20 results on '"Kropp, Mg"'
Search Results
2. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance
- Author
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Avvisati, G, Lo Coco, F, Paoloni, Fp, Petti, Mc, Diverio, D, Vignetti, M, Latagliata, R, Specchia, G, Baccarani, M, Di Bona, E, Fioritoni, G, Marmont, F, Rambaldi, A, DI RAIMONDO, Francesco, Kropp, Mg, Pizzolo, G, Pogliani, Em, Rossi, G, Cantore, N, Nobile, F, Gabbas, A, Ferrara, F, Fazi, P, Amadori, S, Mandelli, F, Gimema, Aieop, and EORTC Cooperative Groups
- Published
- 2011
3. LONG-TERM FOLLOW-UP AND SAFETY OF DASATINIB IN CML/ALL PH1+ IMATINIB RESISTANT PATIENTS IN A COMPASSIONATE USE PROGRAM
- Author
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Gozzini, A, Stagno, F, Rege Cambrin, G, Luciano, L, Breccia, M, Abruzzese, E, Martinelli, G, Orlandi, E, Gobbi, M, Pregno, P, Sica, S, Pungolino, E, Angelucci, E, Musso, M, Bruno, B, Galimberti, S, Nieddu, R, Specchia, G, Kropp, Mg, Annunziata, M, Musto, P, Cervellera, P, Carella, Am, Pini, M, Radaelli, F, Meneghini, V, Russo, D, Montefusco, E, Marasca, R, and Gaidano, G
- Published
- 2009
4. Imatinib in adult and elderly Ph+ ALL patients: preliminary results of the GIMEMA prospective study LAL0201
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Vignetti, M, Fazi, P, Meloni, G, Chiarenza, A, Malagola, Michele, Fabbiano, F, Recchia, A, Kropp, Mg, Offidani, M, Palmieri, S, Cilloni, D, Torelli, G, Elia, L, Ribersani, M, Baccarani, M, and Mandelli, F.
- Published
- 2004
5. Dramatic improvement in CR rate and CR duration with imatinib in adult and elderly Ph plus ALL patients: Results of the GIMEMA prospective study LAL0201
- Author
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Vignetti, Marco, Fazi, P, Meloni, Giovanna, Chiarenza, A, Malagola, M, Fabbiano, F, Recchia, A, Kropp, Mg, Offidani, M, Palmieri, S, Cilloni, D, Torelli, G, Cimino, Giuseppe, Foa, Roberto, Baccarani, M, and Mandelli, F.
- Published
- 2004
6. AIDA: The italian way of treating acute promyelocytic leukemia (APL): final act
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Avvisati, G, Petti, Mc, Lo Coco, F, Testi, Am, Fazi, P, Specchia, G, Malagola, Michele, Di Bona, E, Recchia, A, Marmont, F, Buelli, M, Lazzarino, M, Di Raimondo, F, Leoni, F, Kropp, Mg, Veneri, D, Miccolis, I, Rossi, G, Venditti, A, and Mandelli, F.
- Published
- 2003
7. MRD1/P-gp, MRP1 and LRP expression: frequency and prognostic role in adult acute lymphoblastic leukemia patients uniformly treated according to the GIMEMA 0496 protocol
- Author
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Tafuri, Agostino, Gregorj, C, Petrucci, Mt, Ricciardi, Maria Rosaria, Sborgia, N, Tedeschi, A, Di Raimondo, F, Mirto, S, Liso, V, Kropp, Mg, Ferrara, F, Carella, Am, Gallo, E, Nobile, F, Pizzolo, G, Annino, L, Vitale, A, Vignetti, M, Foà, R, and Mandelli, Franco
- Published
- 2001
8. Adult T-cell acute lymphoblastic leucemia: biologic profile at presentation and correlation with response to induction treatment in patients enrolled in the GIMEMA LAL 0496 protocol
- Author
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Agostino Tafuri, Maria Grazia Kropp, Robin Foà, Giuseppe Saglio, Fabrizio Pane, Felicetto Ferrara, Cristina Mecucci, Marco Vignetti, Nicola Cascavilla, Patrizio Mazza, Antonella Vitale, Francesco Fabbiano, Francesca Paoloni, Giuseppe Cimino, Marco Mancini, Antonio Cuneo, Cristina Ariola, Giovanna Meloni, Claudio Fozza, Anna Guarini, Antonio Romano, Mauro Krampera, Annamaria Grazia Recchia, Vitale, A, Guarini, A, Ariola, C, Mancini, M, Mecucci, C, Cuneo, A, Pane, Fabrizio, Saglio, G, Cimino, G, Tafuri, A, Meloni, G, Fabbiano, F, Recchia, A, Kropp, Mg, Krampera, M, Cascavilla, N, Ferrara, F, Romano, A, Mazza, P, Fozza, C, Paoloni, F, Vignetti, M, and Foa, R.
