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

Author

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

Published
2015
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5. Differences among young adults, adults and elderly chronic myeloid leukemia patients

Author

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

Published
2015
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9. Chronic fatigue is the most important factor limiting health-related quality of life of chronic myeloid leukemia patients treated with imatinib

Author

Efficace, F, Baccarani, M, Breccia, M, Cottone, F, Alimena, G, Deliliers, G L, Baratè, C, Specchia, G, Di Lorenzo, R, Luciano, L, Turri, D, Martino, B, Stagno, F, Dabusti, M, Bergamaschi, M, Leoni, P, Simula, M P, Levato, L, Fava, C, Veneri, D, Sica, S, Rambaldi, A, Rosti, G, Vignetti, M, and Mandelli, F

Published
2013
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10. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study.

Author

Gattermann N., Finelli C., Della Porta M., Fenaux P., Ganser A., Guerci-Bresler A., Schmid M., Taylor K., Vassilieff D., Habr D., Domokos G., Roubert B., Rose C., Agaoglu L., Alimena G., Alonso D., Ame S., Angelucci E., Arrizabalaga B., Athanasiou-Metaxa M., Augustson B., Aydinok Y., Baba A., Baccarani M., Beck J., Beris P., Beyne-Rauzy O., Birgens H., Bordessoule D., Borgna-Pignatti C., Bosly A., Bouabdallah K., Bowden D., Bowen D., Bron D., Cappellini M.D., Capra M., Cartron G., Cazzola M., Chalkias C., Chan L.L., Chancharunee S., Chapman C., Charoenkwan P., Chasapopoulou E., Cheze S., Chuansumrit A., Cianciulli P., Dauriac C., Delforge M., Dolken G., Dombret H., Duyster J., Economopoulos T., Ehninger G., Elalfy M., El-Beshlawy A., Enggaard L., Fillet G., Filosa A., Forni G., Galanello R., Gastl G., Giraudier S., Goldfarb A., Grigg A., Gumruk F., Ha S.Y., Haase D., Heinrich B., Hertzberg M., Ho J., Hsu H.-C., Huang S., Hunault-Berger M., Inusa B., Jaulmes D., Jensen J., Kattamis A., Kilinc Y., Kim K.-H., Kinsey S., Kjeldsen L., Koren A., Lai M.E., Lai Y., Lee J.-W., Lee K.-H., Lee S.-H., Legros L., Li C., Li C.-K., Li Q., Lin K.-H., Linkesch W., Lubbert M., Lutz D., Mohamed Thalha A.J., Mufti G., Muus P., Nobile F., Papadopoulos N., Perrotta S., Petrini M., Pfeilstocker M., Piga A., Poole J., Porter J.B., Pungolino E., Quarta G., Ravoet C., Jolimont Lobbes H.H., Remacha A.F., Roy L., Saglio G., Sanz G., Schmugge M., Schots H., Secchi G., Seymour J.F., Shah F., Shah H., Shen Z., Slama B., Sutcharitchan P., Taher A., Tamary H., Tesch H.-J., Thein S.L., Troncy J., Villegas A., Viprakasit V., Wainwright L., Wassmann B., Wettervald M., Will A., Wormann B., Wright J., Yeh S.-P., Yoon S.-S., Zoumbos N.C., Zweegman S., Gattermann N., Finelli C., Della Porta M., Fenaux P., Ganser A., Guerci-Bresler A., Schmid M., Taylor K., Vassilieff D., Habr D., Domokos G., Roubert B., Rose C., Agaoglu L., Alimena G., Alonso D., Ame S., Angelucci E., Arrizabalaga B., Athanasiou-Metaxa M., Augustson B., Aydinok Y., Baba A., Baccarani M., Beck J., Beris P., Beyne-Rauzy O., Birgens H., Bordessoule D., Borgna-Pignatti C., Bosly A., Bouabdallah K., Bowden D., Bowen D., Bron D., Cappellini M.D., Capra M., Cartron G., Cazzola M., Chalkias C., Chan L.L., Chancharunee S., Chapman C., Charoenkwan P., Chasapopoulou E., Cheze S., Chuansumrit A., Cianciulli P., Dauriac C., Delforge M., Dolken G., Dombret H., Duyster J., Economopoulos T., Ehninger G., Elalfy M., El-Beshlawy A., Enggaard L., Fillet G., Filosa A., Forni G., Galanello R., Gastl G., Giraudier S., Goldfarb A., Grigg A., Gumruk F., Ha S.Y., Haase D., Heinrich B., Hertzberg M., Ho J., Hsu H.-C., Huang S., Hunault-Berger M., Inusa B., Jaulmes D., Jensen J., Kattamis A., Kilinc Y., Kim K.-H., Kinsey S., Kjeldsen L., Koren A., Lai M.E., Lai Y., Lee J.-W., Lee K.-H., Lee S.-H., Legros L., Li C., Li C.-K., Li Q., Lin K.-H., Linkesch W., Lubbert M., Lutz D., Mohamed Thalha A.J., Mufti G., Muus P., Nobile F., Papadopoulos N., Perrotta S., Petrini M., Pfeilstocker M., Piga A., Poole J., Porter J.B., Pungolino E., Quarta G., Ravoet C., Jolimont Lobbes H.H., Remacha A.F., Roy L., Saglio G., Sanz G., Schmugge M., Schots H., Secchi G., Seymour J.F., Shah F., Shah H., Shen Z., Slama B., Sutcharitchan P., Taher A., Tamary H., Tesch H.-J., Thein S.L., Troncy J., Villegas A., Viprakasit V., Wainwright L., Wassmann B., Wettervald M., Will A., Wormann B., Wright J., Yeh S.-P., Yoon S.-S., Zoumbos N.C., and Zweegman S.

