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1. High-dose chemotherapy with autologous stem cell transplants in adult primary non-seminoma mediastinal germ-cell tumors. A report from the Cellular Therapy and Immunobiology working party of the EBMT

Author

Secondino, S., Badoglio, M., Rosti, G., Labopin, M., Delaye, M., Bokemeyer, C., Seidel, C., Kanfer, E., Metafuni, E., Finke, J., Bouhris, J.-H., Kosmas, C., Malard, F., Pagani, A., Kuball, J., Koehl, U., Ruggeri, A., De Giorgi, U., and Pedrazzoli, P.

Published
2024
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2. Impact of age and comorbidities on the efficacy and tolerability of bosutinib in previously treated patients with chronic myeloid leukemia: results from the phase 4 BYOND study

Author

Rosti, G, Brummendorf, T, Gjertsen, B, Giraldo-Castellano, P, Castagnetti, F, Gambacorti-Passerini, C, Ernst, T, Zhao, H, Kuttschreuter, L, Purcell, S, Giles, F, Hochhaus, A, Rosti G., Brummendorf T. H., Gjertsen B. T., Giraldo-Castellano P., Castagnetti F., Gambacorti-Passerini C., Ernst T., Zhao H., Kuttschreuter L., Purcell S., Giles F. J., Hochhaus A., Rosti, G, Brummendorf, T, Gjertsen, B, Giraldo-Castellano, P, Castagnetti, F, Gambacorti-Passerini, C, Ernst, T, Zhao, H, Kuttschreuter, L, Purcell, S, Giles, F, Hochhaus, A, Rosti G., Brummendorf T. H., Gjertsen B. T., Giraldo-Castellano P., Castagnetti F., Gambacorti-Passerini C., Ernst T., Zhao H., Kuttschreuter L., Purcell S., Giles F. J., and Hochhaus A.

Abstract

In the phase 4 BYOND trial, patients with pretreated chronic myeloid leukemia (CML) received bosutinib (starting dose: 500 mg/day). Efficacy and safety after ≥3 years of follow-up in 156 patients with Philadelphia chromosome–positive chronic phase CML by age and Charlson Comorbidity Index scores (without the age component; mCCI) is reported. Cumulative major molecular response rates at any time on treatment were 73.6%, 64.5%, and 74.1% in patients <65, 65–74, and ≥75 years of age, and 77.9%, 63.0%, and 59.3% in patients with mCCI scores 2, 3, and ≥4, respectively. Patients <65, 65–74, and ≥75 years of age experienced grade 3/4 treatment-emergent adverse events (TEAEs) at rates of 74.7%, 78.8%, and 96.4% and permanent discontinuations due to AEs at rates of 22.1%, 39.4%, and 46.4%, respectively. In patients with mCCI 2, 3, and ≥4, respective rates of grade 3/4 TEAEs were 77.8%, 77.8%, and 86.7%, and permanent discontinuations due to AEs were 25.3%, 33.3%, and 43.3%. In conclusion, a substantial proportion of patients maintained/achieved cytogenetic and molecular responses across age groups and mCCI scores. Older patients (≥75 years) and those with high comorbidity burden (mCCI ≥4) may require more careful monitoring due to the increased risk of TEAEs. Clinicaltrials.gov: NCT02228382.

Published
2024

3. Efficacy and safety of bosutinib in patients treated with prior imatinib and/or dasatinib and/or nilotinib: Subgroup analyses from the phase 4 BYOND study

Author

Smith, B, Brümmendorf, T, Roboz, G, Gambacorti-Passerini, C, Charbonnier, A, Viqueira, A, Leip, E, Purcell, S, Goldman, E, Giles, F, Ernst, T, Hochhaus, A, Rosti, G, Smith B. D., Brümmendorf T. H., Roboz G. J., Gambacorti-Passerini C., Charbonnier A., Viqueira A., Leip E., Purcell S., Goldman E. H., Giles F., Ernst T., Hochhaus A., Rosti G., Smith, B, Brümmendorf, T, Roboz, G, Gambacorti-Passerini, C, Charbonnier, A, Viqueira, A, Leip, E, Purcell, S, Goldman, E, Giles, F, Ernst, T, Hochhaus, A, Rosti, G, Smith B. D., Brümmendorf T. H., Roboz G. J., Gambacorti-Passerini C., Charbonnier A., Viqueira A., Leip E., Purcell S., Goldman E. H., Giles F., Ernst T., Hochhaus A., and Rosti G.

Abstract

The BYOND study evaluated the efficacy and safety of bosutinib 500 mg once daily in patients with chronic myeloid leukemia (CML) resistant/intolerant to prior tyrosine kinase inhibitors (TKIs). These post-hoc analyses assessed the efficacy and safety of bosutinib by resistance or intolerance to prior TKIs (imatinib-resistant vs dasatinib/nilotinib-resistant vs TKI-intolerant), and cross-intolerance between bosutinib and prior TKIs (imatinib, dasatinib, nilotinib), in patients with Philadelphia chromosome–positive chronic phase CML. Data are reported after ≥3 years’ follow-up. Of 156 patients with Philadelphia chromosome–positive chronic phase CML, 53 were imatinib-resistant, 29 dasatinib/nilotinib-resistant, and 74 intolerant to all prior TKIs; cumulative complete cytogenetic response rates at any time were 83.7%, 61.5%, and 86.8%, and cumulative major molecular response rates at any time were 72.9%, 40.7%, and 82.4%, respectively. Of 141, 95, and 79 patients who received prior imatinib, dasatinib, and nilotinib, 64 (45.4%), 71 (74.7%), and 60 (75.9%) discontinued the respective TKI due to intolerance; of these, 2 (3.1%), 5 (7.0%), and 0 had cross-intolerance with bosutinib. The response rates observed in TKI-resistant and TKI-intolerant patients, and low cross-intolerance between bosutinib and prior TKIs, further support bosutinib use for patients with Philadelphia chromosome–positive chronic phase CML resistant/intolerant to prior TKIs.

