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1. 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

2. 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

3. 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

4. Impact of comorbidities and body mass index on the outcome of polycythemia vera patients

Author

Alessia Tieghi, Alessandra D'Addio, Florian H. Heidel, Roberto Latagliata, Elisa Bossi, Francesco Cavazzini, Giulia Benevolo, Nicola Vianelli, Michele Cavo, Roberto M. Lemoli, Mauro Krampera, Massimo Breccia, Massimiliano Bonifacio, Gianni Binotto, Antonio Cuneo, Giovanni Caocci, Daniela Bartoletti, Mario Tiribelli, Ida Carmosino, Lucia Catani, Giuseppe Auteri, Francesco Lanza, Giuseppe A. Palumbo, Nicola Polverelli, Francesca Palandri, Micaela Bergamaschi, Monica Crugnola, Elena Maria Elli, Benevolo G., Elli E.M., Bartoletti D., Latagliata R., Tiribelli M., Heidel F.H., Cavazzini F., Bonifacio M., Crugnola M., Binotto G., D'Addio A., Tieghi A., Bergamaschi M., Caocci G., Polverelli N., Bossi E., Auteri G., Carmosino I., Catani L., Cuneo A., Krampera M., Lanza F., Lemoli R.M., Vianelli N., Breccia M., Palumbo G.A., Cavo M., and Palandri F.

Subjects
Male, Cancer Research, Comorbidity, Overweight, Primary Myelofibrosi, 0302 clinical medicine, Retrospective Studie, Risk Factors, body mass index, cancer, Charlson comorbidity index, outcome, polycythemia vera, thrombotic risk, 80 and over, Cumulative incidence, Aged, 80 and over, Incidence, Incidence (epidemiology), Hazard ratio, Hematology, General Medicine, Middle Aged, Oncology, 030220 oncology & carcinogenesis, Thrombosi, Female, Underweight, medicine.symptom, Human, Adult, medicine.medical_specialty, NO, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Humans, Aged, Retrospective Studies, business.industry, Risk Factor, Thrombosis, Retrospective cohort study, medicine.disease, Follow-Up Studies, Polycythemia Vera, Primary Myelofibrosis, Body Mass Index, Body Mass Index, Cancer, Charlson Comorbidity Index, Outcome, Polycythemia Vera, Thrombotic risk, business, Body mass index, 030215 immunology
Abstract

In 816 patients with 2016 World Health Organization-defined polycythemia vera (PV) enrolled in a multicenter retrospective study, we investigated the predictive value of Charlson comorbidity index (CCI) and body mass index (BMI) on thrombosis, progression to post-PV myelofibrosis (PPV-MF) and survival. Patients were subgrouped according to CCI=0 (58.1%, no comorbidities) or CCI≥1 (41.9%) and according to normal/underweight (BMI&nbsp

Published
2021

5. 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

6. Health-related quality of life of newly diagnosed chronic myeloid leukemia patients treated with first-line dasatinib versus imatinib therapy

Author

Marco Vignetti, Antonella Gozzini, Andrea Patriarca, Fausto Castagnetti, Massimo Breccia, Alessandra Iurlo, Monica Crugnola, Elisabetta Abruzzese, Bruno Martino, Claudio Fozza, Nicola Cascavilla, Gianni Binotto, Giovanni Caocci, Massimiliano Bonifacio, I Capodanno, Fabio Stagno, Patrizia Pregno, Micaela Bergamaschi, Francesco Cottone, Fabio Efficace, Mario Tiribelli, Gianantonio Rosti, Susanne Saussele, Efficace F., Stagno F., Iurlo A., Breccia M., Cottone F., Bonifacio M., Abruzzese E., Castagnetti F., Caocci G., Crugnola M., Capodanno I., Martino B., Tiribelli M., Patriarca A., Gozzini A., Pregno P., Saussele S., Cascavilla N., Fozza C., Bergamaschi M., Binotto G., Vignetti M., and Rosti G.

Subjects
Male, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, chronic myeloid leukemia, health-related quality of life, tyrosine kinase inhibitors, EORTC QLQ, Antineoplastic Agents, 03 medical and health sciences, 0302 clinical medicine, Quality of life, chronic myeloid leukemia, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, hemic and lymphatic diseases, Internal medicine, medicine, Humans, dasatinib, Protein Kinase Inhibitors, Aged, business.industry, Case-control study, Myeloid leukemia, Cancer, chronic myeloid leukemia,imatinib,dasatinib,quality of life, Imatinib, Hematology, Middle Aged, medicine.disease, humanities, Clinical trial, Dasatinib, 030104 developmental biology, imatinib, quality of life, Case-Control Studies, 030220 oncology & carcinogenesis, Imatinib Mesylate, Female, Patient-reported outcome, business, medicine.drug
Abstract

There is paucity of evidence-based data on health-related quality of life (HRQOL) outcomes of chronic myeloid leukemia (CML) patients treated with tyrosine kinase inhibitors (TKIs). We performed a multicenter propensity-matched case-control study to compare HRQOL of newly diagnosed CML patients treated with front-line dasatinib (cases) or imatinib (controls). Patient-reported HRQOL was assessed with the EORTC QLQ-C30 and the EORTC QLQ-CML24 questionnaires. The impact on daily life scale of the EORTC QLQ-CML24 was selected a priori in the protocol as the primary HRQOL scale for the comparative analysis. Overall, 323 CML patients were enrolled of whom 223 in therapy with imatinib and 100 in therapy with dasatinib. Patients treated with dasatinib reported better disease-specific HRQOL outcomes in impact on daily life (Δ = 8.72, 95% confidence interval [CI]: 3.17-14.27, p = 0.002), satisfaction with social life (Δ = 13.45, 95% CI: 5.82-21.08, p = 0.001), and symptom burden (Δ = 7.69, 95% CI: 3.42-11.96, p = 0.001). Analysis by age groups showed that, in patients aged 60 years and over, differences favoring dasatinib were negligible across several cancer generic and disease-specific HRQOL domains. Our findings provide novel comparative HRQOL data that extends knowledge on safety and efficacy of these two TKIs and may help to facilitate first-line treatment decisions.

