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2. Translational Research on Azacitidine Post-Remission Therapy of Acute Myeloid Leukemia in Elderly Patients (QOL-ONE Trans-2).

Author

Oliva, Esther Natalie, Cuzzola, Maria, Porta, Matteo Della, Candoni, Anna, Salutari, Prassede, Palumbo, Giuseppe A., Reda, Gianluigi, Iannì, Giuseppe, Zampini, Matteo, D'Amico, Saverio, Tripepi, Giovanni, Capelli, Debora, Alati, Caterina, Cannatà, Maria Concetta, Niscola, Pasquale, Serio, Bianca, Barillà, Santina, Musto, Pellegrino, Vigna, Ernesto, and Melillo, Lorella Maria Antonia

Subjects
ACUTE myeloid leukemia, OLDER patients, PROGRESSION-free survival, NUCLEOTIDE sequencing, BONE marrow
Abstract

The achievement of complete remission (CR) is crucial for acute myeloid leukemia (AML) patients undertaking curative therapy, but relapse often occurs within months, highlighting the need for strategies to prolong disease-free survival (DFS). Our phase III study compared the efficacy and safety of azacitidine (AZA) to best supportive care (BSC) in elderly AML patients who achieved CR following intensive induction and consolidation therapy. This ancillary study (QOL-ONE Trans-2) evaluated biological changes in bone marrow using Next-Generation Sequencing (NGS). We analyzed baseline, randomization, and 6-month post-remission samples from 24 patients (median age of 71 and 12 males). High-throughput NGS targeted 350 myeloid malignancy-related genes, considering variants with a variant allele frequency ≥ 4%. At diagnosis, all patients had 5 to 17 (median = 10) mutations, with DNMT3A (42%), NPM1 (33%), and TET2 (33%) being most frequent. FANCA mutations in four patients were linked to a higher relapse risk (HR = 4.96, p = 0.02) for DFS at both 2 and 5 years. Further HLA-specific NGS analyses are ongoing to confirm these results and their therapeutic implications. [ABSTRACT FROM AUTHOR]

Published
2024
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5. GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia

Author

Venditti, Adriano, Piciocchi, Alfonso, Candoni, Anna, Melillo, Lorella, Calafiore, Valeria, Cairoli, Roberto, de Fabritiis, Paolo, Storti, Gabriella, Salutari, Prassede, Lanza, Francesco, Martinelli, Giovanni, Luppi, Mario, Mazza, Patrizio, Martelli, Maria Paola, Cuneo, Antonio, Albano, Francesco, Fabbiano, Francesco, Tafuri, Agostino, Chierichini, Anna, Tieghi, Alessia, Fracchiolla, Nicola Stefano, Capelli, Debora, Foà, Robin, Alati, Caterina, La Sala, Edoardo, Fazi, Paola, Vignetti, Marco, Maurillo, Luca, Buccisano, Francesco, Del Principe, Maria Ilaria, Irno-Consalvo, Maria, Ottone, Tiziana, Lavorgna, Serena, Voso, Maria Teresa, Lo-Coco, Francesco, Arcese, William, and Amadori, Sergio

Published
2019
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6. Risk-adapted MRD-directed therapy for young adults with acute myeloid leukemia: 6-year update of the GIMEMA AML1310 trial

Author

Venditti, Adriano, Piciocchi, Alfonso, Candoni, Anna, Arena, Valentina, Palmieri, Raffaele, Filì, Carla, Carella, Angelo Michele, Calafiore, Valeria, Cairoli, Roberto, de Fabritiis, Paolo, Storti, Gabriella, Salutari, Prassede, Lanza, Francesco, Martinelli, Giovanni, Curti, Antonio, Luppi, Mario, Ingrosso, Claudia, Martelli, Maria Paola, Cuneo, Antonio, Albano, Francesco, Mulè, Antonino, Tafuri, Agostino, Cudillo, Laura, Tieghi, Alessia, Fracchiolla, Nicola Stefano, Capelli, Debora, Trisolini, Silvia Maria, Alati, Caterina, La Sala, Edoardo, Maurillo, Luca, Del Principe, Maria Ilaria, Irno Consalvo, Maria Antonietta, Divona, Maria Domenica, Ottone, Tiziana, Cerretti, Raffaella, Sconocchia, Giuseppe, Voso, Maria Teresa, Fazi, Paola, Vignetti, Marco, and Buccisano, Francesco

Published
2024
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7. Azacitidine Post-Remission Therapy for Elderly Patients with AML: A Randomized Phase-3 Trial (QoLESS AZA-AMLE)

Author

Oliva, Esther Natalie, primary, Candoni, Anna, additional, Salutari, Prassede, additional, Palumbo, Giuseppe A., additional, Reda, Gianluigi, additional, Iannì, Giuseppe, additional, Tripepi, Giovanni, additional, Cuzzola, Maria, additional, Capelli, Debora, additional, Mammì, Corrado, additional, Alati, Caterina, additional, Cannatà, Maria Concetta, additional, Niscola, Pasquale, additional, Serio, Bianca, additional, Musto, Pellegrino, additional, Vigna, Ernesto, additional, Volpe, Antonio, additional, Melillo, Lorella Maria Antonia, additional, Arcadi, Maria Teresa, additional, Mannina, Donato, additional, Zannier, Maria Elena, additional, and Latagliata, Roberto, additional

Published
2023
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8. Optimal Duration of CPX-351 Treatment and Best Timing for Consolidation with Allogeneic Stem Cell Transplantation: Evidence from a Large Real-World Italian Study