Abstract

The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ~50% were chelation-naive. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naive or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p<0.0001). This large dataset prospectively confirms the efficacy and well characterizes the safety profile of deferasirox in MDS. © 2010 Elsevier Ltd.

Published
2021

18. Lenalidomide treatment of myelodysplastic syndromes with chromosome 5q deletion: Results from the National Registry of the Italian Drug Agency

Author

Arcioni, F., Roncadori, A., Di Battista, V., Tura, S., Covezzoli, A., Cundari, S., Mecucci, C., Abbadessa, A., Alterini, R., Santini, V., Cantonetti, M., Buccisano, F., Bacigalupo, A., Sessarego, M., Tonso, A., Ferrero, D., D'Ardia, S., Tarella, C., Cascavilla, N., Bassan, R., Sancetta, R., Cortelezzi, A., Reda, G., Maria D'Arco, A., De Fabritiis, P., Di Renzo, N., Falini, B., Alimena, G., Avanzini, P., Ilariucci, F., Iuliano, F., La Nasa, G., Caocci, G., Defina, M., Latte, G., Palmas, A., Levis, A., Leone, G., Teresa Voso, M., Leoni, P., Poloni, A., Fozza, C., Crugnola, M., Montanaro, M., Spedini, P., Lanza, F., Pizzuti, M., Pane, F., Paolini, R., Borin, L., Rambaldi, A., Rossi, G., Maria Pelizzari, A., Russo, D., D'Emilio, A., Ruggeri, M., Semenzato, G., Specchia, G., Tagariello, G., Sartori, R., Testore, F., Ciravegna, G., Marasca, R., Cimarosto, L., Fontanive, O., Visani, G., Arcioni, F., Roncadori, A., Di Battista, V., Tura, S., Covezzoli, A., Cundari, S., Mecucci, C., Abbadessa, A., Alterini, R., Santini, V., Cantonetti, M., Buccisano, F., Bacigalupo, A., Sessarego, M., Tonso, A., Ferrero, D., D'Ardia, S., Tarella, C., Cascavilla, N., Bassan, R., Sancetta, R., Cortelezzi, A., Reda, G., Maria D'Arco, A., De Fabritiis, P., Di Renzo, N., Falini, B., Alimena, G., Avanzini, P., Ilariucci, F., Iuliano, F., La Nasa, G., Caocci, G., Defina, M., Latte, G., Palmas, A., Levis, A., Leone, G., Teresa Voso, M., Leoni, P., Poloni, A., Fozza, C., Crugnola, M., Montanaro, M., Spedini, P., Lanza, F., Pizzuti, M., Pane, F., Paolini, R., Borin, L., Rambaldi, A., Rossi, G., Maria Pelizzari, A., Russo, D., D'Emilio, A., Ruggeri, M., Semenzato, G., Specchia, G., Tagariello, G., Sartori, R., Testore, F., Ciravegna, G., Marasca, R., Cimarosto, L., Fontanive, O., and Visani, G.

