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1. Addition of danicopan to ravulizumab or eculizumab in patients with paroxysmal nocturnal haemoglobinuria and clinically significant extravascular haemolysis (ALPHA): a double-blind, randomised, phase 3 trial

Author

Barcellini, Wilma, Barraco, Fiorenza, Beneitez Pastor, David, Capra, Marcelo, Chew, Lee Ping, Chrysavgi, Lalayanni, De Castro, Carlos, de la Tour, Régis Peffault, De Oliveira, Michel Michels, Di Bona, Eros, Forcade, Edouard, Fu, Chieh-Lin, Furha, Cossor, Gaya Valls, Anna, Giannouli, Stavroula, Gonzalez-Fernandez, Ataulfo, Griffin, Morag, Gural, Alexander, Gutierrez, Emilio Ojeda, Hernández-Rodríguez, Inés, Ibrahim, Ibrahim, Iori, Anna Paola, Ishida, Tadao, Jang, Jun Ho, Kim, Jeong-A, Kim, Jin Seok, Kitano, Toshiyuki, Kosugi, Hiroshi, Kreiniz, Natalia, Kulasekararaj, Austin, Lee, Jong Wook, Lee Lee, Lily Wong, Mayer, Jiri, Mitchell, Lindsay, Mori, Yasuo, Nishiwaki, Kaichi, Notaro, Rosario, Nunez, Ramiro, Obara, Naoshi, Oliva, Esther Natalie, Patriquin, Christopher, Pessoa, Viviani, Piatek, Caroline, Piekarska, Agnieszka, Raza, Shahzad, Risitano, Antonio Maria, Rojnuckarin, Ponlapat, Samuel, Desmond, Shammo, Jamile, Tadmor, Tamar, Takami, Akiyoshi, Tamari, Roni, Terriou, Louis, Uchiyama, Hitoji, Vannucchi, Alessandro Maria, Yamaguchi, Hiroki, Nishimura, Jun-ichi, Carrillo Infante, Cynthia, Jain, Deepak, Liu, Peng, Filippov, Gleb, Sicre de Fontbrune, Flore, Risitano, Antonio, and Kulasekararaj, Austin G

Published
2023
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3. Venetoclax in combination with hypomethylating agents in previously untreated patients with acute myeloid leukemia ineligible for intensive treatment: a real-life multicenter experience

Author

De Bellis, Eleonora, Imbergamo, Silvia, Candoni, Anna, Liço, Albana, Tanasi, Ilaria, Mauro, Endri, Mosna, Federico, Leoncin, Matteo, Stulle, Manuela, Griguolo, Davide, Pravato, Stefano, Trentin, Livio, Lazzarotto, Davide, Di Bona, Eros, Bassan, Renato, Lucchini, Elisa, Poiani, Monica, Palmieri, Clara, and Zaja, Francesco

Published
2022
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4. Long-term quality of life of patients with acute promyelocytic leukemia treated with arsenic trioxide vs chemotherapy

Author

Efficace, Fabio, Platzbecker, Uwe, Breccia, Massimo, Cottone, Francesco, Carluccio, Paola, Salutari, Prassede, Di Bona, Eros, Borlenghi, Erika, Autore, Francesco, Levato, Luciano, Finizio, Olimpia, Mancini, Valentina, D'Ardia, Stefano, Schlenk, Richard F., Melillo, Lorella, Fumagalli, Monica, Fiedler, Walter, Beltrami, Germana, Fracchiolla, Nicola Stefano, Bernardi, Massimo, Fazi, Paola, Annibali, Ombretta, Mayer, Karin, Voso, Maria Teresa, and Vignetti, Marco

Published
2021
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5. Prospective assessment of NGS-detectable mutations in CML patients with nonoptimal response: the NEXT-in-CML study

Author

Soverini, Simona, Bavaro, Luana, De Benedittis, Caterina, Martelli, Margherita, Iurlo, Alessandra, Orofino, Nicola, Sica, Simona, Sorà, 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, Eros, 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, Mignone, Flavio, Laginestra, Maria Antonella, Pileri, Stefano Aldo, Percesepe, Antonio, Tenti, Elena, Rosti, Gianantonio, Baccarani, Michele, Cavo, Michele, and Martinelli, Giovanni

