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Start Over Author "Avvisati, G." Publisher american society of hematology
20 results on '"Avvisati, G."'

1. Bortezomib-thalidomide-dexamethasone is superior to thalidomide-dexamethasone as consolidation therapy after autologous hematopoietic stem cell transplantation in patients with newly diagnosed multiple myeloma

Author

Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, F, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, M, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, Quartarone, E, Tosi P, Motta MR, Rizzi S, Fanin R, Buttignol S, Foà R, Levi A, Calabrese E, Rambaldi A, Galli M, Rossi G, Ferrari S, Bringhen S, Leoni P, Offidani M, Polloni C, Corradini P, Montefusco V, Torelli G, Narni F, Fioritoni G, Spadano A, Cortelazzo S, Pescosta N, Billio A, Lambertenghi Deliliers G, Baldini L, Onida F, Annaloro C, La Nasa G, Ledda A, Zaccaria A, Cellini C, De Fabritiis P, Caravita T, Siniscalchi A, Cascavilla N, Bosi A, Semenzato G, Gugliotta L, Merli F, Gherlinzoni F, Angelucci E, Martelli M, Petti MC, Pisani F, Leone G, Rossi E, Za T, Fianchi L, Catania G, Spriano M, Ciceri F, Peccatori J, Girlanda S, Santoro A, Castagna L, Palmieri S, Nobile F, D'Arco AM, Levis A, Primon V, Tamiazzo S, Guardigni L, Pasini S, Gallamini A, Pietrantuono G, Martorelli MC, Fattori P, Pasquini E, Galieni P, Ruggieri M, Morandi S, Tajana M, Amadori D, Ronconi S, Cangini D, Ceccolini M, Gobbi M, Ballerini F, Pane F, Catalano L, Cangialosi C, Vallisa D, Lazzaro A, Paladini G, De Sabbata G, Mozzana R, Ciambelli F, Pinotti G, Rodeghiero F, Elice F, Cantore N, Volpe S, Pavone V, Mele A, POGLIANI, ENRICO MARIA, Rossini F, Liberati A, Majolino I, De Rosa L, Amadori S, Rizzo M, Lauria F, Gozzetti A, Aglietta M, Capaldi A, Quarta G, Mele G, Storti S, Fraticelli V, Morabito F, Gentile C, Capalbo S, Gianni A, Magni M, Mettivier V, Nunziata G, Rizzoli V, Giuliani N, Crugnola M, Bernasconi C, Fregoni V, Visani G, Olivieri A, Pizzuti M, La Verde G, Moscetti A, Avvisati G, Tirindelli M, Longinotti M, Podda L, Gallo E, Pregno P, Dammacco F, Perosa F, Russo D, Roccaro A, Bacigalupo A, Dominietto A, Musolino C, Quartarone E., Cavo, M, Pantani, L, Petrucci, M, Patriarca, F, Zamagni, E, Donnarumma, D, Crippa, C, Boccadoro, M, Perrone, G, Falcone, A, Nozzoli, C, Zambello, R, Masini, L, Furlan, A, Brioli, A, Derudas, D, Ballanti, S, Dessanti, M, De Stefano, V, Carella, A, Marcatti, M, Nozza, A, Ferrara, F, Callea, V, Califano, C, Pezzi, A, Baraldi, A, Grasso, M, Musto, P, Palumbo, A, Tosi, P, Motta, M, Rizzi, S, Fanin, R, Buttignol, S, Foà, R, Levi, A, Calabrese, E, Rambaldi, A, Galli, M, Rossi, G, Ferrari, S, Bringhen, S, Leoni, P, Offidani, M, Polloni, C, Corradini, P, Montefusco, V, Torelli, G, Narni, F, Fioritoni, G, Spadano, A, Cortelazzo, S, Pescosta, N, Billio, A, Lambertenghi Deliliers, G, Baldini, L, Onida, F, Annaloro, C, La Nasa, G, Ledda, A, Zaccaria, A, Cellini, C, De