Subjects
Oncology, Myeloid, Male, Group B, Immunologic Factor, 0302 clinical medicine, Retrospective Studie, hemic and lymphatic diseases, del(5q), Prospective Studies, Registries, Prospective cohort study, Hematology, Leukemia, registry study, Standard treatment, Remission Induction, General Medicine, Middle Aged, lenalidomide, myelodysplastic syndromes, Aged, Chromosomes, Human, Pair 5, Disease Progression, Female, Humans, Immunologic Factors, Italy, Karyotyping, Lenalidomide, Leukemia, Myeloid, Acute, Myelodysplastic Syndromes, Retrospective Studies, Thalidomide, Chromosome Deletion, 030220 oncology & carcinogenesis, Pair 5, medicine.drug, Human, medicine.medical_specialty, Myelodysplastic Syndrome, Acute, Chromosomes, NO, 03 medical and health sciences, Internal medicine, medicine, business.industry, Myelodysplastic syndromes, Retrospective cohort study, medicine.disease, Settore MED/15, Prospective Studie, business, 030215 immunology
Abstract

Objective The most typical cytogenetic aberration in myelodysplastic syndromes is del(5q), which, when isolated, is associated with refractory anaemia and good prognosis. Based on high rates of erythroid response and transfusion independence, Lenalidomide (LEN) became the standard treatment. This multi-centre study was designed to supplement Italian Registry data on LEN by addressing prescription, administration appropriateness, haematological and cytogenetic responses and disease evolution. Methods MORE study was an observational, non-interventional, multi-centre, retrospective and prospective study. Cases were recruited from 45 Haematological Centres throughout Italy. Data were collected from the Italian National Registry for Lenalidomide administration and supplemented by a MORE data form. Results Data from 190/213 patients were analysed. In all, 149 had been diagnosed by conventional cytogenetics (GROUP A) and 41 only by FISH (GROUP B). Overall erythroid response was obtained in 92.8% of cases. Overall cytogenetic remission was achieved in 22.6% of cases. Disease progression occurred in 15.6% of cases. Clonal cytogenetic evolution characterised progression to AML but not to higher risk MDS. Conclusions Erythroid response to Lenalidomide was similar in MDS with isolated del(5q) and with del(5q) plus one anomaly. Progression to AML or higher risk MDS showed different cytogenetic features.

Published
2018

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

Author

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

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

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

Published
2011

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

Author

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

Abstract

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

Published
2016

31. Adherence and future discontinuation of tyrosine kinase inhibitors in chronic phase chronic myeloid leukemia. A patient-based survey on 1133 patients

Author

Breccia, M, Efficace, F, Sica, S, Abruzzese, E, Cedrone, M, Turri, D, Gobbi, M, Carella, A, Gozzini, A, Usala, E, Cavazzini, F, Danise, P, Tiribelli, M, Binotto, G, Pregno, P, Bocchia, M, Gaidano, G, Crugnola, M, Bonifacio, M, Avanzini, P, Celesti, F, Guella, A, Martino, B, Annunziata, M, Luciano, L, Stagno, F, Vallisa, D, Pungolino, E, Iurlo, A, Rambaldi, A, Nardiello, I, Orlandi, E, GAMBACORTI PASSERINI, C, Alimena, G, GAMBACORTI PASSERINI, CARLO, Alimena, G., Breccia, M, Efficace, F, Sica, S, Abruzzese, E, Cedrone, M, Turri, D, Gobbi, M, Carella, A, Gozzini, A, Usala, E, Cavazzini, F, Danise, P, Tiribelli, M, Binotto, G, Pregno, P, Bocchia, M, Gaidano, G, Crugnola, M, Bonifacio, M, Avanzini, P, Celesti, F, Guella, A, Martino, B, Annunziata, M, Luciano, L, Stagno, F, Vallisa, D, Pungolino, E, Iurlo, A, Rambaldi, A, Nardiello, I, Orlandi, E, GAMBACORTI PASSERINI, C, Alimena, G, GAMBACORTI PASSERINI, CARLO, and Alimena, G.