Published
2024

4. High-dose chemotherapy with autologous stem cell transplants in adult primary non-seminoma mediastinal germ-cell tumors. A report from the Cellular Therapy and Immunobiology working party of the EBMT

Author

CTI Kuball, MS Hematologie, Cancer, Infection & Immunity, Regenerative Medicine and Stem Cells, Secondino, S, Badoglio, M, Rosti, G, Labopin, M, Delaye, M, Bokemeyer, C, Seidel, C, Kanfer, E, Metafuni, E, Finke, J, Bouhris, J-H, Kosmas, C, Malard, F, Pagani, A, Kuball, J, Koehl, U, Ruggeri, A, De Giorgi, U, Pedrazzoli, P, EBMT Cellular Therapy & Immunobiology WP, CTI Kuball, MS Hematologie, Cancer, Infection & Immunity, Regenerative Medicine and Stem Cells, Secondino, S, Badoglio, M, Rosti, G, Labopin, M, Delaye, M, Bokemeyer, C, Seidel, C, Kanfer, E, Metafuni, E, Finke, J, Bouhris, J-H, Kosmas, C, Malard, F, Pagani, A, Kuball, J, Koehl, U, Ruggeri, A, De Giorgi, U, Pedrazzoli, P, and EBMT Cellular Therapy & Immunobiology WP

Published
2024

7. Treatment discontinuation following low-dose TKIs in 248 chronic myeloid leukemia patients: Updated results from a campus CML real-life study

Author

Iurlo, A., primary, Cattaneo, D., additional, Consonni, D., additional, Castagnetti, F., additional, Miggiano, M. C., additional, Binotto, G., additional, Bonifacio, M., additional, Rege-Cambrin, G., additional, Tiribelli, M., additional, Lunghi, F., additional, Gozzini, A., additional, Pregno, P., additional, Abruzzese, E., additional, Capodanno, I., additional, Bucelli, C., additional, Pizzuti, M., additional, Artuso, S., additional, Iezza, M., additional, Scalzulli, E., additional, La Barba, G., additional, Maggi, A., additional, Russo, S., additional, Elena, C., additional, Scortechini, A. R., additional, Tafuri, A., additional, Latagliata, R., additional, Caocci, G., additional, Bocchia, M., additional, Galimberti, S., additional, Luciano, L., additional, Fava, C., additional, Foà, R., additional, Saglio, G., additional, Rosti, G., additional, and Breccia, M., additional

Published
2023
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8. Efficacy and safety of nilotinib as frontline treatment in elderly (> 65 years) chronic myeloid leukemia patients outside clinical trials

Author

Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), Sica S. (ORCID:0000-0003-2426-3465), Luciano, L., Latagliata, R., Gugliotta, G., Annunziata, M., Tiribelli, M., Martino, B., Sica, A., Esposito, M. R., Bocchia, M., Galimberti, S., Sora', Federica, Albano, F., Palmieri, R., Pregno, P., Dragani, M., Iovine, M., Sica, Simona, Iurlo, A., Castagnetti, F., Rosti, G., Breccia, M., Sora' F. (ORCID:0000-0002-9607-5298), and Sica S. (ORCID:0000-0003-2426-3465)

Abstract

Here, we report real-world evidence on the safety and efficacy of nilotinib as a first-line treatment in elderly patients with chronic phase CML, treated in 18 Italian centers. Sixty patients aged > 65 years (median age 72 years (65–84)) were reported: 13 patients were older than 75 years. Comorbidities were recorded at baseline in 56/60 patients. At 3 months of treatment, all patients obtained complete hematological response (CHR), 43 (71.6%) an early molecular response (EMR), while 47 (78%) reached a complete cytogenetic response (CCyR). At last follow-up, 63.4% of patients still had a deep molecular response (MR4 or better), 21.6% reached MR3 as best response and 11.6% persisted without MR. Most patients (85%) started the treatment at the standard dose (300 mg BID), maintained at 3 months in 80% of patients and at 6 months in 89% of them. At the last median follow-up of 46.3 months, 15 patients discontinued definitively the treatment (8 due to side effects, 4 died for unrelated CML causes, 1 for failure, 2 were lost to follow-up). One patient entered in treatment-free remission. As to safety, 6 patients (10%) experienced cardiovascular events after a median time of 20.9 months from the start. Our data showed that nilotinib could be, as first-line treatment, effective and relatively safe even in elderly CML patients. In this setting, more data in the long term are needed about possible dose reduction to improve the tolerability, while maintaining the optimal molecular response.

Published
2023

10. 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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11. Treatment and outcome of 2904 CML patients from the EUTOS population-based registry

Author

Hoffmann, V S, Baccarani, M, Hasford, J, Castagnetti, F, Di Raimondo, F, Casado, L F, Turkina, A, Zackova, D, Ossenkoppele, G, Zaritskey, A, Höglund, M, Simonsson, B, Indrak, K, Sninska, Z, Sacha, T, Clark, R, Bogdanovic, A, Hellmann, A, Griskevicius, L, Schubert-Fritschle, G, Sertic, D, Guilhot, J, Lejniece, S, Zupan, I, Burgstaller, S, Koskenvesa, P, Everaus, H, Costeas, P, Lindoerfer, D, Rosti, G, Saussele, S, Hochhaus, A, and Hehlmann, R

Published
2017
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12. S156: INTERNATIONAL, PROSPECTIVE STUDY COMPARING NILOTINIB VERSUS IMATINIB WITH EARLY SWITCH TO NILOTINIB TO OBTAIN SUSTAINED TREATMENT-FREE REMISSION IN PATIENTS WITH WITH CHRONIC MYELOID LEUKEMIA

Author

Pane, F., primary, Castagnetti, F., additional, Luciano, L., additional, Russo Rossi, A., additional, Abruzzese, E., additional, Bassan, R., additional, Binotto, G., additional, Caocci, G., additional, Cimino, G., additional, Fazi, P., additional, Gozzini, A., additional, Lunghi, M., additional, Marasca, R., additional, Martino, B., additional, Bonifacio, M., additional, Cavazzini, F., additional, Paoloni, F., additional, Saglio, G., additional, Sica, S., additional, Tafuri, A., additional, Vallisa, D., additional, Vignetti, M., additional, Westerweel, P., additional, Rosti, G., additional, and Breccia, M., additional

Published
2022
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13. P707: DOSE MODIFICATION DYNAMICS OF PONATINIB IN PATIENTS WITH CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) FROM THE PACE AND OPTIC TRIALS

Author

Apperley, J., primary, Kantarjian, H., additional, Deininger, M., additional, Abruzzese, E., additional, Cortes, J., additional, Chuah, C., additional, DeAngelo, D. J., additional, DiPersio, J., additional, Hochhaus, A., additional, Lipton, J., additional, Nicolini, F., additional, Pinilla-Ibarz, J., additional, Rea, D., additional, Rosti, G., additional, Rousselot, P., additional, Mauro, M., additional, Shah, N., additional, Talpaz, M., additional, Vorog, A., additional, Ren, X., additional, and Jabbour, E., additional

Published
2022
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14. P698: BOSUTINIB DOSE OPTIMIZATION IN THE SECOND-LINE TREATMENT OF ELDERLY CML PATIENTS: EXTENDED 3-YEAR FOLLOW-UP AND FINAL RESULTS OF THE BEST STUDY

