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637 results on '"Vignetti, M."'

2. Real World Outcome of Unfit Patients with Acute Myeloid Leukemia Treated with the Combination Venetoclax Plus Hypomethylating Agents in the Gimema AML2320 Observational Trial

Author

Venditti, A, Piciocchi, A, Soddu, S, Frigeni, M, Palmieri, R, Borlenghi, E, Fracchiolla, N, Martelli, M, Audisio, E, Gianfaldoni, G, Vetro, C, di Rienzo, N, Esposito, D, Di Veroli, A, Selleri, C, Gigli, F, Curti, A, Mulè, A, Califano, C, Bigliardi, S, Breccia, M, Fozza, C, Bocchia, M, Lico, A, Simonetti, F, Pierdomenico, E, Buccisano, F, Del Principe, M, Maurillo, L, Fazi, P, Vignetti, M, Ferrara, F, Cairoli, R, Rossi, G, Rambaldi, A, Venditti, Adriano, Piciocchi, Alfonso, Soddu, Stefano, Frigeni, Marco, Palmieri, Raffaele, Borlenghi, Erika, Fracchiolla, Nicola, Martelli, Maria Paola, Audisio, Ernesta, Gianfaldoni, Giacomo, Vetro, Calogero, di Rienzo, Nicola, Esposito, Daniela, Di Veroli, Ambra, Selleri, Carmine, Gigli, Federica, Curti, Antonio, Mulè, Antonino, Califano, Catello, Bigliardi, Sara, Breccia, Massimo, Fozza, Claudio, Bocchia, Monica, Lico, Albana, Simonetti, Federico, Pierdomenico, Elisabetta, Buccisano, Francesco, Del Principe, Maria Ilaria, Maurillo, Luca, Fazi, Paola, Vignetti, Marco, Ferrara, Felicetto, Cairoli, Roberto, Rossi, Giuseppe, Rambaldi, Alessandro, Venditti, A, Piciocchi, A, Soddu, S, Frigeni, M, Palmieri, R, Borlenghi, E, Fracchiolla, N, Martelli, M, Audisio, E, Gianfaldoni, G, Vetro, C, di Rienzo, N, Esposito, D, Di Veroli, A, Selleri, C, Gigli, F, Curti, A, Mulè, A, Califano, C, Bigliardi, S, Breccia, M, Fozza, C, Bocchia, M, Lico, A, Simonetti, F, Pierdomenico, E, Buccisano, F, Del Principe, M, Maurillo, L, Fazi, P, Vignetti, M, Ferrara, F, Cairoli, R, Rossi, G, Rambaldi, A, Venditti, Adriano, Piciocchi, Alfonso, Soddu, Stefano, Frigeni, Marco, Palmieri, Raffaele, Borlenghi, Erika, Fracchiolla, Nicola, Martelli, Maria Paola, Audisio, Ernesta, Gianfaldoni, Giacomo, Vetro, Calogero, di Rienzo, Nicola, Esposito, Daniela, Di Veroli, Ambra, Selleri, Carmine, Gigli, Federica, Curti, Antonio, Mulè, Antonino, Califano, Catello, Bigliardi, Sara, Breccia, Massimo, Fozza, Claudio, Bocchia, Monica, Lico, Albana, Simonetti, Federico, Pierdomenico, Elisabetta, Buccisano, Francesco, Del Principe, Maria Ilaria, Maurillo, Luca, Fazi, Paola, Vignetti, Marco, Ferrara, Felicetto, Cairoli, Roberto, Rossi, Giuseppe, and Rambaldi, Alessandro

Published
2023

3. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996

Author

Piciocchi, A, Messina, M, Elia, L, Vitale, A, Soddu, S, Testi, A, Chiaretti, S, Mancini, M, Albano, F, Spadano, A, Krampera, M, Bonifacio, M, Cairoli, R, Vetro, C, Colella, F, Ferrara, F, Cimino, G, Bassan, R, Fazi, P, Vignetti, M, Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, Vignetti M, Piciocchi, A, Messina, M, Elia, L, Vitale, A, Soddu, S, Testi, A, Chiaretti, S, Mancini, M, Albano, F, Spadano, A, Krampera, M, Bonifacio, M, Cairoli, R, Vetro, C, Colella, F, Ferrara, F, Cimino, G, Bassan, R, Fazi, P, Vignetti, M, Piciocchi A, Messina M, Elia L, Vitale A, Soddu S, Testi AM, Chiaretti S, Mancini M, Albano F, Spadano A, Krampera M, Bonifacio M, Cairoli R, Vetro C, Colella F, Ferrara F, Cimino G, Bassan R, Fazi P, and Vignetti M

Published
2021

4. Fatigue in newly diagnosed acute myeloid leukaemia: general population comparison and predictive factors

Author

Oswald, L, Venditti, A, Cella, D, Cottone, F, Candoni, A, Melillo, L, Cairoli, R, Storti, G, Salutari, P, Luppi, M, Albano, F, Martelli, M, Cuneo, A, Tafuri, A, Trisolini, S, Tieghi, A, Fazi, P, Vignetti, M, Efficace, E, Oswald LB, Venditti A, Cella D, Cottone F, Candoni A, Melillo L, Cairoli R, Storti G, Salutari P, Luppi M, Albano F, Martelli MP, Cuneo A, Tafuri A, Trisolini SM, Tieghi A, Fazi P, Vignetti M, Efficace E., Oswald, L, Venditti, A, Cella, D, Cottone, F, Candoni, A, Melillo, L, Cairoli, R, Storti, G, Salutari, P, Luppi, M, Albano, F, Martelli, M, Cuneo, A, Tafuri, A, Trisolini, S, Tieghi, A, Fazi, P, Vignetti, M, Efficace, E, Oswald LB, Venditti A, Cella D, Cottone F, Candoni A, Melillo L, Cairoli R, Storti G, Salutari P, Luppi M, Albano F, Martelli MP, Cuneo A, Tafuri A, Trisolini SM, Tieghi A, Fazi P, Vignetti M, and Efficace E.