Author

Guolo, F, Fianchi, L, Martelli, M, Chiusolo, P, Lussana, F, Grimaldi, F, Pilo, F, Rondoni, M, Fili, C, Capelli, D, Breccia, M, Mastaglio, S, Bocchia, M, Fumagalli, M, Galimberti, S, Mancini, V, Piccioni, A, Maurillo, L, Palmieri, R, Corbingi, A, Vetro, C, Sperotto, A, Gigli, F, Zappasodi, P, Mulé, A, Borlenghi, E, Dargenio, M, Lessi, F, Cerrano, M, Isidori, A, Brunetti, L, Papayannidis, C, Lunghi, M, Alati, C, Gatani, S, Mannelli, F, Fracchiolla, N, Gottardi, M, Cairoli, R, Ferrara, F, Lemoli, R, Venditti, A, Pagano, L, Todisco, E, Guolo, Fabio, Fianchi, Luana, Martelli, Maria Paola, Chiusolo, Patrizia, Lussana, Federico, Grimaldi, Francesco, Pilo, Federica, Rondoni, Michela, Fili, Carla, Capelli, Debora, Breccia, Massimo, Mastaglio, Sara, Bocchia, Monica, Fumagalli, Monica, Galimberti, Sara, Mancini, Valentina, Piccioni, Anna Lina, Maurillo, Luca, Palmieri, Raffaele, Corbingi, Andrea, Vetro, Calogero, Sperotto, Alessandra, Gigli, Federica, Zappasodi, Patrizia, Mulé, Antonio, Borlenghi, Erika, Dargenio, Michelina, Lessi, Federica, Cerrano, Marco, Isidori, Alessandro, Brunetti, Lorenzo, Papayannidis, Cristina, Lunghi, Monia, Alati, Caterina, Gatani, Samuele, Mannelli, Francesco, Fracchiolla, Nicola, Gottardi, Michele, Cairoli, Roberto, Ferrara, Felicetto, Lemoli, Roberto Massimo, Venditti, Adriano, Pagano, Livio, Todisco, Elisabetta, Guolo, F, Fianchi, L, Martelli, M, Chiusolo, P, Lussana, F, Grimaldi, F, Pilo, F, Rondoni, M, Fili, C, Capelli, D, Breccia, M, Mastaglio, S, Bocchia, M, Fumagalli, M, Galimberti, S, Mancini, V, Piccioni, A, Maurillo, L, Palmieri, R, Corbingi, A, Vetro, C, Sperotto, A, Gigli, F, Zappasodi, P, Mulé, A, Borlenghi, E, Dargenio, M, Lessi, F, Cerrano, M, Isidori, A, Brunetti, L, Papayannidis, C, Lunghi, M, Alati, C, Gatani, S, Mannelli, F, Fracchiolla, N, Gottardi, M, Cairoli, R, Ferrara, F, Lemoli, R, Venditti, A, Pagano, L, Todisco, E, Guolo, Fabio, Fianchi, Luana, Martelli, Maria Paola, Chiusolo, Patrizia, Lussana, Federico, Grimaldi, Francesco, Pilo, Federica, Rondoni, Michela, Fili, Carla, Capelli, Debora, Breccia, Massimo, Mastaglio, Sara, Bocchia, Monica, Fumagalli, Monica, Galimberti, Sara, Mancini, Valentina, Piccioni, Anna Lina, Maurillo, Luca, Palmieri, Raffaele, Corbingi, Andrea, Vetro, Calogero, Sperotto, Alessandra, Gigli, Federica, Zappasodi, Patrizia, Mulé, Antonio, Borlenghi, Erika, Dargenio, Michelina, Lessi, Federica, Cerrano, Marco, Isidori, Alessandro, Brunetti, Lorenzo, Papayannidis, Cristina, Lunghi, Monia, Alati, Caterina, Gatani, Samuele, Mannelli, Francesco, Fracchiolla, Nicola, Gottardi, Michele, Cairoli, Roberto, Ferrara, Felicetto, Lemoli, Roberto Massimo, Venditti, Adriano, Pagano, Livio, and Todisco, Elisabetta

Published
2023

9. The Time Has Come for Targeted Therapies for AML: Lights and Shadows

Author

Fiorentini, Alessandro, Capelli, Debora, Saraceni, Francesco, Menotti, Diego, Poloni, Antonella, and Olivieri, Attilio

Abstract

Acute myeloid leukemia (AML) is a complex disease characterized by genetic and clinical heterogeneity and high mortality. After 40 years during which the standard of care for patients evolved very little, the therapeutic landscape has recently seen rapid changes, with the approval of eight new drugs by the Food and Drug Administration (FDA) within the last 2 years, providing new opportunities, as well as new challenges, for treating clinicians. These therapies include FLT3 inhibitors midostaurin and gilteritinib, CPX-351 (liposomal cytarabine and daunorubicin), gemtuzumab ozogamicin (GO, anti-CD33 monoclonal antibody conjugated with calicheamicin), IDH1/IDH2 inhibitors ivosidenib and enasidenib, Hedgehog inhibitor glasdegib, and BCL-2 inhibitor venetoclax. In this review, we summarize currently available data on these new drugs and discuss the rapidly evolving therapeutic armamentarium for AML, focusing on targeted therapies.