Author

Castagnetti, F., primary, Bocchia, M., additional, Abruzzese, E., additional, Capodanno, I., additional, Bonifacio, M., additional, Rege Cambrin, G., additional, Crugnola, M., additional, Binotto, G., additional, Elena, C., additional, Lucchesi, A., additional, Bergamaschi, M., additional, Albano, F., additional, Luciano, L., additional, Sorà, F., additional, Lunghi, F., additional, Stagno, F., additional, Cerrano, M., additional, Iurlo, A., additional, Scortechini, A. R., additional, Leonetti Crescenzi, S., additional, Spadano, R., additional, Trabacchi, E., additional, Lunghi, M., additional, Spinosa, G., additional, Ferrero, D., additional, Rapezzi, D., additional, Ladetto, M., additional, Nocilli, L., additional, Gugliotta, G., additional, Iezza, M., additional, Cavo, M., additional, Saglio, G., additional, Pane, F., additional, and Rosti, G., additional

Published
2022
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15. P1706: CLINICAL UTILITY OF ONLINE MONITORING OF PATIENT-REPORTED SYMPTOMS IN NEWLY DIAGNOSED PATIENTS WITH CHRONIC MYELOID LEUKEMIA IN REAL-LIFE PRACTICE

Author

Efficace, F., primary, Cottone, F., additional, Yanez, B., additional, Castagnetti, F., additional, Caocci, G., additional, Bonifacio, M., additional, Patriarca, A., additional, Capodanno, I., additional, Miggiano, M. C., additional, Tiribelli, M., additional, Breccia, M., additional, Luciano, L., additional, Giai, V., additional, Iurlo, A., additional, Abruzzese, E., additional, Fava, C., additional, Rosti, G., additional, Cortes, J., additional, Kota, V., additional, Vignetti, M., additional, and Cella, D., additional

Published
2022
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16. S152: SETD2/H3K36ME3 DEFICIENCY SUSTAINS GENOMIC INSTABILITY AND ENHANCES CLONOGENIC POTENTIAL OF CHRONIC MYELOID LEUKEMIA (CML) PROGENITORS

Author

Mancini, M., primary, De Santis, S., additional, Monaldi, C., additional, Bruno, S., additional, Castagnetti, F., additional, Gugliotta, G., additional, Iurlo, A., additional, Cerrano, M., additional, Galimberti, S., additional, Balducci, S., additional, Stagno, F., additional, Rosti, G., additional, Cavo, M., additional, and Soverini, S., additional

Published
2022
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18. Erratum: ☆Corrigendum to “Recommendations for surveillance and follow-up of men with testicular germ cell tumors: A multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica” (Critical Reviews in Oncology / Hematology (2019) 137 (154–164), (S1040842819300587), (10.1016/j.critrevonc.2019.03.006))

Author

Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

The authors regret that the affiliation of Drs. Barone and De. Giorgi in the Acknowledgements section is incorrect and should be as follows: Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. Barone and Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. De Giorgi and The authors would like to apologise for any inconvenience caused.

Published
2020

19. Erratum: ☆Corrigendum to “Recommendations for surveillance and follow-up of men with testicular germ cell tumors: A multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica” (Critical Reviews in Oncology / Hematology (2019) 137 (154–164), (S1040842819300587), (10.1016/j.critrevonc.2019.03.006))

Author

Banna G. L., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna G. L., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, Da Pozzo, L, Di Nardo, D, Fornarini, G, Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., Da Pozzo L., Di Nardo D., Fornarini G., Galetti T. P., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

The authors regret that the affiliation of Drs. Barone and De. Giorgi in the Acknowledgements section is incorrect and should be as follows: Radiology Unit, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. Barone and Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy for Dr. De Giorgi and The authors would like to apologise for any inconvenience caused.

Published
2020

20. A retrospective analysis about frequency of monitoring in italian chronic myeloid leukemia patients after discontinuation

Author

Dragani, M, Cambrin, G, Berchialla, P, Dogliotti, I, Rosti, G, Castagnetti, F, Capodanno, I, Martino, B, Cerrano, M, Ferrero, D, Gambacorti Passerini, C, Crugnola, M, Elena, C, Breccia, M, Iurlo, A, Cattaneo, D, Galimberti, S, Gozzini, A, Bocchia, M, Lunghi, F, Cedrone, M, Sgherza, N, Luciano, L, Russo, S, Santoro, M, Giai, V, Caocci, G, Levato, L, Abruzzese, E, Sora, F, Saglio, G, Fava, C, Dragani M., Cambrin G. R., Berchialla P., Dogliotti I., Rosti G., Castagnetti F., Capodanno I., Martino B., Cerrano M., Ferrero D., Gambacorti Passerini C., Crugnola M., Elena C., Breccia M., Iurlo A., Cattaneo D., Galimberti S., Gozzini A., Bocchia M., Lunghi F., Cedrone M., Sgherza N., Luciano L., Russo S., Santoro M., Giai V., Caocci G., Levato L., Abruzzese E., Sora F., Saglio G., Fava C., Dragani, M, Cambrin, G, Berchialla, P, Dogliotti, I, Rosti, G, Castagnetti, F, Capodanno, I, Martino, B, Cerrano, M, Ferrero, D, Gambacorti Passerini, C, Crugnola, M, Elena, C, Breccia, M, Iurlo, A, Cattaneo, D, Galimberti, S, Gozzini, A, Bocchia, M, Lunghi, F, Cedrone, M, Sgherza, N, Luciano, L, Russo, S, Santoro, M, Giai, V, Caocci, G, Levato, L, Abruzzese, E, Sora, F, Saglio, G, Fava, C, Dragani M., Cambrin G. R., Berchialla P., Dogliotti I., Rosti G., Castagnetti F., Capodanno I., Martino B., Cerrano M., Ferrero D., Gambacorti Passerini C., Crugnola M., Elena C., Breccia M., Iurlo A., Cattaneo D., Galimberti S., Gozzini A., Bocchia M., Lunghi F., Cedrone M., Sgherza N., Luciano L., Russo S., Santoro M., Giai V., Caocci G., Levato L., Abruzzese E., Sora F., Saglio G., and Fava C.

Abstract

Successful discontinuation of tyrosine kinase inhibitors has been achieved in patients with chronic-phase chronic myeloid leukemia (CML). Careful molecular monitoring after discontinuation warrants safe and prompt resumption of therapy. We retrospectively evaluated how molecular monitoring has been conducted in Italy in a cohort of patients who discontinued tyrosine kinase inhibitor (TKI) treatment per clinical practice. The outcome of these patients has recently been reported—281 chronic-phase CML patients were included in this subanalysis. Median follow-up since discontinuation was 2 years. Overall, 2203 analyses were performed, 17.9% in the first three months and 38.4% in the first six months. Eighty-six patients lost major molecular response (MMR) in a mean time of 5.7 months—65 pts (75.6%) during the first six months. We evaluated the number of patients who would experience a delay in diagnosis of MMR loss if a three-month monitoring schedule was adopted. In the first 6 months, 19 pts (29.2%) would have a one-month delay, 26 (40%) a 2-month delay. Very few patients would experience a delay in the following months. A less intense frequency of monitoring, particularly after the first 6 months off treatment, would not have affected the success of treatment-free remission (TFR) nor put patients at risk of progression.

