E., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), Rossi, Elena (ORCID:0000-0002-7572-9379), De Stefano, Valerio, Vannucchi, A. M., Ruggeri, M., Cervantes, F., Alvarez Larrán, A., Iurlo, A., Randi, M. L., Pieri, L., Rossi, Elena, Guglielmelli, P., Betti, Silvia, Elli, E., Finazzi, M. C., Finazzi, G., Zetterberg, E., Vianelli, N., Gaidano, G., Nichele, I., Cattaneo, D., Palova, M., Ellis, M. H., Cacciola, E., Tieghi, A., Hernandez Boluda, J. C., Pungolino, E., Specchia, G., Rapezzi, D., Forcina, A., Musolino, C., Carobbio, A., Griesshammer, M., Barbui, T., De Stefano, Valerio (ORCID:0000-0002-5178-5827), and Rossi, Elena (ORCID:0000-0002-7572-9379)

Abstract

We retrospectively studied 181 patients with polycythaemia vera (n=67), essential thrombocythaemia (n=67) or primary myelofibrosis (n=47), who presented a first episode of splanchnic vein thrombosis (SVT). Budd-Chiari syndrome (BCS) and portal vein thrombosis were diagnosed in 31 (17.1%) and 109 (60.3%) patients, respectively; isolated thrombosis of the mesenteric or splenic veins was detected in 18 and 23 cases, respectively. After this index event, the patients were followed for 735 patient years (pt-years) and experienced 31 recurrences corresponding to an incidence rate of 4.2 per 100 pt-years. Factors associated with a significantly higher risk of recurrence were BCS (hazard ratio (HR): 3.03), history of previous thrombosis (HR: 3.62), splenomegaly (HR: 2.66) and leukocytosis (HR: 2.8). Vitamin K-antagonists (VKA) were prescribed in 85% of patients and the recurrence rate was 3.9 per 100 pt-years, whereas in the small fraction (15%) not receiving VKA more recurrences (7.2 per 100 pt-years) were reported. Intracranial and extracranial major bleeding was recorded mainly in patients on VKA and the corresponding rate was 2.0 per 100 pt-years. In conclusion, despite anticoagulation treatment, the recurrence rate after SVT in myeloproliferative neoplasms is high and suggests the exploration of new avenues of secondary prophylaxis with new antithrombotic drugs and JAK-2 inhibitors.

Published
2016

30. Splanchnic vein thrombosis in myeloproliferative neoplasms: risk factors for recurrences in a cohort of 181 patients

Author

De Stefano, V, primary, Vannucchi, A M, additional, Ruggeri, M, additional, Cervantes, F, additional, Alvarez-Larrán, A, additional, Iurlo, A, additional, Randi, M L, additional, Pieri, L, additional, Rossi, E, additional, Guglielmelli, P, additional, Betti, S, additional, Elli, E, additional, Finazzi, M C, additional, Finazzi, G, additional, Zetterberg, E, additional, Vianelli, N, additional, Gaidano, G, additional, Nichele, I, additional, Cattaneo, D, additional, Palova, M, additional, Ellis, M H, additional, Cacciola, E, additional, Tieghi, A, additional, Hernandez-Boluda, J C, additional, Pungolino, E, additional, Specchia, G, additional, Rapezzi, D, additional, Forcina, A, additional, Musolino, C, additional, Carobbio, A, additional, Griesshammer, M, additional, and Barbui, T, additional

Published
2016
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31. 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, M, 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, Spinosa, G, Pierri, I, Bergamaschi, M, Carella, A, Bacigalupo, A, De Blasio, A, Ciccone, F, Di Renzo, N, Musolino, C, Russo, S, Cortelezzi, A, Morra, E, Pungolino, E, Luppi, M, Marasca, R, Pogliani, E, 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, Pisani, F, Tafuri, A, Montefusco, E, Iuliano, F, Dore, F, Pardini, S, Bocchia, M, Defina, M, Liberati, A, Luzzi, D, Boccadoro, M, Ferrero, D, Vitolo, U, Gherlinzoni, F, Calistri, E, Fanin, R, Pizzolo, G, Meneghini, V, Rodighiero, F, D'Emilio, A, GAMBACORTI PASSERINI, CARLO, 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, 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, M, 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, Spinosa, G, Pierri, I, Bergamaschi, M, Carella, A, Bacigalupo, A, De Blasio, A, Ciccone, F, Di Renzo, N, Musolino, C, Russo, S, Cortelezzi, A, Morra, E, Pungolino, E, Luppi, M, Marasca, R, Pogliani, E, 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, Pisani, F, Tafuri, A, Montefusco, E, Iuliano, F, Dore, F, Pardini, S, Bocchia, M, Defina, M, Liberati, A, Luzzi, D, Boccadoro, M, Ferrero, D, Vitolo, U, Gherlinzoni, F, Calistri, E, Fanin, R, Pizzolo, G, Meneghini, V, Rodighiero, F, D'Emilio, A, GAMBACORTI PASSERINI, CARLO, and D'Emilio, A.