Published
2024
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10. Mobilization-Driven Postconsolidation Therapy in Elderly Patients with Acute Myeloid Leukemia: Feasibility and Efficacy of Autologous Stem Cell Transplantation versus Low-Dose Gemtuzumab Ozogamicin

Author

Capelli, Debora, Chiarucci, Martina, Poloni, Antonella, Saraceni, Francesco, Mancini, Giorgia, Trappolini, Silvia, Troiani, Emanuela, Montanari, Mauro, Scortechini, Ilaria, Offidani, Massimo, Rupoli, Serena, Scortechini, Anna Rita, Gini, Guido, Discepoli, Giancarlo, Leoni, Pietro, and Olivieri, Attilio

Published
2014
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12. Mechanisms of Resistence of New Target Drugs in Acute Myeloid Leukemia

Author

Capelli, Debora, Olivieri, Attilio, Fiorentini, Alessandro, Menotti, Diego, and Saraceni, Francesco

Subjects
Medical
Abstract

New drugs targeting single mutations have been recently approved for Acute Myeloid Leukemia (AML) treatment, but allogeneic transplant still remains the only curative option in intermediate and unfavorable risk settings, because of the high incidence of relapse. Molecular analysis repertoire permits the identification of the target mutations and drives the choice of target drugs, but the etherogeneity of the disease reduces the curative potential of these agents. Primary and secondary AML resistance to new target agents is actually an intriguing issue and some of these mechanisms have already been explored and identified. Changes in mutations, release of microenvironment factors competing for the same therapeutic target or promoting the survival of blasts or of the leukemic stem cell, the upregulation of the target-downstream pathways and of proteins inhibiting the apoptosis, the inhibition of the cytochrome drug metabolism by other concomitant treatments are some of the recognized patterns of tumor escape. The knowledge of these topics might implement the model of the ‘AML umbrella trial’ study through the combinations or sequences of new target drugs, preemptively targeting known mechanisms of resistance, with the aim to improve the potential curative rates, expecially in elderly patients not eligible to transplant.

Published
2022

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. Applicability of SIE/Sies/GITMO Fitness Criteria to Therapy-Related and AML-MRC Receiving CPX-351: Results from a Large, Retrospective, Multicentric, Observational Study

Author

Palmieri, Raffaele, Guolo, Fabio, Fianchi, Luana, Ferrara, Felicetto, Martelli, Maria Paola, Rondoni, Michela, Saveria, Capria, Minetto, Paola, Minotti, Clara, Sciabolacci, Sofia, Pilo, Federica, Perrone, Salvatore, Corbingi, Andrea, Grimaldi, Francesco, De Luca, Giulia, Fili, Carla, Alati, Caterina, Mannelli, Francesco, Lessi, Federica, Marchesi, Francesco, Brunetti, Lorenzo, Capelli, Debora, Piccioni, Anna Lina, Vetro, Calogero, Mazzone, Carla, Sperotto, Alessandra, Luzi, Giovanni, Dargenio, Michelina, Mariani, Sabrina, Cerrano, Marco, Mulè, Antonino, Di Veroli, Ambra, Papayannidis, Cristina, Isidori, Alessandro, Lanza, Francesco, Gottardi, Michele, Todisco, Elisabetta, Pagano, Livio, Lemoli, Roberto Massimo, Buccisano, Francesco, and Venditti, Adriano

Published
2023
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15. Novel Gene Mutations Associated with Disease-Free Survival in Elderly Patients with Acute Myeloid Leukemia Receiving First-Line Induction-Consolidation with or without Azacitidine Post-Remission Treatment

Author

Oliva, Esther Natalie, Cuzzola, Maria, Candoni, Anna, Salutari, Prassede, Palumbo, Giuseppe Alberto, Reda, Gianluigi, Ianni', Giuseppe, Tripepi, Giovanni, Capelli, Debora, Alati, Caterina, Cannatà, Maria Concetta, Niscola, Pasquale, Serio, Bianca, Barillà, Santina, Musto, Pellegrino, Vigna, Ernesto, Melillo, Lorella Maria Antonia, Tripepi, Rocco, Delfino, Ilaria Maria, Zannier, Maria Elena, Nannya, Yasuhito, Ogawa, Seishi, and Mammì, Corrado

Published
2023
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16. Late Hematologic Recovery after CPX-351 Induction Chemotherapy in AML: Predictive Disease and Patient's Factors and Their Impact on Survival

Author

Rondoni, Michela, Minetto, Paola, Puglisi, Bruna, Saraceni, Francesco, Brunetti, Lorenzo, Mianulli, Anna Maria, Bocchia, Monica, Santoni, Adele, Riva, Carola, Giannini, Barbara, Monaco, Federica, Zannetti, Beatrice, Cellini, Claudia, Nicoletti, Annalisa, Valenti, Anna Maria, Capelli, Debora, Raspadori, Donatella, Olivieri, Attilio, Lanza, Francesco, Graziano, Claudio, Tosi, Patrizia, Lemoli, Roberto Massimo, and Guolo, Fabio

Published
2023
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17. Optimal Duration of CPX-351 Treatment and Best Timing for Consolidation with Allogeneic Stem Cell Transplantation: Evidence from a Large Real-World Italian Study

Author

Guolo, Fabio, Fianchi, Luana, Martelli, Maria Paola, Chiusolo, Patrizia, Lussana, Federico, Grimaldi, Francesco, Pilo, Federica, Rondoni, Michela, Fili, Carla, Capelli, Debora, Breccia, Massimo, Mastaglio, Sara, Bocchia, Monica, Fumagalli, Monica, Galimberti, Sara, Mancini, Valentina, Piccioni, Anna Lina, Maurillo, Luca, Palmieri, Raffaele, Corbingi, Andrea, Vetro, Calogero, Sperotto, Alessandra, Gigli, Federica, Zappasodi, Patrizia, Mulé, Antonio, Borlenghi, Erika, Dargenio, Michelina, Lessi, Federica, Cerrano, Marco, Isidori, Alessandro, Brunetti, Lorenzo, Papayannidis, Cristina, Lunghi, Monia, Alati, Caterina, Gatani, Samuele, Mannelli, Francesco, Fracchiolla, Nicola, Gottardi, Michele, Cairoli, Roberto, Ferrara, Felicetto, Lemoli, Roberto Massimo, Venditti, Adriano, Pagano, Livio, and Todisco, Elisabetta