Published
2020

21. Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia: primary results of the phase 4 BYOND study

Author

Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., Stenke L., Hochhaus, A, Gambacorti Passerini, C, Abboud, C, Gjertsen, B, Brummendorf, T, Smith, B, Ernst, T, Giraldo-Castellano, P, Olsson-Stromberg, U, Saussele, S, Bardy-Bouxin, N, Viqueira, A, Leip, E, Russell-Smith, T, Leone, J, Rosti, G, Watts, J, Giles, F, Abruzzese, E, Akard, L, Bosi, A, Cervantes, F, Charbonnier, A, Di Raimondo, F, Etienne, G, Garcia Gutierrez, V, Guerci-Bresler, A, Hjorth-Hansen, H, Karsenti, J, Kelly, K, Le Coutre, P, Martinez Chamorro, C, Oehler, V, Orti Pascual, G, Petzer, A, Pungolino, E, Rege-Cambrin, G, Rigal-Huguet, F, Roboz, G, Rousselot, P, Sanchez-Guijo, F, Sanz Santillana, G, Schafhausen, P, Scheid, C, Schmidt, S, Specchia, G, Steegmann, J, Stenke, L, Hochhaus A., Gambacorti Passerini C., Abboud C., Gjertsen B. T., Brummendorf T. H., Smith B. D., Ernst T., Giraldo-Castellano P., Olsson-Stromberg U., Saussele S., Bardy-Bouxin N., Viqueira A., Leip E., Russell-Smith T. A., Leone J., Rosti G., Watts J., Giles F. J., Abruzzese E., Akard L. P., Bosi A., Cervantes F., Charbonnier A., Di Raimondo F., Etienne G., Garcia Gutierrez V., Guerci-Bresler A. P., Hjorth-Hansen H., Karsenti J. M., Kelly K. R., Le Coutre P., Martinez Chamorro C., Oehler V. G., Orti Pascual G., Petzer A., Pungolino E., Rege-Cambrin G., Rigal-Huguet F., Roboz G. J., Rousselot P., Sanchez-Guijo F. M., Sanz Santillana G., Schafhausen P., Scheid C., Schmidt S., Specchia G., Steegmann J. L., and Stenke L.

Abstract

Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.

Published
2020

22. COVID-19 infection in chronic myeloid leukemia after one year of the pandemic in Italy Campus CML report

Author

Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, Sora, Federica (ORCID:0000-0002-9607-5298), Breccia, M, Abruzzese, E, Accurso, V, Attolico, I, Barulli, S, Bergamaschi, M, Binotto, G, Bocchia, M, Bonifacio, M, Caocci, G, Capodanno, I, Castagnetti, F, Cavazzini, F, Crisà, E, Crugnola, M, De Candia, M, Elena, C, Fava, C, Galimberti, S, Gozzini, A, Gugliotta, G, Intermesoli, T, Iurlo, A, La Barba, G, Latagliata, R, Crescenzi, Sl, Levato, L, Loglisci, G, Lucchesi, A, Luciano, L, Lunghi, F, Luzi, D, Malato, A, Miggiano, Mc, Pizzuti, M, Pregno, P, Rapezzi, D, Rege-Cambrin, G, Rosti, G, Russo, S, Sancetta, R, Scortechini, Ar, Sora', Federica, Sportoletti, P, Stagno, F, Tafuri, A, Tiribelli, M, Foà, R, Saglio, G, and Sora, Federica (ORCID:0000-0002-9607-5298)

Abstract

Limited information is available on the impact of the COVID-19 pandemic on the management of chronic myeloid leukaemia (CML). The Campus CML network collected retrospective information on 8 665 CML patients followed at 46 centres throughout Italy during the pandemic between February 2020 and January 2021. Within this cohort, we recorded 217 SARS-CoV-2-positive patients (2·5%). Most patients (57%) were diagnosed as having SARS-CoV-2 infection during the second peak of the pandemic (September 2020 to January 2021). The majority (35%) was aged between 50 and 65 years with a male prevalence (73%). Fifty-six percent of patients presented concomitant comorbidities. The median time from CML diagnosis to SARS-CoV-2 infection was six years (three months to 18 years). Twenty-one patients (9·6%) required hospitalization without the need of respiratory assistance, 18 (8·2%) were hospitalized for respiratory assistance, 8 (3·6%) were admitted to an intensive care unit, while 170 (78%) were only quarantined. Twenty-three percent of patients discontinued tyrosine kinase inhibitor (TKI) therapy during the infection. Twelve patients died due to COVID-19 with a mortality rate of 5·5% in the positive cohort and of 0·13% in the whole cohort. We could also document sequelae caused by the SARS-CoV-2 infection and an impact of the pandemic on the overall management of CML patients.