Fabritiis, P, Caravita, T, Siniscalchi, A, Cascavilla, N, Bosi, A, Semenzato, G, Gugliotta, L, Merli, F, Gherlinzoni, F, Angelucci, E, Martelli, M, Petti, M, Pisani, F, Leone, G, Rossi, E, Za, T, Fianchi, L, Catania, G, Spriano, M, Ciceri, F, Peccatori, J, Girlanda, S, Santoro, A, Castagna, L, Palmieri, S, Nobile, F, D'Arco, A, Levis, A, Primon, V, Tamiazzo, S, Guardigni, L, Pasini, S, Gallamini, A, Pietrantuono, G, Martorelli, M, Fattori, P, Pasquini, E, Galieni, P, Ruggieri, M, Morandi, S, Tajana, M, Amadori, D, Ronconi, S, Cangini, D, Ceccolini, M, Gobbi, M, Ballerini, F, Pane, F, Catalano, L, Cangialosi, C, Vallisa, D, Lazzaro, A, Paladini, G, De Sabbata, G, Mozzana, R, Ciambelli, F, Pinotti, G, Rodeghiero, F, Elice, F, Cantore, N, Volpe, S, Pavone, V, Mele, A, Pogliani, E, Rossini, F, Liberati, A, Majolino, I, De Rosa, L, Amadori, S, Rizzo, M, Lauria, F, Gozzetti, A, Aglietta, M, Capaldi, A, Quarta, G, Mele, G, Storti, S, Fraticelli, V, Morabito, F, Gentile, C, Capalbo, S, Gianni, A, Magni, M, Mettivier, V, Nunziata, G, Rizzoli, V, Giuliani, N, Crugnola, M, Bernasconi, C, Fregoni, V, Visani, G, Olivieri, A, Pizzuti, M, La Verde, G, Moscetti, A, Avvisati, G, Tirindelli, M, Longinotti, M, Podda, L, Gallo, E, Pregno, P, Dammacco, F, Perosa, F, Russo, D, Roccaro, A, Bacigalupo, A, Dominietto, A, Musolino, C, Quartarone, E, Tosi P, Motta MR, Rizzi S, Fanin R, Buttignol S, Foà R, Levi A, Calabrese E, Rambaldi A, Galli M, Rossi G, Ferrari S, Bringhen S, Leoni P, Offidani M, Polloni C, Corradini P, Montefusco V, Torelli G, Narni F, Fioritoni G, Spadano A, Cortelazzo S, Pescosta N, Billio A, Lambertenghi Deliliers G, Baldini L, Onida F, Annaloro C, La Nasa G, Ledda A, Zaccaria A, Cellini C, De Fabritiis P, Caravita T, Siniscalchi A, Cascavilla N, Bosi A, Semenzato G, Gugliotta L, Merli F, Gherlinzoni F, Angelucci E, Martelli M, Petti MC, Pisani F, Leone G, Rossi E, Za T, Fianchi L, Catania G, Spriano M, Ciceri F, Peccatori J, Girlanda S, Santoro A, Castagna L, Palmieri S, Nobile F, D'Arco AM, Levis A, Primon V, Tamiazzo S, Guardigni L, Pasini S, Gallamini A, Pietrantuono G, Martorelli MC, Fattori P, Pasquini E, Galieni P, Ruggieri M, Morandi S, Tajana M, Amadori D, Ronconi S, Cangini D, Ceccolini M, Gobbi M, Ballerini F, Pane F, Catalano L, Cangialosi C, Vallisa D, Lazzaro A, Paladini G, De Sabbata G, Mozzana R, Ciambelli F, Pinotti G, Rodeghiero F, Elice F, Cantore N, Volpe S, Pavone V, Mele A, POGLIANI, ENRICO MARIA, Rossini F, Liberati A, Majolino I, De Rosa L, Amadori S, Rizzo M, Lauria F, Gozzetti A, Aglietta M, Capaldi A, Quarta G, Mele G, Storti S, Fraticelli V, Morabito F, Gentile C, Capalbo S, Gianni A, Magni M, Mettivier V, Nunziata G, Rizzoli V, Giuliani N, Crugnola M, Bernasconi C, Fregoni V, Visani G, Olivieri A, Pizzuti M, La Verde G, Moscetti A, Avvisati G, Tirindelli M, Longinotti M, Podda L, Gallo E, Pregno P, Dammacco F, Perosa F, Russo D, Roccaro A, Bacigalupo A, Dominietto A, Musolino C, and Quartarone E.