Published
2019

7. Prognostic Factors for Overall Survival In Chronic Myeloid Leukemia Patients: A Multicentric Cohort Study by the Italian CML GIMEMA Network

Author

Giovanni Reddiconto, Maria Stella De Candia, Sara Galimberti, Fabrizio Pane, Michele Pizzuti, Luciano Levato, Massimiliano Bonifacio, Massimo Breccia, Anna Rita Scortechini, Elisabetta Abruzzese, Giovanni Caocci, Valentina Giai, Paolo Ditonno, Andrea Patriarca, Federica Sorà, Giuseppe Pietrantuono, Gaetano La Barba, Fabio Stagno, Patrizia Pregno, Antonella Gozzini, Francesco Di Raimondo, Michele Baccarani, Grazia Sanpaolo, Giovannino Ciccone, Micaela Bergamaschi, Gianni Binotto, Alessandro Maggi, Chiara Monagheddu, Giuseppe Saglio, Maria Cristina Miggiano, Monica Bocchia, Pellegrino Musto, Anna Guella, Luigiana Luciano, Giorgina Specchia, Bruno Martino, Francesco Albano, Fabio Saccona, Giovanna Rege-Cambrin, Olga Mulas, Gianantonio Rosti, Carmen Fava, Mario Tiribelli, Fausto Castagnetti, Isabella Capodanno, Specchia G., Pregno P., Breccia M., Castagnetti F., Monagheddu C., Bonifacio M., Tiribelli M., Stagno F., Caocci G., Martino B., Luciano L., Pizzuti M., Gozzini A., Scortechini A.R., Albano F., Bergamaschi M., Capodanno I., Patriarca A., Fava C., Rege-Cambrin G., Sora F., Galimberti S., Bocchia M., Binotto G., Reddiconto G., DiTonno P., Maggi A., Sanpaolo G., De Candia M.S., Giai V., Abruzzese E., Miggiano M.C., La Barba G., Pietrantuono G., Guella A., Levato L., Mulas O., Saccona F., Rosti G., Musto P., Di Raimondo F., Pane F., Baccarani M., Saglio G., and Ciccone G.

Subjects
ELT, chronic myeloid leukemia, ELTs, prognostic factors, Sokal score, tyrosine kinase inhibitors, Cancer Research, medicine.medical_specialty, Patient characteristics, Internal medicine, Overall survival, Medicine, Prospective cohort study, prognostic factor, RC254-282, Original Research, business.industry, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Myeloid leukemia, Imatinib, prognostic factors for overall survival in chronic myeloid leukemia patient a multicentric cohort study, Settore MED/15 - MALATTIE DEL SANGUE, Oncology, Cohort, business, Sokal Score, Cohort study, medicine.drug
Abstract

An observational prospective study was conducted by the CML Italian network to analyze the role of baseline patient characteristics and first line treatments on overall survival and CML-related mortality in 1206 newly diagnosed CML patients, 608 treated with imatinib (IMA) and 598 with 2nd generation tyrosine kinase inhibitors (2GTKI). IMA-treated patients were much older (median age 69 years, IQR 58-77) than the 2GTKI group (52, IQR 41-63) and had more comorbidities. Estimated 4-year overall survival of the entire cohort was 89% (95%CI 85.9-91.4). Overall, 73 patients (6.1%) died: 17 (2.8%) in the 2GTKI vs 56 (9.2%) in the IMA cohort (adjusted HR=0.50; 95% CI=0.26-0.94), but no differences were detected for CML-related mortality (10 (1.7%) vs 11 (1.8%) in the 2GTKIs vs IMA cohort (sHR=1.61; 0.52-4.96). The ELTS score was associated to CML mortality (high risk vs low, HR=9.67; 95%CI 2.94-31.74; p

Published
2021

8. Ruxolitinib discontinuation syndrome: incidence, risk factors, and management in 251 patients with myelofibrosis

Author

Bruno Martino, Daniele Cattaneo, Florian H. Heidel, Elisabetta Abruzzese, Gianni Binotto, Rossella Stella, Giulia Benevolo, Michele Cavo, Micaela Bergamaschi, Roberto Latagliata, Francesco Cavazzini, Novella Pugliese, Massimo Breccia, Alessandro Isidori, Gianpietro Semenzato, Daniela Bartoletti, Mauro Krampera, Malgorzata Monica Trawinska, Costanza Bosi, Giovanni Caocci, Fabrizio Pane, Alessia Tieghi, Francesca Palandri, Roberto M. Lemoli, Elena Maria Elli, Antonio Cuneo, Fiorella Ciantia, Alessandra Iurlo, Monica Crugnola, Giuseppe Auteri, Mario Tiribelli, Massimiliano Bonifacio, Nicola Vianelli, Luigi Scaffidi, Giuseppe A. Palumbo, Nicola Polverelli, Palandri F., Palumbo G.A., Elli E.M., Polverelli N., Benevolo G., Martino B., Abruzzese E., Tiribelli M., Tieghi A., Latagliata R., Cavazzini F., Bergamaschi M., Binotto G., Crugnola M., Isidori A., Caocci G., Heidel F., Pugliese N., Bosi C., Bartoletti D., Auteri G., Cattaneo D., Scaffidi L., Trawinska M.M., Stella R., Ciantia F., Pane F., Cuneo A., Krampera M., Semenzato G., Lemoli R.M., Iurlo A., Vianelli N., Cavo M., Breccia M., and Bonifacio M.