Published
2022

24. The proportion of different BCR-ABL1 transcript types in chronic myeloid leukemia. An international overview

Author

Baccarani, M, Castagnetti, F, Gugliotta, G, Rosti, G, Soverini, S, Albeer, A, Pfirrmann, M, Bekadja, Ma, Entasoltan, B, Nachi, M, Elghandour, A, El Sorady, M, Abdelfattah, R, El Nahass, Y, Samra, M, Azzazi, M, Elsobki, E, Moussa, M, Fahmy, O, Mattar, M, Shehata, Azmy, Se, (Azmy, E, 9 ), Emad), Bolarinwa, (Bolarinwa, Ra, ( 10 ), Rahman A., Eid, (Eid, S, Samir)( 11, ), Khelif, (Khelif, A, Abderrhaim)( 11, ), Hached, (Hached, F, Farhat)( 11, ), Menif, (Menif, S, Samia)( 12, ), Rahman, (Rahman, H, Hafizur)( 13, ), Huang, (Huang, Xj, Xiaojun)(, 14, 15, ), Jiang, (Jiang, Q, Qian)(, 14, (Ye, Yx, Yuanxin)( 16, ), Zhu, (Zhu, Hl, Huanling)( 16, ), Chen, (Chen, Sn, Suning)( 17, ), Varma, (Varma, N, Neelam)( 18, ), Ganesan, (Ganesan, P, Prasanth)( 19, ), Gundeti, (Gundeti, S, Sadashivudu)( 20, ), Malhotra, (Malhotra, H, Hemant)( 21, ), Radhakrishnan, (Radhakrishnan, Vs, ( 22 ), Vivek S., Kumar, (Kumar, L, Lalit)( 23, ), Sharawat, (Sharawat, Sk, Surender Kumar)( 23, ), Seth, (Seth, T, Tulika)( 24, ), Ausekar, (Ausekar, Bv, ( 25 ), B. V., Balasubramanian, (Balasubramanian, P, Poonkuzhali)( 26, ), Poopak, (Poopak, B, Behzad)(, 27, 28, ), Inokuchi, (Inokuchi, K, Koiti)( 29, ), Kim, (Kim, Dw, Dong-Wook)( 30, ), Kindi, Al, S (Al Kindi, Salam)( 31, ), Mirasol, (Mirasol, A, Angelina)( 32, ), Qari, (Qari, M, Mohammed)( 33, ), Goh, (Goh, Yt, Yeow Tee)( 34, ), Shih, (Shih, Ly, Lee-Yung)(, 35, 36, ), Branford, (Branford, S, Susan)(, 37, 38, ), Lion, (Lion, T, Thomas)( 39, ), Valent, (Valent, P, Peter)( 40, ), Burgstaller, (Burgstaller, S, Sonja)( 41, ), Thaler, (Thaler, J, Joseph)( 41, ), Labar, (Labar, B, Boris)( 42, ), Zadro, (Zadro, R, Renata)( 42, ), Mayer, (Mayer, J, Jiri)(, 43, 44, ), Zackova, (Zackova, D, Daniela)(, 43, Faber, (Faber, E, Edgar)( 45, ), Pallisgaard, (Pallisgaard, N, Niels)( 46, ), Xavier-Mahon, (Xavier-Mahon, F, Francois)( 47, ), Lippert, (Lippert, E, Eric)( 48, ), Cayuela, (Cayuela, Jm, Jean Michel)( 49, ), Rea, (Rea, D, Delphine)( 49, ), Millot, (Millot, F, Frederic)( 50, ), Suttorp, (Suttorp, M, Meinolf)( 51, ), Hochhaus, (Hochhaus, A, Andreas)( 52, ), Niederwieser, (Niederwieser, D, Dietger)( 53, ), Saussele, (Saussele, S, Susanne)( 54, ), Haferlach, (Haferlach, T, Torsten)( 55, ), Jeromine, (Jeromine, S, Sabine)( 55, ), Panayiotidis, (Panayiotidis, P, Panayiotis)(, 56, 57, ), Conneally, (Conneally, E, Eibhlin)( 58, ), Langabeer, (Langabeer, S, Steve)( 58, ), Nagler, (Nagler, A, Arnon)(, 59, 60, ), Rupoli, (Rupoli, S, Serena)( 61, ), Santoro, (Santoro, N, Nicola)( 62, ), Albano, (Albano, F, Francesco)( 63, ), Castagnetti, (Castagnetti, F, Fausto), Ottaviani, (Ottaviani, E, Emanuela)(, 64, 65, ), Rambaldi, (Rambaldi, A, Alessandro)(, 66, 67, ), Stagno, (Stagno, F, Fabio)( 68, ), Molica, (Molica, S, Stefano)( 69, ), Biagiotti, (Biagiotti, C, Caterina)( 70, ), Scappini, (Scappini, B, Barbara)( 70, ), Lemoli, (Lemoli, R, Roberto)( 71, ), Iurlo, (Iurlo, A, Alessandra)(, 72, 73, ), Pungolino, (Pungolino, E, Ester)( 74, ), Menna, (Menna, G, Giuseppe), Pane, (Pane, F, Fabrizio)( 76, ), Gottardi, (Gottardi, E, Enrico)(, 77, 78, ), Rege-Cambrin, (Rege-Cambrin, G, Giovanna)(, 77, Binotto, (Binotto, G, Gianni)( 79, ), Putti, (Putti, Mc, Maria Caterina)( 80, ), Falzetti, (Falzetti, F, Franca)( 81, ), Visani, (Visani, G, Giuseppe)( 82, ), Galimberti, (Galimberti, S, Sara)( 83, ), Musto, (Musto, P, Pellegrino)( 84, ), Abruzzese, (Abruzzese, E, Elisabetta)( 85, ), Breccia, (Breccia, M, Massimo)( 86, ), Giona, (Giona, F, Fiorina)( 86, ), Chiusolo, (Chiusolo, P, Patrizia)( 87, ), Sica, (Sica, S, Simona)( 87, ), Fava, (Fava, C, Carmen)( 88, ), Ferrero, (Ferrero, D, Dario)( 88, ), Tiribelli, (Tiribelli, M, Mario)( 89, ), Bonifacio, (Bonifacio, M, Massimiliano)( 90, ), Griskevicius, (Griskevicius, L, Laimonas)( 91, ), Musteata, (Musteata, V, Vasile)( 92, ), Janssen, (Janssen, J, Jeroen)( 93, ), Prejzner, (Prejzner, W, Witold)( 94, ), Sacha, (Sacha, T, Tomasz)( 95, ), Waclaw, (Waclaw, J, Joanna)( 95, ), Almeida, (Almeida, Am, Antonio Medina)( 96, ), Kulikov, (Kulikov, S, Sergei)( 97, ), Turkina, (Turkina, A, Anna)( 97, ), Bogdanovic, (Bogdanovic, A, Andrija)( 98, ), Zupan, (Zupan, I, Irena)( 99, ), Marce, (Marce, S, Silvia)( 100, ), Cervantes, (Cervantes, F, Francisco)( 101, ), Steegmann, (Steegmann, Jl, Juan Luis)( 102, ), Kotlyarchuk, (Kotlyarchuk, K, Konstyantyn)( 103, ), Milner, (Milner, Bj, ( 104 ), Benedict J., Rose, (Rose, S, Susan)( 105, ), Clench, (Clench, T, Tim)( 106, ), Waits, (Waits, P, Paula)( 107, ), Austin, (Austin, S, Steve)( 108, ), Wickham, (Wickham, C, Caroline)( 109, ), Clark, (Clark, R, Richard)( 110, ), Apperley, (Apperley, J, Jane), Claudiani, (Claudiani, S, Simone)( 111, ), Foroni, (Foroni, L, Letizia)( 111, ), Szydlo, (Szydlo, R, Richard)( 111, ), Burt, (Burt, E, Emma)( 112, ), Bescoby, (Bescoby, R, Ruth)( 113, ), Cork, (Cork, L, Leanne)( 113, ), O'Brien, (O'Brien, S, Stephen)( 113, ), Green, (Green, B, Bethaney)( 114, ), Hawtree, (Hawtree, S, Sarah)( 114, ), Watson, (Watson, M, Mark)( 114, ), Bengio, (Bengio, Rm, Raquel Maria)( 115, ), Larripa, (Larripa, I, Irene)( 115, ), Pavlovsky, (Pavlovsky, C, Carolina)( 116, ), Moiraghi, (Moiraghi, B, Beatriz)( 117, ), Pinna, De, CAR (Requiao de Pinna, Cristiane Almeida)( 118, ), Magalhaes, GHR (Romani Magalhaes, Gustavo Henrique)( 119, ), Pagnano, (Pagnano, K, Katia)( 120, ), Funke, (Funke, V, Vaneuza)( 121, ), Tavares, (Tavares, Rs, Renato Sampaio)( 122, ), Prado, (Prado, A, Adriana)( 123, ), Azevedo, (Azevedo, Aa, Alita Andrade)( 124, ), Fogliatto, (Fogliatto, L, Laura)( 125, ), Bonecker, (Bonecker, S, Simone)( 126, ), Centrone, (Centrone, R, Renato)( 127, ), Moellman, (Moellman, A, Artur)( 128, ), Conchon, (Conchon, M, Monika)( 130, ), Centurion, (Centurion, Me, Maria Elida)( 131, ), (Prado, Ai, Ana-Ines)( 132, ), Lopez, (Lopez, Jl, ( 133 ), J. L., Petruzziello, (Petruzziello, F, Fara)( 75, ), Bendit, (Bendit, I, Israel), Baccarani M., Castagnetti F., Gugliotta G., Rosti G., Soverini S., Albeer A., and Pfirrmann M.