Abstract

In a randomized, phase 3 study, superior complete/near-complete response (CR/nCR) rates and extended progression-free survival were demonstrated with bortezomib-thalidomide-dexamethasone (VTD) versus thalidomide-dexamethasone (TD) as induction therapy before, and consolidation after, double autologous stem cell transplantation for newly diagnosed myeloma patients (intention-to-treat analysis; VTD, n = 236; TD, n = 238). This per-protocol analysis (VTD, n = 160; TD, n = 161) specifically assessed the efficacy and safety of consolidation with VTD or TD. Before starting consolidation, CR/nCR rates were not significantly different in the VTD (63.1%) and TD arms (54.7%). After consolidation, CR (60.6% vs 46.6%) and CR/nCR (73.1% vs 60.9%) rates were significantly higher for VTD-treated versus TD-treated patients. VTD consolidation significantly increased CR and CR/nCR rates, but TD did not (McNemar test). With a median follow-up of 30.4 months from start of consolidation, 3-year progression-free survival was significantly longer for the VTD group (60% vs 48% for TD). Grade 2 or 3 peripheral neuropathy (8.1% vs 2.4%) was more frequent with VTD (grade 3, 0.6%) versus TD consolidation. The superior efficacy of VTD versus TD as induction was retained despite readministration as consolidation therapy after double autologous transplantation. VTD consolidation therapy significantly contributed to improved clinical outcomes observed for patients randomly assigned to the VTD arm of the study. The study is registered at www.clinicaltrials.gov as #NCT01134484.

Published
2012

3. Increased body mass index correlates with higher risk of disease relapse and differentiation syndrome in patients with acute promyelocytic leukemia treated with the AIDA protocols

Author

Breccia, M, Mazzarella, L, Bagnardi, V, Disalvatore, D, Loglisci, G, Cimino, G, Testi, A, Avvisati, G, Petti, M, Minotti, C, Latagliata, R, Foà, R, Pelicci, P, Lo Coco, F, BAGNARDI, VINCENZO, Testi, AM, Petti, MC, Pelicci, PG, Lo Coco, F., Breccia, M, Mazzarella, L, Bagnardi, V, Disalvatore, D, Loglisci, G, Cimino, G, Testi, A, Avvisati, G, Petti, M, Minotti, C, Latagliata, R, Foà, R, Pelicci, P, Lo Coco, F, BAGNARDI, VINCENZO, Testi, AM, Petti, MC, Pelicci, PG, and Lo Coco, F.