Abstract

Background: The incidence of chronic myeloid leukemia (CML) increases with age, but it is unclear how the characteristics of the disease vary with age. In children, where CML is very rare, it presents with more aggressive features, including huge splenomegaly, higher cell count and higher blast cell percentage. Patients and methods: To investigate if after childhood the disease maintains or loses these characteristics of aggressiveness, we analyzed 2784 adult patients, at least 18 years old, registered by GIMEMA CMLWP over a 40-year period. Results: Young adults (YAs: 18-29 years old) significantly differed from adults (30-59 years old) and elderly patients (at least 60 years old) particularly for the frequency of splenomegaly (71%, 63% and 55%, P < 0.001), and the greater spleen size (median value: 4.5, 3.0 and 1.0 cm, P < 0.001). According to the EUTOS score, that is age-independent, high-risk patients were more frequent among YAs, than among adult and elderly patients (18%, 9% and 6%, P < 0.001). In tyrosine kinase inhibitors-treated patients, the rates of complete cytogenetic and major molecular response were lower in YAs, and the probability of transformation was higher (16%, 5% and 7%, P = 0.011). Conclusions: The characteristics of CML or the host response to leukemia differ with age. The knowledge of these differences and of their causes may help to refine the treatment and to improve the outcome.

Published
2015

34. Bortezomib treatment followed by a second non-myeloablative allogeneic stem cell transplant in two previously autografted patients with multiple myeloma relapse

Author

Mattei, D., Mordini, N., Taglianti, R. V., Benedetto Bruno, Rapezzi, D., and Gallamini, A.

Subjects
Male, Salvage Therapy, Transplantation Conditioning, Hematopoietic Stem Cell Transplantation, Antineoplastic Agents, Middle Aged, Boronic Acids, Combined Modality Therapy, Transplantation, Autologous, Thalidomide, Bortezomib, Recurrence, Pyrazines, Humans, Transplantation, Homologous, Female, Stem Cell Transplantation
Abstract

We report two cases of multiple myeloma relapse and progression following a combination of autologous stem cell transplantation and non-myeloablative allogeneic stem cell transplantation. After failure of donor lymphocyte infusions and thalidomide salvage therapy, the patients were treated successfully with bortezomib and eventually underwent a second non-myeloablative allogeneic stem cell transplantation.

Published
2005

42. Ropeginterferon alfa-2b versus phlebotomy in low-risk patients with polycythaemia vera (Low-PV study): a multicentre, randomised phase 2 trial

Author

Alberto Ferrari, Cristina Bucelli, Elisa Rumi, Barbara Mora, Alessandra Carobbio, Fabrizio Pane, Tiziano Barbui, Gianni Tognoni, Andrea Patriarca, Francesca Palandri, Giuseppe Carli, Nicola Cascavilla, Elena Rossi, Sergio Siragusa, Alessandra Iurlo, Giuseppe Gaetano Loscocco, Fabio Ciceri, Maria Chiara Finazzi, Alessandro M. Vannucchi, Davide Rapezzi, Carmela Mannarelli, Giulia Benevolo, Arianna Masciulli, Marianna Caramella, Luigi Scaffidi, Arianna Ghirardi, Nicola Vianelli, Silvia Betti, Massimiliano Bonifacio, Alessandro Rambaldi, Valerio De Stefano, Marta Bellini, Paola Guglielmelli, Francesca Lunghi, Emma Cacciola, Alessandra Ricco, Caterina Musolino, Barbui T., Vannucchi A.M., De Stefano V., Masciulli A., Carobbio A., Ferrari A., Ghirardi A., Rossi E., Ciceri F., Bonifacio M., Iurlo A., Palandri F., Benevolo G., Pane F., Ricco A., Carli G., Caramella M., Rapezzi D., Musolino C., Siragusa S., Rumi E., Patriarca A., Cascavilla N., Mora B., Cacciola E., Mannarelli C., Loscocco G.G., Guglielmelli P., Betti S., Lunghi F., Scaffidi L., Bucelli C., Vianelli N., Bellini M., Finazzi M.C., Tognoni G., Rambaldi A., Barbui, T., Vannucchi, A. M., De Stefano, V., Masciulli, A., Carobbio, A., Ferrari, A., Ghirardi, A., Rossi, E., Ciceri, F., Bonifacio, M., Iurlo, A., Palandri, F., Benevolo, G., Pane, F., Ricco, A., Carli, G., Caramella, M., Rapezzi, D., Musolino, C., Siragusa, S., Rumi, E., Patriarca, A., Cascavilla, N., Mora, B., Cacciola, E., Mannarelli, C., Loscocco, G. G., Guglielmelli, P., Betti, S., Lunghi, F., Scaffidi, L., Bucelli, C., Vianelli, N., Bellini, M., Finazzi, M. C., Tognoni, G., and Rambaldi, A.

