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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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2. 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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4. LONG TERM OUTCOME OF INTERMITTENT IMATINIB TREATMENT POLICY FOR MANAGINGCHRONIC MYELOID LEUKEMIA IN THE ELDERLY

Author

Russo, Domenico, Malagola, Michele, Skert, C., Cancelli, V., Turri, D., Pregno, P., Pierri, I., Fogli, M., Testoni, N., De Vivo, A., Castagnetti, F., Pungolino, E., Stagno, F., Breccia, M., Martino, B., Intermesoli, T., Rege Cambrin, G., 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., Cesana, Bruno Mario, Soverini, S., Martinelli, G., Rosti, G., and Baccarani, M. .

Published
2015

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

Author

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

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

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

Published
2015

6. Updating Long-Term Outcome of Intermittent Imatinib (INTERIM) Treatment in Elderly Patients with Ph plus -CML

Author

Russo, D, Martinelli, G, Malagola, M, Cancelli, V, Skert, C, Soverini, S, Iacobucci, I, Turri, D, Mirto, S, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Fogli, M, Testoni, N, De Vivo, A, Castagnetti, F, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, A, Intermesoli, T, Saglio, G, Cambrin, Gr, Visani, G, Nicolini, G, de Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D'Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, Di Lorenzo, R, Cesana, Bm, and Rosti, G

Published
2014

8. SEVEN YEAR-EXPERIENCE OF BCR-ABL MUTATION ANALYSIS IN PHILADELPHIA-CHROMOSOME POSITIVE (PH+) PATIENTS ON IMATINIB (IM) OR 2ND-GENERATION TYROSINE KINASE INHIBITORS (TKIS): BY THE GIMEMA CML WORKING PARTY

Author

Soverini, S, Gnani, A, De Benedittis, C, Castagnetti, F, Gugliotta, G, Breccia, M, Pregno, P, Abruzzese, E, Sorà, F, Baratè, C, Gangemi, D, Capucci, A, Girasoli, M, Orlandi, E, Specchia, G, Russo, D, Giannini, B, Poletti, G, Iacobucci, I, Bochicchio, T, Pane, F, Saglio, G, Rosti, G, Baccarani, M, and Martinelli, G

Published
2011

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

Author

Russo, D, primary, Malagola, M, additional, Skert, C, additional, Cancelli, V, additional, Turri, D, additional, Pregno, P, additional, Bergamaschi, M, additional, Fogli, M, additional, Testoni, N, additional, De Vivo, A, additional, Castagnetti, F, additional, Pungolino, E, additional, Stagno, F, additional, Breccia, M, additional, Martino, B, additional, Intermesoli, T, additional, Cambrin, G R, additional, Nicolini, G, additional, Abruzzese, E, additional, Tiribelli, M, additional, Bigazzi, C, additional, Usala, E, additional, Russo, S, additional, Russo-Rossi, A, additional, Lunghi, M, additional, Bocchia, M, additional, D'Emilio, A, additional, Santini, V, additional, Girasoli, M, additional, Lorenzo, R Di, additional, Bernardi, S, additional, Palma, A Di, additional, Cesana, B M, additional, Soverini, S, additional, Martinelli, G, additional, Rosti, G, additional, and Baccarani, M, additional

Published
2015
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11. MONITORING OF COMPLETE CYTOGENETIC RESPONSE (CCGR) BY INTERPHASE FLUORESCENCE IN SITU HYBRIDIZATION (I-FISH) ON PERIPHERAL BLOOD IN ELDERLY PH+ CML PATIENTS WITH STABLE CCGR TREATED WITH INTERMITTENT IMATINIB (IM)EUDRACT NUMBER 2007-005102-42, CLINICALTRIALS.GOV NCT 00858806

Author

Russo, Domenico, Malagola, Michele, Testoni, N, Martinelli, G, Colombi, C, Skert, C, Rosti, G, Amabile, M, Fogli, M, Mirto, S, Turri, D, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, R, Intermesoli, T, Saglio, G, Rege Cambrin, G, Visani, G, Nicolini, G, De Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Liso, V, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D’Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, Di Lorenzo, R, De Vivo, A, Soverini, S, Iacobucci, I, and Baccarani, M.

Published
2010

12. PRE-FINAL ANALYSIS OF THE PHASE II EXPLORATIVE STUDY OF INTERMITTENT IMATINIB (IM) TREATMENT (INTERIM) IN ELDERLY PH+ CML PATIENTS WITH STABLE COMPLETE CYTOGENETIC RESPONSE (CCGR) – EUDRACT NUMBER 2007-005102-42, CLINICALTRIALS.GOV NCT 00858806

Author

Russo, Domenico, Martinelli, G, Malagola, Michele, Colombi, C, Rosti, G, Amabile, M, Fogli, M, Mirto, S, Turri, D, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, R, Intermesoli, T, Saglio, G, Rege Cambrin, G, Visani, G, Nicolini, G, De Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Liso, V, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D’Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, and Di Lorenzo, R.