Subjects
Ruxolitinib, medicine.medical_specialty, Humans, Janus Kinases, Multivariate Analysis, Primary Myelofibrosis, Protein Kinase Inhibitors, Pyrazoles, Risk Factors, Treatment Outcome, medicine.medical_treatment, Splenectomy, lcsh:RC254-282, Nitriles, Pyrimidines, Ruxolitinib discontinuation syndrome, risk factors, myelofibrosis, NO, Myeloproliferative disease, Internal medicine, Correspondence, medicine, Risk factor, Bone pain, Myelofibrosis, Respiratory distress, business.industry, Incidence (epidemiology), Hematology, medicine.disease, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Discontinuation, Oncology, medicine.symptom, business, Haematological diseases, medicine.drug
Abstract

No abstract available

Published
2020

9. Risk factors for progression to blast phase and outcome in 589 patients with myelofibrosis treated with ruxolitinib: Real-world data

Author

Massimo Breccia, Mauro Krampera, Alessandro Isidori, Monica Crugnola, Daniela Bartoletti, Elena Maria Elli, Alessia Tieghi, Massimiliano Bonifacio, Micaela Bergamaschi, Costanza Bosi, Roberto Latagliata, Roberto M. Lemoli, Francesco Cavazzini, Florian H. Heidel, Michele Cavo, Nicola Polverelli, Malgorzata Monika Trawinska, Francesca Palandri, Bruno Martino, Daniele Cattaneo, Giulia Benevolo, Giuseppe Auteri, Elisabetta Abruzzese, Gianni Binotto, Alessandra Iurlo, Nicola Vianelli, Antonio Cuneo, Francesco Di Raimondo, Dorian Forte, Davide Griguolo, Gianpietro Semenzato, Giuseppe A. Palumbo, Mario Tiribelli, Palandri F., Breccia M., Tiribelli M., Bonifacio M., Benevolo G., Iurlo A., Elli E.M., Binotto G., Tieghi A., Polverelli N., Martino B., Abruzzese E., Bergamaschi M., Heidel F.H., Cavazzini F., Crugnola M., Bosi C., Isidori A., Auteri G., Forte D., Latagliata R., Griguolo D., Cattaneo D., Trawinska M., Bartoletti D., Krampera M., Semenzato G., Lemoli R.M., Cuneo A., Di Raimondo F., Vianelli N., Cavo M., and Palumbo G.A.

Subjects
Male, Cancer Research, Ruxolitinib, ruxolitinib, Gastroenterology, 0302 clinical medicine, myelofibrosi, 80 and over, risk factors, blast phase, myelofibrosis, outcome, Adult, Aged, Aged, 80 and over, Blast Crisis, Disease Progression, Female, Follow-Up Studies, Humans, Janus Kinases, Middle Aged, Primary Myelofibrosis, Prognosis, Pyrazoles, Retrospective Studies, Survival Rate, Young Adult, Incidence (epidemiology), Hematology, General Medicine, risk factor, Oncology, 030220 oncology & carcinogenesis, blast phase, myelofibrosis, outcome, risk factors, ruxolitinib, Blast Crisis, Disease Progression, medicine.drug, medicine.medical_specialty, Socio-culturale, Alpha interferon, 03 medical and health sciences, Internal medicine, Nitriles, medicine, Risk factor, Myelofibrosis, Survival rate, business.industry, Induction chemotherapy, Anagrelide, medicine.disease, Pyrimidines, business, 030215 immunology
Abstract

The impact of ruxolitinib therapy on evolution to blast phase (BP) in patients with myelofibrosis (MF) is still uncertain. In 589 MF patients treated with ruxolitinib, we investigated incidence and risk factors for BP and we described outcome according to disease characteristics and treatment strategy. After a median follow-up from ruxolitinib start of 3 years (range 0.1-7.6), 65 (11%) patients transformed to BP during (93.8%) or after treatment. BP incidence rate was 3.7 per 100 patient-years, comparably in primary and secondary MF (PMF/SMF) but significantly lower in intermediate-1 risk patients (2.3 vs 5.6 per 100 patient-years in intermediate-2/high-risk patients, P

Published
2020

10. Increased tumor burden in patients with chronic myeloid leukemia after 36 months of imatinib discontinuation

Author

Silvia Mori, Bruno Martino, Sarit Assouline, Micaela Bergamaschi, Eros Di Bona, Marcio Andrade-Campos, Chiara Elena, Patrizia Crivori, Ester Pungolino, Alessandra Iurlo, Antonella Gozzini, Philipp le Coutre, Elisa Diral, Elisabetta Abruzzese, Laura Antolini, Alessandra Pirola, Diletta Fontana, Fabio Stagno, Maria Luisa Bonanomi, Rocco Piazza, Carmen Fava, Carlo Gambacorti-Passerini, Jessica Petiti, Diral, E, Mori, S, Antolini, L, Abruzzese, E, Le Coutre, P, Martino, B, Pungolino, E, Elena, C, Bergamaschi, M, Assouline, S, Di Bona, E, Gozzini, A, Andrade-Campos, M, Stagno, F, Iurlo, A, Pirola, A, Fontana, D, Petiti, J, Bonanomi, M, Crivori, P, Piazza, R, Fava, C, and Gambacorti Passerini, C

Subjects
Adult, Male, Oncology, medicine.medical_specialty, Adolescent, Immunology, Tumor burden, Antineoplastic Agents, Biochemistry, Young Adult, chronic myeloid leukemia, MED/15 - MALATTIE DEL SANGUE, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Recurrence free survival, Internal medicine, medicine, Humans, In patient, Aged, Aged, 80 and over, business.industry, Myeloid leukemia, Imatinib, clinical trial, Cell Biology, Hematology, Middle Aged, Prognosis, BCR-ABL protein, Tumor Burden, Discontinuation, Survival Rate, Withholding Treatment, Imatinib Mesylate, Female, business, Follow-Up Studies, Cohort study, medicine.drug, discontinuation
Abstract