Subjects
Adult, Male, medicine.medical_specialty, Polycythaemia, Neutropenia, Adolescent, Policithemia vera, Interferon alpha-2, Polymorphism, Single Nucleotide, law.invention, Polyethylene Glycols, 03 medical and health sciences, Young Adult, 0302 clinical medicine, Randomized controlled trial, Phlebotomy, law, Bone Marrow, Internal medicine, medicine, Clinical endpoint, Data monitoring committee, Humans, Polycythemia Vera, business.industry, Standard treatment, Interferon-alpha, Hematology, Janus Kinase 2, Middle Aged, Interim analysis, medicine.disease, Recombinant Proteins, Regimen, Treatment Outcome, 030220 oncology & carcinogenesis, Quality of Life, Female, business, 030215 immunology
Abstract

Summary Background There is no evidence that phlebotomy alone is sufficient to steadily maintain haematocrit on target level in low-risk patients with polycythaemia vera. This study aimed to compare the efficacy and safety of ropeginterferon alfa-2b on top of the standard phlebotomy regimen with phlebotomy alone. Methods In 2017, we launched the Low-PV study, a multicentre, open-label, two-arm, parallel-group, investigator-initiated, phase 2 randomised trial with a group-sequential adaptive design. The study involved 21 haematological centres across Italy. Participants were recruited in a consecutive order. Participants enrolled in the study were patients, aged 18–60 years, with a diagnosis of polycythaemia vera according to 2008–16 WHO criteria. Eligible patients were randomly allocated (1:1) to receive either phlebotomy and low-dose aspirin (standard group) or ropeginterferon alfa-2b on top of the standard treatment (experimental group). Randomisation sequence was generated using five blocks of variable sizes proportional to elements of Pascal's triangle. Allocation was stratified by age and time from diagnosis. No masking was done. Patients randomly allocated to the standard group were treated with phlebotomy (300 mL for each phlebotomy to maintain the haematocrit values of lower than 45%) and low-dose aspirin (100 mg daily), if not contraindicated. Patients randomly allocated to the experimental group received ropeginterferon alfa-2b subcutaneously every 2 weeks in a fixed dose of 100 μg on top of the phlebotomy-only regimen. The primary endpoint was treatment response, defined as maintenance of the median haematocrit values of 45% or lower without progressive disease during a 12-month period. Analyses were done by intention-to-treat principle. The study was powered assuming a higher percentage of responders in the experimental group (75%) than in the standard group (50%). Here we report results from the second planned interim analysis when 50 patients had been recruited to each group. The trial is ongoing, and registered with ClinicalTrials.gov , NCT03003325 . Findings Between Feb 2, 2017, and March 13, 2020, 146 patients were screened, and 127 patients were randomly assigned to the standard group (n=63) or the experimental group (n=64). The median follow-up period was 12·1 months (IQR 12·0–12·6). For the second pre-planned interim analysis, a higher response rate in the experimental group was seen (42 [84%] of 50 patients) than in the standard group (30 [60%] of 50 patients; absolute difference 24%, 95% CI 7–41%, p=0·0075). The observed z value (2·6001) crossed the critical bound of efficacy (2·5262), and the stagewise adjusted p value early showed superiority of experimental treatment. Thus, the data safety monitoring board decided to stop patient accrual for overwhelming efficacy and to continue the follow-up, as per protocol, for 2 years. Under the safety profile, no statistically significant difference between groups in frequency of adverse events of grade 3 or higher was observed; the most frequently reported adverse events were neutropenia (four [8%] of 50 patients) in the experimental group and skin symptoms (two [4%] of 50 patients) in the standard group. No grade 4 or 5 adverse events occurred. Interpretation Supplementing phlebotomy with ropeginterferon alfa-2b seems to be safe and effective in steadily maintaining haematocrit values on target in low-risk patients with polycythaemia vera. Findings from the current study might have implications for changing the current management of low-risk patients with polycythaemia vera. Funding AOP Orphan Pharmaceuticals, Associazione Italiana per la Ricerca sul Cancro

Published
2020

43. Managing chronic myeloid leukemia for treatment-free remission: A proposal from the GIMEMA CML WP

Author

Francesca Lunghi, Gabriele Gugliotta, Chiara Elena, Valentina Giai, Monica Bocchia, Marco Cerrano, Monia Lunghi, Gaetano La Barba, Fausto Castagnetti, Germana Beltrami, Simona Soverini, Paola Fazi, Micaela Bergamaschi, Sara Galimberti, Mario Tiribelli, Claudio Fozza, Antonella Gozzini, Fabrizio Pane, Elena Trabacchi, Massimo Breccia, Mario Annunziata, Isabella Capodanno, Domenico Russo, Serena Rupoli, Sara Barulli, Giovanna Rege-Cambrin, Michele Baccarani, Gianni Binotto, Fausto Palmieri, Roberto Marasca, Bruno Martino, Alessandro Lucchesi, E Abruzzese, Paolo Vigneri, Carmen Fava, Alessandra Iurlo, Francesco Albano, Caterina Musolino, Michele Cedrone, Luigia Luciano, Fabio Stagno, Gianantonio Rosti, Patrizia Pregno, Rosaria Sancetta, Angela Melpignano, Raffaele Spadano, Massimiliano Bonifacio, Luciano Levato, Marzia Salvucci, Vincenzo Accurso, Monica Crugnola, Michele Malagola, Davide Rapezzi, Giovanni Caocci, Mariella D'Adda, Simona Sica, Giuseppe Saglio, Maria Cristina Miggiano, Enrico Montefusco, Simona Tomassetti, Francesco Cavazzini, Baccarani, M., Abruzzese, E., Accurso, V., Albano, F., Annunziata, M., Barulli, S., Beltrami, G., Bergamaschi, M., Binotto, G., Bocchia, M., Caocci, G., Capodanno, I., Cavazzini, F., Cedrone, M., Cerrano, M., Crugnola, M., D'Adda, M., Elena, C., Fava, C., Fazi, P., Fozza, C., Galimberti, S., Giai, V., Gozzini, A., Gugliotta, G., Iurlo, A., la Barba, G., Levato, L., Lucchesi, A., Luciano, L., Lunghi, F., Lunghi, M., Malagola, M., Marasca, R., Martino, B., Melpignano, A., Miggiano, M. C., Montefusco, E., Musolino, C., Palmieri, F., Pregno, P., Rapezzi, D., Rege-Cambrin, G., Rupoli, S., Salvucci, M., Sancetta, R., Sica, S., Spadano, R., Stagno, F., Tiribelli, M., Tomassetti, S., Trabacchi, E., Bonifacio, M., Breccia, M., Castagnetti, F., Pane, F., Russo, D., Saglio, G., Soverini, S., Vigneri, P., Rosti, G., Baccarani M., Abruzzese E., Accurso V., Albano F., Annunziata M., Barulli S., Beltrami G., Bergamaschi M., Binotto G., Bocchia M., Caocci G., Capodanno I., Cavazzini F., Cedrone M., Cerrano M., Crugnola M., D'Adda M., Elena C., Fava C., Fazi P., Fozza C., Galimberti S., Giai V., Gozzini A., Gugliotta G., Iurlo A., la Barba G., Levato L., Lucchesi A., Luciano L., Lunghi F., Lunghi M., Malagola M., Marasca R., Martino B., Melpignano A., Miggiano M.C., Montefusco E., Musolino C., Palmieri F., Pregno P., Rapezzi D., Rege-Cambrin G., Rupoli S., Salvucci M., Sancetta R., Sica S., Spadano R., Stagno F., Tiribelli M., Tomassetti S., Trabacchi E., Bonifacio M., Breccia M., Castagnetti F., Pane F., Russo D., Saglio G., Soverini S., Vigneri P., and Rosti G.