Published
2023
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19. Thalidomide, dexamethasone, and pegylated liposomal doxorubicin (ThaDD) for patients older than 65 years with newly diagnosed multiple myeloma

Author

Offidani, Massimo, Corvatta, Laura, Piersantelli, Maria-Novella, Visani, Giuseppe, Alesiani, Francesco, Brunori, Marino, Galieni, Piero, Catarini, Massimo, Burattini, Maurizio, Centurioni, Riccardo, Ferranti, Mario, Rupoli, Serena, Scortechini, Anna Rita, Giuliodori, Luciano, Candela, Marco, Capelli, Debora, Montanari, Mauro, Olivieri, Attilio, Poloni, Antonella, Polloni, Claudia, Marconi, Monica, and Leoni, Pietro

Published
2006
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21. Azacitidine for Post-Remission Therapy in Elderly Patients with Acute Myeloid Leukemia : Final Results of the Qoless AZA-Amle Randomized Trial

Author

Oliva, Esther Natalie, primary, Candoni, Anna, primary, Salutari, Prassede, primary, Di Raimondo, Francesco, primary, Reda, Gianluigi, primary, Capelli, Debora, primary, Niscola, Pasquale, primary, Selleri, Carmine, primary, Musto, Pellegrino, primary, Vigna, Ernesto, primary, Volpe, Antonio, primary, Cascavilla, Nicola, primary, Mannina, Donato, primary, Carluccio, Paola, primary, Zannier, Maria Elena, primary, Mauro, Elisa, primary, Freyrie, Alessandra, primary, Mazzone, Carla, primary, Martino, Bruno, primary, and Alati, Caterina, primary

Published
2019
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23. Quality of Life in Elderly Patients with Acute Myeloid Leukemia Undergoing Induction Chemotherapy

Author

Oliva, Esther Natalie, primary, Salutari, Prassede, additional, Candoni, Anna, additional, Freyrie, Alessandra, additional, Capelli, Debora, additional, Di Raimondo, Francesco, additional, Volpe, Antonio, additional, Cascavilla, Nicola, additional, Di Bartolomeo, Paolo, additional, Simeone, Erica, additional, Cortelezzi, Agostino, additional, Leoni, Pietro, additional, Musto, Pellegrino, additional, Morabito, Fortunato, additional, Niscola, Pasquale, additional, Ranieri, Natale, additional, Santacaterina, Irene, additional, Marino, Antonio Giovanni, additional, Cufari, Patrizia, additional, Alati, Caterina, additional, and Ronco, Francesca, additional

Published
2015
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24. Two or More Chemotherapy Consolidation Courses, Followed By Autologous Bone Marrow Transplantation, and MRD Negativity, Give Long Term Overall Survival in Acute Myeloid Leukemia Patients

Author

Marconi, Giovanni, primary, Papayannidis, Cristina, additional, Mosna, Federico, additional, Gottardi, Michele, additional, Simonetti, Giorgia, additional, Soverini, Simona, additional, Curti, Antonio, additional, Zuffa, Elisa, additional, Abbenante, Maria Chiara, additional, Parisi, Sarah, additional, Paolini, Stefania, additional, Sartor, Chiara, additional, Franchini, Eugenia, additional, Ottaviani, Emanuela, additional, Venturi, Claudia, additional, Fontana, Maria Chiara, additional, Padella, Antonella, additional, Guadagnuolo, Viviana, additional, Bochicchio, Maria Teresa, additional, Ferrari, Anna, additional, Testoni, Nicoletta, additional, Baldazzi, Carmen, additional, Manfrini, Marco, additional, Capelli, Debora, additional, Galieni, Piero, additional, Piccin, Andrea, additional, Visani, Giuseppe, additional, Rodeghiero, Francesco, additional, Tecchio, Cristina, additional, Gherlinzoni, Filippo, additional, Cavo, Michele, additional, and Martinelli, Giovanni, additional

Published
2015
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27. A Combination of Lenalidomide and Rituximab (ReRi) As Salvage Therapy in Elderly Patients Affected By Diffuse Large B Cells (DLBCL) Lymphoma Relapsed and Refractory

Author

Gini, Guido, primary, Bocci, Caterina, additional, Sampaolo, Michela, additional, Trappolini, Silvia, additional, Cacciagiù, Sonia, additional, Olivieri, Jacopo, additional, Olivieri, Attilio, additional, Offidani, Massimo, additional, Rupoli, Serena, additional, Poloni, Antonella, additional, Scortechini, Anna Rita, additional, Capelli, Debora, additional, Montanari, Mauro, additional, Scortechini, Ilaria, additional, and Leoni, Pietro, additional

Published
2015
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28. Primary B-cell lymphoblastic lymphoma of the testis

Author

Tombolini, Flavia, primary, Lacetera, Vito, additional, Gini, Guido, additional, Capelli, Debora, additional, Leoni, Pietro, additional, Montironi, Rodolfo, additional, Galosi, Andrea Benedetto, additional, and Muzzonigro, Giovanni, additional

Published
2014
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29. Preventive Effects of Cardotoxicities By Liposomal Anthracyclines non Pegilated in 95 Perspective Patients Affected By Lymphoma and Monitored By Biomarkers and Ecocardiography

Author

Gini, Guido, primary, Olivieri, Jacopo, additional, Bocci, Caterina, additional, Sampaolo, Michela, additional, Trappolini, Silvia, additional, Olivieri, Attilio, additional, Offidani, Massimo, additional, Rupoli, Serena, additional, Poloni, Antonella, additional, Scortechini, Anna Rita, additional, Capelli, Debora, additional, Montanari, Mauro, additional, Scortechini, Ilaria, additional, Perna, Gian Piero, additional, and Leoni, Pietro, additional