Abstract

We investigated whether body mass index (BMI) correlates with distinct outcomes in newly diagnosed acute promyelocytic leukemia (APL). The study population included 144 patients with newly diagnosed and genetically confirmed APL consecutively treated at a single institution. All patients received All-trans retinoic acid and idarubicin according to the GIMEMA protocols AIDA-0493 and AIDA-2000. Outcome estimates according to the BMI were carried out together with multivariable analysis for the risk of relapse and differentiation syndrome. Fifty-four (37.5%) were under/normal weight (BMI < 25), whereas 90 (62.5%) patients were overweight/obese (BMI ≥ 25). An increased BMI was associated with older age (P < .0001) and male sex (P = .02). BMI was the most powerful predictor of differentiation syndrome in multivariable analysis (odds ratio = 7.24; 95% CI, 1.50-34; P = .014). After a median follow-up of 6 years, the estimated cumulative incidence of relapse at 5 years was 31.6% (95% CI, 22.7%-43.8%) in overweight/obese and 11.2% (95% CI, 5.3%-23.8%) in underweight/normal weight patients (P = .029). Multivariable analysis showed that BMI was an independent predictor of relapse (hazard ratio = 2.45, 95% CI, 1.00-5.99, in overweight/obese vs under/normal weight patients, P = .049). An increased BMI at diagnosis is associated with a higher risk of developing differentiation syndrome and disease relapse in APL patients treated with AIDA protocols. © 2012 by The American Society of Hematology.

Published
2012

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

Author

Avvisati, G, Lo Coco, F, Paoloni, F, Petti, M, Diverio, D, Vignetti, M, Latagliata, R, Specchia, G, Baccarani, M, Di Bona, E, Fioritoni, G, Marmont, F, Rambaldi, A, Di Raimondo, F, Kropp, M, Pizzolo, G, Pogliani, E, Rossi, G, Cantore, N, Nobile, F, Gabbas, A, Ferrara, F, Fazi, P, Amadori, S, Mandelli, F, Paoloni, FP, Petti, MC, Kropp, MG, POGLIANI, ENRICO MARIA, Mandelli, F., Avvisati, G, Lo Coco, F, Paoloni, F, Petti, M, Diverio, D, Vignetti, M, Latagliata, R, Specchia, G, Baccarani, M, Di Bona, E, Fioritoni, G, Marmont, F, Rambaldi, A, Di Raimondo, F, Kropp, M, Pizzolo, G, Pogliani, E, Rossi, G, Cantore, N, Nobile, F, Gabbas, A, Ferrara, F, Fazi, P, Amadori, S, Mandelli, F, Paoloni, FP, Petti, MC, Kropp, MG, POGLIANI, ENRICO MARIA, and Mandelli, F.

Abstract

All-trans-retinoic acid (ATRA) has greatly modified the prognosis of acute promyelocytic leukemia; however, the role of maintenance in patients in molecular complete remission after consolidation treatment is still debated. From July 1993 to May 2000, 807 genetically proven newly diagnosed acute promyelocytic leukemia patients received ATRA plus idarubicin as induction, followed by 3 intensive consolidation courses. Thereafter, patients reverse-transcribed polymerase chain reaction-negative for the PML-RARA fusion gene were randomized into 4 arms: oral 6-mercaptopurine and intramuscular methotrexate (arm 1); ATRA alone (arm 2); 3 months of arm1 alternating to 15 days of arm 2 (arm 3); and no further therapy (arm 4). Starting from February 1997, randomization was limited to ATRA-containing arms only (arms 2 and 3). Complete remission was achieved in 761 of 807 (94.3%) patients, and 681 completed the consolidation program. Of these, 664 (97.5%) were evaluated for the PML-RARA fusion gene, and 586 of 646 (90.7%) who tested reverse-transcribed polymerase chain reaction-negative were randomized to maintenance. The event-free survival estimate at 12 years was 68.9% (95% confidence interval, 66.4%-71.4%), and no differences in disease-free survival at 12 years were observed among the maintenance arms.