Subjects
Male, Pediatrics, Fusion Proteins, bcr-abl, Chronic myelogenous leukemia, tyrosine kinase inhibitors, additional chromosomal-abnormalities, deep molecular responses, high-dose imatinib, randomized cml, domain mutations, prognostic-significance, cytogenetic response, frontline nilotinib, Pregnancy, chronic myeloid leukemia,management,recommendations,Gimema,treatment-free remission, hemic and lymphatic diseases, Antineoplastic Combined Chemotherapy Protocols, Medicine, Young adult, Disease management (health), Myeloid Neoplasia, Remission Induction, Myeloid leukemia, Disease Management, Hematology, Health Care Costs, Middle Aged, Leukemia, Treatment Outcome, Italy, Retreatment, Treatment strategy, Female, management, Human, Adult, medicine.medical_specialty, Adolescent, Chronic Myeloid Leukemia, Protein Kinase Inhibitor, Socio-culturale, Treatment-Free Remission, Gimema, Myelogenous, Young Adult, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Long term survival, Humans, Protein Kinase Inhibitors, Antineoplastic Combined Chemotherapy Protocol, business.industry, medicine.disease, Health Care Cost, Settore MED/15 - MALATTIE DEL SANGUE, treatment in chronic phase chronic myeloid leukemia, Health Care Survey, Health Care Surveys, recommendations, Disease risk, business
Abstract

Several papers authored by international experts have proposed recommendations on the management of BCR-ABL1+ chronic myeloid leukemia (CML). Following these recommendations, survival of CML patients has become very close to normal. The next, ambitious, step is to bring as many patients as possible into a condition of treatment-free remission (TFR). The Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA; Italian Group for Hematologic Diseases of the Adult) CML Working Party (WP) has developed a project aimed at selecting the treatment policies that may increase the probability of TFR, taking into account 4 variables: the need for TFR, the tyrosine kinase inhibitors (TKIs), the characteristics of leukemia, and the patient. A Delphi-like method was used to reach a consensus among the representatives of 50 centers of the CML WP. A consensus was reached on the assessment of disease risk (EUTOS Long Term Survival [ELTS] score), on the definition of the most appropriate age boundaries for the choice of first-line treatment, on the choice of the TKI for first-line treatment, and on the definition of the responses that do not require a change of the TKI (BCR-ABL1 ≤10% at 3 months, ≤1% at 6 months, ≤0.1% at 12 months, ≤0.01% at 24 months), and of the responses that require a change of the TKI, when the goal is TFR (BCR-ABL1 >10% at 3 and 6 months, >1% at 12 months, and >0.1% at 24 months). These suggestions may help optimize the treatment strategy for TFR.

Published
2019

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

Author

Gianantonio Rosti, Carmen Fava, Carlo Gambacorti-Passerini, Valentina Giai, Fabio Stagno, Patrizia Pregno, Bruno Martino, Daniele Cattaneo, Micaela Bergamaschi, Roberto Latagliata, Francesco Cavazzini, Marco Cerrano, Fabrizio Pane, Federica Sorà, Sara Galimberti, Monica Bocchia, Paola Berchialla, Giorgina Specchia, Pellegrino Musto, Giuseppe Saglio, Marco Santoro, Michele Baccarani, Francesca Lunghi, Chiara Elena, Sabina Russo, Irene Dogliotti, Luciano Levato, Massimo Breccia, Monica Crugnola, Davide Rapezzi, Giovanna Rege-Cambrin, Michele Cedrone, Isabella Capodanno, Francesco Iuliano, Mario Annunziata, Nicola Sgherza, Luigia Luciano, Matteo Dragani, Antonella Gozzini, Dario Ferrero, Giovanni Caocci, Alessandra Iurlo, Fausto Castagnetti, Elisabetta Abruzzese, Gabriele Gugliotta, 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