Abstract

Objectives: This study compared the burden of fatigue between treatment-naïve patients with newly diagnosed acute myeloid leukaemia (AML) and the general population and investigated patient factors associated with fatigue severity. Methods: Pretreatment patient-reported fatigue was assessed with the Functional Assessment of Chronic Illness Therapy-Fatigue questionnaire in a sample of 463 newly diagnosed patients with AML who were enrolled in a clinical trial. Multivariable linear regression models were used to estimate the adjusted mean differences in fatigue between patients with AML and adults from the general population (n=847) by AML disease risk categories. A clinically meaningful difference in fatigue was defined as ≥3 points. Univariable and multivariable linear regression models were used to identify sociodemographic, clinical and molecular correlates of worse fatigue in patients with AML. Results: Patients with AML reported adjusted mean fatigue scores that were 7.5 points worse than the general population (95% CI -8.6 to -6.4, p<0.001). Across AML disease risk categories, adjusted mean differences in fatigue compared with the general population ranged from 6.7 points worse (patients with favourable risk: 95% CI -8.6 to -4.8, p<0.001) to 8.9 points worse (patients with poor risk, 95% CI -10.5 to -7.2, p<0.001). Overall, 91% of patients with AML reported fatigue that was equal to or worse than the general population's median fatigue score. Higher pretreatment fatigue was independently associated with female sex, WHO performance status ≥1 and lower platelet levels. Conclusions: Patients with newly diagnosed AML reported worse fatigue than the general population, and mean differences exceeded twice the threshold for clinical significance. Our findings may help to identify patients with AML most likely to benefit from supportive care interventions to reduce fatigue.

Published
2021

5. LABNET AML: AN EFFICIENT NETWORK THAT CONNECTS HEMATOLOGY CENTERS AND LABORATORIES FOR A HIGH-LEVEL DIAGNOSTIC/PROGNOSTIC WORKUP OF AML

Author

Voso, M, Cucci, R, Messina, M, Santoro, A, Divona, M, Albano, F, Ottaviani, E, Bertorelle, R, Guerrasio, A, Gottardi, E, Izzo, B, Tarantini, G, Scardocci, A, Siragusa, S, Forghieri, F, Cairoli, R, Cambo, B, Vallisa, D, Venditti, A, Ferrara, F, Mannina, D, Cilloni, D, La, S, Piciocchi, A, Falini, B, Pane, F, Saglio, G, Vignetti, M, Amadori, S, Voso MT, Cucci R, Messina M, Santoro A, Divona M, Albano F, Ottaviani E, Bertorelle R, Guerrasio A, Gottardi E, Izzo B, Tarantini G, Scardocci A, Siragusa S, Forghieri F, Cairoli R, Cambo B, Vallisa D, Venditti A, Ferrara F, Mannina D, Cilloni D, La SalaE, Piciocchi A, Falini B, Pane F, Saglio G, Vignetti M, Amadori S, Voso, M, Cucci, R, Messina, M, Santoro, A, Divona, M, Albano, F, Ottaviani, E, Bertorelle, R, Guerrasio, A, Gottardi, E, Izzo, B, Tarantini, G, Scardocci, A, Siragusa, S, Forghieri, F, Cairoli, R, Cambo, B, Vallisa, D, Venditti, A, Ferrara, F, Mannina, D, Cilloni, D, La, S, Piciocchi, A, Falini, B, Pane, F, Saglio, G, Vignetti, M, Amadori, S, Voso MT, Cucci R, Messina M, Santoro A, Divona M, Albano F, Ottaviani E, Bertorelle R, Guerrasio A, Gottardi E, Izzo B, Tarantini G, Scardocci A, Siragusa S, Forghieri F, Cairoli R, Cambo B, Vallisa D, Venditti A, Ferrara F, Mannina D, Cilloni D, La SalaE, Piciocchi A, Falini B, Pane F, Saglio G, Vignetti M, and Amadori S

Published
2021

6. S113: NATIONAL PEGASPARGASE-MODIFIED RISK-ORIENTED PROGRAM FOR PHILADELPHIA-NEGATIVE ADULT ACUTE LYMPHOBLASTIC LEUKEMIA/LYMPHOBLASTIC LYMPHOMA (PH− ALL/LL). GIMEMA LAL 1913 FINAL RESULTS.

Author

Bassan, R., primary, Chiaretti, S., additional, Della Starza, I., additional, Spinelli, O., additional, Santoro, A., additional, Elia, L., additional, De Propris, M. S., additional, Scattolin, A. M., additional, Paoloni, F., additional, Messina, M., additional, Audisio, E., additional, Marbello, L., additional, Borlenghi, E., additional, Zappasodi, P., additional, Vetro, C., additional, Martinelli, G., additional, Mattei, D., additional, Fracchiolla, N., additional, Bocchia, M., additional, De Fabritiis, P., additional, Bonifacio, M., additional, Candoni, A., additional, Cassibba, V., additional, Di Bartolomeo, P., additional, Latte, G., additional, Trappolini, S., additional, Guarini, A., additional, Vitale, A., additional, Fazi, P., additional, Vignetti, M., additional, Rambaldi, A., additional, and Foà, R., additional