Published
2011

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

Author

Lo Coco, F, Avvisati, G, Vignetti, M, Breccia, M, Gallo, E, Rambaldi, A, Paoloni, F, Fioritoni, G, Ferrara, F, Specchia, G, Cimino, G, Diverio, D, Borlenghi, E, Martinelli, G, Di Raimondo, F, Di Bona, E, Fazi, P, Peta, A, Bosi, A, Carella, A, Fabbiano, F, Pogliani, E, Petti, M, Amadori, S, Mandelli, F, Carella, AM, Petti, MC, Mandelli, F., POGLIANI, ENRICO MARIA, Lo Coco, F, Avvisati, G, Vignetti, M, Breccia, M, Gallo, E, Rambaldi, A, Paoloni, F, Fioritoni, G, Ferrara, F, Specchia, G, Cimino, G, Diverio, D, Borlenghi, E, Martinelli, G, Di Raimondo, F, Di Bona, E, Fazi, P, Peta, A, Bosi, A, Carella, A, Fabbiano, F, Pogliani, E, Petti, M, Amadori, S, Mandelli, F, Carella, AM, Petti, MC, Mandelli, F., and POGLIANI, ENRICO MARIA

Abstract

After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving all-trans retinoic and idarubicin (AIDA)-like therapies, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) designed a protocol for newly diagnosed APL (AIDA-2000) in which postremission treatment was risk-adapted. Patients with low/intermediate risk received remission at 3 anthracycline-based consolidation courses, whereas high-risk patients received the same schedule as in the previous, non-risk-adapted AIDA-0493 trial including cytarabine. In addition, all patients in the AIDA-2000 received all-trans retinoic acid (ATRA) for 15 days during each consolidation. After induction, 600 of 636 (94.3%) and 420 of 445 (94.4%) patients achieved complete remission in the AIDA-0493 and AIDA-2000, respectively. The 6-year overall survival and cumulative incidence of relapse (CIR) rates were 78.1% versus 87.4% (P = .001) and 27.7% versus 10.7% (P < .0001). Significantly lower CIR rates for patients in the AIDA-2000 were most evident in the high-risk group (49.7% vs 9.3%, respectively, P < .0001). Our data confirm that anthracycline-based consolidation is at least equally effective as cytarabine-containing regimens for low-/intermediate-risk patients and suggest that a risk-adapted strategy including ATRA for consolidation improves outcome in newly diagnosed APL. Furthermore, our results highlight the role of cytarabine coupled to anthracyclines and ATRA during consolidation in the high-risk group.

Published
2010

6. Therapy-Related Myelodysplastic Syndrome (sMDS) /Acute Myelogenous Leukemia (sAML) in Acute Promyelocytic Leukemia (APL) Patients with Long-Lasting Molecular Remission: The GIMEMA Experience.

Author

Latagliata, R., primary, Breccia, M., primary, Fazi, P., primary, Gubbiotti, S., primary, Di Bona, E., primary, Specchia, G., primary, Chiarenza, A., primary, Murru, R., primary, Carella, A.M., primary, Ferrara, F., primary, Rossi, G., primary, Melillo, L., primary, Sica, S., primary, Invernizzi, R., primary, Cimino, G., primary, Petti, M.C., primary, Avvisati, G., primary, Lo-Coco, F., primary, and Mandelli, F., primary

Published
2005
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7. Long-Term Results of the GIMEMA LAP AIDA 0493 Amended Protocol in Elderly Patients with Acute Promyelocytic Leukemia (APL).

Author

Latagliata, R., primary, Breccia, M., primary, Fazi, P., primary, Vignetti, M., primary, Cupri, A., primary, Sborgia, M., primary, Vincelli, D., primary, Candoni, A., primary, Salvi, F., primary, Rupoli, S., primary, Martinelli, G., primary, Kropp, M.G., primary, Di Rienzo, N., primary, Zampaglione, V., primary, Venditti, A., primary, Melillo, L., primary, Cimino, G., primary, Petti, M.C., primary, Avvisati, G., primary, Coco, F. Lo, primary, and Mandelli, F., primary

Published
2005
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14. Identification of DNA rearrangements at the retinoic acid receptor- alpha (RAR-alpha) locus in all patients with acute promyelocytic leukemia (APL) and mapping of APL breakpoints within the RAR-alpha second intron. Italian Cooperative Study Group "GIMEMA"