Subjects
Male, Imatinib mesylate discontinuation, chronic myelogenous leukemia, treatment-free remission, long-term outcomes, molecular response, cml patients, recommendations, management, dasatinib, cessation, chemistry.chemical_compound, 0302 clinical medicine, Treatment Free Remission, Pregnancy, MED/15 - MALATTIE DEL SANGUE, Interquartile range, inglese, Medicine, Chronic Myelogenous Leukemia, Ponatinib, Hematology, Middle Aged, Protein-Tyrosine Kinases, Dasatinib, Treatment Outcome, Leukemia, Myeloid, Chronic-Phase, Disease Progression, Imatinib Mesylate, Female, Discontinuation, medicine.drug, Adult, medicine.medical_specialty, Chronic Myeloid Leukemia, Socio-culturale, Article, tyrosine kinase inhibitors, discontinued treatment, chronic myeloid leukemia, treatment-free remission (TFR), Safety-Based Drug Withdrawals, 03 medical and health sciences, chronic myeloid leukemia, tyrosine kinase inhibitors discontinuation, Median follow-up, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, Humans, Protein Kinase Inhibitors, Retrospective Studies, business.industry, Imatinib, medicine.disease, respiratory tract diseases, Settore MED/15 - MALATTIE DEL SANGUE, Nilotinib, chemistry, business, 030215 immunology, Chronic myelogenous leukemia
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

Published
2019

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

Author

D. Ielo, Mario Cazzola, A. De Vivo, Mario Petrini, G. Fioritoni, Simona Sica, Fausto Castagnetti, B. Falini, Miriam Fogli, Agostino Cortelezzi, C. Viganò, Giuliana Alimena, Maurizio Musso, G. Spinosa, Flavia Salvi, Giancarlo Latte, Michele Pizzuti, Nicola Cantore, D. Luzzi, B. Ronci, Francesco Merli, Mario Boccadoro, Diamante Turri, Monica Bocchia, Patrizia Tosi, A. M. Carella, Simona Luatti, G. Semenzato, Mariella Grasso, Nicoletta Testoni, Giovanni Martinelli, Ester Pungolino, Giuseppe Tagariello, A. Russo Rossi, Simona Soverini, Francesca Ronco, Franco Iuliano, Giovanni Rosti, Alberto Bosi, Tamara Intermesoli, Dario Ferrero, Sara Galimberti, Giovanna Rege-Cambrin, Ferdinando Porretto, Sabina Russo, Roberto Latagliata, Pellegrino Musto, E. Morra, Agostino Tafuri, Franca Falzetti, Francesco Cavazzini, P. Galieni, Marzia Salvucci, F. Rodighiero, Stefana Impera, Fausto Dore, P. De Fabritiis, V. Meneghini, Elisabetta Calistri, Paolo Vigneri, Ivana Pierri, Michele Cavo, Massimo Pini, Fabrizio Ciccone, Domenico Russo, E Trabacchi, Franco Gherlinzoni, Michele Baccarani, Ilaria Iacobucci, Roberto Sartori, Paolo Avanzini, D. Noli, Roberto Marasca, Simonetta Pardini, A. Malpignano, Maria Concetta Petti, Bruno Martino, M. Bergamaschi, Giovanni Pizzolo, Valeria Santini, E Orlandi, Catia Bigazzi, Serena Rupoli, Giuseppe Saglio, I. Cervello, Clementina Caracciolo, Anna Merli, R. Di Lorenzo, Enrico Pogliani, Francesco Lanza, Mariella Girasoli, M. Apolinari, Caterina Musolino, Francesco Fabbiano, D. Vallisa, Mario Annunziata, Gabriele Gugliotta, V. De Stefano, Ignazio Majolino, Sergio Storti, P. Leoni, Adele Capucci, Massimo Breccia, Alessandro Isidori, Carmen Fava, Gianni Binotto, Carlo Gambacorti-Passerini, L. Pacilli, Mario Tiribelli, Luciano Levato, Felicetto Ferrara, N. Di Renzo, Anna D'Emilio, Francesco Pisani, Fabio Stagno, Monica Crugnola, M. Trawiska, Patrizia Pregno, Marzia Defina, Stefano Molica, Mario Luppi, Michele Malagola, Davide Rapezzi, A. M. Liberati, E. De Biasi, A. Iurlo, Umberto Vitolo, Silvana Capalbo, Maria Teresa Bochicchio, F. Di Raimondo, Franco Aversa, Giuseppe Visani, Fausto Palmieri, Alessandro Rambaldi, Sergio Siragusa, Massimiliano Bonifacio, Luigiana Luciano, Giorgina Specchia, Elisabetta Abruzzese, A. De Blasio, Francesco Albano, Antonio Cuneo, Emilio Usala, Alfonso Zaccaria, R Fanin, Francesca Palandri, Fabrizio Pane, Enrico Montefusco, A. Gozzini, Giulio Rossi, Emanuele Angelucci, A. Bacigalupo, Marco Gobbi, Michele Cedrone, 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., on behalf of the, GIMEMA CML Working Party [.., Palandri, F., Testoni, N., Luatti, S., Soverini, S., Iacobucci, I., Bochicchio, M.T., Apolinari, M., Fogli, M., Cervello, I., ]., Castagnetti, Fausto, De Vivo, A., Pane, Fabrizio, 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., Bochicchio, M. T., 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, 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, M, 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, Spinosa, G, Pierri, I, Bergamaschi, M, Carella, A, Bacigalupo, A, De Blasio, A, Ciccone, F, Di Renzo, N, Musolino, C, Russo, S, Cortelezzi, A, Morra, E, Pungolino, E, Luppi, M, Marasca, R, Pogliani, E, 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, Pisani, F, Tafuri, A, Montefusco, E, Iuliano, F, Dore, F, Pardini, S, Bocchia, M, Defina, M, Liberati, A, Luzzi, D, Boccadoro, M, Ferrero, D, Vitolo, U, Gherlinzoni, F, Calistri, E, Fanin, R, Pizzolo, G, Meneghini, V, Rodighiero, F, and D'Emilio, A