TO THE EDITOR: The Imatinib Suspension and Validation (ISAV) study1 is a multicenter trial of imatinib discontinuation (ID) among patients with chronic myeloid leukemia (CML) in undetectable deep molecular remission (U-DMR). After 12 months of follow-up, 48% of patients relapsed (total n = 107), with the majority of relapses occurring within the first 9 months. An inverse relationship between patient age and risk of relapse was also observed at this timepoint. Here we report the final results of ISAV after a median follow-up of 49 months, as well as the dynamics of leukemic tumor load as determined by digital polymerase chain reaction (dPCR) in nonrelapsed patients. This trial is registered at www.clinicaltrials.gov (NCT01578213). Eligible patients were 18 years and older and had CML, either in chronic or accelerated phase, with U-DMR of at least 18 months’ duration and at least...

Published
2020

11. Second primary malignancy in myelofibrosis patients treated with ruxolitinib

Author

Elena Maria Elli, Florian H. Heidel, Uros Markovic, Fabrizio Pane, Gianpietro Semenzato, Daniela Bartoletti, Francesca Palandri, Giulia Benevolo, Mauro Krampera, Malgorzata Monika Trawinska, Micaela Bergamaschi, Mario Tiribelli, Giovanni Caocci, Lucia Catani, Elisabetta Abruzzese, Massimo Breccia, Rossella Stella, Antonio Cuneo, Fabio D'Amore, Alessandro Isidori, Costanza Bosi, Monica Crugnola, Lisa Gandolfi, Domenico Russo, Alessandra Iurlo, Nicola Polverelli, Roberto M. Lemoli, Michele Cavo, Gianni Binotto, Roberto Latagliata, Francesco Cavazzini, Bruno Martino, Daniele Cattaneo, Nicola Vianelli, Novella Pugliese, Luigi Scaffidi, Massimiliano Bonifacio, Mariella D'Adda, Alessia Tieghi, Giuseppe Auteri, Giuseppe A. Palumbo, Polverelli N., Elli E.M., Abruzzese E., Palumbo G.A., Benevolo G., Tiribelli M., Bonifacio M., Tieghi A., Caocci G., D'Adda M., Bergamaschi M., Binotto G., Heidel F.H., Cavazzini F., Crugnola M., Pugliese N., Bosi C., Isidori A., Bartoletti D., Auteri G., Latagliata R., Gandolfi L., Martino B., Scaffidi L., Cattaneo D., D'Amore F., Trawinska M.M., Stella R., Markovic U., Catani L., Pane F., Cuneo A., Krampera M., Semenzato G., Lemoli R.M., Vianelli N., Breccia M., Russo D., Cavo M., Iurlo A., and Palandri F.

Subjects
Male, Ruxolitinib, Skin Neoplasms, Lymphoma, ruxolitinib, Aggressive lymphoma, Gastroenterology, Hydroxycarbamide, 0302 clinical medicine, myelofibrosi, Risk Factors, Neoplasms, 80 and over, Aged, 80 and over, Thrombocytosis, Incidence (epidemiology), Incidence, Hazard ratio, Neoplasms, Second Primary, Hematology, Arteries, Middle Aged, Second Primary, JAK inhibitor, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.medical_specialty, Context (language use), myelofibrosis, JAK inhibitors, second cancer, toxicity, NO, 03 medical and health sciences, Internal medicine, Nitriles, medicine, Humans, Janus Kinase Inhibitors, Myelofibrosis, Aged, Retrospective Studies, business.industry, Thrombosis, medicine.disease, Case-Control Studies, Follow-Up Studies, Multivariate Analysis, Primary Myelofibrosis, Pyrazoles, Pyrimidines, business, 030215 immunology
Abstract

Ruxolitinib (RUX), the first JAK1/JAK2 inhibitor approved for myelofibrosis (MF) therapy, has recently been associated with the occurrence of second primary malignancies (SPMs), mainly lymphomas and non-melanoma skin cancers (NMSCs). We analyzed the incidence, risk factors and outcome of SPMs in 700 MF patients treated with RUX in a real-world context. Median follow-up from starting RUX was 2·9years. Overall, 80 (11·4%) patients developed 87 SPMs after RUX start. NMSCs were the most common SPMs (50·6% of the cases). Multivariate analysis demonstrated that male sex [hazard ratio (HR): 2·37, 95% confidence interval (95%CI): 1·22–4·60, P=0·01] and thrombocytosis>400×109/l at RUX start (HR:1·98, 95%CI: 1·10–4·60, P=0·02) were associated with increased risk for SPMs. Risk factors for NMSC alone were male sex (HR: 3·14, 95%CI: 1·24–7·92, P=0·02) and duration of hydroxycarbamide and RUX therapy>5years (HR: 3·20, 95%CI: 1·17–8·75, P=0·02 and HR: 2·93, 95%CI: 1·39–6·17, P=0·005 respectively). In SPMs excluding NMSCs, male sex (HR: 2·41, 95%CI: 1·11–5·25, P=0·03), platelet>400×109/l (HR: 3·30, 95%CI: 1·67–6·50, P=0·001) and previous arterial thromboses (HR: 3·47, 95%CI: 1·48–8·14, P=0·004) were shown to be associated with higher risk of SPMs. While it is reassuring that no aggressive lymphoma was documented, active skin surveillance is recommended in all patients and particularly after prolonged hydroxycaramide therapy; oncological screening should be triggered by thrombocytosis and arterial thrombosis, particularly in males.