Author

Diverio, D, primary, Lo Coco, F, additional, D'Adamo, F, additional, Biondi, A, additional, Fagioli, M, additional, Grignani, F, additional, Rambaldi, A, additional, Rossi, V, additional, Avvisati, G, additional, and Petti, MC, additional

Published
1992
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17. Front-line treatment of acute promyelocytic leukemia with AIDA induction followed by risk-adapted consolidation for adults younger than 61 years: results of the AIDA-2000 trial of the GIMEMA Group

Author

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

Subjects
Adult, Acute promyelocytic leukemia, medicine.medical_specialty, Adolescent, Anthracycline, Immunology, Antineoplastic Agents, Tretinoin, Biochemistry, Antineoplastic Agent, Young Adult, Leukemia, Promyelocytic, Acute, MED/15 - MALATTIE DEL SANGUE, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Idarubicin, Anthracyclines, Cumulative incidence, Antibiotics, Antineoplastic, Antineoplastic Combined Chemotherapy Protocol, business.industry, Remission Induction, Cytarabine, ACUTE PROMYELOCYTIC LEUKEMIA (APL), Cell Biology, Hematology, Middle Aged, medicine.disease, Surgery, Clinical trial, ALL-TRANS RETINOIC AND IDARUBICIN (AIDA), Leukemia, business, Settore MED/15 - Malattie del Sangue, Human, GIMEMA, medicine.drug
Abstract

After the identification of discrete relapse-risk categories in patients with acute promyelocytic leukemia (APL) receiving all-trans retinoic and idarubicin (AIDA)–like therapies, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) designed a protocol for newly diagnosed APL (AIDA-2000) in which postremission treatment was risk-adapted. Patients with low/intermediate risk received remission at 3 anthracycline-based consolidation courses, whereas high-risk patients received the same schedule as in the previous, non–risk-adapted AIDA-0493 trial including cytarabine. In addition, all patients in the AIDA-2000 received all-trans retinoic acid (ATRA) for 15 days during each consolidation. After induction, 600 of 636 (94.3%) and 420 of 445 (94.4%) patients achieved complete remission in the AIDA-0493 and AIDA-2000, respectively. The 6-year overall survival and cumulative incidence of relapse (CIR) rates were 78.1% versus 87.4% (P = .001) and 27.7% versus 10.7% (P < .0001). Significantly lower CIR rates for patients in the AIDA-2000 were most evident in the high-risk group (49.7% vs 9.3%, respectively, P < .0001). Our data confirm that anthracycline-based consolidation is at least equally effective as cytarabine-containing regimens for low-/intermediate-risk patients and suggest that a risk-adapted strategy including ATRA for consolidation improves outcome in newly diagnosed APL. Furthermore, our results highlight the role of cytarabine coupled to anthracyclines and ATRA during consolidation in the high-risk group. This trial was registered at www.clinicaltrials.gov as #NCT 001064570.

Published
2010
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18. Increased BMI correlates with higher risk of disease relapse and differentiation syndrome in patients with acute promyelocytic leukemia treated with the AIDA protocols

Author

Giuseppe Avvisati, Massimo Breccia, Francesco Lo-Coco, Davide Disalvatore, Roberto Latagliata, Luca Mazzarella, Vincenzo Bagnardi, Maria Concetta Petti, Clara Minotti, Giuseppina Loglisci, Pier Giuseppe Pelicci, Anna Maria Testi, Robin Foà, Giuseppe Cimino, Breccia, M, Mazzarella, L, Bagnardi, V, Disalvatore, D, Loglisci, G, Cimino, G, Testi, A, Avvisati, G, Petti, M, Minotti, C, Latagliata, R, Foà, R, Pelicci, P, and Lo Coco, F