Subjects
Male, Pediatrics, Host response, BCR-ABL, Chronic myeloid leukemia, Prognosis, Tyrosine kinase inhibitors, Young adults, Adult, Age Factors, Aged, Aged, 80 and over, Antineoplastic Agents, Female, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Middle Aged, Prospective Studies, Protein Kinase Inhibitors, Protein-Tyrosine Kinases, Spleen, Splenomegaly, Young Adult, Oncology, Hematology, Tyrosine kinase inhibitor, Disease, Antineoplastic Agent, Tyrosin kinase inhibitor, Protein-Tyrosine Kinase, hemic and lymphatic diseases, 80 and over, Age Factor, Young adult, Chronic, Leukemia, Incidence (epidemiology), Myeloid leukemia, bcr-abl1, chronic myeloid leukemia, prognosis, tyrosine kinase inhibitors, young adults, Human, medicine.medical_specialty, Prognosi, Protein Kinase Inhibitor, NO, medicine, Adult patients, business.industry, medicine.disease, Clinical trial, Prospective Studie, Medicine (all), Immunology, BCR-ABL Positive, BCR-ABL, chronic myeloid leukemia, prognosis, tyrosine kinase inhibitors, young adults, business, Myelogenous
Abstract

BACKGROUND: The incidence of chronic myeloid leukemia (CML) increases with age, but it is unclear how the characteristics of the disease vary with age. In children, where CML is very rare, it presents with more aggressive features, including huge splenomegaly, higher cell count and higher blast cell percentage. PATIENTS AND METHODS: To investigate if after childhood the disease maintains or loses these characteristics of aggressiveness, we analyzed 2784 adult patients, at least 18 years old, registered by GIMEMA CML WP over a 40-year period. RESULTS: Young adults (YAs: 18-29 years old) significantly differed from adults (30-59 years old) and elderly patients (at least 60 years old) particularly for the frequency of splenomegaly (71%, 63% and 55%, P < 0.001), and the greater spleen size (median value: 4.5, 3.0 and 1.0 cm, P < 0.001). According to the EUTOS score, that is age-independent, high-risk patients were more frequent among YAs, than among adult and elderly patients (18%, 9% and 6%, P < 0.001). In tyrosine kinase inhibitors-treated patients, the rates of complete cytogenetic and major molecular response were lower in YAs, and the probability of transformation was higher (16%, 5% and 7%, P = 0.011). CONCLUSIONS: The characteristics of CML or the host response to leukemia differ with age. The knowledge of these differences and of their causes may help to refine the treatment and to improve the outcome. CLINICAL TRIAL NUMBERS: NCT00510926, NCT00514488, NCT00769327, NCT00481052. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Published
2015

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

Author

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

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

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

Published
2022

47. Personal history and quality of life in chronic myeloid leukemia patients: a cross-sectional study using narrative medicine and quantitative analysis

Author

Guendalina Graffigna, Alessandro Maggi, Fabio Efficace, Sara Galimberti, Lucia Mastrullo, Roberta Della Seta, Tamara Intermesoli, Matteo Pacilli, Silvana Capalbo, Ester Pungolino, Michele Pizzuti, Chiara Elena, Margherita Maffioli, Massimo Breccia, Enrico Capochiani, Nicola Di Renzo, Giuliana Alimena, Davide Rapezzi, Alessandro Melosi, Elena Trabacchi, Carlo Gambacorti-Passerini, Mario Luppi, Federico Simonetti, Daniele Vallisa, Franca Falzetti, Ester Orlandi, Alessandra Iurlo, Breccia, M, Graffigna, G, Galimberti, S, Iurlo, A, Pungolino, E, Pizzuti, M, Maggi, A, Falzetti, F, Capalbo, S, Intermesoli, T, Maffioli, M, Elena, C, Melosi, A, Simonetti, F, Capochiani, E, Seta, R, Pacilli, M, Luppi, M, Di Renzo, N, Mastrullo, L, Trabacchi, E, Vallisa, D, Rapezzi, D, Orlandi, E, GAMBACORTI PASSERINI, C, Efficace, F, and Alimena, G