Published
2022
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7. 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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8. PB1762: PONATINIB VERSUS IMATINIB WITH REDUCED-INTENSITY CHEMOTHERAPY IN PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME–POSITIVE (PH+) ACUTE LYMPHOBLASTIC LEUKEMIA (ALL): PHALLCON STUDY

Author

Jabbour, E., primary, Martinelli, G., additional, Vignetti, M., additional, Kantarjian, H., additional, Gomez-Almaguer, D., additional, Minami, Y., additional, Dombret, H., additional, Hennessy, M., additional, Vorog, A., additional, Wang, B., additional, and Ribera, J.-M., additional

Published
2022
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9. P353: FORTY MONTHS UPDATE OF THE GIMEMA LAL2116 (D-ALBA) PROTOCOL AND ANCILLARY LAL2217 STUDY FOR NEWLY DIAGNOSED ADULT PH+ ALL

Author

Chiaretti, S., primary, Bassan, R., additional, Vitale, A., additional, Elia, L., additional, Piciocchi, A., additional, Viero, P., additional, Ferrara, F., additional, Lunghi, M., additional, Fabbiano, F., additional, Bonifacio, M., additional, Fracchiolla, N., additional, Di Bartolomeo, P., additional, Fazi, P., additional, De Propris, M. S., additional, Vignetti, M., additional, Guarini, A., additional, Rambaldi, A., additional, and Foà, R., additional

Published
2022
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10. 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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11. Long-term results of all-trans retinoic acid and arsenic trioxide in non-high-risk acute promyelocytic leukemia: update of the APL0406 Italian-German randomized trial

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2020

12. PB1762: ponatinib versus imatinib with reduced-intensity chemotherapy in patients with newly diagnosed philadelphia chromosome–positive (ph+) acute lymphoblastic leukemia (all): phallcon study

Author

Jabbour, E., Martinelli, G., Vignetti, M., Kantarjian, H., Gómez Almaguer, D., Minami, Y., Dombret, H., Hennessy, M., Vorog, A., Wang, B., Ribera, J. M., Jabbour, E., Martinelli, G., Vignetti, M., Kantarjian, H., Gómez Almaguer, D., Minami, Y., Dombret, H., Hennessy, M., Vorog, A., Wang, B., and Ribera, J. M.

Published
2022

13. ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol

Author

Buccisano, F, Palmieri, R, Piciocchi, A, Arena, V, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, de Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Capria, S, Maurillo, L, Del Principe, M, Paterno, G, Consalvo, M, Ottone, T, Lavorgna, S, Voso, M, Fazi, P, Vignetti, M, Arcese, W, Venditti, A, Del Principe, MI, Consalvo, MAI, Voso, MT, Buccisano, F, Palmieri, R, Piciocchi, A, Arena, V, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, de Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Capria, S, Maurillo, L, Del Principe, M, Paterno, G, Consalvo, M, Ottone, T, Lavorgna, S, Voso, M, Fazi, P, Vignetti, M, Arcese, W, Venditti, A, Del Principe, MI, Consalvo, MAI, and Voso, MT

Abstract

The 2017 version of the European LeukemiaNet (ELN) recommendations, by integrating cytogenetics and mutational status of specific genes, divides patients with acute myeloid leukemia into 3 prognostically distinct risk categories: favorable (ELN2017-FR), intermediate (ELN2017-IR), and adverse (ELN2017-AR). We performed a post hoc analysis of the GIMEMA (Gruppo Italiano Malattie EMatologiche dell’Adulto) AML1310 trial to investigate the applicability of the ELN2017 risk stratification to our study population. In this trial, after induction and consolidation, patients in complete remission were to receive an autologous stem cell transplant (auto-SCT) if categorized as favorable risk or an allogeneic stem cell transplant (allo-SCT) if adverse risk. Intermediate-risk patients were to receive auto-SCT or allo-SCT based on the postconsolidation levels of measurable residual disease as measured by using flow cytometry. Risk categorization was originally conducted according to the 2009 National Comprehensive Cancer Network recommendations. Among 500 patients, 445 (89%) were reclassified according to the ELN2017 criteria: ELN2017-FR, 186 (41.8%) of 455; ELN2017-IR, 179 (40.2%) of 445; and ELN2017-AR, 80 (18%) of 455. In 55 patients (11%), ELN2017 was not applicable. Two-year overall survival (OS) was 68.8%, 51.3%, 45.8%, and 42.8% for the ELN2017-FR, ELN2017-IR, ELN2017-not classifiable, and ELN2017-AR groups, respectively (P, .001). When comparing the 2 different transplant strategies in each ELN2017 risk category, a significant benefit of auto-SCT over allo-SCT was observed among ELN2017-FR patients (2-year OS of 83.3% vs 66.7%; P 5 .0421). The 2 transplant procedures performed almost equally in the ELN2017-IR group (2-year OS of 73.9% vs 70.8%; P 5 .5552). This post hoc analysis of the GIMEMA AML1310 trial confirms that the ELN2017 classification is able to accurately discriminate patients with different outcomes and who may benefit from different transplant strategies. Th

Published
2022

17. INCB84344-201: Ponatinib and steroids in frontline therapy for unfit patients with Ph1 acute lymphoblastic leukemia

Author

Martinelli, G., Papayannidis, C., Piciocchi, A., Robustelli, V., Soverini, S., Terragna, C., Marconi, G., Lemoli, R. M., Guolo, F., Fornaro, A., Lunghi, M., de Fabritiis, P., Candoni, A., Selleri, C., Simonetti, F., Bocchia, M., Vitale, A., Frison, L., Tedeschi, A., Cuneo, A., Bonifacio, M., Martelli, M. P., D'Ardia, S., Trappolini, S., Tosi, P., Galieni, P., Fabbiano, F., Abbenante, M. C., Granier, M., Zhu, Z., Wang, M., Sartor, C., Paolini, S., Cavo, M., Foa, R., Fazi, P., Vignetti, M., and Baccarani, M.