Subjects
Male, 0301 basic medicine, Cancer Research, bcr-abl, Fusion Proteins, bcr-abl, Global Health, 0302 clinical medicine, hemic and lymphatic diseases, 80 and over, Odds Ratio, Prevalence, Age Factor, Chronic, Young adult, Child, MOLECULAR RESPONSE, Leukemic, Aged, 80 and over, Leukemia, Hematology, Gene Expression Regulation, Leukemic, CHRONIC MYELOGENOUS LEUKEMIA, Age Factors, Myeloid leukemia, Middle Aged, Oncology, Child, Preschool, 030220 oncology & carcinogenesis, Female, Life Sciences & Biomedicine, Human, Adult, Transcriptional Activation, medicine.medical_specialty, Adolescent, Immunology, IMATINIB MESYLATE, DENDRITIC CELLS, CML PATIENTS, Young Adult, 03 medical and health sciences, Myelogenous, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Internal medicine, medicine, Humans, 1112 Oncology and Carcinogenesis, BCR/ABL TRANSCRIPT, Preschool, CYTOGENETIC RESPONSE, Aged, Science & Technology, CHRONIC-PHASE, business.industry, Infant, Newborn, Fusion Proteins, ABL FUSION PROTEINS, P190 BCR-ABL, Infant, 1103 Clinical Sciences, Odds ratio, Newborn, medicine.disease, International BCR-ABL Study Group, Settore MED/15 - MALATTIE DEL SANGUE, 030104 developmental biology, Imatinib mesylate, Gene Expression Regulation, BCR-ABL Positive, business, Chronic myelogenous leukemia
Abstract

There are different BCR-ABL1 fusion genes that are translated into proteins that are different from each other, yet all leukemogenic, causing chronic myeloid leukemia (CML) or acute lymphoblastic leukemia. Their frequency has never been systematically investigated. In a series of 45503 newly diagnosed CML patients reported from 45 countries, it was found that the proportion of e13a2 (also known as b2a2) and of e14a2 (also known as b3a2), including the cases co-expressing e14a2 and e13a2, was 37.9% and 62.1%, respectively. The proportion of these two transcripts was correlated with gender, e13a2 being more frequent in males (39.2%) than in females (36.2%), was correlated with age, decreasing from 39.6% in children and adolescents down to 31.6% in patients ≥ 80 years old, and was not constant worldwide. Other, rare transcripts were reported in 666/34561 patients (1.93%). The proportion of rare transcripts was associatedwith gender (2.27% in females and 1.69% in males) and with age (from 1.79% in children and adolescents up to 3.84% in patients ≥ 80 years old). These data show that the differences in proportion are not by chance. This is important, as the transcript type is a variable that is suspected to be of prognostic importance for response to treatment, outcome of treatment, and rate of treatment-free remission.

Published
2019

25. First-line treatment of chronic myeloid leukemia with nilotinib: critical evaluation

Author

Piccaluga PP, Paolini S, Bertuzzi C, De Leo A, and Rosti G

Subjects
Diseases of the blood and blood-forming organs, RC633-647.5
Abstract

Pier Paolo Piccaluga,* Stefania Paolini,* Clara Bertuzzi, Antonio De Leo, Gianantonio RostiHematopathology and Hematology Sections, Department of Hematology and Oncological Sciences, "L and A Seràgnoli", S Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy*These authors contributed equally to this workAbstract: The therapeutic landscape of chronic myeloid leukemia (CML) has changed dramatically in the last decade. In particular, the availability of imatinib mesylate, a tyrosine kinase inhibitor targeting BCR-ABL, has led to profound and durable remissions in the majority of patients. However, a couple of issues have emerged and partially obscured this scenario. First, it has become clear that a significant proportion of patients either present with primary resistance to imatinib or develop secondary resistance sooner or later during treatment. Second, although the drug is generally well tolerated, a percentage of patients eventually cease treatment because of toxicity. Bearing this in mind, second-generation tyrosine kinase inhibitors have been introduced, including nilotinib. Phase I and II studies indicate remarkable activity for this compound in CML cases resistant to imatinib, including some of those carrying BCR-ABL1 mutants. More recently, two Phase II studies and a III randomized Phase clinical trial demonstrated the superiority of nilotinib compared with imatinib in terms of complete cytogenetic and major molecular responses, which are two relevant surrogate measures of long-term survival in CML. In this paper, we review the most relevant data on nilotinib as first-line treatment for CML, and discuss the rationale for its routine use, as well as some possible future perspectives for CML patients.Keywords: chronic myeloid leukemia, nilotinib, targeted therapy, BCR-ABL1

Published
2012

26. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study

Author

Hochhaus, A, Rosti, G, Cross, N CP, Steegmann, J L, le Coutre, P, Ossenkoppele, G, Petrov, L, Masszi, T, Hellmann, A, Griskevicius, L, Wiktor-Jedrzejczak, W, Rea, D, Coriu, D, Brümmendorf, T H, Porkka, K, Saglio, G, Gastl, G, Müller, M C, Schuld, P, Di Matteo, P, Pellegrino, A, Dezzani, L, Mahon, F-X, Baccarani, M, and Giles, F J

Published
2016
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27. Observational study of chronic myeloid leukemia italian patients who discontinued tyrosine kinase inhibitors in clinical practice