Published
2014
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30. Azacitidine As Post-Remission Therapy in Elderly Patients with Acute Myeloid Leukemia Significantly Prolongs Disease-Free Survival: Interim Results from a Prospective, Randomized, Open-Label, Phase III Multicenter Trial

Author

Oliva, Esther Natalie, primary, Alati, Caterina, additional, Salutari, Prassede, additional, Freyrie, Alessandra, additional, Candoni, Anna, additional, Simeone, Erica, additional, Ventura, Giovanna, additional, Cortelezzi, Agostino, additional, Capelli, Debora, additional, Leoni, Pietro, additional, Di Bartolomeo, Paolo, additional, Marino, Antonio Giovanni, additional, Cufari, Patrizia, additional, Di Raimondo, Francesco, additional, Mauro, Elisa, additional, Volpe, Antonio, additional, Cascavilla, Nicola, additional, Musto, Pellegrino, additional, Morabito, Fortunato, additional, Niscola, Pasquale, additional, Specchia, Giorgina, additional, and Ronco, Francesca, additional

Published
2014
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31. A Randomized Open-Label Study To Evaluate The Efficacy Of Azacitidine For Post-Remission Therapy Of Acute Myeloid Leukemia In Elderly Patients (QOLESS AZA-AMLE)

Author

Oliva, Esther Natalie, primary, Santarone, Stella, additional, Leoni, Pietro, additional, Alati, Caterina, additional, Volpe, Antonio, additional, Cascavilla, Nicola, additional, Candoni, Anna, additional, Musto, Pellegrino, additional, Morabito, Fortunato, additional, Di Raimondo, Francesco, additional, Cufari, Patrizia, additional, Santacaterina, Irene, additional, Vincelli, Iolanda, additional, Capelli, Debora, additional, Freyrie, Alessandra, additional, Salutari, Prassede, additional, Di Bartolomeo, Paolo, additional, Martino, Bruno, additional, Ronco, Francesca, additional, and Cortelezzi, Agostino, additional

Published
2013
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32. Geriatric Assessment Driven Treatment In 149 AML Elderly Patients

Author

Capelli, Debora, primary, Saraceni, Francesco, additional, Chiarucci, Martina, additional, Poloni, Antonella, additional, Mancini, Giorgia, additional, Trappolini, Silvia, additional, Offidani, Massimo, additional, Rupoli, Serena, additional, Montanari, Mauro, additional, Scortechini, Anna Rita, additional, Gini, Guido, additional, Scortechini, Ilaria, additional, Discepoli, Giancarlo, additional, Leoni, Pietro, additional, and Olivieri, Attilio, additional

Published
2013
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33. Efficacy and Feasibility of High-Dose Cytarabine Plus Idarubicin and Amifostine As Induction Schedule: A Prospective Observational Study of 100 AML Elderly Fit Patients

Author

Capelli, Debora, primary, Chiarucci, Martina, additional, Saraceni, Francesco, additional, Poloni, Antonella, additional, Montanari, Mauro, additional, Offidani, Massimo, additional, Rupoli, Serena, additional, Scortechini, Anna Rita, additional, Gini, Guido, additional, Scortechini, Ilaria, additional, Leoni, Pietro, additional, and Olivieri, Attilio, additional

Published
2012
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34. LATE EFFECTS IN Hodgkin's POPULATION Treated BETWEEN 1980-2005 IN A SINGLE INSTITUTION.

Author

Gini, Guido, primary, Caraffa, Patrizia, additional, Offidani, Massimo, additional, Trappolini, Silvia, additional, Bocci, Caterina, additional, Stronati, Andrea, additional, Corvatta, Laura, additional, Polloni, Claudia, additional, Gentili, Silvia, additional, Savini, Agnese, additional, Montanari, Mauro, additional, Capelli, Debora, additional, Poloni, Antonella, additional, Olivieri, Attilio, additional, and Leoni, Pietro, additional

Published
2009
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35. Multicentric prospective Study of Differential Treatment for Elderly Patients Affected by Aggressive Non Hodgkin Lymphoma Based On a Geriatric Multidimensional Analysis.

Author

Gini, Guido, primary, Olivieri, Attilio, additional, Bocci, Caterina, additional, Catarini, Massimo, additional, Visani, Giuseppe, additional, Montanari, Mauro, additional, Guiducci, Barbara, additional, Isidori, Alessandro, additional, Brunori, Marino, additional, Alesiani, Francesco, additional, Giuliodori, Luciano, additional, Marcellini, Massimo, additional, Offidani, Massimo, additional, Caraffa, Patrizia, additional, Stronati, Andrea, additional, Capelli, Debora, additional, Trappolini, Silvia, additional, and Leoni, Pietro, additional

Published
2009
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36. Gemtuzumab-Ozogamicin as Post-Consolidation Therapy In Elderly Patients with Acute Myeloid Leukemia: a Pilot Study

Author

Ilaria Scortechini, Guido Gini, Benedetta Costantini, Francesco Saraceni, Martina Chiarucci, Capelli Debora, Pietro Leoni, Attilio Olivieri, Antonella Poloni, Mauro Montanari, Giorgia Mancini, and Silvia Trappolini

Subjects
Chemotherapy, medicine.medical_specialty, business.industry, Gemtuzumab ozogamicin, medicine.medical_treatment, Immunology, Cell Biology, Hematology, Transplant-Related Mortality, medicine.disease, Biochemistry, Surgery, Median follow-up, Cohort, medicine, business, Prospective cohort study, Adverse effect, Progressive disease, medicine.drug
Abstract