Published
2020
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6. Efficacy and toxicity of Decitabine in patients with acute myeloid leukemia (AML): A multicenter real-world experience

Author

Filì, Carla, Candoni, Anna, Zannier, Maria Elena, Olivieri, Jacopo, Imbergamo, Silvia, Caizzi, Manuela, Nadali, Gianpaolo, Di Bona, Eros, Ermacora, Anna, Gottardi, Michele, Facchinelli, Davide, Ciancia, Rosanna, Lazzarotto, Davide, Dubbini, Maria Vittoria, Festini, Gianluca, Gherlinzoni, Filippo, Michieli, Maria Grazia, Semenzato, Gianpietro, and Fanin, Renato

Published
2019
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7. Clinical heterogeneity and predictors of outcome in primary autoimmune hemolytic anemia: a GIMEMA study of 308 patients

Author

Barcellini, Wilma, Fattizzo, Bruno, Zaninoni, Anna, Radice, Tommaso, Nichele, Ilaria, Di Bona, Eros, Lunghi, Monia, Tassinari, Cristina, Alfinito, Fiorella, Ferrari, Antonella, Leporace, Anna Paola, Niscola, Pasquale, Carpenedo, Monica, Boschetti, Carla, Revelli, Nicoletta, Villa, Maria Antonietta, Consonni, Dario, Scaramucci, Laura, De Fabritiis, Paolo, Tagariello, Giuseppe, Gaidano, Gianluca, Rodeghiero, Francesco, Cortelezzi, Agostino, and Zanella, Alberto

Published
2014
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8. The long‐acting anti‐C5 ravulizumab results in C3 binding to PNH red cells similar to its parental molecule eculizumab.

Author

Sica, Michela, Barone, Federica, Nannelli, Caterina, Ricci, Patrizia, Marano, Luana, De Angioletti, Maria, Di Bona, Eros, Risitano, Antonio M., and Notaro, Rosario

Subjects
ERYTHROCYTES, PAROXYSMAL hemoglobinuria, ECULIZUMAB, COMPLEMENT (Immunology), LIFE sciences
Abstract

(A) C3d binding to PNH red cells in a PNH patient naïve to anti-C5 therapy who started ravulizumab. C3d binding to PNH red cells in a PNH patient naïve to anti-C5 therapy (left panel), during eculizumab treatment (middle panel) and after the switch to ravulizumab (right panel). [Extracted from the article]

Published
2023
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10. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance

Author

Avvisati, Giuseppe, Lo-Coco, Francesco, Paoloni, Francesca Paola, Petti, Maria Concetta, Diverio, Daniela, Vignetti, Marco, Latagliata, Roberto, Specchia, Giorgina, Baccarani, Michele, Di Bona, Eros, Fioritoni, Giuseppe, Marmont, Filippo, Rambaldi, Alessandro, Di Raimondo, Francesco, Kropp, Maria Grazia, Pizzolo, Giovanni, Pogliani, Enrico M., Rossi, Giuseppe, Cantore, Nicola, Nobile, Francesco, Gabbas, Attilio, Ferrara, Felicetto, Fazi, Paola, Amadori, Sergio, and Mandelli, Franco

Published
2011
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11. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group

Author

Lo-Coco, Francesco, Avvisati, Giuseppe, Vignetti, Marco, Breccia, Massimo, Gallo, Eugenio, Rambaldi, Alessandro, Paoloni, Francesca, Fioritoni, Giuseppe, Ferrara, Felicetto, Specchia, Giorgina, Cimino, Giuseppe, Diverio, Daniela, Borlenghi, Erika, Martinelli, Giovanni, Di Raimondo, Francesco, Di Bona, Eros, Fazi, Paola, Peta, Antonio, Bosi, Alberto, Carella, Angelo M., Fabbiano, Francesco, Pogliani, Enrico M., Petti, Maria C., Amadori, Sergio, and Mandelli, Franco

Published
2010
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13. Complex karyotype, older age, and reduced first-line dose intensity determine poor survival in core binding factor acute myeloid leukemia patients with long-term follow-up