Published
2020

12. Hypertensive Emergencies and Urgencies: Blood Pressure Management and its Relationship with Short and Medium Term Outcome

Author

Cristina Giannattasio, Silvia Gheda, Carlo Campanella, Antonella Moreo, M. Battistini, Gloria Magni, Andrea Luigi Roberto Beretta, Marta Bergamaschi, Andrea Bellone, G.M. Azin, Tommaso Valobra, M. Zacchino, Nicolò Capsoni, Alessandro Maloberti, Giulio Cassano, Alessandra Rossi, Giannattasio, C, Maloberti, A, Magni, G, Cassano, G, Capsoni, N, Gheda, S, Azin, G, Zacchino, M, Rossi, A, Campanella, C, Bergamaschi, M, Battistini, M, Valobra, T, Moreo, A, Beretta, A, Bellone., A, and Bellone, A

Subjects
Blood pressure management, medicine.medical_specialty, education.field_of_study, Physiology, business.industry, Population, HYPERTENSIVE EMERGENCIES AND URGENCIES, OUTCOME, Emergency department, Hypertensive emergencies and urgencies, blood pressure management, short and medium term outcome, Medium term, Emergency medicine, Internal Medicine, Medicine, Cardiology and Cardiovascular Medicine, business, education
Abstract

Introduction: Data regarding prevalence and clinical management of hypertensive emergencies and urgencies are lacking and heterogeneous. Aim: To characterize patients with hypertensive emergencies and urgencies admitted to the emergency department (ED) of Niguarda hospital. In this population we also want to evaluate factors associated with organ damage, adherence to guidelines and the impact of blood pressure (BP) management on short-term (admission to hospital and hospital mortality) and medium-term outcomes (recurrence). Methods: We performed a single-center retrospective study collecting data about all adult patients with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 120 mmHg admitted to our hospital’s ED during 2017. Results: Admission to ED for BP elevation were 706 (0.95% of total admission to ED), of whom 34.8% were hypertensive emergencies and 65.2% were hypertensive urgencies. Patients with hypertensive emergencies were older, mainly male, with more comorbidities and more symptomatic at ED admission. In the emergencies group, we observe a BP reduction rate of 18.82 ± 12.1% within 110.1 ± 11.9 min; the most used drugs were nitroglycerin, furosemide and labetalol. In the urgencies group, the BP reduction rate was 19% and the most used drug was short-acting nifedipine. Age, sex, smoking, clinical history of heart failure and chronic obstructive pulmonary disease, symptoms at ED admission ad eGFR have been recognized as factors associated with organ damage. Instead, BP at ED admission and its management didn’t appear to have a significant impact on outcomes. Conclusions: Our study demonstrated good adherence to guidelines in the treatment of hypertensive emergency than of hypertensive urgencies. On the other hand, no significant association were found between the BP management in the ED and the short-term and medium-term outcomes.

Published
2019

13. Increased Tumour Burden over a 36 Month Period in Chronic Myeloid Leukemia Patients Following Imatinib Discontinuation: Role of Digital PCR

Author

Chiara Elena, Eros Di Bona, Elisa Diral, Enrico Gottardi, Philipp le Coutre, Alessandra Pirola, Micaela Bergamaschi, Dong-Wook Kim, Jessica Petiti, Alessandra Iurlo, Maria Luisa Bonanomi, Rocco Piazza, Carmen Fava, Patrizia Crivori, Fabio Stagno, Carlo Gambacorti-Passerini, Sarit Assouline, Diral, E, Le Coutre, P, Gottardi, E, Elena, C, Bergamaschi, M, Assouline, S, Di Bona, E, Petiti, J, Stagno, F, Iurlo, A, Kim, D, Pirola, A, Bonanomi, M, Crivori, P, Piazza, R, Fava, C, and Gambacorti-Passerini, C

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, Immunology, Tumor burden, Leukemia Myelogenous Chronic, BCR-ABL Positive, polymerase chain reaction, neoplasms, reverse transcriptase polymerase chain reaction, imatinib mesylate, protein-tyrosine kinase inhibitor, disease remission, Positive control, Biochemistry, 03 medical and health sciences, 0302 clinical medicine, MED/15 - MALATTIE DEL SANGUE, hemic and lymphatic diseases, Internal medicine, medicine, Digital polymerase chain reaction, business.industry, Myeloid leukemia, Imatinib, Cell Biology, Hematology, Discontinuation, 030104 developmental biology, Imatinib mesylate, Functional status, business, 030215 immunology, medicine.drug
Abstract