Abstract 4357 The optimal post-remission treatment for elderly patients with acute myeloid leukemia (AML) is presently unknown. We evaluated safety and efficacy of low dose Gemtuzumab-Ozogamicin (GO) as post-remission late consolidation therapy in a cohort of 19 consecutive patients, enrolled in a pilot prospective study. Between June 1999 and February 2010 we observed 152 elderly patients, aged more than 60 years and affected by AML. One hundred and two patients (67%) were considered fit for aggressive therapy and received intensive induction and consolidation therapy including HD Ara-C, Idarubicine and Amifostine. Thirty-nine patients (38%) were over 70 years, 38% had a secondary disease, 35% unfavourable, 45% intermediate and 4 % favourable prognosis Karyotype. Those achieving successful mobilization received autologous transplant while poor mobilizers received a second consolidation with three monthly courses of GO 3 mg/sm i.v. followed by three other courses of GO administered every 3 months. Seventy-two patients achieved CR (69%) after induction: one patiente died in CR, 5 patients had a PS ≥2 and the remaining 66 were elegible for first consolidation. Fifty of these maintained the CR status and received a second consolidation: 19 with GO, 20 with Autologous transplant, and 6 with chemotherapy alone for patient decision. Five patients with a family donor received Allogeneic Transplant and were not included in this analysis. GO was well tolerated: no major adverse events were seen. We overall observed 18 WHO grade III/IV adverse events were all transitory and included hematological toxicity (n = 17), hypertransaminasemia (n = 1). Eight patients (42%) relapsed after GO consolidation and received a GO reinduction: five eventually died after a median follow-up of 13 months while three are still alive with a median follow up of 10 months. Five out of 20 patients died of transplant related toxicity (25%) and 9 relapsed (45%) after autologous transplant. All nine patients died of progressive disease. Five of the 6 patients receiving chemotherapy (83%) relapsed and died. Five years Overall survival was 22% and Disease Free Survival 29.5% in the whole cohort of patients (median follow-up: 50 mouths). The landmark analysis showed a superior outcome in patients receiving GO with a 60% 5 yrs OS and DFS (median follow-up: 60 months) in comparison with patients receiving autologous transplant (28% 5 yrs OS and DFS with median follow-up 70 months) and chemotherapy (17% 5 yrs OS and DFS with a median follow-up of 77 months) (p= 0.009). In conclusion patients receiving GO had a better outcome in comparison with patients receiving autologous transplant and chemothearapy. High percentages of poor mobilizers and transplant related mortality seem to jeopardize autologous transplant feasibility and safety in elderly patients. GO showed to be an alternative and feasible choice in our series, with a low relapse rate, and a low toxicity profile. Disclosures: Leoni: Celgene: Honoraria.

Published
2010
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37. Thalidomide, Dexamethasone and Pegylated-Liposomal Doxorubicin (ThaDD) for Untreated Multiple Myeloma Patients Aged over 65 Years.

Author

Offidani, Massimo, primary, Corvatta, Laura, primary, Marconi, Monica, primary, Visani, Giuseppe, primary, Alesiani, Francesco, primary, Brunori, Marino, primary, Galieni, Piero, primary, Catarini, Massimo, primary, Burattini, Maurizio, primary, Centurioni, Riccardo, primary, Rupoli, Serena, primary, Scortechini, Anna Rita, primary, Giuliodori, Luciano, primary, Candela, Marco, primary, Capelli, Debora, primary, Montanari, Mauro, primary, Olivieri, Attilio, primary, Piersantelli, Maria-Novella, primary, and Leoni, Pietro, primary

Published
2005
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39. High Dose Chemotherapy (HD CHT) Followed by Autologous PBPC Transplant in Elderly ANLL Patients.

Author

Capelli, Debora, primary, Troiani, Emanuela, additional, Discepoli, Giancarlo, additional, Poloni, Antonella, additional, Montanari, Mauro, additional, Catarini, Massimo, additional, Centurioni, Riccardo, additional, Alesiani, Francesco, additional, Brunori, Marino, additional, Lucesole, Moira, additional, Leoni, Pietro, additional, and Olivieri, Attilio, additional

Published
2004
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40. The Kinetics and Extent of Engraftment of Chronic Myelogenous Leukemia Cells in Non-Obese Diabetic/Severe Combined Immunodeficiency Mice Reflect the Phase of the Donor’s Disease: An In Vivo Model of Chronic Myelogenous Leukemia Biology

Author

Dazzi, Francesco, primary, Capelli, Debora, additional, Hasserjian, Robert, additional, Cotter, Finbarr, additional, Corbo, Margherita, additional, Poletti, Alessandro, additional, Chinswangwatanakul, Wimol, additional, Goldman, John M., additional, and Gordon, Myrtle Y., additional

Published
1998
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41. Two or More Chemotherapy Consolidation Courses, Followed By Autologous Bone Marrow Transplantation, and MRD Negativity, Give Long Term Overall Survival in Acute Myeloid Leukemia Patients

Author

Simona Soverini, Cristina Papayannidis, Filippo Gherlinzoni, Debora Capelli, Michele Cavo, Sarah Parisi, Antonella Padella, A. Ferrari, Marco Manfrini, Piero Galieni, Nicoletta Testoni, Antonio Curti, Chiara Sartor, Cristina Tecchio, Andrea Piccin, Viviana Guadagnuolo, Giorgia Simonetti, Elisa Zuffa, Eugenia Franchini, Michele Gottardi, Giovanni Martinelli, Emanuela Ottaviani, Giuseppe Visani, Maria Chiara Fontana, Carmen Baldazzi, Francesco Rodeghiero, Stefania Paolini, Maria Chiara Abbenante, Federico Mosna, Giovanni Marconi, Maria Teresa Bochicchio, Claudia Venturi, Marconi, Giovanni, Papayannidis, Cristina, Mosna, Federico, Gottardi, Michele, Simonetti, Giorgia, Soverini, Simona, Curti, Antonio, Zuffa, Elisa, Abbenante, Mariachiara, Parisi, Sarah, Paolini, Stefania, Sartor, Chiara, Franchini, Eugenia, Ottaviani, Emanuela, Venturi, Claudia, Fontana, MARIA CHIARA, Padella, Antonella, Guadagnuolo, Viviana, Bochicchio, MARIA TERESA, Ferrari, Anna, Testoni, Nicoletta, Baldazzi, Carmen, Manfrini, Marco, Capelli, Debora, Galieni, Piero, Piccin, Andrea, Visani, Giuseppe, Rodeghiero, Francesco, Tecchio, Cristina, Gherlinzoni, Filippo, Cavo, Michele, and Martinelli, Giovanni