Abstract

Therapeutic approach for chronic myeloid leukemia (CML) patients has undergone a revolutionary change with the introduction of tyrosine kinase inhibitors, which improved overall survival and quality of life. Optimal therapy adherence has become of paramount importance to maximize the benefits in the long-term outcome. Several evidences have been reported that personal factors, such as social support, psychological and subjective perceptions about the drug used and the future, could influence adherence. We here report the results of a questionnaire specifically designed to evaluate factors influencing adherence and perceptions about the future, distributed to patients during regional Italian meetings. Overall, 1133 patients compiled the questionnaire: median age was 57 years. High rate of adherence was reported, but 42% of interviewed patients admitted that they had occasionally postponed a dose and 58% had discontinued therapy mainly for forgetfulness. The majority of patients discussed with personal physician about the importance of adherence and received sufficient information about illness and treatment, but would like to have discussed more about discomfort, anxiety and fear of the future. Summarizing personal drug compliance and estimating how many days a month, on average, the patients did not take the drug, the majority answered that it was less than 3 days (55%) and only a minority (4%) admitted that it was more than 7 days. Interviewed about discontinuation, 49% of patients answered that wouldn't interrupt because of fear of losing all the results achieved so far. This study suggests a higher level of satisfaction with more information received but the need of improving communication about possible future treatment free remission.

Published
2015

41. The long term outcome of the patients with chronic myeloid leukemia (CML) who have achieved complete cytogenetic response (CCgR) to interferon-alpha (IFN alpha). A collaborative European study of 317 cases

Author

Bonifazi, F, De Vivo, A, Rosti, G, Guilhot, F, Guilhot, J, Trabacchi, E, Hehlmann, R, Hochhaus, A, Shepherd, P, Steegmann, J, Kluin-Nelemans, H, Thaler, J, Simonsson, B, Louwagie, A, Reiffers, J, Mahon, F, Montefusco, E, Alimena, G, Hasford, J, Richards, S, Saglio, G, Testoni, N, Martinelli, G, Tura, S, and Baccarani, M

Published
2016

42. Long term outcome of ph+ cml patients achieving complete cytogenetic remission with interferon based therapy moving from interferon to imatinib era

Author

Malagola M, Breccia M, Skert C, Cancelli V, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Russo D., SOVERINI, SIMONA, IACOBUCCI, ILARIA, CASTAGNETTI, FAUSTO, MARTINELLI, GIOVANNI, ROSTI, GIANANTONIO, BACCARANI, MICHELE, Malagola M, Breccia M, Skert C, Cancelli V, Soverini S, Iacobucci I, Cattina F, Liberati AM, Tiribelli M, Annunziata M, Trabacchi E, De Vivo A, Castagnetti F, Martinelli G, Fogli M, Stagno F, Pica G, Iurlo A, Pregno P, Abruzzese E, Pardini S, Bocchia M, Russo S, Pierri I, Lunghi M, Barulli S, Merante S, Mandelli F, Alimena G, Rosti G, Baccarani M, and Russo D.

Subjects
Adult, Male, EUROPE, Fusion Proteins, bcr-abl, MULTICENTER, Antineoplastic Agents, Piperazines, RECOMMENDATIONS, Young Adult, CHRONIC MYELOID-LEUKEMIA, CHRONIC MYELOGENOUS LEUKEMIA, MOLECULAR RESPONSE, RESIDUAL DISEASE, T-LYMPHOCYTES, ALPHA, TRANSCRIPTS, INTERFERON THERAPY, hemic and lymphatic diseases, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Antineoplastic Combined Chemotherapy Protocols, Humans, BCR-ABL, Protein Kinase Inhibitors, Aged, Retrospective Studies, Drug Substitution, Remission Induction, Interferon-alpha, Middle Aged, Cross-Sectional Studies, Pyrimidines, Treatment Outcome, Benzamides, Imatinib Mesylate, Female, CHRONIC MYELOID LEUKEMIA (CML), Follow-Up Studies
Abstract