Author

Mosna, Federico, Papayannidis, Cristina, Martinelli, Giovanni, Di Bona, Eros, Bonalumi, Angela, Tecchio, Cristina, Candoni, Anna, Capelli, Debora, Piccin, Andrea, Forghieri, Fabio, Bigazzi, Catia, Visani, Giuseppe, Zambello, Renato, Zanatta, Lucia, Volpato, Francesca, Paolini, Stefania, Testoni, Nicoletta, Gherlinzoni, Filippo, and Gottardi, Michele

Published
2015
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14. Improved risk classification for risk-specific therapy based on the molecular study of minimal residual disease (MRD) in adult acute lymphoblastic leukemia (ALL)

Author

Bassan, Renato, Spinelli, Orietta, Oldani, Elena, Intermesoli, Tamara, Tosi, Manuela, Peruta, Barbara, Rossi, Giuseppe, Borlenghi, Erika, Pogliani, Enrico M., Terruzzi, Elisabetta, Fabris, Pietro, Cassibba, Vincenzo, Lambertenghi-Deliliers, Giorgio, Cortelezzi, Agostino, Bosi, Alberto, Gianfaldoni, Giacomo, Ciceri, Fabio, Bernardi, Massimo, Gallamini, Andrea, Mattei, Daniele, Di Bona, Eros, Romani, Claudio, Scattolin, Anna Maria, Barbui, Tiziano, and Rambaldi, Alessandro

Published
2009
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15. Complement fraction 3 binding on erythrocytes as additional mechanism of disease in paroxysmal nocturnal hemoglobinuria patients treated by eculizumab

Author

Risitano, Antonio M., Notaro, Rosario, Marando, Ludovica, Serio, Bianca, Ranaldi, Danilo, Seneca, Elisa, Ricci, Patrizia, Alfinito, Fiorella, Camera, Andrea, Gianfaldoni, Giacomo, Amendola, Angela, Boschetti, Carla, Di Bona, Eros, Fratellanza, Giorgio, Barbano, Filippo, Rodeghiero, Francesco, Zanella, Alberto, Iori, Anna Paola, Selleri, Carmine, Luzzatto, Lucio, and Rotoli, Bruno

Published
2009
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16. Myeloblative therapy with autologous haematopoietic stem cell support as consolidation of first remission in acute myeloid leukaemia – very long follow-up

Author

Rohatiner, Ama Z. S., Smith, Matthew L., Spinelli, Orietta, Rambaldi, Alessandro, Bassan, Renato, di Bona, Eros, Rodeghiero, Francesco, Raimondi, Roberto, Björkholm, Magnus, Johnson, Steve, Newland, Adrian C., Cavenagh, Jamie D., Macdougall, Finlay, Waters, Rachel, Fitzgibbon, Jude, Barbui, Tiziano, and Lister, Andrew

Published
2014
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19. Retinoic Acid and Arsenic Trioxide for Acute Promyelocytic Leukemia

Author

Lo-Coco, Francesco, Avvisati, Giuseppe, Vignetti, Marco, Thiede, Christian, Orlando, Sonia Maria, Iacobelli, Simona, Ferrara, Felicetto, Fazi, Paola, Cicconi, Laura, Di Bona, Eros, Specchia, Giorgina, Sica, Simona, Divona, Mariadomenica, Levis, Alessandro, Fiedler, Walter, Cerqui, Elisa, Breccia, Massimo, Fioritoni, Giuseppe, Salih, Helmut R., Cazzola, Mario, Melillo, Lorella, Carella, Angelo M., Brandts, Christian H., Morra, Enrica, von Lilienfeld-Toal, Marie, Hertenstein, Bernd, Wattad, Mohammed, Lübbert, Michael, Hänel, Matthias, Schmitz, Norbert, Link, Hartmut, Kropp, Maria Grazia, Rambaldi, Alessandro, La Nasa, Giorgio, Luppi, Mario, Ciceri, Fabio, Finizio, Olimpia, Venditti, Adriano, Fabbiano, Francesco, Döhner, Konstanze, Sauer, Michaela, Ganser, Arnold, Amadori, Sergio, Mandelli, Franco, Döhner, Hartmut, Ehninger, Gerhard, Schlenk, Richard F., and Platzbecker, Uwe

Published
2013
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23. Clinical and biological features of acute myeloid leukaemia occurring as second malignancy: GIMEMA archive of adult acute leukaemia

Author

Pagano, Livio, Pulsoni, Alessandro, Tosti, Maria Elena, Avvisati, Giuseppe, Mele, Luca, Mele, Alfonso, Martino, Bruno, Visani, Giuseppe, Cerri, Raffaella, Di Bona, Eros, Invernizzi, Rosangela, Nosari, Annamaria, Clavio, Marino, Allione, Bernardino, Coser, Paolo, Candoni, Anna, Levis, Alessandro, Camera, Andrea, Melillo, Lorella, Leone, Giuseppe, and Mandelli, Franco

Published
2001

25. The serological prevalence of SARS‐CoV‐2 infection in patients with chronic myeloid leukemia is similar to that in the general population.