Introduction. Discontinuation (D/C) of Imatinib or other TKIs in Chronic Myeloid Leukemia (CML) represents an important issue in the management of this disease. It is generally accepted that relapse develops (and treatment must be resumed) when patients (pts) lose Major Molecular Remission (MMR), i.e. when the amount of the BCR-ABL1 transcript, measured in peripheral blood by RT-PCR, exceeds 0.1 %. The Imatinib Suspension And Validation (ISAV) study, which started in 2011, enrolled pts with CML treated with Imatinib who showed no evidence of BCR-ABL1 transcript for at least 18 months before enrollment. Methods. A digital PCR (dPCR) for BCR-ABL1 was performed at the time of Imatinib D/C while a second dPCR was performed when non relapsed patients exited the study, 36 months later. dPCR experiments were performed by the QX200 system (BioRad) in the same lab and using the same methodology. The BCR-ABL1 fusion and ABL1 transcripts were quantified using DigiDrop P210 MasterMix and DigiDrop P210 Positive Control (Bioclarma), according to manufacturer's protocol. The target concentration in each sample was expressed as percentage of BCR-ABL1/ABL1. Results. A total of 107 pts were enrolled in the ISAV study. Relapses occurred in 54 pts (52%); among the 53 non relapsed pts, 41 (77%) presented at least one positive RT-PCR result following Imatinib D/C, and only 12 (23%) maintained PCR negativity throughout the duration of the study. Among the non-relapsed pts dPCR performed at treatment D/C showed positivity in 20.6% of cases (95% confidence interval [C.I.] 9-36%), while 91.1% of pts (95%, C.I. 80-97%) evaluated 36 months later showed a positive dPCR value, although no patient resumed treatment. The evaluation of non relapsed pts by dPCR showed that mean values at D/C were 0.00143% +/- 0.0006 (SE); when tested at study exit, the same pts showed average dPCR values of 0.0115 % +/- 0.002. This difference is statistically highly significant and corresponds to a change of approximately 1 log in the residual tumor burden: from 2x107 to 2x108 cells. There was no correlation between the results of RT-PCR performed during the study and the dPCR status at study exit: pts who tested negative by RT-PCR during the study were uniformly negative in dPCR at D/C but tested positive at study exit in 83.3% of cases; pts who showed at least on positive RT-PCR during the study showed positivity by dPCR in 25% at D/C and in 89.3% at study exit. Finally, half of the pts who tested negative by dPCR at study exit showed dPCR positivity when tested at the time of Imatinib D/C. Conclusions. These results show that during a three year period, the D/C of Imatinib led to the increase of approximately 1 log in the tumour burden of non-relapsed pts, although none of them lost MMR and resumed treatment. These data strongly indicate the need for a long-term monitoring of pts who D/C Imatinib; they also suggest that the functional status of residual CML cells rather than their number could represent the critical factor to predict the tumour load present after 3 years of Imatinib D/C. Disclosures Le Coutre: Incyte: Honoraria, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Pfizer: Honoraria, Speakers Bureau; Bristol-Myers Squibb: Honoraria, Speakers Bureau. Elena:Novartis: Consultancy; Pfizer: Consultancy. Assouline:Abbvie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria, Speakers Bureau; Pfizer: Consultancy, Honoraria, Speakers Bureau; F. Hoffmann-La Roche Ltd: Consultancy, Honoraria. Stagno:Incyte: Honoraria; Novartis: Honoraria; Pfizer: Honoraria; BMS: Honoraria. Iurlo:Novartis: Other: Speaker Honoraria; Incyte: Other: Speaker Honoraria; Pfizer: Other: Speaker Honoraria. Kim:Novartis: Research Funding; BMS: Research Funding; Pfizer: Research Funding; Takeda: Research Funding; Il-Yang co.: Research Funding. Fava:Pfizer: Honoraria; Novartis: Honoraria; Incyte: Honoraria; BMS: Honoraria. Gambacorti-Passerini:Bristol-Meyers Squibb: Consultancy; Pfizer: Honoraria, Research Funding.

Published
2019

14. Differences in presenting features, outcome and prognostic models in patients with primary myelofibrosis and post-polycythemia vera and/or post-essential thrombocythemia myelofibrosis treated with ruxolitinib. New perspective of the MYSEC-PM in a large multicenter study

Author

Costanza Bosi, Franco Aversa, Elisabetta Abruzzese, Nicola Vianelli, Giulia Benevolo, G. Semenzato, Bruno Martino, Daniele Cattaneo, Adalberto Ibatici, Nicola Polverelli, Daniela Bartoletti, Nicola Sgherza, Massimiliano Bonifacio, Roberto Latagliata, Francesca Palandri, Francesco Di Raimondo, Francesco Cavazzini, Micaela Bergamaschi, Michele Cavo, Massimo Breccia, Mariella D'Adda, Alessandra Iurlo, Alessandro Isidori, Maria Letizia Bacchi Reggiani, Giuseppe A. Palumbo, Luigi Scaffidi, Alessia Tieghi, Gianni Binotto, Antonio Cuneo, Monica Crugnola, Francesco Soci, Roberto M. Lemoli, Mario Tiribelli, Lucia Catani, Giuseppe Auteri, Malgorzata Monika Trawinska, Florian H. Heidel, Domenico Penna, Domenico Russo, and Palandri F, Palumbo GA, Iurlo A, Polverelli N, Benevolo G, Breccia M, Abruzzese E, Tiribelli M, Bonifacio M, Tieghi A, Isidori A, Martino B, Sgherza N, D'Adda M, Bergamaschi M, Crugnola M, Cavazzini F, Bosi C, Binotto G, Auteri G, Latagliata R, Ibatici A, Scaffidi L, Penna D, Cattaneo D, Soci F, Trawinska M, Russo D, Cuneo A, Semenzato G, Di Raimondo F, Aversa F, Lemoli RM, Heidel F, Reggiani MLB, Bartoletti D, Cavo M, Catani L, Vianelli N.

Subjects
Ruxolitinib, medicine.medical_specialty, Anemia, Socio-culturale, Myelofibrosis, Gastroenterology, MYSEC-PM, Efficacy, 03 medical and health sciences, Essential, 0302 clinical medicine, Polycythemia vera, Internal medicine, Nitriles, Risk scores, Humans, Medicine, Thrombocythemia, Polycythemia Vera, Survival rate, Janus Kinases, business.industry, Essential thrombocythemia, IPSS, Myelofibrosi, Hematology, Prognosis, medicine.disease, Primary Myelofibrosis, Pyrazoles, Survival Rate, Thrombocythemia, Essential, Pyrimidines, International Prognostic Scoring System, 030220 oncology & carcinogenesis, Risk score, business, IPSS, MYSEC-PM, Myelofibrosis, Risk scores, Ruxolitinib, 030215 immunology, medicine.drug
Abstract