Published
2022

18. Prognostic impact of KMT2A-AFF1-positivity in 926 BCR-ABL1-negative B-lineage acute lymphoblastic leukemia patients treated in GIMEMA clinical trials since 1996

Author

Piciocchi, A., Messina, M., Elia, L., Vitale, A., Soddu, S., Testi, A. M., Chiaretti, S., Mancini, M., Albano, F., Spadano, A., Krampera, M., Bonifacio, M., Cairoli, R., Vetro, C., Colella, F., Ferrara, F., Cimino, G., Bassan, R., Fazi, P., Vignetti, M., Piciocchi, A, Messina, M, Elia, L, Vitale, A, Soddu, S, Testi, A, Chiaretti, S, Mancini, M, Albano, F, Spadano, A, Krampera, M, Bonifacio, M, Cairoli, R, Vetro, C, Colella, F, Ferrara, F, Cimino, G, Bassan, R, Fazi, P, and Vignetti, M

Subjects
Adult, Male, Oncogene Proteins, Fusion, Prognosi, DNA-Binding Protein, bcr-abl, Fusion Proteins, bcr-abl, Histone-Lysine N-Methyltransferase, MED/15 - MALATTIE DEL SANGUE, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, DNA-binding proteins, adult, female, fusion proteins, bcr-abl, humans, male, Female, Survival Analysi, Transcriptional Elongation Factors, fusion proteins, Myeloid-Lymphoid Leukemia Protein, Human
Published
2021

19. LABNET AML: AN EFFICIENT NETWORK THAT CONNECTS HEMATOLOGY CENTERS AND LABORATORIES FOR A HIGH-LEVEL DIAGNOSTIC/PROGNOSTIC WORKUP OF AML

Author

Voso, M. T., Cucci, R., Messina, M., Santoro, A., Divona, M., Albano, F., Ottaviani, E., Roberta Bertorelle, Guerrasio, A., Gottardi, E., Izzo, B., Tarantini, G., Scardocci, A., Siragusa, S., Forghieri, F., Cairoli, R., Cambo, B., Vallisa, D., Venditti, A., Ferrara, F., Mannina, D., Cilloni, D., La Sala, E., Piciocchi, A., Falini, B., Pane, F., Saglio, G., Vignetti, M., Amadori, S., Voso, M, Cucci, R, Messina, M, Santoro, A, Divona, M, Albano, F, Ottaviani, E, Bertorelle, R, Guerrasio, A, Gottardi, E, Izzo, B, Tarantini, G, Scardocci, A, Siragusa, S, Forghieri, F, Cairoli, R, Cambo, B, Vallisa, D, Venditti, A, Ferrara, F, Mannina, D, Cilloni, D, La, S, Piciocchi, A, Falini, B, Pane, F, Saglio, G, Vignetti, M, and Amadori, S

Subjects
Hematology
Published
2021

20. Clofarabine in combination with a standard remission induction regimen (cytosine arabinoside and idarubicin) in patients with previously untreated intermediate and bad-risk acute myelogenous leukemia (AML) or high-risk myelodysplastic syndrome (HR-MDS): phase I results of an ongoing phase I/II study of the leukemia groups of EORTC and GIMEMA (EORTC GIMEMA 06061/AML-14A trial)

Author

Willemze, R., Suciu, S., Muus, P., Halkes, C. J. M., Meloni, G., Meert, L., Karrasch, M., Rapion, J., Vignetti, M., Amadori, S., de Witte, T., and Marie, J. P.

Published
2014
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21. Bendamustine in combination with Ofatumumab in relapsed or refractory chronic lymphocytic leukemia: a GIMEMA Multicenter Phase II Trial

Author

Cortelezzi, A, Sciumè, M, Liberati, A M, Vincenti, D, Cuneo, A, Reda, G, Laurenti, L, Zaja, F, Marasca, R, Chiarenza, A, Gritti, G, Orsucci, L, Storti, S, Angelucci, E, Cascavilla, N, Gobbi, M, Mauro, F R, Morabito, F, Fabris, S, Piciocchi, A, Vignetti, M, Neri, A, Rossi, D, Giannarelli, D, Guarini, A, and Foà, R

Published
2014
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24. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, Lo-Coco, F, Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, and Lo-Coco F.

Published
2019

25. IN ADULT ACUTE MYELOID LEUKEMIA (AML) PERIPHERAL BLOOD MEASURABLE RESIDUAL DISEASE (MRD) BY FLOW CYTOMETRY (FC) IS FEASIBLE AND IS PROGNOSTICALLY RELEVANT