Author

Bonifacio, Massimiliano, Tiribelli, Mario, Miggiano, Maria Cristina, Abruzzese, Elisabetta, Binotto, Gianni, Scaffidi, Luigi, Cordioli, Maddalena, Damiani, Daniela, Di Bona, Eros, Trawinska, Malgorzata Monika, Tanasi, Ilaria, Dubbini, Maria Vittoria, Velotta, Vanessa, Ceccarelli, Giulia, Pierdomenico, Elisabetta, Lo Schirico, Mariella, Semenzato, Gianpietro, Ruggeri, Marco, Fanin, Renato, and Tacconelli, Evelina

Subjects
CHRONIC myeloid leukemia, SARS-CoV-2, PROTEIN-tyrosine kinase inhibitors, COVID-19 pandemic, COVID-19, INFECTION, H7N9 Influenza
Abstract

Background: Patients with hematological malignancies are at an increased risk of SARS‐CoV‐2 disease (COVID‐19) and adverse outcome. However, a low mortality rate has been reported in patients with chronic myeloid leukemia (CML). Preclinical evidence suggests that tyrosine kinase inhibitors (TKIs) may have a protective role against severe COVID‐19. Methods: We conducted a cross‐sectional study of 564 consecutive patients with CML who were tested for anti‐SARS‐CoV‐2 IgG/IgM antibodies at their first outpatient visit between May and early November 2020 in five hematologic centers representative of three Italian regions. Results: The estimated serological prevalence of SARS‐CoV‐2 infection in patients with CML after the first pandemic wave was similar to that in the general population (about 2%), both at national and regional levels. CML patients with positive anti‐SARS‐CoV‐2 serology were more frequently male (p = 0.027) and active workers (p = 0.012), while there was no significant association with TKI treatment type. Only 3 out of 11 IgG‐positive patients had previously received a molecular diagnosis of COVID‐19, while the remainders were asymptomatic or with mild symptoms. Conclusions: Our data confirm that the course of SARS‐CoV‐2 infection in patients with CML is generally mild and reassure about the safety of continuing TKIs during the COVID‐19 pandemic. Furthermore, we suggest that patients with CML succeed to mount an antibody response after exposure to SARS‐CoV‐2, similar to the general population. [ABSTRACT FROM AUTHOR]

Published
2021
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30. Induction therapy with idarubicin alone significantly influences event-free survival duration in patients with newly diagnosed hypergranular acute promyelocytic leukemia: final results of the GIMEMA randomized study LAP 0389 with 7 years of minimal follow-up

Author

Avvisati, Giuseppe, Petti, Maria Concetta, Lo-Coco, Francesco, Vegna, Maria Luce, Amadori, Sergio, Baccarani, Michele, Cantore, Nicola, Di Bona, Eros, Ferrara, Felicetto, Fioritoni, Giuseppe, Gallo, Eugenio, Invernizzi, Rosangela, Lazzarino, Mario, Liso, Vincenzo, Mariani, Guglielmo, Ricciuti, Francesco, Selleri, Carmine, Sica, Simona, Veneri, Dino, and Mandelli, Franco

Published
2002
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31. Clinicobiological features and outcome of acute promyelocytic leukemia occurring as a second tumor: the GIMEMA experience

Author

Pulsoni, Alessandro, Pagano, Livio, Lo Coco, Francesco, Avvisati, Giuseppe, Mele, Luca, Di Bona, Eros, Invernizzi, Rosangela, Leoni, Franco, Marmont, Filippo, Mele, Alfonso, Melillo, Lorella, Nosari, Anna Maria, Pogliani, Enrico Maria, Vignetti, Marco, Visani, Giuseppe, Zagonel, Vittorina, Leone, Giuseppe, and Mandelli, Franco

Published
2002
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32. Perspectives and Emotional Experiences of Patients With Chronic Myeloid Leukemia During ENESTPath Clinical Trial and Treatment-Free Remission: Rationale and Protocol of the Italian Substudy.