Published
2010

13. One Year of Intermittent Imatinib (IM) Treatment (InterIM) Maintains the Complete Cytogenetic Response (CCgR) Previously Achieved with Standard IM Therapy In Elderly ( 65 years) Ph+ CML Patients – EudraCT Number 2007–005102-42, ClinicalTrials.Gov NCT 00858806

Author

Russo, D, Martinelli, G, Malagola, M, Colombi, C, Rosti, G, Amabile, M, Fogli, M, Turri, D, Mirto, S, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, A, Intermesoli, T, Saglio, G, Rege Cambrin, G, Visani, G, Nicolini, G, de Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Specchia, G, Liso, V, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D'Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, Di Lorenzo, R, Testoni, N, De Vivo, A, Soverini, S, Iacobucci, I, and Baccarani, M

Published
2010

14. PRE-FINAL ANALYSIS OF THE PHASE II EXPLORATIVE STUDY OF INTERMITTENT IMATINIB (IM) TREATMENT (INTERIM) IN ELDERLY PH+ CML PATIENTS WITH STABLE COMPLETE CYTOGENETIC RESPONSE (CCGR) – EUDRACT NUMBER 2007-005102-42, CLINICALTRIALS.GOV NCT 00858806

Author

Russo, D, Martinelli, G, Malagola, M, Colombi, C, Rosti, G, Amabile, M, Fogli, M, Mirto, S, Turri, D, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Morra, E, Pungolino, E, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Nobile, F, Martino, B, Rambaldi, R, Intermesoli, T, Saglio, G, Rege Cambrin, G, Visani, G, Nicolini, G, De Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Liso, V, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Rodeghiero, F, D’Emilio, A, Bosi, A, Santini, V, Quarta, G, Girasoli, M, Fioritoni, G, Di Lorenzo, R, Testoni, N, De Vivo, A, Soverini, S, Iacobucci, I, and Baccarani, M

Published
2010

15. UPDATE OF CYTOGENETIC AND MOLECULAR RESPONSE IN 88 ELDERLY PH+ CHRONIC MYELOID LEUKEMIA PATIENTS ENROLLED IN THE PHASE II EXPLORATIVE STUDY OF INTERMITTENT IMATINIB (IM) TREATMENT (INTERIM)

Author

Russo, Domenico, Rosti, G., Martinelli, G., Malagola, Michele, Mirto, S., Turri, D., Gobbi, M., Pierri, I., Vitolo, U., Pregno, P., Morra, E., Pungolino, E., Di Raimondo, F., Stagno, F., Foà, R., Alimena, G., Breccia, M., Nobile, F., Martino, B., Rambaldi, A., Intermesoli, T., Saglio, G., Rege Cambrin, G., Visani, G., Nicolini, G., De Fabritiis, P., Abruzzese, E., Fanin, R., Tiribelli, M., Galieni, P., Bigazzi, C., Liso, V., Specchia, G., Angelucci, E., Usala, E., Musolino, C., Russo, S., Gaidano, G., Lunghi, M., Lauria, F., Bocchia, M., D’Emilio, A., Bosi, A., Sanitini, V., Quarta, G., Girasoli, M., Fioritoni, G., Di Lorenzo, R., Colombi, C., Fogli, M., Amabile, 2 M., Testoni, N., De Vivo, A., and Baccarani, M.

Published
2010

16. Results of high dose of imatinib mesylate in intermediate Sokal risk chronic myeloid leukemia patients in early chronic phase trial of the GIMEMA Working Party

Author

Castagnetti, F, Palandri, F, Amabile, M, Testoni, N, Luatti, S, Soverini, S, Iacobucci, I, Breccia, M, Rege Cambrin, G, Stagno, F, Specchia, G, Galieni, P, Iuliano, F, Pane, F, Saglio, G, Alimena, G, Martinelli, G, Baccarani, M, Rostilevis, A, Pini, M, Bigazzi, C, Liso, V, Bassan, R, Intermesoli, T, Marzocchi, G, Capucci, A, Rossi, G, Girasoli, M, Giustolisi, R, Levato, L, Peta, A, Musolino, Caterina, Luciano, L, Rotoli, B, Cilloni, D, Fava, C, Semenzato, G, Musso, M, Porretto, F, Barulli, S, Visani, G, Di Lorenzo, R, Fioritoni, G, Trabacchi, E, Vallisa, D, Leone, G, Sica, S, Abruzzese, E, Foà, R, Petti, Mc, Bocchia, M, Lauria, F, Gherlinzoni, F, Gallo, E, and Pregno, P.