Interferon α (IFNα) prolongs survival of CML patients achieving CCyR and potentially synergizes with TKIs. We report on the molecular status and long term outcome of 121 patients who were treated in Italy between 1986 and 2000 with IFNα based therapy and who obtained CCyR. After a median follow up of 16.5 years, 74 (61%) patients were switched to standard imatinib: 48 (65%) lost the CCyR on IFNα, and 36 (75%) are alive and in CCyR; 26 (35%) were switched to imatinib when they were still in CCyR on IFNα, and all 26 are alive and in CCyR. Forty-seven patients (39%) were never switched to imatinib: 24 (51%) continued and 23 (49%) discontinued IFNα, respectively, and 39/47 (83%) are alive and in CCyR. At last follow-up, the BCR-ABL transcripts level was available in 96/101 living patients (95%) The BCR-ABL:ABL ratio was between 0.1 and 0.01% (MR(3.0) ) in 17%, and less than 0.01% (MR(4.0) ) in 81% of patients. No patient was completely molecular negative (MR(4.5) or MR(5.0) ). The OS at 10 and 20 years is 92 and 84%, respectively. This study confirms that CCyR achieved with IFNα and maintained with or without imatinib or any other therapy significantly correlates with long term survival in CML patients who mostly have MR(4.0) . Complete molecular response (MR(4.5) or MR(5.0) ) seems to be unnecessary for such a long survival. This study further supports development of studies testing the clinical effect of the combinations of TKIs with IFNα.

Published
2014

43. THE EUTOS LONG-TERM SURVIVAL SCORE IS PREDICTIVE FOR RESPONSE AND OUTCOME IN CML PATIENTS TREATED FRONTLINE WITH NILOTINIB-BASED REGIMENS

Author

Castagnetti, F., Gugliotta, G., Breccia, M., Stagno, F., D’Adda, M., Levato, L., Carella, Am, Martino, B., Tiribelli, M., Fava, C., Binotto, G., Avanzini, P., Bocchia, M., Bergamaschi, M., Russo Rossi, A., Cavazzini, Francesco, Abruzzese, E., Soverini, S., Alimena, G., Cavo, M., Martinelli, G., Pane, F., Saglio, G., Baccarani, M., and Rosti, G.

Subjects
Socio-culturale
Published
2016

44. Symptomatic mucocutaneous toxicity of hydroxyurea in Philadelphia chromosome-negative myeloproliferative neoplasms

Author

Latagliata, R, Spadea, A, Cedrone, M, Di Giandomenico, J, De Muro, M, Villiva, N, Breccia, M, Anaclerico, B, Porrini, R, Spirito, F, Rago, A, Avvisati, G, Alimena, G, Montanaro, M, Andriani, A, Volpicelli, P, Ferretti, A, Mazzucconi, M, Annino, L, Felici, S, Montefusco, E, Majolino, I, Trape, G, Pessina, G, Cotroneo, E, LO COCO, F, Abruzzese, E, and Cimino, G

Subjects
Adult, Male, Drug, Cancer Research, medicine.medical_specialty, Erythema, media_common.quotation_subject, Philadelphia Chromosome Negative, Mucocutaneous zone, Antineoplastic Agents, Partial resolution, Skin Diseases, Gastroenterology, Interquartile range, Internal medicine, Skin Ulcer, 80 and over, medicine, Humans, Hydroxyurea, Philadelphia Chromosome, Aged, media_common, Aged, 80 and over, hydroxyurea, mucocutaneous toxicity, myeloproliferative neoplasms, partial resolution, Myeloproliferative Disorders, business.industry, Cancer, Middle Aged, medicine.disease, Surgery, Withholding Treatment, Oncology, Toxicity, Female, medicine.symptom, business, Settore MED/15 - Malattie del Sangue
Abstract