- Subjects
Adult ,Male ,medicine.medical_specialty ,Pathology ,Adolescent ,Oncogene Proteins, Fusion ,Immunology ,CD33 ,Drug resistance ,ACUTE MYELOID-LEUKEMIA ,Biochemistry ,Gastroenterology ,Immunophenotyping ,Antigen ,ACUTE LYMPHOCYTIC-LEUKEMIA ,Acute lymphocytic leukemia ,Internal medicine ,medicine ,PROGNOSTIC FACTORS ,HOMOZYGOUS DELETIONS ,Humans ,Leukemia-Lymphoma, Adult T-Cell ,ACUTE LYMPHOCYTIC-LEUKEMIA, ACUTE MYELOID-LEUKEMIA, P-GLYCOPROTEIN P-170, CLINICAL-SIGNIFICANCE, MULTIDRUG-RESISTANCE, PROGNOSTIC FACTORS, CYTOGENETIC ABNORMALITIES, HOMOZYGOUS DELETIONS, CD34 EXPRESSION, RAP1GDS1 GENES ,Clinical significance ,ATP Binding Cassette Transporter, Subfamily B, Member 1 ,MULTIDRUG-RESISTANCE ,CLINICAL-SIGNIFICANCE ,RAP1GDS1 GENES ,CYTOGENETIC ABNORMALITIES ,Chromosome Aberrations ,business.industry ,Remission Induction ,Cytogenetics ,Cell Biology ,Hematology ,Middle Aged ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,medicine.disease ,Prognosis ,Drug Resistance, Multiple ,Treatment Outcome ,P-GLYCOPROTEIN P-170 ,Cytogenetic Analysis ,Alanine aminopeptidase ,Female ,business ,CD34 EXPRESSION - Abstract
Between 1996 and 2000, 90 newly diagnosed adult patients with T-acute lymphoblastic leukemia (T-ALL) were registered in the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Leucemia Acuta Limfoide (LAL) 0496 protocol. Cases were centrally processed for morphology, immunophenotype, cytogenetics, molecular biology, and multidrug resistance (MDR). Twenty-two patients were females and 68 were males. Four percent of cases were pro-T, 47% pre-T, 39% cortical T, and 10% mature T-ALL. Fifty-six percent of patients with pro-T + pre-T-ALL achieved complete remission (CR) compared with 91% for cortical + mature cases (P = .002). CD34 expression was associated with a significantly lower CR rate: 54% versus 84% (P = .009). Thirty-one (36.5%) of 85 patients had an abnormal karyotype, the most common abnormality (15%) being a partial del(6q). The cytogenetic profile did not impact on CR achievement. MDR1 function, present in 26% of cases, correlated significantly with CR achievement (P = .004). A highly significant (P = .001) difference in CR rate was observed between patients who did not express the CD13/CD33/CD34 antigens and were MDR functionally negative (96%) compared with patients positive for at least one of these markers (57%). Multivariate analysis showed an impact on CR achievement for CD33 expression and MDR1 function. An extensive biologic workup of adult T-ALL cases at presentation is recommended in order to design tailored therapeutic strategies aimed at improving CR rates.
- Published
- 2006
9. A comprehensive genetic classification of adult acute lymphoblastic leukemia (ALL): analysis of the GIMEMA 0496 protocol
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Luciana Annino, Fabrizio Pane, Antonella Vitale, Franco Mandelli, Robin Foà, Mauro Nanni, Agostino Tafuri, Giuseppe Saglio, Andrea Camera, Giuseppe Cimino, Daniela Scappaticci, Francesco Nobile, Gianluigi Castoldi, Valentina Derme, Nicola Cascavilla, Alessandra Tedeschi, Antonio Cuneo, Pietro Leoni, Filippo Marmont, Antonio Tabilio, Cristina Mecucci, Maria Grazia Kropp, Marco Vignetti, Francesco Fabbiano, Francesco Di Raimondo, Giuseppe Fioritoni, Giorgina Specchia, Marco Mancini, Giuseppe Todeschini, Mario Luppi, Loredana Elia, Felicetto Ferrara, Mancini, M, Scappaticci, D, Cimino, G, Nanni, M, Derme, V, Elia, L, Tafuri, A, Vignetti, M, Vitale, A, Cuneo, A, Castoldi, G, Saglio, G, Pane, Fabrizio, Mecucci, C, Camera, A, Specchia, G, Tedeschi, A, DI RAIMONDO, F, Fioritoni, G, Mirto, S, Marmont, F, Ferrara, F, Cascavilla, N, Todeschini, G, Nobile, F, Kropp, Mg, Leoni, P, Tabilio, A, Luppi, M, Annino, L, Mandelli, F, and Foa, R.