Author

Fava, C, Rege-Cambrin, G, Dogliotti, I, Cerrano, M, Berchialla, P, Dragani, M, Rosti, G, Castagnetti, F, Gugliotta, G, Martino, B, Gambacorti-Passerini, C, Abruzzese, E, Elena, C, Pregno, P, Gozzini, A, Capodanno, I, Bergamaschi, M, Crugnola, M, Bocchia, M, Galimberti, S, Rapezzi, D, Iurlo, A, Cattaneo, D, Latagliata, R, Breccia, M, Cedrone, M, Santoro, M, Annunziata, M, Levato, L, Stagno, F, Cavazzini, F, Sgherza, N, Giai, V, Luciano, L, Russo, S, Musto, P, Caocci, G, Sora, F, Iuliano, F, Lunghi, F, Specchia, G, Pane, F, Ferrero, D, Baccarani, M, Saglio, G, Fava C., Rege-Cambrin G., Dogliotti I., Cerrano M., Berchialla P., Dragani M., Rosti G., Castagnetti F., Gugliotta G., Martino B., Gambacorti-Passerini C., Abruzzese E., Elena C., Pregno P., Gozzini A., Capodanno I., Bergamaschi M., Crugnola M., Bocchia M., Galimberti S., Rapezzi D., Iurlo A., Cattaneo D., Latagliata R., Breccia M., Cedrone M., Santoro M., Annunziata M., Levato L., Stagno F., Cavazzini F., Sgherza N., Giai V., Luciano L., Russo S., Musto P., Caocci G., Sora F., Iuliano F., Lunghi F., Specchia G., Pane F., Ferrero D., Baccarani M., Saglio G., Fava, C, Rege-Cambrin, G, Dogliotti, I, Cerrano, M, Berchialla, P, Dragani, M, Rosti, G, Castagnetti, F, Gugliotta, G, Martino, B, Gambacorti-Passerini, C, Abruzzese, E, Elena, C, Pregno, P, Gozzini, A, Capodanno, I, Bergamaschi, M, Crugnola, M, Bocchia, M, Galimberti, S, Rapezzi, D, Iurlo, A, Cattaneo, D, Latagliata, R, Breccia, M, Cedrone, M, Santoro, M, Annunziata, M, Levato, L, Stagno, F, Cavazzini, F, Sgherza, N, Giai, V, Luciano, L, Russo, S, Musto, P, Caocci, G, Sora, F, Iuliano, F, Lunghi, F, Specchia, G, Pane, F, Ferrero, D, Baccarani, M, Saglio, G, Fava C., Rege-Cambrin G., Dogliotti I., Cerrano M., Berchialla P., Dragani M., Rosti G., Castagnetti F., Gugliotta G., Martino B., Gambacorti-Passerini C., Abruzzese E., Elena C., Pregno P., Gozzini A., Capodanno I., Bergamaschi M., Crugnola M., Bocchia M., Galimberti S., Rapezzi D., Iurlo A., Cattaneo D., Latagliata R., Breccia M., Cedrone M., Santoro M., Annunziata M., Levato L., Stagno F., Cavazzini F., Sgherza N., Giai V., Luciano L., Russo S., Musto P., Caocci G., Sora F., Iuliano F., Lunghi F., Specchia G., Pane F., Ferrero D., Baccarani M., and Saglio G.

Abstract

It is judged safe to discontinue treatment with tyrosine kinase inhibitors (TKI) for chronic myeloid leukemia (CML) in experimental trials on treatment-free remission (TFR). We collected a total of 293 Italian patients with chronic phase CML who discontinued TKI in deep molecular response. Seventy-two percent of patients were on treatment with imatinib, and 28% with second generation TKI at the time of discontinuation. Median duration of treatment with the last TKI was 77 months [Interquartile Range (IQR) 54;111], median duration of deep molecular response was 46 months (IQR 31;74). Duration of treatment with TKI and duration of deep molecular response were shorter with second generation TKI than with imatinib (P<0.001). Eighty-eight percent of patients discontinued as per clinical practice, and reasons for stopping treatment were: toxicity (20%), pregnancy (6%), and shared decision between treating physician and patient (62%). After a median follow up of 34 months (range, 12-161) overall estimated TFR was 62% (95%CI: 56;68). At 12 months, TFR was 68% (95%CI: 62;74) for imatinib, 73% (95%CI: 64;83) for second generation TKI. Overall median time to restart treatment was six months (IQR 4;11). No progressions occurred. Although our study has the limitation of a retrospective study, our experience within the Italian population confirms that discontinuation of imatinib and second generation TKI is feasible and safe in clinical practice

Published
2019

28. Recommendations for surveillance and follow-up of men with testicular germ cell tumors: a multidisciplinary consensus conference by the Italian Germ cell cancer Group and the Associazione Italiana di Oncologia Medica

Author

Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, DA POZZO, L, Di Nardo, D, Fornarini, G, Prayer Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., DA POZZO, LUIGI FILIPPO, Di Nardo D., Fornarini G., Prayer Galetti T., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., De Giorgi U., Banna, G, Nicolai, N, Palmieri, G, Ottaviano, M, Balzarini, L, Barone, D, Basso, U, Bavila, A, Bertoni, F, Calliada, F, Cai, T, Carrafiello, G, Condello, C, DA POZZO, L, Di Nardo, D, Fornarini, G, Prayer Galetti, T, Garolla, A, Giannatempo, P, Guerra, L, La Spina, S, Malatino, L, Marchiano', A, Monti, M, Morbiato, F, Morelli, F, Nole', F, Palazzi, S, Procopio, G, Rosti, G, Sacco, C, Salvetti, A, Salvioni, R, Sava, T, Secondino, S, Serpentini, S, Spreafico, C, Tavolini, I, Valcamonico, F, Verri, E, Zucali, P, De Giorgi, U, Banna G. L., Nicolai N., Palmieri G., Ottaviano M., Balzarini L., Barone D., Basso U., Bavila A., Bertoni F., Calliada F., Cai T., Carrafiello G., Condello C., DA POZZO, LUIGI FILIPPO, Di Nardo D., Fornarini G., Prayer Galetti T., Garolla A., Giannatempo P., Guerra L., La Spina S., Malatino L., Marchiano' A., Monti M., Morbiato F. F., Morelli F., Nole' F., Palazzi S., Procopio G., Rosti G., Sacco C., Salvetti A., Salvioni R., Sava T., Secondino S., Serpentini S., Spreafico C., Tavolini I. M., Valcamonico F., Verri E., Zucali P., and De Giorgi U.

Abstract

Background: No compelling evidence is available about surveillance and follow-up of patients with testicular germ cell tumour (TGCT). Methods: In the light of the best clinical evidence, the Italian Germ cell cancer Group (IGG) and the Associazione Italiana di Oncologia Medica (AIOM) set up a multidisciplinary national consensus conference, involving 42 leading experts and 3 TGCT survivors. A minimum of 50% of votes was required in order to achieve a consensus recommendation on 29 questions. Results: Recommendations have been summarized in three tables, divided by stage I seminoma, stage I nonseminoma and the advanced disease, which may be useful for clinicians to appropriately choose the clinical investigation and its timing during the surveillance and follow-up of TGCT patients based on an accurate estimation of their risk of disease relapse. Conclusions: The IGG-AIOM consensus recommendations may help clinicians to choose appropriate clinical investigations for the surveillance and follow-up of TGCT patients.