Author

Maurillo, L, Buccisano, F, Piciocchi, A, Del Principe, M, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Mazza, P, Martelli, M, Cuneo, A, Albano, F, Fabbiano, F, Tafuri, A, Chierichini, A, Tieghi, A, Fracchiolla, N, Capelli, D, Foa, R, Alati, C, La Sala, E, Voso, M, Fazi, P, Vignetti, M, Consalvo, M, Ottone, T, Lavorgna, S, Arcese, W, Lo Coco, F, Amadori, S, Venditti, A, Maurillo L, Buccisano F, Piciocchi A, Del Principe MI, Candoni A, Melillo L, Calafiore V, Cairoli R, De Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Mazza P, Martelli MP, Cuneo A, Albano F, Fabbiano F, Tafuri A, Chierichini A, Tieghi A, Fracchiolla NS, Capelli D, Foa R, Alati C, La Sala E, Voso MT, Fazi P, Vignetti M, Consalvo MI, Ottone T, Lavorgna S, Arcese W, Lo Coco F, Amadori S, Venditti a., Maurillo, L, Buccisano, F, Piciocchi, A, Del Principe, M, Candoni, A, Melillo, L, Calafiore, V, Cairoli, R, De Fabritiis, P, Storti, G, Salutari, P, Lanza, F, Martinelli, G, Luppi, M, Mazza, P, Martelli, M, Cuneo, A, Albano, F, Fabbiano, F, Tafuri, A, Chierichini, A, Tieghi, A, Fracchiolla, N, Capelli, D, Foa, R, Alati, C, La Sala, E, Voso, M, Fazi, P, Vignetti, M, Consalvo, M, Ottone, T, Lavorgna, S, Arcese, W, Lo Coco, F, Amadori, S, Venditti, A, Maurillo L, Buccisano F, Piciocchi A, Del Principe MI, Candoni A, Melillo L, Calafiore V, Cairoli R, De Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Mazza P, Martelli MP, Cuneo A, Albano F, Fabbiano F, Tafuri A, Chierichini A, Tieghi A, Fracchiolla NS, Capelli D, Foa R, Alati C, La Sala E, Voso MT, Fazi P, Vignetti M, Consalvo MI, Ottone T, Lavorgna S, Arcese W, Lo Coco F, Amadori S, and Venditti a.

Published
2019

26. 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
Full Text
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28. Efficacy of idelalisib and rituximab in relapsed/refractory chronic lymphocytic leukemia treated outside of clinical trials. A report of the Gimema Working Group

Author

Rigolin, G. M., Cavazzini, F., Piciocchi, A., Arena, V., Visentin, A., Reda, G., Zamprogna, G., Cibien, F., Vitagliano, O., Coscia, M., Farina, L., Gaidano, G., Murru, R., Varettoni, M., Paolini, R., Sportoletti, P., Pietrasanta, D., Molinari, A. L., Quaglia, F. M., Laurenti, L., Marasca, R., Marchetti, M., Mauro, F. R., Crea, E., Vignetti, M., Gentile, M., Montillo, M., Foa, R., Cuneo, A., Chiarenza, A., Perbellini, O., Mannina, D., Sancetta, R., Olivieri, A., Molica, S., Pane, F., Patti, C., Iliariucci, F., Gozzetti, A., Califano, C., Galieni, P., Augello, A. F., Vallisa, D., Cura, F., Frustaci, A. M., Fazi, P., Trentin, L., and Ferrara, F.

Subjects
Male, Oncology, Cancer Research, idelalisib, law.invention, 0302 clinical medicine, Randomized controlled trial, Recurrence, law, Original Research Articles, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Original Research Article, Chronic, Aged, 80 and over, Leukemia, real‐world evidence, Hematology, General Medicine, Middle Aged, Lymphocytic, Survival Rate, 030220 oncology & carcinogenesis, Female, Rituximab, Refractory Chronic Lymphocytic Leukemia, Idelalisib, chronic lymphocytic leukemia, real-world evidence, Aged, Disease-Free Survival, Humans, Leukemia, Lymphocytic, Chronic, B-Cell, Purines, Quinazolinones, medicine.drug, medicine.medical_specialty, NO, 03 medical and health sciences, Internal medicine, medicine, Survival rate, Performance status, business.industry, B-Cell, Clinical trial, Settore MED/15 - MALATTIE DEL SANGUE, Regimen, business, 030215 immunology
Abstract

Because the efficacy of new drugs reported in trials may not translate into similar results when used in the real‐life, we analyzed the efficacy of idelalisib and rituximab (IR) in 149 patients with relapsed/refractory chronic lymphocytic leukemia treated at 34 GIMEMA centers. Median progression‐free survival (PFS) and overall survival were 22.9 and 44.5 months, respectively; performance status (PS) ≥2 and ≥3 previous lines of therapy were associated with shorter PFS and overall survival (OS). 48% of patients were on treatment at 12 months; the experience of the centers (≥5 treated patients) and PS 0–1 were associated with a significantly longer treatment duration (p = 0.015 and p = 0.002, respectively). TP53 disruption had no prognostic significance. The overall response rate to subsequent treatment was 49.2%, with median OS of 15.5 months and not reached in patients who discontinued, respectively, for progression and for toxicity (p

Published
2021

31. 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

32. Blastic plasmocitoid dendritic cell neoplasm with leukemic spread: a GIMEMA survey

Author

Valentini, C. G., Piciocchi, A., Facchetti, F., Guolo, F., Pulsoni, A., Vignetti, M., Pagano, Livio, Pagano L. (ORCID:0000-0001-8287-928X), Valentini, C. G., Piciocchi, A., Facchetti, F., Guolo, F., Pulsoni, A., Vignetti, M., Pagano, Livio, and Pagano L. (ORCID:0000-0001-8287-928X)

Abstract

no abstract

Published
2021

35. Different isoforms of the B-cell mutator activation-induced cytidine deaminase are aberrantly expressed in BCR–ABL1-positive acute lymphoblastic leukemia patients

Author

Iacobucci, I, Lonetti, A, Messa, F, Ferrari, A, Cilloni, D, Soverini, S, Paoloni, F, Arruga, F, Ottaviani, E, Chiaretti, S, Messina, M, Vignetti, M, Papayannidis, C, Vitale, A, Pane, F, Piccaluga, P P, Paolini, S, Berton, G, Baruzzi, A, Saglio, G, Baccarani, M, Foà, R, and Martinelli, G