Published
2009

17. PHASE II MULTICENTRIC EXPLORATIVE STUDY OF INTERMITTENT IMATINIB (IM) TREATMENT (INTERIM) IN ELDERLY PATIENTS WITH PH+ CHRONIC MYELOID LEUKEMIA (CML) WHO ACHIEVED A STABLE COMPLETE CYTOGENETIC RESPONSE (CCGR) WITH STANDARD IM THERAPY

Author

Russo, D., Rosti, G., Martinelli, G., Malagola, M., Mirto, S., Turri, D., Gobbi, M, Pierri, I., Vitolo, U., Pregno, P., Di Raimondo, F., Stagno, F., Foà, R., Alimena, G., Breccia, M, Rambaldi, R., Intermesoli, T, Saglio, G., Rege Cambrin, G., Visani, G., Nicolini, G., De Fabritiis, P., Abruzzese, E., Nobile, F., Martino, B., Fanin, R., Tiribelli, M., Galieni, P., Bigazzi, C., Liso, V., Specchia, G., Angelucci, E., Usala, E., Musolino, C., Russo, S., Gaidano, G. ., Lunghi, M., Lauria, F., Bocchia, M., Quarta, G., Girasoli, M., Bosi, A., Santini, V., Fioritoni, G., Di Lorenzo, R., Colombi, C., Fogli, M., Amabile, M., and De Vivo, A. Baccarani M.

Published
2009

18. Phase II multicentric explorative study of Intermittent Imatinib (IM) treatment (INTERIM) in elderly patients with Ph+ chronic myeloid leukemia (CML) who achieved a stable complete cytogenetic response (CCgR) with standard IM therapy

Author

Russo, Domenico, Rosti, G, Martinelli, G, Malagola, Michele, Mirto, S, Turri, D, Gobbi, M, Pierri, I, Vitolo, U, Pregno, P, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Rambaldi, A, Intermesoli, T, Saglio, G, Rege Cambrin, G, Visani, G, Nicolini, G, De Fabritiis, P, Abruzzese, E, Nobile, F, Martino, B, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Liso, V, Specchia, G, Angelucci, E, Usala, E, Musolino, C, Russo, S, Gaidano, G, Lunghi, M, Lauria, F, Bocchia, M, Quarta, G, Girasoli, M, Bosi, A, Santini, V, Fioritoni, G, Di Lorenzo, R, Colombi, C, Fogli, M, Amabile, M, De Vivo, A, and B. a. c. c. a. r. a. n. i. M.

Published
2009

19. PHASE II MULTICENTRIC EXPLORATIVE STUDY OF INTERMITTENT IMATINIB (IM) TREATMENT (INTERIM) IN ELDERLY PATIENTS WITH PH+ CHRONIC MYELOID LEUKEMIA (CML) WHO ACHIEVED A STABLE COMPLETE CYTOGENETIC RESPONSE (CCGR) WITH STANDARD IM THERAPY

Author

Russo, D, Rosti, G, Martinelli, G, Malagola, M, Mirto, S, Turri, D, Vitolo, U, Pregno, P, Gobbi, M, Pierri, I, Di Raimondo, F, Stagno, F, Foà, R, Alimena, G, Breccia, M, Saglio, G, Rege Cambrin, G, De Fabritiis, P, Abruzzese, E, Fanin, R, Tiribelli, M, Galieni, P, Bigazzi, C, Liso, V, Specchia, G, Rambaldi, A, Intermesoli, T, Lauria, F, Bocchia, M, Quarta, G, and Girasoli, M

Published
2009

20. 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

21. 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

22. 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

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

Author

Soverini S, Bavaro L, De Benedittis C, Martelli M, Iurlo A, Orofino N, Sica S, Sorà F, Lunghi F, Ciceri F, Galimberti S, Baratè C, Bonifacio M, Scaffidi L, Castagnetti F, Gugliotta G, Albano F, Russo Rossi AV, 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 MA, Pileri SA, Percesepe A, Tenti E, Rosti G, Baccarani M, Cavo M, and Martinelli G

Subjects
Adult, Aged, Aged, 80 and over, Drug Resistance, Neoplasm, Female, High-Throughput Nucleotide Sequencing, Humans, Male, Middle Aged, Mutation, Mutation Rate, Prospective Studies, Fusion Proteins, bcr-abl genetics, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive genetics, Protein Kinase Inhibitors therapeutic use
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., (© 2020 by The American Society of Hematology.)

Published
2020
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24. OAP combination in the treatment of elderly leukaemic patients with preexisting severe internal disease.

Author

Marra R, Pagano L, Liene DR, Storti S, Girasoli M, and Leone G

Subjects
Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cytarabine administration & dosage, Female, Humans, Male, Prednisone administration & dosage, Risk Factors, Vincristine administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Leukemia, Myeloid, Acute drug therapy
Abstract

Sixteen elderly patients affected by acute non lymphoblastic leukaemia (ANLL) with a preexisting severe internal disease were treated with a low systemic toxicity drugs combination: OAP (Vincristine, Cytarabine and Prednisone). Complete remission was achieved in 5 patients (31%) after 2 OAP courses. The mean duration of remission was 18 weeks. Six patients were resistant to the therapy. Six patients died during the treatment: 5 in induction phase and 1 in consolidation phase. Even though the duration of remission was short we retain that OAP combination may be still considered a good therapeutical approach in elderly ANLL patients with associated severe internal disease.

Published
1989

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