Subjects
Adult, Male, medicine.medical_specialty, Cross-sectional study, Pain medicine, Population, Tyrosine kinase inhibitor, Settore M-PSI/06 - PSICOLOGIA DEL LAVORO E DELLE ORGANIZZAZIONI, Disease, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Internal medicine, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Chronic myeloid leukemia, Narrative medicine, Tyrosine kinase inhibitors, Oncology, Medicine, Humans, Psychiatry, education, Protein Kinase Inhibitors, Aged, Aged, 80 and over, education.field_of_study, Narration, business.industry, Nursing research, Myeloid leukemia, Middle Aged, Cross-Sectional Studies, Evaluation Studies as Topic, 030220 oncology & carcinogenesis, Quality of Life, Female, business, 030215 immunology
Abstract

Background: Tyrosine kinase inhibitors (TKIs) drastically changed the outcome of patients diagnosed with chronic myeloid leukemia (CML). Several reports indicated the advantage of continue long-term adherence associated with positive outcome. Therefore, it is important to better understand from the patient’s standpoint the experience of living with the disease and the related treatment. Objectives: In this study, quantitative analysis and narrative medicine were combined to get insights on this issue in a population of 257 patients with CML in chronic phase treated with TKIs (43 % men, with a median age of 58 years, 27 % aged 31–50 years), followed for a median time of 5 years. Sixty-one percent of patients enrolled were treated in first line, whereas 37 % were treated in second line. Results: The results showed more positive perceptions and acceptance in males compared to females, without impact of disease on relationships. Level of positive acceptance was more evident in elderly compared to younger patients, with a close connection with median time from diagnosis. Overall, female patients reported negative perceptions and an impact of disease on family daily living. The majority of patients understood the importance of continue adherence to treatment, with 27 % resulting less adherent (60 % for forgetfulness), even if well informed and supported by his/her physician. Discussion and conclusions: Narrative medicine, in association to quantitative analysis, can help physicians to understand needs of their patients in order to improve communication.

Published
2016

48. The impact of histopathologic examination of graft-versus-host disease in the era of reduced-intensity conditioning regimen: a study from the Gruppo Italiano Trapianto di Midollo Osseo

Author

Fedro A. Peccatori, Loredana Villari, Paola Rafaniello, Marco Casini, Francesca Patriarca, Silvia Benemei, Luca Messerini, Roberto Raimondi, Anna Maria Cesinaro, Maurilio Ponzoni, Francesco Lapi, Giovanni Negri, Chiara Nozzoli, Vito Colombetti, Andrea Tendas, Edvige Salomone, Camilla E. Comin, Giuseppe Milone, Luca Albarello, Amedea Donelli, Stefano Guidi, Marco Santucci, Fabio Ciceri, Emanuela Bonoldi, Cristina Fondi, Davide Rapezzi, Daniela Massi, Alberto Bosi, Claudio Avellini, Stefano Fratoni, Mirella Fortunato, Massi, D, Fondi, C, Nozzoli, C, Benemei, S, Lapi, F, Albarello, L, Avellini, C, Bonoldi, E, Casini, M, Cesinaro, Am, Ciceri, Fabio, Colombetti, V, Comin, Ce, Donelli, A, Fortunato, M, Fratoni, S, Guidi, S, Messerini, L, Milone, G, Rapezzi, D, Negri, G, Patriarca, F, Peccatori, Fa, Ponzoni, Maurilio, Rafaniello, P, Raimondi, R, Salomone, E, Tendas, A, Villari, L, Santucci, M, and Bosi, A.

Subjects
Adult, Male, medicine.medical_specialty, Pathology, Transplantation Conditioning, medicine.medical_treatment, Graft vs Host Disease, Hematopoietic stem cell transplantation, Disease, Gastroenterology, Pathology and Forensic Medicine, Young Adult, Internal medicine, medicine, Humans, Survival rate, Aged, Bone Marrow Transplantation, Univariate analysis, business.industry, Hematopoietic Stem Cell Transplantation, Overlap syndrome, Middle Aged, medicine.disease, Prognosis, Survival Rate, surgical procedures, operative, Graft-versus-host disease, Histopathology, Female, business
Abstract

Reduced-intensity conditioning regimens have reshaped the clinical presentation of graft-versus-host disease after hematopoietic stem cell transplants. However, histopathologic features of graft-versus-host disease following reduced-intensity conditioning regimens have not been fully characterized. In a series of 112 biopsies (skin, n = 60; gastrointestinal [GI] tract, n = 44; liver, n = 8), we described the morphologic profile of graft-versus-host disease following reduced-intensity conditioning and investigated whether histopathologic changes of graft-versus-host disease following reduced-intensity conditioning have a diagnostic and/or prognostic value. Forty-four patients (49.5%) experienced acute graft-versus-host disease, 2(2.2%) late-onset acute graft-versus-host disease (grade I, n = 13; grade II-IV, n = 33), 24(27.0%) chronic graft-versus-host disease (de novo n = 12, progressive n = 12) and 19 (21.3%) overlap syndrome. In the skin, we observed: (i) phase-nonspecific changes, such as acute graft-versus-host disease features in chronic graft-versus-host disease patients (n = 4/24; 16.6%), (ii) subtle alterations such as superficial fibrosis in widened dermal papillae (n = 8), in acute graft-versus-host disease/late-onset graft-versus-host disease (n = 6/46; 13.0%) or chronic graft-versus-host disease (n = 2/24, 8.3%) patients, and (iii) features of chronic and acute graft-versus-host disease coexisting in the same specimen in overlap syndrome (n = 3/19; 15.7%). In the GI tract, we did not demonstrate peculiar features differing from those commonly observed in the myeloablative setting. By univariate analysis, a reduced overall survival was associated with graft-versus-host disease type (chronic graft-versus-host disease P = .006, acute graft-versus-host disease P = .03), older age (P = .04), and histopathologic diagnosis of "consistent with" + definite graft-versus-host disease (P = .02). Histopathologic diagnosis retained an independent prognostic value by multivariate analysis (P = .01). The present study indicates that pathologists should be aware of the peculiar morphologic changes of cutaneous graft-versus-host disease following reduced-intensity conditioning and further recommends histopathology in the diagnostic workup of graft-versus-host disease in patients undergoing reduced-intensity conditioning regimen. (C) 2011 Elsevier Inc. All rights reserved.