Recently, the myelofibrosis secondary to PV and ET prognostic model (MYSEC-PM) was introduced to assess prognosis in myelofibrosis (MF) secondary to polycythemia vera and essential thrombocythemia (post-PV and post-ET MF), replacing the International Prognostic Scoring System (IPSS) and/or Dynamic IPSS (DIPSS) that was applied for primary MF (PMF). In a cohort of 421 ruxolitinib (RUX)-treated patients (post-PV and post-ET MF: 44.2%), we evaluated the following: (1) disease phenotype, responses, and toxicity to RUX; and (2) performance of the MYSEC-PM in post-PV or post-ET ME. While the IPSS failed to correctly stratify post-PV or post-ET MF patients at diagnosis, the MYSEC-PM identified 4 risk categories projected at significantly different survival probability (P < .001). Additionally, the MYSEC-PM maintained a prognostic value in post-PV and post-ET MF also when used over time, at RUX start. Notably, the MYSEC-PM reclassified 41.8% and 13.6% of patients into a lower and higher risk category, respectively. Finally, patients at intermediate-1 risk had significantly higher spleen responses and lower hematological toxicities compared to higher risk patients. Compared to PMF, post-PV and post-ET MF presented a more hyperproliferative disease, with higher leukocyte and/or platelet count and hemoglobin levels both at diagnosis and at RUX start. Despite comparable response rates, post-PV and post-ET MF had lower rate of RUX-induced anemia and thrombocytopenia at 3 and 6 months. The study validates MYSEC-PM in post-PV and post-ET MF prognostication. Post-PV or post-ET MF represents a separate entity compared to PMF in terms of clinical manifestations and toxicity to RUX. (C) 2018 Elsevier Inc. All rights reserved.

Published
2018

15. Managing chronic myeloid leukaemia in the elderly with intermittent imatinib treatment

Author

Anna D'Emilio, Diamante Turri, Sabina Russo, Tamara Intermesoli, Simona Soverini, Bruno Mario Cesana, Nicoletta Testoni, Monia Lunghi, M. Bergamaschi, Valeria Cancelli, Massimo Breccia, Domenico Russo, A. De Vivo, Emilio Usala, Valeria Santini, Mariella Girasoli, Bruno Martino, Michele Malagola, Antonella Russo-Rossi, Simona Bernardi, Monica Bocchia, Ester Pungolino, Giovanni Martinelli, Michele Baccarani, Catia Bigazzi, Elisabetta Abruzzese, Mario Tiribelli, Fabio Stagno, Giovanna Rege Cambrin, G Nicolini, R. Di Lorenzo, A Di Palma, Patrizia Pregno, Giovanni Rosti, Miriam Fogli, Fausto Castagnetti, Cristina Skert, Russo, D, Malagola, M., Skert, C., Cancelli, V., Turri, D., Pregno, P., Bergamaschi, M., Fogli, M., Testoni, N., De Vivo, A., Castagnetti, F., Pungolino, E., Stagno, F., Breccia, M., Martino, B., Intermesoli, T., Cambrin, G.R., Nicolini, G., Abruzzese, E., Tiribelli, M., Bigazzi, C., Usala, E., Russo, S., Russo-Rossi, A., Lunghi, M., Bocchia, M., D'Emilio, A., Santini, V., Girasoli, M., Di Lorenzo, R., Bernardi, S., Di Palma, A., Cesana, B.M., Soverini, S., Martinelli, G., Rosti, G., and Baccarani, M.

Subjects
Male, medicine.medical_specialty, Chronic Myeloid Leukemia, Antineoplastic Agents, Pilot Projects, Kaplan-Meier Estimate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, hemic and lymphatic diseases, medicine, Humans, In Situ Hybridization, Fluorescence, Aged, Aged, 80 and over, Hematology, business.industry, Remission Induction, Imatinib, medicine.disease, Confidence interval, Surgery, Clinical trial, Leukemia, Regimen, Imatinib mesylate, Oncology, Female, Imatinib Mesylate, Molecular Response, Original Article, business, medicine.drug
Abstract

The aim of this study was to investigate the effects of a non-standard, intermittent imatinib treatment in elderly patients with Philadelphia-positive chronic myeloid leukaemia and to answer the question on which dose should be used once a stable optimal response has been achieved. Seventy-six patients aged ⩾65 years in optimal and stable response with ⩾2 years of standard imatinib treatment were enrolled in a study testing a regimen of intermittent imatinib (INTERIM; 1-month on and 1-month off). With a minimum follow-up of 6 years, 16/76 patients (21%) have lost complete cytogenetic response (CCyR) and major molecular response (MMR), and 16 patients (21%) have lost MMR only. All these patients were given imatinib again, the same dose, on the standard schedule and achieved again CCyR and MMR or an even deeper molecular response. The probability of remaining on INTERIM at 6 years was 48% (95% confidence interval 35–59%). Nine patients died in remission. No progressions were recorded. Side effects of continuous treatment were reduced by 50%. In optimal and stable responders, a policy of intermittent imatinib treatment is feasible, is successful in about 50% of patients and is safe, as all the patients who relapsed could be brought back to optimal response.