BACKGROUND: The current study was conducted to evaluate severe mucocutaneous toxicity during treatment with hydroxyurea (HU) in a large cohort of patients with Philadelphia chromosome-negative myeloproliferative neoplasms (MPN). METHODS: Among 993 consecutive patients newly diagnosed with MPN at 4 centers in Rome between January 1980 and December 2009, 614 patients (277 men and 337 women with a median age of 64.4 years [interquartile range (IR), 54.4 years-72.7 years]) received HU. HU was administered as first-line treatment in 523 patients (85.2%) and as ≥ second-line treatment in 91 patients (14.8%). RESULTS: Mucocutaneous toxicity was reported in 51 patients (8.3%) after a median period from the initiation of HU treatment of 32.1 months (IR, 10.5 months-74.6 months) and a mean HU dose of 1085 mg (± 390 mg); 30 patients (58.8%) developed a painful ulcerative skin toxicity, mainly located in the perimalleolar area; 11 patients (21.6%) had oral aphthous ulcers; and 10 patients (19.6%) developed a nonulcerative skin toxicity with erythema and skin infiltration. After the mucocutaneous toxicity occurred, HU treatment was continued at the same dose in 5 patients (9.8%), reduced in 12 patients (23.5%), and temporarily discontinued in 7 patients (13.7%); the remaining 27 patients (52.9%) required a permanent drug discontinuation. After a median period of 4.3 months (IR, 2.4 months-9.0 months) from the onset of the skin toxicity, 39 patients (76.5%) had a complete resolution and 12 patients (23.5%) had improvement without complete resolution. CONCLUSIONS: Mucocutaneous toxicity during HU treatment is more common than expected and may present with different clinical features. Moreover, it often requires a permanent drug discontinuation and only a partial resolution is reported to occur in approximately 25% of patients. Cancer 2011;. © 2011 American Cancer Society.

Published
2011

45. Spleen enlargement is a risk factor for thrombosis in essential thrombocythemia: Evaluation on 1,297 patients

Author

Andriani, A., Latagliata, R., Anaclerico, B., Spadea, A., Rago, A., Di Veroli, A., Spirito, F., Porrini, R., De Muro, M., Crescenzi Leonetti, S., Villiva, N., De Gregoris, C., Montefusco, E., Polverelli, N., Santoro, C., Breccia, M., Cimino, G., Majolino, I., Mazzucconi, M. G., Vianelli, N., Alimena, G., Montanaro, M., and Palandri, F.

Subjects
Adult, Male, Databases, Factual, Platelet Count, Thrombosis, Janus Kinase 2, Middle Aged, Prognosis, Risk Factors, Mutation, Splenomegaly, Humans, Female, Platelet Aggregation Inhibitors, Aged, Retrospective Studies, Thrombocythemia, Essential, Ultrasonography
Abstract

Spleen enlargement, present in 10-20% of Essential Thrombocythemia (ET) patients at diagnosis, is a feature clinically easy to assess, confirmable by echography with a very low chance of misinterpretation. Nonetheless, the clinical and prognostic role of splenomegaly has been seldom evaluated. From 1979 to 2013, 1297 ET patients retrospectively collected in the database of the Lazio Cooperative Group and Bologna University Hospital were evaluable for spleen enlargement at diagnosis and included in the analysis. On the whole, spleen was enlarged in 172/1297 (13.0%) patients; in most cases (94.8%) splenomegaly was mild (≤5 cm). Patients with splenomegaly were younger, predominantly male, presented higher platelet count and JAK2V617F allele burden and had a lower incidence of concomitant cardiovascular risk factors. At least one thrombotic event during follow-up occurred in 97/1,125 (8.6%) patients without spleen enlargement compared to 27/172 (15.7%) patients with spleen enlargement (P = 0.003). Despite comparable use of cytoreductive/antiplatelet therapies in the two groups, the cumulative risk of thrombosis at 5 years was significantly higher in patients with baseline splenomegaly (9.8% versus 4.4% in patients without splenomegaly, P = 0.012). In multivariate analysis exploring risk factors for thrombosis, splenomegaly retained its negative prognostic role, together with previous thrombosis, leucocyte count and male gender. Baseline splenomegaly seems to be an independent additional risk factor for thrombosis in nonstrictly WHO-defined ET patients. This data could be useful in the real-life clinical management of these patients.

Published
2015

46. VERY ELDERLY CP-CML PATIENTS TREATED WITH IMATINIB FRONTLINE: HAVE CONCOMITANT THERAPIES AN IMPACT ON OUTCOME AND TOXICITY?