Published
2010
Full Text
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36. VERY LONG-TERM RESULTS OF ALL-TRANS RETINOIC ACID AND ARSENIC TRIOXIDE IN NON-HIGH RISK ACUTE PROMYELOCYTIC LEUKEMIA: LATEST UPDATE OF THE ITALIAN-GERMAN APL0406 RANDOMIZED TRIAL

Author

Cicconi L, Platzbecker U, Avvisati G, Paoloni F, Thiede C, Vignetti M, Fazi P, Ferrara F, Divona M, Albano F, Efficace F, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Annibali O, Wattad M, Lubbert M, Brandts C, Hanel M, Rollig C, Schmitz N, Lin H, Frairia C, Fozza C, Maria D’Arco A, Di Renzo N, Cortelezzi A, Fabbiano F, Dohner K, Ganser A, Dohner H, Amadori S, Mandelli F, Teresa Voso M, Ehninger G, Schlenk RF, Lo-Coco F., Cicconi, L, Platzbecker, U, Avvisati, G, Paoloni, F, Thiede, C, Vignetti, M, Fazi, P, Ferrara, F, Divona, M, Albano, F, Efficace, F, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Annibali, O, Wattad, M, Lubbert, M, Brandts, C, Hanel, M, Rollig, C, Schmitz, N, Lin, H, Frairia, C, Fozza, C, Maria D’Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Dohner, K, Ganser, A, Dohner, H, Amadori, S, Mandelli, F, Teresa Voso, M, Ehninger, G, Schlenk, R, and Lo-Coco, F

Subjects
Hematology
Published
2019

38. Impact of the type of anthracycline and of stem cell transplantation in younger patients with acute myeloid leukaemia: Long-term follow up of a phase III study

Author

Baron, F., Efficace, F., Cannella, L., Muus, P., Trisolini, S., Halkes, C.J., Fazi, P., Vignetti, M., Marie, J.P., Chiusolo, P., Velden, W.J. van der, La Sala, E., Vitolo, U., Thomas, X., Lefrere, F., Raimondo, F. Di, Bourhis, J.H., Specchia, G., Guimaraes, J.E., Allione, B., Vrhovac, R., Ferrara, F., Stevens-Kroef, M.J., Meert, L., Witte, T.J. de, Willemze, R., Amadori, S., Suciu, S., Baron, F., Efficace, F., Cannella, L., Muus, P., Trisolini, S., Halkes, C.J., Fazi, P., Vignetti, M., Marie, J.P., Chiusolo, P., Velden, W.J. van der, La Sala, E., Vitolo, U., Thomas, X., Lefrere, F., Raimondo, F. Di, Bourhis, J.H., Specchia, G., Guimaraes, J.E., Allione, B., Vrhovac, R., Ferrara, F., Stevens-Kroef, M.J., Meert, L., Witte, T.J. de, Willemze, R., Amadori, S., and Suciu, S.

Abstract

Item does not contain fulltext, We provide a long-term evaluation of patients enrolled in the EORTC/GIMEMA AML-10 trial which included a total of 2157 patients, 15-60 years old, randomized to receive either daunorubicin (DNR, 50 mg/m(2) ), mitoxantrone (MXR, 12 mg/m(2) ), or idarubicin (IDA, 10 mg/m(2) ) in addition to standard-dose cytarabine and etoposide for induction chemotherapy and intermediate dose cytarabine for consolidation. Younger patients who reached complete remission with complete (CR) or incomplete (CRi) recovery were then scheduled to receive an allogeneic hematopoietic stem cell transplantation (HSCT). That was if they had a HLA-identical sibling donor; in all other cases, an autologous HSCT had to be administered. At an 11-year median follow-up, the 5-year, 10-year and 15-year overall survival (OS) rates were 33.2%, 30.1% and 28.0%, respectively. No significant difference between the three randomized groups regarding OS was observed (P = .38). In young patients, 15-45 years old, no treatment difference (P = .89) regarding OS was observed, while in patients 46-60 years old, MXR and IDA groups had a trend for a longer OS as compared to the DNR group (P = .029). Among younger patients without a favorable MRC cytogenetic risk subgroup who achieved a CR/CRi after induction chemotherapy, those with a HLA-identical sibling donor had higher 10-year and 15-year OS rates than those without. In older patients who reached CR/CRi, the long-term outcomes of those with or without a donor was similar. In conclusion, long-term outcomes of the study confirmed similar OS in the three randomized groups in the whole cohort of patients.

Published
2020

39. Long-term follow-up of a trial comparing post-remission treatment with autologous or allogeneic bone marrow transplantation or intensive chemotherapy in younger acute myeloid leukemia patients

Author

Baron, F., Efficace, F., Cannella, L., Willemze, R., Vignetti, M., Muus, P., Marie, J.P., Ferrero, D., Fazi, P., La Sala, E., Bourhis, J.H., Fabbiano, F., Bosi, A., Sborgia, M., Martinelli, G., Wittnebel, S., Trisolini, S., Petti, M.C., Halkes, C.J., Velden, W.J.F.M. van der, Witte, T.J. de, Amadori, S., Zittoun, R.A., Suciu, S., Baron, F., Efficace, F., Cannella, L., Willemze, R., Vignetti, M., Muus, P., Marie, J.P., Ferrero, D., Fazi, P., La Sala, E., Bourhis, J.H., Fabbiano, F., Bosi, A., Sborgia, M., Martinelli, G., Wittnebel, S., Trisolini, S., Petti, M.C., Halkes, C.J., Velden, W.J.F.M. van der, Witte, T.J. de, Amadori, S., Zittoun, R.A., and Suciu, S.