Author

Borghi, Lidia, Rosti, Gianantonio, Maggi, Alessandro, Breccia, Massimo, Di Bona, Eros, Iurlo, Alessandra, La Barba, Gaetano, Sportoletti, Paolo, Albano, Francesco, Galimberti, Sara, Rivellini, Flavia, Cambrin, Giovanna Rege, Capodanno, Isabella, Cuneo, Antonio, Bonifacio, Massimiliano, Sica, Simona, Arcaini, Luca, Capochiani, Enrico, Minotto, Claudia, and Ciceri, Fabio

Subjects
CHRONIC myeloid leukemia, PATIENTS' attitudes, PROTEIN-tyrosine kinase inhibitors, INDIVIDUALIZED medicine, MEDICAL personnel, EMOTIONAL experience
Abstract

Achievement of deep molecular response following treatment with a tyrosine kinase inhibitor (TKI) allows for treatment-free remission (TFR) in many patients with chronic myeloid leukemia (CML). Successful TFR is defined as the achievement of a sustained molecular response after cessation of ongoing TKI therapy. The phase 3 ENESTPath study was designed to determine the required optimal duration of consolidation treatment with the second-generation TKI, nilotinib 300 mg twice-daily, to remain in successful TFR without relapse after entering TFR for 12 months. The purpose of this Italian 'patient's voice CML' substudy was to evaluate patients' psycho-emotional characteristics and quality of life through their experiences of stopping treatment with nilotinib and entering TFR. The purpose of the present contribution is to early present the study protocol of an ongoing study to the scientific community, in order to describe the study rationale and to extensively present the study methodology. Patients aged ≥18 years with a confirmed diagnosis of Philadelphia chromosome positive BCR-ABL1 + CML in chronic phase and treated with front-line imatinib for a minimum of 24 months from the enrollment were eligible. Patients consenting to participate the substudy will have quality of life questionnaires and in-depth qualitative interviews conducted. The substudy will include both qualitative and quantitative design aspects to evaluate the psychological outcomes as assessed via patients' emotional experience during and after stopping nilotinib therapy. Randomization is hypothesized to be a timepoint of higher psychological alert or distress when compared to consolidation and additionally any improvement in health-related quality of life (HRQoL) due to nilotinib treatment is expected across the timepoints (from consolidation, to randomization, and TFR). An association is also expected between dysfunctional coping strategies, such as detachments and certain personality traits, and psychological distress and HRQoL impairments. Better HRQoL outcomes are expected in TFR compared to the end of consolidation. This substudy is designed for in-depth assessment of all potential psycho-emotional variables and aims to determine the need for personalized patient care and counselling, and also guide clinicians to consider the psychological well-being of patients who are considering treatment termination. NCT number: NCT01743989, EudraCT number: 2012-005124-15 [ABSTRACT FROM AUTHOR]

Published
2021
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34. COVID‐19 in patients with paroxysmal nocturnal haemoglobinuria: an Italian multicentre survey.

Author

Barcellini, Wilma, Fattizzo, Bruno, Giannotta, Juri A., Quattrocchi, Luisa, Aydin, Semra, Barone, Federica, Carbone, Cecilia, Pomponi, Fabrizio, Metafuni, Elisabetta, Beggiato, Eloise, Sica, Simona, Di Bona, Eros, Lanza, Francesco, Notaro, Rosario, and Iori, Anna P.

Subjects
COVID-19, PAROXYSMAL hemoglobinuria, LOW-molecular-weight heparin, MIDDLE East respiratory syndrome
Abstract

Main clinical characteristics of PNH patients affected by SARS-CoV-2 infection are reported in the table. Keywords: paroxysmal nocturnal hemoglobinuria; COVID-19 pneumonia; complement inhibitors EN paroxysmal nocturnal hemoglobinuria COVID-19 pneumonia complement inhibitors 854 856 3 09/02/21 20210901 NES 210901 The COVID-19 pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has raised several concerns regarding patients with haematologic and immune-mediated diseases. As regards the remaining 152 patients without a demonstrated SARS-CoV-2 infection, eight experienced a febrile episode, two haemolytic crises in untreated patients ( I n i = 50), and two a BTH event (101 patients on C5 inhibitor); four patients required transfusion support. [Extracted from the article]

Published
2021
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35. Real-world experience with decitabine as a first-line treatment in 306 elderly acute myeloid leukaemia patients unfit for intensive chemotherapy.