Author

Iurlo, A, Latagliata, R, Bucelli, C, Ferrero, Dario, Castagnetti, F, Breccia, M, Abruzzese, E, Fava, Carmen, Annunziata, M, Stagno, F, Vigneri, P, Tiribelli, M, Cavazzini, F, Binotto, G, Mansueto, G, Gozzini, A, Russo, S, Falzetti, F, Montefusco, E, Gugliotta, G, Cattaneo, D, Djade, Cd, Cedrone, M, Rossi, Ar, Avanzini, P, Pregno, P, Mauro, E, Endri, M, Spadea, A, Celesti, F, Giglio, G, Isidori, A, Crugnola, M, Calistri, E, Sora, F, Sica, S, Storti, S, D'Addosio, A, Rege Cambrin, G, Luciano, L, Saglio, Giuseppe, Rosti, G, Alimena, G, Nobili, A, and Cortelezzi, A.

Published
2015

47. LONG-TERM OUTCOME OF ALTERNATING NILOTINIB 400 MG TWICE DAILY AND IMATINIB 400 MG ONCE DAILY AS FRONTLINE TREATMENT OF CHRONIC MYELOID LEUKEMIA: A PHASE 2 STUDY OF THE GIMEMA CML WORKING PARTY

Author

Gugliotta, G., Castagnetti, F., Breccia, M., Gozzini, A., Stagno, F., Rege Cambrin, G., Carella, A. M., Luciano, L., Abruzzese, E., Martino, B., Usala, E., Rossi, G., Bocchia, M., Cavazzini, Francesco, Tiribelli, M., Luatti, S., Venturi, C., Soverini, S., Cavo, M., Specchia, G., Alimena, G., Pane, F., Martinelli, G., Saglio, G., Rosti, G., and Baccarani, M.

Subjects
Socio-culturale
Published
2015

48. CARDIOVASCULAR EVENTS IN CHRONIC MYELOID LEUKEMIA PATIENTS TREATED WITH NILOTINIB FIRST-LINE: AN ANALISYS OF THE GIMEMA CML WP

Author

Gugliotta, G, Castagnetti, F, Breccia, M, Stagno, F, Martino, B, Fava, Carmen, Luciano, L, Gozzini, A, Carella, Am, Abruzzese, E, Levato, L, Usala, E, Rossi, G, Bocchia, M, Tiribelli, M, Cavazzini, F, Salvucci, M, Cedrone, M, Trabacchi, E, Binotto, G, Venturi, C, Soverini, S, Cavo, M, Specchia, G, Alimena, G, Pane, F, Martinelli, G, Saglio, Giuseppe, Baccarani, M, and Rosti, G.

Subjects
Socio-culturale
Published
2015

49. ROLE OF TREATMENT ON THE DEVELOPMENT OF SECONDARY MALIGNANCIES IN PATIENTS WITH ESSENTIAL THROMBOCYTEMIA

Author

Santoro, Cristina, Sperduti, I, Di Giandomenico, J, De Muro, M, Villiva, N, Di Veroli, A, Montanaro, M, Latagliata, R, Anaclerico, B, Avvisati, G, Breccia, M, Cedrone, M, Cimino, Giuseppe, Felici, S, Ferrara, G, Crescenzi, Sl, Majolino, I, Montefusco, E, Montanaro, G, Porrini, R, Rago, A, Spadea, A, Spirito, F, Alimena, G, Andriani, A, Foa, Roberto, and Mazzucconi, Maria Gabriella

Published
2015

50. ROLE OF TREATMENT ON THE DEVELOPMENT OF SECONDARY MALIGNANCIES IN PATIENTS WITH ESSENTIAL THROMBOCYTEMIA

Author

Santoro, C., Isabella Sperduti, Di Giandomenico, J., Muro, M., Villiva, N., Di Veroli, A., Montanaro, M., Latagliata, R., Anaclerico, B., Giuseppe, A., Breccia, M., Cedrone, M., Cimino, G., Felici, S., Crescenzi, S. Leonetti, Majolino, I., Montefusco, E., Montanaro, G., Porrini, R., Rago, A., Spadea, A., Spirito, F., Alimena, G., Andriani, A., Foa, R., and Mazzucconi, M. G.

Published
2015

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