Published
2019

30. 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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32. 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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36. Validation and reference values of the EORTC QLQ-CML24 questionnaire to assess health-related quality of life in patients with chronic myeloid leukemia

Author

Efficace, F., Iurlo, A., Patriarca, A., Stagno, F., Bee, P.C., Ector, G.I.C.G., Capodanno, I., Elena, C., Bonifacio, M., Blijlevens, N.M.A., Caocci, G., Wan, C., Abruzzese, E., Breccia, M., Cottone, F., Okumura, I., Oerlemans, S., Cascavilla, N., Albano, F., Kota, V., Sztankay, M., Miggiano, M.C., Saussele, S., Renzo, N. Di, Sorà, F., Castagnetti, F., Baccarani, M., Vignetti, M., Rosti, G., Efficace, F., Iurlo, A., Patriarca, A., Stagno, F., Bee, P.C., Ector, G.I.C.G., Capodanno, I., Elena, C., Bonifacio, M., Blijlevens, N.M.A., Caocci, G., Wan, C., Abruzzese, E., Breccia, M., Cottone, F., Okumura, I., Oerlemans, S., Cascavilla, N., Albano, F., Kota, V., Sztankay, M., Miggiano, M.C., Saussele, S., Renzo, N. Di, Sorà, F., Castagnetti, F., Baccarani, M., Vignetti, M., and Rosti, G.

Abstract

Item does not contain fulltext, Health-related quality of life (HRQOL) assessment is important to facilitate decisions in the current treatment landscape of chronic myeloid leukemia (CML). Therefore, the availability of a validated HRQOL questionnaire, specifically developed for CML patients treated with tyrosine kinase inhibitors (TKIs), may enhance quality of research in this area. We performed an international study including 782 CML patients to assess the validity of the EORTC QLQ-CML 24 questionnaire, and to generate HRQOL reference values to facilitate interpretation of results in future studies. Internal consistency, assessed with Cronbach's alpha coefficients, ranged from 0.66 to 0.83. In the confirmatory factor analysis, all standardized factor loadings exceeded the threshold of 0.40 (range 0.49-0.97), confirming the hypothesized scale structure. Reference values stratified by age and sex were also generated. Our findings support the use of the EORTC QLQ-CML 24, in conjunction with the EORTC QLQ-C30, as a valuable measure to assess HRQOL in CML patients.

Published
2021

38. Chronic myeloid leukemia management at the time of the COVID-19 pandemic in Italy. A campus CML survey

Author

Breccia, M., Abruzzese, E., Bocchia, M., Bonifacio, M., Castagnetti, F., Fava, C., Galimberti, S., Gozzini, A., Gugliotta, G., Iurlo, A., Latagliata, R., Luciano, L., Pregno, P., Rege-Cambrin, G., Rosti, G., Stagno, F., Tiribelli, M., Foa, R., Saglio, G., Mariacristina, M. M., Isabella, C., Vincenzo, A., Federica, S., Debora, L., Mario, A., Immacolata, A., Alessandra, M., Rosaria, S., Chiara, E., Sara, B., Rita, S. A., Sabrina, L. -C., Agostino, T., Francesco, C., Giovanni, C., Alessandro, L., Davide, R., Michele, P., Gianni, B., Tamara, I., Alessandro, M., Elena, C., Monica, C., Mariella, D. A., Germana, B., Francesca, L., Iolanda -Donatella, V., Grazia, S., Luca, F., Sabina, R., Gaetano, L. B., Breccia M., Abruzzese E., Bocchia M., Bonifacio M., Castagnetti F., Fava C., Galimberti S., Gozzini A., Gugliotta G., Iurlo A., Latagliata R., Luciano L., Pregno P., Rege-Cambrin G., Rosti G., Stagno F., Tiribelli M., Foa R., Saglio G., MariaCristina M.M., Isabella C., Vincenzo A., Federica S., Debora L., Mario A., Immacolata A., Alessandra M., Rosaria S., Chiara E., Sara B., Rita S.A., Sabrina L.-C., Agostino T., Francesco C., Giovanni C., Alessandro L., Davide R., Michele P., Gianni B., Tamara I., Alessandro M., Elena C., Monica C., Mariella D.A., Germana B., Francesca L., Iolanda -Donatella V., Grazia S., Luca F., Sabina R., and Gaetano L.B.

Subjects
Cancer Research, 2019-20 coronavirus outbreak, medicine.medical_specialty, Coronavirus disease 2019 (COVID-19), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Pneumonia, Viral, Protein Kinase Inhibitor, Time-to-Treatment, Betacoronavirus, Myelogenous, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Surveys and Questionnaires, Correspondence, Pandemic, Surveys and Questionnaire, COVID-19, Coronavirus Infections, Disease Management, Humans, Infection Control, Italy, Pandemics, Practice Guidelines as Topic, Protein Kinase Inhibitors, SARS-CoV-2, Telemedicine, Medicine, Viral, Chronic, Disease management (health), Chronic myeloid leukaemia, Leukemia, Betacoronaviru, Coronavirus Infection, business.industry, Myeloid leukemia, Pneumonia, Hematology, medicine.disease, Oncology, Family medicine, BCR-ABL Positive, business, Haematological diseases, Human
Abstract

No abstract available.

Published
2020

41. Maintaining success, reducing treatment burden, focusing on survivorship: highlights from the third European consensus conference on diagnosis and treatment of germ-cell cancer

Author

Beyer, J., Albers, P., Altena, R., Aparicio, J., Bokemeyer, C., Busch, J., Cathomas, R., Cavallin-Stahl, E., Clarke, N. W., Claen, J., Cohn-Cedermark, G., Dahl, A. A., Daugaard, G., De Giorgi, U., De Santis, M., De Wit, M., De Wit, R., Dieckmann, K. P., Fenner, M., Fizazi, K., Flechon, A., Fossa, S. D., Germá Lluch, J. R., Gietema, J. A., Gillessen, S., Giwercman, A., Hartmann, J. T., Heidenreich, A., Hentrich, M., Honecker, F., Horwich, A., Huddart, R. A., Kliesch, S., Kollmannsberger, C., Krege, S., Laguna, M. P., Looijenga, L. H. J., Lorch, A., Lotz, J. P., Mayer, F., Necchi, A., Nicolai, N., Nuver, J., Oechsle, K., Oldenburg, J., Oosterhuis, J. W., Powles, T., Rajpert-De Meyts, E., Rick, O., Rosti, G., Salvioni, R., Schrader, M., Schweyer, S., Sedlmayer, F., Sohaib, A., Souchon, R., Tandstad, T., Winter, C., and Wittekind, C.

Published
2013
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