Subjects
medicine.medical_specialty, Pediatrics, business.industry, medicine.medical_treatment, Mortality rate, Immunology, Induction chemotherapy, Cell Biology, Hematology, Biochemistry, Minimal residual disease, Fludarabine, Regimen, Autologous stem-cell transplantation, Median follow-up, Internal medicine, AUTOLOGOUS STEM CELL TRANSPLANTATION, AML, medicine, business, Neoadjuvant therapy, medicine.drug
Abstract

Introduction. Autologous Bone Marrow Transplantation (Auto-BMT) is currently rarely used in the treatment of Acute Myeloid Leukemia (AML). However, it may represent a good therapeutic option in a specific subset of patients, mainly in consolidation of both low risk (LR) and MRD negative AML without an available HLA matched donor. Aims. To review our database of AML patients who received Auto-BMT from 2005 to 2014 and who were referred to Bologna Institution, in order to assess the efficacy of the procedure in terms of Overall Survival (OS) and Disease Free Survival (DFS). Patients and methods: From 2005 to 2014, 98 AML patients underwent Auto-BMT in several Italian Institutions. 89/98 patients are evaluable for survival and outcome data. The 89 patients considered (42 female, 47 male), had a median age of 49 years (range 15-70). Cytogenetics was performed in all patients by conventional karyotype (22 patients were also analyzed by Single Nucleotide Polymorphisms Array); molecular analysis (FLT3 TKD and ITD, and NPM1 mutational analysis) was available for 51/89 patients. Molecular monitoring by specific fusion transcripts (CBF-MYH11 and AML1-ETO) was performed in CBF positive leukemias (inv(16) and t(8;21)) at the time of diagnosis, after induction, consolidation courses, and every 3 months in the first 2 years of follow-up. Based on this data, and according to ELN guidelines, a risk stratification identified 41 patients with a LR AML (t(8:21), inv(16) or NPM1+/FLT3- with normal karyotype), 4 patients with a high risk (HR) AML (complex karyotype or FLT3 ITD mutated or inv(3) or t(6;9)) and 44 patients with a standard risk (SR) AML (normal karyotype, other alterations). Results. All the patients received an induction chemotherapy treatment, as follows: a "3+7-like" course in 48 cases, a Fludarabine-based regimen in 20 patients and a Gemtuzumab-ozogamicin (GO)-based regimen in 21. 83/89 (93.3%) patients received a median of 2 consolidation courses of chemotherapy (range 1-4) before proceeding to Auto-BMT, performed in 1st CR. 6/89 (6.7%) patients received Auto-BMT in first relapse. 41 patients relapsed after auto-BMT and were treated with a re-induction chemotherapy, or were enrolled in clinical trials. 24 patients reached a 2nd complete remission, and 12 patients underwent an allogeneic BMT in 2nd CR. With a median follow up of 6 years, the median Overall Survival (OS) of the entire population was 64.3 months (range 5.8-294.2 months); the 1 year OS and the 5 years OS were, 97.1%, and 67.9%, respectively. The median Disease Free Survival (DFS) of the 83 patients treated with Auto-BMT in 1st CR was 36 months (range 1.3-293 months). The 1-year DFS and the 5-years DFS were 85% and 56.7%, respectively. Transplant related mortality (TRM, death in 100 days after BMT) was 1.2% for auto-BMT and 6.5% for allogeneic BMT. First, to assess the role of the number of consolidation courses we compared patients who received none or 1 consolidation course with patients who received 2 or more cycles, who showed a better OS (p= 0.0061, Figure 1). There was no statistical difference in terms of OS between young and elderly patients (cut off=65 years). Second, we compared patients who achieved a negative minimal residual disease status before auto-BMT (n=37) with patients who did not (n=9). MRD negativity offered a significantly better outcome in terms of 5-years OS (83.4% and 50% respectively); the median OS of MRD neg was not yet reached; the median OS of MRD pos was 27 months (p= 0.0130) (Figure 2). Conclusions: Auto-BMT offers a chance to achieve long-term DFS and OS if used as a consolidation therapy both in patients with LR and SR AML. The major role could be played in MRD negative patients, offering the best chances to achieve a long-term OS. Auto-BMT can be also a good choice as consolidation therapy for elderly patients, in which allo-BMT could induce high morbidity and mortality rates. The small patients cohort and the retrospective analysis don't allow us to define the best induction therapy to be used before auto-BMT. However, based on our findings we suggest a therapy schedule including two or more consolidation courses in patients who obtain a first CR, and to proceed then to auto-BMT. Acknowledgments: work supported by ELN, AIL, AIRC, Progetto Regione-Università 2010-12 (L.Bolondi), Fondazione del Monte di Bologna e Ravenna, FP7 NGS-PTL project. Figure 1. Figure 1. Figure 2. Figure 2. Disclosures Soverini: Novartis, Briston-Myers Squibb, ARIAD: Consultancy. Rodeghiero:Celgene Corporation: Honoraria, Research Funding. Cavo:Janssen-Cilag, Celgene, Amgen, BMS: Honoraria. Martinelli:AMGEN: Consultancy; Novartis: Consultancy, Speakers Bureau; Ariad: Consultancy; BMS: Consultancy, Speakers Bureau; ROCHE: Consultancy; Pfizer: Consultancy; MSD: Consultancy.

