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1. 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

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

Author

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

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

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

Published
2020

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

Author

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

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

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

Published
2020

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

Author

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

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

No abstract available.

Published
2020

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

Author

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

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

Not available.

Published
2020

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

Author

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

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

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

Published
2020

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

Author

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

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

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

Published
2020

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

Author

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

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

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

Published
2019

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

Author

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

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

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

Published
2019

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

Author

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

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

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

Published
2012

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