Published
2015

16. De novo AML patients with favourable-intermediate karyotype may benefit from the addition of low-dose gemtuzumab ozogamicin (GO) to fludarabine, Ara-C and idarubicin (FLAI): a contribution to the reopened 'GO question'

Author

Marino Clavio, Daniele Avenoso, Fabio Cruciani, Sara Aquino, Laura Mitscheunig, Giordana Pastori, Enrico De Astis, Chiara Ghiggi, Paola Minetto, Micaela Bergamaschi, Fabio Guolo, Carlo Marani, Marco Gobbi, Davide Lovera, Nicoletta Colombo, Filippo Ballerini, Maurizio Miglino, Raffaella Grasso, Clavio, M, Cruciani, F, Minetto, P, Guolo, F, Ballerini, F, Marani, C, De Astis, E, Aquino, S, Bergamaschi, M, Mitscheunig, L, Grasso, R, Colombo, N, Ghiggi, C, Lovera, D, Pastori, G, Avenoso, D, Miglino, M, and Gobbi, M

Subjects
Male, medicine.medical_specialty, Pediatrics, Gemtuzumab ozogamicin, CD33, Karyotype, Ara-C, Lower risk, Antibodies, Monoclonal, Humanized, Gastroenterology, Fludarabine, AML, Internal medicine, medicine, Idarubicin, Humans, Cumulative incidence, Prospective Studies, Prospective cohort study, Aged, Aged, 80 and over, business.industry, Cytarabine, Hematology, General Medicine, Middle Aged, Gemtuzumab, Regimen, Leukemia, Myeloid, Acute, Aminoglycosides, Treatment Outcome, Female, business, Vidarabine, medicine.drug
Abstract

We report the final results of a prospective trial testing the combination of fludarabine, Ara-C and idarubicin (FLAI) followed by low-dose gemtuzumab ozogamicin (FLAI-GO) in 85 patients aged 60 years or more with CD33+ acute myeloid leukaemia (AML). Median age was 68 years (60-82); karyotype was unfavourable in 21 patients (24 %), intermediate in 63 (74 %) and favourable in 1 (2 %). There were five therapy-related deaths. Of the 80 evaluable patients, 47 achieved complete response (CR) (58 %); CR rates were 65 and 32 % in good-intermediate/poor karyotype patients, respectively. Median length of CR was 7 months (3-76). The cumulative incidence of relapse was 84 % with an actuarial survival of 50.3 % at 1 year and 14.4 % at 2 years. The study control population is an unselected consecutive historic cohort of 104 patients treated with the FLAI regimen, who were matched for age and prognostic factors. CR rates after FLAI-GO and FLAI were comparable. However, patients with de novo AML and intermediate-favourable karyotype receiving GO had a significantly lower risk of relapse at 2 years as compared to patients not receiving GO (n = 77) (40 vs 80 %, p = 0.01) and significantly better disease-free survival (p = 0.018) and overall survival (p = 0.022).

Published
2013

17. Effects and outcome of a policy of intermittent imatinib treatment in elderly patients with chronic myeloid leukemia

Author

Domenico, Russo, Giovanni, Martinelli, Michele, Malagola, Cristina, Skert, Simona, Soverini, Ilaria, Iacobucci, Antonio, De Vivo, Nicoletta, Testoni, Fausto, Castagnetti, Gabriele, Gugliotta, Diamante, Turri, Micaela, Bergamaschi, Michela, Bergamaschi, Patrizia, Pregno, Ester, Pungolino, Fabio, Stagno, Massimo, Breccia, Bruno, Martino, Tamara, Intermesoli, Carmen, Fava, Elisabetta, Abruzzese, Mario, Tiribelli, Catia, Bigazzi, Bruno Mario, Cesana, Gianantonio, Rosti, Michele, Baccarani, Russo D, Martinelli G, Malagola M, Skert C, Soverini S, Iacobucci I, De Vivo A, Testoni N, Castagnetti F, Gugliotta G, Turri D, Bergamaschi M, Pregno P, Pungolino E, Stagno F, Breccia M, Martino B, Intermesoli T, Fava C, Abruzzese E, Tiribelli M, Bigazzi C, Cesana BM, Rosti G, and Baccarani M.

Subjects
Oncology, Male, EUROPEAN-LEUKEMIANET, bcr-abl, Fusion Proteins, bcr-abl, PHILADELPHIA-CHROMOSOME, Imatinib treatment, Biochemistry, Piperazines, Remission induction, TARGETED THERAPY, hemic and lymphatic diseases, 80 and over, Chronic, GeneralLiterature_REFERENCE(e.g.,dictionaries,encyclopedias,glossaries), Aged, 80 and over, Hematology, Leukemia, Health Policy, Remission Induction, Myeloid leukemia, Survival Rate, Treatment Outcome, Benzamides, Cytogenetic Analysis, Aged, Female, Follow-Up Studies, Humans, Imatinib Mesylate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Protein Kinase Inhibitors, Pyrimidines, Cell Biology, Immunology, medicine.drug, medicine.medical_specialty, Internal medicine, medicine, TYROSINE KINASE INHIBITORS, neoplasms, Survival rate, business.industry, Fusion Proteins, Imatinib, Alternative treatment, Imatinib mesylate, BCR-ABL Positive, business, Myelogenous
Abstract

We report a study of an alternative treatment schedule of imatinib (IM) in chronic myeloid leukemia (CML). Seventy-six Philadelphia-positive (Ph+), BCR-ABL-positive patients aged 65 years or older who had been treated with IM for more than 2 years and who were in stable complete cytogenetic response (CCgR) and major molecular response (MMR) were enrolled in a single-arm study to test the effects of a policy of intermittent IM (INTERIM) therapy for 1 month on and 1 month off. With a minimum follow-up of 4 years, 13 patients (17%) lost CCgR and MMR and 14 (18%) lost MMR only. All these patients resumed continuous IM and all but one (lost to follow-up) regained CCgR and MMR. No patients progressed to accelerated or blastic phase or developed clonal chromosomal abnormalities in Ph+ cells or BCR-ABL mutations. In elderly Ph+ CML patients carefully selected for a stable CCgR (lasting >2 years), the policy of INTERIM treatment affected the markers of residual disease, but not the clinical outcomes (overall and progression-free survival). This trial was registered at www.clinicaltrials.gov as NCT 00858806.

Published
2013

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