Author

Bocchia, Monica, Candoni, Anna, Borlenghi, Erika, Defina, Marzia, Filì, Carla, Cattaneo, Chiara, Sammartano, Vincenzo, Fanin, Renato, Sciumè, Margherita, Sicuranza, Anna, Imbergamo, Silvia, Riva, Marta, Fracchiolla, Nicola, Latagliata, Roberto, Caizzi, Emanuela, Mazziotta, Francesco, Alunni, Giulia, Di Bona, Eros, Crugnola, Monica, and Rossi, Marianna

Subjects
LEUCOCYTES, LEUKEMIA, CANCER chemotherapy, OLDER patients
Abstract

Despite widespread use of decitabine to treat acute myeloid leukaemia (AML), data on its effectiveness and safety in the real-world setting are scanty. Thus, to analyze the performance of decitabine in clinical practice, we pooled together patient-level data of three multicentric observational studies conducted since 2013 throughout Italy, including 306 elderly AML patients (median age 75 years), unfit for intensive chemotherapy, treated with first-line decitabine therapy at the registered schedule of 20 mg/m2 /iv daily for 5 days every 4 weeks. Overall response rate (ORR), overall survival (OS) curves, and multivariate hazard ratios (HRs) of all-cause mortality were computed. Overall, 1940 cycles of therapy were administered (median, 5 cycles/patient). A total of 148 subjects were responders and, therefore, ORR was 48.4%. Seventy-one patients (23.2%) had complete remission, 32 (10.5%) had partial remission, and 45 (14.7%) had haematologic improvement. Median OS was 11.6 months for patients with favourable-intermediate cytogenetic risk and 7.9 months for those with adverse cytogenetic risk. Median relapse-free survival after CR was 10.9 months (95% confidence interval [CI]: 8.7-16.0). In multivariate analysis, mortality was higher in patients with adverse cytogenetic risk (HR=1.58; 95% CI: 1.13-2.21) and increased continuously with white blood cell (WBC) count (HR=1.12; 95% CI: 1.06-1.18). A total of 183 infectious adverse events occurred in 136 patients mainly (>90%) within the first five cycles of therapy. This pooled analysis of clinical care studies confirmed, outside of clinical trials, the effectiveness of decitabine as first-line therapy for AML in elderly patients unfit for intensive chemotherapy. An adverse cytogenetic profile and a higher WBC count at diagnosis were, in this real life setting, unfavourable predictors of survival. [ABSTRACT FROM AUTHOR]

Published
2019
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39. Improved Outcomes With Retinoic Acid and Arsenic Trioxide Compared With Retinoic Acid and Chemotherapy in Non-High-Risk Acute Promyelocytic Leukemia: Final Results of the Randomized Italian-German APL0406 Trial.

Author

Platzbecker, Uwe, Avvisati, Giuseppe, Cicconi, Laura, Thiede, Christian, Paoloni, Francesca, Vignetti, Marco, Ferrara, Felicetto, Divona, Mariadomenica, Albano, Francesco, Efficace, Fabio, Fazi, Paola, Sborgia, Marco, Di Bona, Eros, Breccia, Massimo, Borlenghi, Erika, Cairoli, Roberto, Rambaldi, Alessandro, Melillo, Lorella, La Nasa, Giorgio, and Fiedler, Walter

Published
2017
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40. Randomized Phase III Trial of Retinoic Acid and Arsenic Trioxide Versus Retinoic Acid and Chemotherapy in Patients With Acute Promyelocytic Leukemia: Health-Related Quality-of-Life Outcomes.