Published
2010

49. Choice of Frontline Tyrosine-Kinase Inhibitor and Early Events in Very Elderly Patients With Chronic Myeloid Leukemia in Chronic Phase: A "Campus CML" Study.

Author

Bucelli C, Capodanno I, Miggiano MC, Cavazzini F, Crescenzi SL, Russo S, Carmosino I, Annunziata M, Sorà F, Bonifacio M, Luciano L, Caocci G, Loglisci G, Elena C, Lunghi F, Mullai R, Attolico I, Binotto G, Crisà E, Sportoletti P, Di Veroli A, Scortechini AR, Leporace AP, Maggi A, Crugnola M, Stagno F, Sancetta R, Murgano P, Rapezzi D, Luzi D, Vincelli DI, Galimberti S, Bocchia M, Fava C, Malato A, Abruzzese E, Saglio G, Specchia G, Breccia M, Iurlo A, Tiribelli M, and Latagliata R

Abstract

Objectives: The study aimed to evaluate the utilization of frontline TKI therapy in a large cohort of elderly CP-CML patients., Methods: A retrospective analysis was conducted on 332 CP-CML patients aged 75 years or older among 1929 diagnosed from January 2012 to December 2019 followed at 36 participating Hematology Centers involved in the "Campus CML" project., Results: Among the patients analyzed, 85.8% received imatinib (IM) while 14.2% received second-generation TKIs (2G-TKI), 59.5% dasatinib, and 40.5% nilotinib. Most patients initiated IM at standard dose (67.3%) while 32.7% at reduced dose. A similar trend was observed with 2G-TKIs. The cumulative incidence of permanent TKI discontinuation at 12 months was 28.4%, primarily due to primary resistance (10.1%) and extra-hematologic toxicity (9.5%), with no significant difference between IM and 2G-TKI groups. Following the introduction of generic IM in Italy in 2018, IM usage increased significantly compared with 2G-TKIs., Conclusions: IM was in our Centers the preferred frontline therapy for older CP-CML patients, with increasing utilization after the introduction of generic formulations. However, 2G-TKIs are still used in a substantial proportion of patients, suggesting individualized physician assessments regarding patient suitability and expectations. Further investigation is needed to assess efficacy and safety of reduced TKI doses in this patient population., (© 2024 The Author(s). European Journal of Haematology published by John Wiley & Sons Ltd.)

Published
2024
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50. High-dose chemotherapy and autologous stem cell transplant as first salvage treatment for relapsed or refractory Hodgkin Lymphoma in the era of PET-adapted strategies.

Author

Viviani S, Vanazzi A, Frassoni S, Rusconi C, Rossi A, Romano A, Patti C, Schiavotto C, Sorasio R, Marasco V, Lissandrini L, Rapezzi D, Gottardi D, Cocito F, Mulè A, Leotta S, Gini G, Sorio M, Derenzini E, Rambaldi A, Bagnardi V, and Tarella C

Subjects
Adult, Humans, Salvage Therapy, Combined Modality Therapy, Antineoplastic Combined Chemotherapy Protocols adverse effects, Retrospective Studies, Transplantation, Autologous, Stem Cell Transplantation, Positron-Emission Tomography, Hodgkin Disease therapy, Hodgkin Disease drug therapy, Hematopoietic Stem Cell Transplantation adverse effects
Abstract

Data on the efficacy of high-dose chemotherapy and autologous stem cell transplantation (ASCT) for classical Hodgkin lymphoma (cHL) patients who failed a PET-driven first-line therapy are limited.We retrospectively evaluated 220 adult cHL patients who underwent ASCT from 2009 to 2021 at 11 centers in Italy. Overall, 49.5% had refractory disease, 23.2% relapsed < 12 and 27.3% ≥12 months from the end of first-line chemotherapy. The 3-year progression-free survival (PFS) and overall survival (OS) were 73.8% and 89.4%. In univariable analysis for PFS events PET-2+ (HR 2.69, p  = .001), anemia (HR 2.22, p  = .019), refractory disease (HR 1.76, p  = .045), less than CR before ASCT (HR 3.24, p < .001) and >2 lines of salvage therapy (HR 2.52; p  = .004) were associated with a higher risk of failure after ASCT. In multivariable analysis, >2 lines of salvage therapy (HR 3.28, p  = .004) and RT before ASCT (HR 3.00, p  = 0.041) retained significance.ASCT is an effective salvage approach for cHL patients treated in the era of PET-adapted therapies.

Published
2024
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