Published
2015
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42. Long-term survival can be achieved in a significant fraction of older patients with core binding factor acute myeloid leukemia treated with intensive chemotherapy.

Author

Mosna F, Borlenghi E, Litzow M, Byrd JC, Papayannidis C, Tecchio C, Ferrara F, Marcucci G, Cairoli R, Morgan EA, Gurrieri C, Yeung CCS, Deeg HJ, Capelli D, Candoni A, Gotlib JR, Lunghi M, Pullarkat S, Lanza F, Galimberti S, Forghieri F, Venditti A, Festuccia M, Audisio E, Marvalle D, Rigolin GM, Roti G, DiBona E, Visani G, Albano F, Eisfeld AK, Valent P, Huls G, Borthakur G, Krampera M, Martinelli G, Kröger N, Sperotto A, and Gottardi M

Abstract

Acute Myeloid Leukemia is mainly a disease of the elderly: however, the knowledge on the outcomes of treatment in core binding factor AML (CBFAML) in older population, is limited. We retrospectively collected data on 229 patients with CBF- AML followed long-term in the last two decades. A 5-year overall survival (OS) of 44.2% (95%CI, 39.9-47.5) and a 5-year event - free survival (EFS) of 32.9% (95%CI, 25.5-40.1) was observed. In a subgroup of >70-year patients who completed intensive therapy (induction + >3 courses of consolidation including autologous stem cell transplant: 10 patients) the median EFS was 11.8 months (95%CI, 9.4 - 15.2) and OS was 40.0% (95%CI, 36.4 - 44.1) at 5yr. In univariate analysis, age >70 (hazard ratio (HR) 1.78, [95%CI, 1.15 - 2.54], p=.008), failure to achieve remission following induction (HR, 8.96 [95%CI, 5.5 - 13.8], p=<.0001), no consolidation therapy (HR, 0.75 [95%CI, 0.47 - 1.84], p=.04) and less than 3 cycles of consolidation (HR, 1.48 [95%CI, 0.75 - 3.2], p=.0004), predicted poorer EFS. Our study shows that intensive therapy, in selected older CBF-AML patients, leads to longer survival. Achieving a CR seems to be the most important first step and at least 3 cycles of consolidation, an important second one. The analysis suggests that these patients should not be excluded from studies with intensive therapies.

Published
2024
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43. Secondary Acute Myeloid Leukemia: Pathogenesis and Treatment

Author

Capelli D, Menotti D, Fiorentini A, Saraceni F, Olivieri A, and Li W

Abstract

Secondary acute myeloid leukemia includes acute myeloid leukemia that arises either from a previous myeloid hematologic disease such as myelodysplastic syndrome, chronic myeloproliferative syndrome, or myelodysplastic/myeloproliferative overlap syndromes or from a previous chemotherapy or radiotherapy performed for another disease. Secondary acute myeloid leukemia is characterized by a worse prognosis than its de novo counterparts, with a 5-year overall survival of <30% despite an advanced insight into pathogenesis and new available treatments. The best therapeutic strategy is to achieve complete remission with a negative minimal residual disease followed by hematopoietic stem cell transplantation; however, advanced age of patients at diagnosis, multiple comorbidities, and lower rate of complete remission makes these approaches available only for a small fraction of secondary acute myeloid leukemia patients. In this chapter, we discuss the epidemiology, pathogenesis, and prognostic factors of secondary acute myeloid leukemia. Also, we discuss the main treatments currently available for eligible patients (fit patients) and non-eligible patients (unfit patients) for intensive chemotherapy and future treatment perspectives., (Copyright: The Authors.; The authors confirm that the materials included in this chapter do not violate copyright laws. Where relevant, appropriate permissions have been obtained from the original copyright holder(s), and all original sources have been appropriately acknowledged or referenced.)

Published
2022
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44. Low-dose thalidomide with pegylated liposomal doxorubicin and high-dose dexamethasone for relapsed/refractory multiple myeloma: a prospective, multicenter, phase II study.

Author

Offidani M, Corvatta L, Marconi M, Visani G, Alesiani F, Brunori M, Galieni P, Catarini M, Burattini M, Centurioni R, Rupoli S, Scortechini AR, Giuliodori L, Candela M, Capelli D, Montanari M, Olivieri A, Piersantelli MN, and Leoni P

Subjects
Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols toxicity, Dexamethasone administration & dosage, Disease-Free Survival, Doxorubicin administration & dosage, Female, Humans, Male, Middle Aged, Multiple Myeloma complications, Multiple Myeloma mortality, Polyethylene Glycols, Salvage Therapy methods, Survival Rate, Thalidomide administration & dosage, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Multiple Myeloma drug therapy
Abstract

The aim of this prospective, multicenter, phase II study was to investigate the combination of pegylated liposomal doxorubicin (Caelyx) 40 mg/m2 on day 1 every 28 days, dexamethasone 40 mg p.o. on days 1-4 and 9-12 and thalidomide 100 mg daily in 50 patients with advanced multiple myeloma. Twenty-six percent of patients achieved a complete response, 6% a near complete response, 6% a very good partial response, 38% a partial response, 16% a minor response and 8% progressed, for an overall response rate of 92%. The median event-free survival was 17 months and the median overall survival was not reached. Grade 3 non-hematologic toxicity occurred in 12% of patients, thromboembolic disease in 12% and severe infection in 16%. The combination of pegylated liposomal doxorubicin, dexamethasone an thalidomide is safe and very effective in advanced multiple myeloma.

Published
2006

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