Author

Efficace, Fabio, Mandelli, Franco, Avvisati, Giuseppe, Cottone, Francesco, Ferrara, Felicetto, Di Bona, Eros, Specchia, Giorgina, Breccia, Massimo, Levis, Alessandro, Sica, Simona, Finizio, Olimpia, Kropp, Maria Grazia, Fioritoni, Giuseppe, Cerqui, Elisa, Vignetti, Marco, Amadori, Sergio, Schlenk, Richard F., Platzbecker, Uwe, and Lo-Coco, Francesco

Published
2014
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41. Transplant-finalized salvage of adult acute lymphoblastic leukemia: results of a mitoxantrone- and methotrexate-based regimen in 36 patients.

Author

Di Bona, Eros, Pogliani, Enrico, Rossi, Giuseppe, Lerede, Teresa, D'Emilio, Anna, Vespignani, Michele, Rodeghiero, Francesco, Barbui, Tiziano, and Bassan, Renato

Subjects
*LYMPHOBLASTIC leukemia, *LYMPHOCYTIC leukemia, *IMMUNOSUPPRESSIVE agents, *STEM cells, *HEMATOPOIETIC stem cells, *BLOOD cells
Abstract

Idarubicin-based induction programs in acute lymphoblastic leukemia (ALL) account for 75?–?85% of complete remission rate. A small amount of patients exhibit primary refractoriness, and approximately 60% of those achieving a remission eventually relapse. The present study aimed to review the outcome of patients relapsing after or resistant to an idarubicin-based, induction-consolidation regimen (with/without additional high dose cytarabine). The ‘ABC’ phase II trial consisted of mitoxantrone (50?mg/m 2 over 5 days) associated with high-dose methotrexate (1.5?g/m 2 over 24?h, followed by folinic acid rescue), high-dose methyl-prednisolone (125?mg b.i.d.) and vincristine, plus granulocyte colony-stimulating factor. Eligible patients were treated with two courses (‘A’ and ‘B’, the latter with reduced drug dosages), followed by allogeneic or autologous haematopoietic stem cell transplantation (HSCT, ‘C’). Thirty-six patients (3 primary resistant, 33 at first marrow relapse) were evaluated. With ‘A’, 21 achieved a complete remission (CR), 10 were refractory and 5 died early. Eighteen patients received ‘B’ (with one more CR, for an overall CR rate of 61%) and, eventually, 12 patients had ‘C’ procedures (7 autologous, 5 allogeneic HSCT). WHO grade ??3 treatment-related toxicity developed in 50% and 34% of ‘A’ and ‘B’ courses, respectively. The median duration of CR was 5.2 (range 0.5?–?19.7) months and median overall survival was 7.6 (range 0.5?–?20) months. In spite of 12 HSCTs, there was no long-term survivor. ‘ABC’ salvage proved feasible and comparable to reported rescue chemotherapic regimens, but the achievement of cure in refractory/relapsing ALL remains an outstanding clinical task. [ABSTRACT FROM AUTHOR]

Published
2005
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42. Rabbit antithymocyte globulin (r-ATG) plus cyclosporine and granulocyte colony stimulating factor is an effective treatment for aplastic anaemia patients unresponsive to a first course of intensive immunosuppressive therapy.

Author

Di Bona, Rodeghiero, Bruno, Gabbas, Foa, Locasciulli, Rosanelli, Camba, Saracco, Lippi, Iori, Porta, De Rossi, Comotti, Iacopino, Dufour, Bacigalupo, and Di Bona, Eros

Subjects
APLASTIC anemia treatment, GLOBULINS, CYCLOSPORINE, THERAPEUTICS
Abstract

About 30% of patients with severe aplastic anaemia (SAA) unresponsive to one course of immunosuppressive (IS) therapy with antithymocyte or antilymphocyte globulin can achieve complete or partial remission after a second IS treatment. Among various second-line treatments, rabbit ATG (r-ATG) could represent a safe and effective alternative to horse ALG (h-ALG). In a multicentre study, 30 patients with SAA (17 males and 13 females, median age 21 years, range 2–67) not responding to a first course with h-ALG plus cyclosporin (CyA) and granulocyte colony stimulating factor (G-CSF), were given a second course using r-ATG (3.5 mg/kg/d for 5 d), CyA (5 mg/kg orally from day 1 to 180) and G-CSF (5 μg/kg subcutaneously from day 1 to 90). The median interval between first and second treatment was 151 d (range 58–361 d). No relevant side-effects were observed, but one patient died early during treatment because of sepsis. Overall response, defined as transfusion independence, was achieved in 23/30 (77%) patients after a median time of 95 d (range 14–377). Nine patients (30%) achieved complete remission (neutrophils >=2.0 × 109/l, haemoglobin >=11 g/dl and platelets >=100 × 109/l). The overall survival rate was 93% with a median follow-up of 914 d (range 121–2278). So far, no patient has relapsed. Female gender was significantly associated with a poorer likelihood to respond (P = 0.0006). These data suggest that r-ATG is a safe and effective alternative to h-ALG for SAA patients unresponsive to first-line IS treatment. [ABSTRACT FROM AUTHOR]