Abstract

Contains fulltext : 218286.pdf (publisher's version ) (Open Access)

Published
2020

40. Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study

Author

Cuneo, A, Mato, AR, Rigolin, GM, Piciocchi, A, Gentile, M, Laurenti, L, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Winter, A, Lamanna, N, Tam, CS, Jacobs, R, Lansigan, F, Barr, PM, Shadman, M, Skarbnik, AP, Pu, JJ, Sehgal, AR, Schuster, SJ, Shah, NN, Ujjani, CS, Roeker, L, Orlandi, EM, Billio, A, Trentin, L, Spacek, M, Marchetti, M, Tedeschi, A, Ilariucci, F, Gaidano, G, Doubek, M, Farina, L, Molica, S, Di Raimondo, F, Coscia, M, Mauro, FR, de la Serna, J, Medina Perez, A, Ferrarini, I, Cimino, G, Cavallari, M, Cucci, R, Vignetti, M, Foa, R, Ghia, P, Cuneo, A, Mato, AR, Rigolin, GM, Piciocchi, A, Gentile, M, Laurenti, L, Allan, JN, Pagel, JM, Brander, DM, Hill, BT, Winter, A, Lamanna, N, Tam, CS, Jacobs, R, Lansigan, F, Barr, PM, Shadman, M, Skarbnik, AP, Pu, JJ, Sehgal, AR, Schuster, SJ, Shah, NN, Ujjani, CS, Roeker, L, Orlandi, EM, Billio, A, Trentin, L, Spacek, M, Marchetti, M, Tedeschi, A, Ilariucci, F, Gaidano, G, Doubek, M, Farina, L, Molica, S, Di Raimondo, F, Coscia, M, Mauro, FR, de la Serna, J, Medina Perez, A, Ferrarini, I, Cimino, G, Cavallari, M, Cucci, R, Vignetti, M, Foa, R, and Ghia, P

Abstract

Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) <70 mL/min and/or CIRS score >6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.

Published
2020

41. Efficacy of bendamustine and rituximab in unfit patients with previously untreated chronic lymphocytic leukemia. Indirect comparison with ibrutinib in a real-world setting. A GIMEMA-ERIC and US study

Author

Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., Foa R., Cuneo, A., Mato, A. R., Rigolin, G. M., Piciocchi, A., Gentile, Marino, Laurenti, Luca, Allan, J. N., Pagel, J. M., Brander, D. M., Hill, B. T., Winter, A., Lamanna, N., Tam, C. S., Jacobs, R., Lansigan, F., Barr, P. M., Shadman, M., Skarbnik, A. P., Pu, J. J., Sehgal, A. R., Schuster, S. J., Shah, N. N., Ujjani, C. S., Roeker, L., Orlandi, E. M., Billio, Atto, Trentin, L., Spacek, M., Marchetti, M., Tedeschi, Alessandra, Ilariucci, F., Gaidano, G., Doubek, M., Farina, L., Molica, Serena, Di Raimondo, F., Coscia, M., Mauro, F. R., de la Serna, J., Medina Perez, A., Ferrarini, I., Cimino, Giovanni, Cavallari, M., Cucci, R., Vignetti, M., Foa, Robin, Ghia, P., Gentile M., Laurenti L. (ORCID:0000-0002-8327-1396), Billio A., Tedeschi A., Molica S., Cimino G., and Foa R.

Abstract

Limited information is available on the efficacy of front-line bendamustine and rituximab (BR) in chronic lymphocytic leukemia (CLL) with reduced renal function or coexisting conditions. We therefore analyzed a cohort of real-world patients and performed a matched adjusted indirect comparison with a cohort of patients treated with ibrutinib. One hundred and fifty-seven patients with creatinine clearance (CrCl) <70 mL/min and/or CIRS score >6 were treated with BR. The median age was 72 years; 69% of patients had ≥2 comorbidities and the median CrCl was 59.8 mL/min. 17.6% of patients carried TP53 disruption. The median progression-free survival (PFS) was 45 months; TP53 disruption was associated with a shorter PFS (P = 0.05). The overall survival (OS) at 12, 24, and 36 months was 96.2%, 90.1%, and 79.5%, respectively. TP53 disruption was associated with an increased risk of death (P = 0.01). Data on 162 patients ≥65 years treated with ibrutinib were analyzed and compared with 165 patients ≥65 years treated with BR. Factors predicting for a longer PFS at multivariable analysis in the total patient population treated with BR and ibrutinib were age (HR 1.06, 95% CI 1.02-1.10, P < 0.01) and treatment with ibrutinib (HR 0.55, 95% CI 0.33-0.93, P = 0.03). In a post hoc analysis of patients in advanced stage, a significant PFS advantage was observed in patient who had received ibrutinib (P = 0.03), who showed a trend for OS advantage (P = 0.08). We arrived at the following conclusions: (a) BR is a relatively effective first-line regimen in a real-world population of unfit patients without TP53 disruption, (b) ibrutinib provided longer disease control than BR in patients with advanced disease stage.