Subjects
Male, Overweight, Biochemistry, Leukemia, Promyelocytic, Acute, Risk Factors, Antineoplastic Combined Chemotherapy Protocols, Cumulative incidence, Child, Adolescent, Adult, Aged, Child, Preschool, Female, Follow-Up Studies, Humans, Idarubicin, Infant, Infant, Newborn, Middle Aged, Neoplasm Recurrence, Local, Obesity, Prognosis, Survival Rate, Syndrome, Tretinoin, Young Adult, Body Mass Index, Promyelocytic, Leukemia, Hazard ratio, Hematology, Local, medicine.symptom, Underweight, Acute promyelocytic leukemia, medicine.medical_specialty, Immunology, body mass index, Acute, Internal medicine, medicine, Preschool, business.industry, Cell Biology, Odds ratio, Newborn, medicine.disease, Surgery, Neoplasm Recurrence, business, Settore MED/15 - Malattie del Sangue, Body mass index, Weight gain
Abstract

We investigated whether body mass index (BMI) correlates with distinct outcomes in newly diagnosed acute promyelocytic leukemia (APL). The study population included 144 patients with newly diagnosed and genetically confirmed APL consecutively treated at a single institution. All patients received All-trans retinoic acid and idarubicin according to the GIMEMA protocols AIDA-0493 and AIDA-2000. Outcome estimates according to the BMI were carried out together with multivariable analysis for the risk of relapse and differentiation syndrome. Fifty-four (37.5%) were under/normal weight (BMI < 25), whereas 90 (62.5%) patients were overweight/obese (BMI ≥ 25). An increased BMI was associated with older age (P < .0001) and male sex (P = .02). BMI was the most powerful predictor of differentiation syndrome in multivariable analysis (odds ratio = 7.24; 95% CI, 1.50-34; P = .014). After a median follow-up of 6 years, the estimated cumulative incidence of relapse at 5 years was 31.6% (95% CI, 22.7%-43.8%) in overweight/obese and 11.2% (95% CI, 5.3%-23.8%) in underweight/normal weight patients (P = .029). Multivariable analysis showed that BMI was an independent predictor of relapse (hazard ratio = 2.45, 95% CI, 1.00-5.99, in overweight/obese vs under/normal weight patients, P = .049). An increased BMI at diagnosis is associated with a higher risk of developing differentiation syndrome and disease relapse in APL patients treated with AIDA protocols.

Published
2012
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19. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance

Author

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

Subjects
Male, fusion, Oncogene Proteins, Fusion, Biochemistry, oncogene proteins, Clinical Protocols, Leukemia, Promyelocytic, Acute, Antineoplastic Combined Chemotherapy Protocols, AIDA 0493 protocol, genetics, administration /&/ dosage, Child, promyelocytic, acute promyelocytic leukemia, Hematology, acute, adolescent, adult, aged, antineoplastic combined chemotherapy protocols, child, clinical protocols, diagnosis/drug therapy/genetics, disease-free survival, female, humans, idarubicin, infant, leukemia, male, middle aged, preschool, remission induction, tretinoin, young adult, Remission Induction, Middle Aged, Leukemia, Child, Preschool, Female, medicine.drug, Human, Acute promyelocytic leukemia, Adult, medicine.medical_specialty, Randomization, Adolescent, Immunology, Tretinoin, Disease-Free Survival, Young Adult, Internal medicine, medicine, Idarubicin, Humans, Clinical Protocol, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Cancer, Infant, Cell Biology, medicine.disease, Surgery, Methotrexate, business, Settore MED/15 - Malattie del Sangue
Abstract