Published
1999
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44. Corrigendum to "Venetoclax in combination with hypomethylating agents in previously untreated patients with acute myeloid leukemia ineligible for intensive treatment: a real-life multicenter experience" [Leukemia Res. 114 (March 2022) 106803].

Author

De Bellis, Eleonora, Imbergamo, Silvia, Candoni, Anna, Liço, Albana, Tanasi, Ilaria, Mauro, Endri, Mosna, Federico, Leoncin, Matteo, Stulle, Manuela, Griguolo, Davide, Pravato, Stefano, Trentin, Livio, Lazzarotto, Davide, Di Bona, Eros, Sancetta, Rosaria, Lucchini, Elisa, Poiani, Monica, Palmieri, Clara, and Zaja, Francesco

Subjects
*ACUTE myeloid leukemia, *VENETOCLAX, *LEUKEMIA
Published
2022
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45. Role of early anthracycline dose-intensity according to expression of Philadelphia chromosome/BCR–ABL rearrangements in B-precursor adult acute lymphoblastic leukemia.

Author

Bassan, Renato, Rohatiner, Ama ZS, Lerede, Teresa, Di Bona, Eros, Rambaldi, Alessandro, Pogliani, Enrico, Rossi, Giuseppe, Fabris, Pietro, Morandi, Sergio, Casula, Paolo, Carter, Maxine, Lambertenghi-Deliliers, Giorgio, Lister, T Andrew, and Barbui, Tiziano

Subjects
*ANTHRACYCLINES, *LYMPHOBLASTIC leukemia, *ACUTE leukemia
Abstract

INTRODUCTION:: The use of anthracycline antibiotics in adult acute lymphoblastic leukemia (ALL) has resulted in an improved outcome to remission induction therapy. However,the exact role of these drugs in consolidation therapy is less clear, especially in specific ALL subsets. MATERIALS AND METHODS:: A retrospective analysis was conducted on the outcome of 308 patients (median age 35 years, range 13–75) with the most frequent subtype, early-B ALL, treated between 1974 and 1998 on eight consecutive protocols. Anthracycline-related effects were assessed by evaluating the impact of planned anthracycline dose-intensity (A-DI) on long-term outcome. A-DI (in mg/m2/week) during the first twelve weeks of consolidation therapy was classified as either ‘high’ (doxorubicin>20, idarubicin>7) or ‘low’. RESULTS:: Complete remission was achieved in 78% of cases. With a median follow-up of 6.5 years, on multivariate analysis, disease-free survival (DFS) correlated only with expression of the Philadelphia (Ph) chromosome and/or associated BCR–ABL rearrangements (Ph/BCR+) (P=0.0001) and planned A-DI (P<0.0001). On this basis, four major prognostic groups with significantly different DFS could be identified: (1) Ph/BCR-, ‘high’ A-DI (n=102), median 3.5 years and 41% at five years, respectively; (2) Ph/BCR-, ‘low’ A-DI (n=64), 1.3 years and 16%; (3) Ph/BCR+, ‘high’ A-DI (n=35), 1.7 years and 20%; (4) Ph/BCR+, ‘low’ A-DI (n=39), 0.75 years and 0%. When analyzed separately for Ph/BCR- (n=166) and Ph/BCR+ (n=74) patients, the A-DI effect on DFS was preserved in the former (P=0.018) whereas, in Ph/BCR+ patients, only age <50 years (P=0.004) and blast count <25×109/l (P=0.02) correlated with better DFS. However, Ph/BCR+ patients with the best prognostic profile (age... [ABSTRACT FROM AUTHOR]

Published
2000
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