Published
2020

42. Survival improvement over time of 960 s-AML patients included in 13 EORTC-GIMEMA-HOVON trials

Author

Ramadan, SM, Suciu, S, Stevens-Kroef, MJ, Willemze, R, Amadori, S, Witte, T, Löwenberg, Bob, Muus, P, Labar, B, Meert, L, de Schaetzen, G, Meloni, G, Leone, G, Vignetti, M, Marie, JP, Lübbert, M, Baron, F, Ramadan, SM, Suciu, S, Stevens-Kroef, MJ, Willemze, R, Amadori, S, Witte, T, Löwenberg, Bob, Muus, P, Labar, B, Meert, L, de Schaetzen, G, Meloni, G, Leone, G, Vignetti, M, Marie, JP, Lübbert, M, and Baron, F

Published
2020

43. Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups

Author

Amadori, S, Suciu, S, Stasi, R, Willemze, R, Mandelli, F, Selleslag, D, Denzlinger, C, Muus, P, Stauder, R, Berneman, Z, Pruijt, J, Nobile, F, Cassibba, V, Marie, J-P, Beeldens, F, Baila, L, Vignetti, M, and de Witte, T

Published
2005
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49. 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, U, Avvisati, G, Cicconi, L, Thiede, C, Paoloni, F, Vignetti, M, Ferrara, F, Divona, M, Albano, F, Efficace, F, Fazi, P, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Wattad, M, Lübbert, M, Brandts, C, Hänel, M, Röllig, C, Schmitz, N, Link, H, Frairia, C, Pogliani, E, Fozza, C, D'Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Döhner, K, Ganser, A, Döhner, H, Amadori, S, Mandelli, F, Ehninger, G, Schlenk, R, Lo-Coco, F, Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, Ferrara F, Divona M, Albano F, Efficace F, Fazi P, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Wattad M, Lübbert M, Brandts CH, Hänel M, Röllig C, Schmitz N, Link H, Frairia C, Pogliani EM, Fozza C, D'Arco AM, Di Renzo N, Cortelezzi A, Fabbiano F, Döhner K, Ganser A, Döhner H, Amadori S, Mandelli F, Ehninger G, Schlenk RF, Lo-Coco F., Platzbecker, U, Avvisati, G, Cicconi, L, Thiede, C, Paoloni, F, Vignetti, M, Ferrara, F, Divona, M, Albano, F, Efficace, F, Fazi, P, Sborgia, M, Di Bona, E, Breccia, M, Borlenghi, E, Cairoli, R, Rambaldi, A, Melillo, L, La Nasa, G, Fiedler, W, Brossart, P, Hertenstein, B, Salih, H, Wattad, M, Lübbert, M, Brandts, C, Hänel, M, Röllig, C, Schmitz, N, Link, H, Frairia, C, Pogliani, E, Fozza, C, D'Arco, A, Di Renzo, N, Cortelezzi, A, Fabbiano, F, Döhner, K, Ganser, A, Döhner, H, Amadori, S, Mandelli, F, Ehninger, G, Schlenk, R, Lo-Coco, F, Platzbecker U, Avvisati G, Cicconi L, Thiede C, Paoloni F, Vignetti M, Ferrara F, Divona M, Albano F, Efficace F, Fazi P, Sborgia M, Di Bona E, Breccia M, Borlenghi E, Cairoli R, Rambaldi A, Melillo L, La Nasa G, Fiedler W, Brossart P, Hertenstein B, Salih HR, Wattad M, Lübbert M, Brandts CH, Hänel M, Röllig C, Schmitz N, Link H, Frairia C, Pogliani EM, Fozza C, D'Arco AM, Di Renzo N, Cortelezzi A, Fabbiano F, Döhner K, Ganser A, Döhner H, Amadori S, Mandelli F, Ehninger G, Schlenk RF, and Lo-Coco F.

Abstract

Purpose: The initial results of the APL0406 trial showed that the combination of all-trans-retinoic acid (ATRA) and arsenic trioxide (ATO) is at least not inferior to standard ATRA and chemotherapy (CHT) in first-line therapy of low- or intermediate-risk acute promyelocytic leukemia (APL). We herein report the final analysis on the complete series of patients enrolled onto this trial. Patients and Methods: The APL0406 study was a prospective, randomized, multicenter, open-label, phase III noninferiority trial. Eligible patients were adults between 18 and 71 years of age with newly diagnosed, low- or intermediate-risk APL (WBC at diagnosis ≤ 10 × 109/L). Overall, 276 patients were randomly assigned to receive ATRA-ATO or ATRA-CHT between October 2007 and January 2013. Results: Of 263 patients evaluable for response to induction, 127 (100%) of 127 patients and 132 (97%) of 136 patients achieved complete remission (CR) in the ATRA-ATO and ATRA-CHT arms, respectively (P = .12). After a median follow-up of 40.6 months, the event-free survival, cumulative incidence of relapse, and overall survival at 50 months for patients in the ATRA-ATO versus ATRA-CHT arms were 97.3% v 80%, 1.9% v 13.9%, and 99.2% v 92.6%, respectively (P < .001, P = .0013, and P = .0073, respectively). Postinduction events included two relapses and one death in CR in the ATRA-ATO arm and two instances of molecular resistance after third consolidation, 15 relapses, and five deaths in CR in the ATRA-CHT arm. Two patients in the ATRA-CHT arm developed a therapy-related myeloid neoplasm. Conclusion: These results show that the advantages of ATRA-ATO over ATRA-CHT increase over time and that there is significantly greater and more sustained antileukemic efficacy of ATO-ATRA compared with ATRA-CHT in low- and intermediate-risk APL.

Published
2017

50. IKZF1 (IKAROS) deletions represent a poor prognostic marker in BCR-ABL1 positive acute lymphoblastic leukaemia patients: a GIMEMA ALL WP report: O133

Author

Iacobucci, I., Lonetti, A., Ferrari, A., Vignetti, M., Storlazzi, C. T., Paoloni, F., Cilloni, D., Soverini, S., Vitale, A., Chiaretti, S., Cimino, G., Astolfi, A., Testoni, N., Papayannidis, C., Paolini, S., Piccaluga, PP., Elia, L., Messa, F., DellʼAgnola, C., Cingarlini, S., Meloni, G., Leone, G., Amadori, S., Russo, D., Saglio, G., Pane, F., Baccarani, M., Foà, R., and Martinelli, G.

Published
2009

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