All-trans-retinoic acid (ATRA) has greatly modified the prognosis of acute promyelocytic leukemia; however, the role of maintenance in patients in molecular complete remission after consolidation treatment is still debated. From July 1993 to May 2000, 807 genetically proven newly diagnosed acute promyelocytic leukemia patients received ATRA plus idarubicin as induction, followed by 3 intensive consolidation courses. Thereafter, patients reverse-transcribed polymerase chain reaction–negative for the PML-RARA fusion gene were randomized into 4 arms: oral 6-mercaptopurine and intramuscular methotrexate (arm 1); ATRA alone (arm 2); 3 months of arm1 alternating to 15 days of arm 2 (arm 3); and no further therapy (arm 4). Starting from February 1997, randomization was limited to ATRA-containing arms only (arms 2 and 3). Complete remission was achieved in 761 of 807 (94.3%) patients, and 681 completed the consolidation program. Of these, 664 (97.5%) were evaluated for the PML-RARA fusion gene, and 586 of 646 (90.7%) who tested reverse-transcribed polymerase chain reaction–negative were randomized to maintenance. The event-free survival estimate at 12 years was 68.9% (95% confidence interval, 66.4%-71.4%), and no differences in disease-free survival at 12 years were observed among the maintenance arms.

Published
2011

20. Prednisone vs high-dose dexamethasone in newly diagnosed adult primary immune thrombocytopenia: a randomized trial.

Author

Mazzucconi MG, Rodeghiero F, Avvisati G, De Stefano V, Gugliotta L, Ruggeri M, Vianelli N, Fazi P, Paoloni F, Sargentini V, Baldacci E, Ferretti A, Martino B, Vincelli ID, Carli G, Fortuna S, Di Ianni M, Ranalli P, Palandri F, Polverelli N, Lugli E, Rivolti E, Patriarca A, Rago A, D'Adda M, Gentile M, Siragusa S, Sibilla S, Carella AM, Rossi E, Battistini R, Zaja F, Bocchia M, Di Renzo N, Musto P, Crugnola M, Giuffrida AC, Krampera M, Tafuri A, and Santoro C

Subjects
Adult, Humans, Prednisone adverse effects, Dexamethasone, Platelet Count, Disease-Free Survival, Purpura, Thrombocytopenic, Idiopathic diagnosis, Purpura, Thrombocytopenic, Idiopathic drug therapy, Purpura, Thrombocytopenic, Idiopathic chemically induced
Abstract

Abstract: A debate exists regarding which type of corticosteroids (standard-dose prednisone [PDN] or high-dose dexamethasone [HD-DXM]) is the best first-line treatment for adult patients with newly diagnosed untreated primary immune thrombocytopenia (pITP). An ad hoc study compared PDN with HD-DXM in newly diagnosed untreated patients with pITP (aged ≥18 but ≤80 years, platelet count of ≤20 or >20 but <50 × 109/L, and bleeding score of ≥8). Patients were randomised to receive PDN 1 mg/kg per day from days 0 to 28 (Arm A) or HD-DXM 40 mg per day for 4 days, every 14 days, for 3 consecutive courses (Arm B). Fifty-nine of 113 patients (52.2%) were randomized to Arm A and 54 of 113 (47.8%) to Arm B. In evaluable patients, total initial responses (complete response [CR], partial response [PR], minimal response [MR]) were 44 of 56 (78.57%) in Arm A and 46 of 49 (93.88%) in Arm B at days 42 and 46, respectively (P = 0.0284). Total final responses (at day 180 from initial response) were 26 of 43 (60.47%) in Arm A and 23 of 39 (58.97%) in Arm B (P = 0.8907). Total persistent responses (at 12 months from initial response) were 25 of 31 (80.65%) in Arm A and 20 of 36 (55.56%) in Arm B (P = 0.0292). Seven relapses occurred. Median follow-up was 44.4 months. Overall survival was 100% at 48 months, overall disease-free survival was 81.11% at 48 months from day 180. PDN and pulsed HD-DXM were well tolerated; HD-DXM allows effective initial responses but less long lasting than PDN. This trial was registered at www.clinicaltrials.gov as #NCT00657410., (© 2024 by The American Society of Hematology. Licensed under Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International (CC BY-NC-ND 4.0), permitting only noncommercial, nonderivative use with attribution. All other rights reserved.)

Published
2024
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