- Subjects
Oncology ,Adult ,Male ,medicine.medical_specialty ,Pathology ,Adolescent ,Oncogene Proteins, Fusion ,Immunology ,Biochemistry ,Text mining ,Risk Factors ,hemic and lymphatic diseases ,Internal medicine ,Acute lymphocytic leukemia ,medicine ,Humans ,Survival analysis ,Chromosome Aberrations ,Analysis of Variance ,Ploidies ,business.industry ,Cytogenetics ,Karyotype ,Cell Biology ,Hematology ,Middle Aged ,Precursor Cell Lymphoblastic Leukemia-Lymphoma ,medicine.disease ,Classification ,Prognosis ,Survival Analysis ,medicine.anatomical_structure ,Treatment Outcome ,Karyotyping ,ALL ,genetic profile ,Cytogenetic Analysis ,Adult Acute Lymphoblastic Leukemia ,Female ,Hyperdiploidy ,Bone marrow ,business - Abstract
The Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) 0496 protocol, through the central handling of bone marrow samples at presentation, allowed us to combine cytogenetic and molecular information on a large series of adults with acute lymphoblastic leukemia (ALL) treated homogeneously, enabling us to define as broadly as possible their genetic profile and to determine the impact on outcome of the cytogenetic-molecular signature. Of 414 patients centrally processed, 325 were considered for the categorization into the following cytogenetic-molecular subgroups: normal, t(9;22)/BCR-ABL, t(4;11)/MLL-AF4, t(1;19)/E2A-PBX1, 9p/p15-p16 deletions, 6q deletions, miscellaneous structural abnormalities, and hyperdiploid. The inclusion into each subgroup was based on a hierarchical approach: molecular abnormalities with adverse prognosis had precedence over karyotypic changes with less-defined prognosis and the latter over ploidy. Patients without abnormalities and those with isolated 9p/p15-p16 deletions showed a relatively favorable outcome (median disease-free survival [DFS], > 3 years). The t(9;22)/BCR-ABL, t(4;11)/MLL-AF4, t(1; 19)/E2A-PBX1 defined a group with dismal prognosis (median DFS, 7 months), whereas 6q deletions, miscellaneous aberrations, and hyperdiploidy predicted an intermediate prognosis (median DFS, 19 months). This study highlights the importance of a combined cytogenetic-molecular profiling of adult ALL at presentation as a critical independent determinant of their outcome, providing further evidence of the necessity of a risk-adapted therapeutic algorithm for an optimal management of these patients.
- Published
- 2005
10. PML-RARα kinetics and impact of FLT3-ITD mutations in newly diagnosed acute promyelocytic leukaemia treated with ATRA and ATO or ATRA and chemotherapy.
- Author
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Cicconi L, Divona M, Ciardi C, Ottone T, Ferrantini A, Lavorgna S, Alfonso V, Paoloni F, Piciocchi A, Avvisati G, Ferrara F, Di Bona E, Albano F, Breccia M, Cerqui E, Sborgia M, Kropp MG, Santoro A, Levis A, Sica S, Amadori S, Voso MT, Mandelli F, and Lo-Coco F
- Subjects
- Adolescent, Adult, Aged, Arsenic Trioxide, Arsenicals therapeutic use, Disease-Free Survival, Female, Humans, Induction Chemotherapy methods, Italy, Kinetics, Leukemia, Promyelocytic, Acute genetics, Leukemia, Promyelocytic, Acute mortality, Male, Middle Aged, Mutation, Oxides therapeutic use, Prognosis, Tretinoin therapeutic use, Young Adult, Arsenicals administration & dosage, Leukemia, Promyelocytic, Acute drug therapy, Oncogene Proteins, Fusion blood, Oxides administration & dosage, Tretinoin administration & dosage, fms-Like Tyrosine Kinase 3 genetics
- Abstract
The APL0406 study showed that arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) are not inferior to standard ATRA and chemotherapy (CHT) in newly diagnosed, low-intermediaterisk acute promyelocytic leukaemia (APL). We analysed the kinetics of promyelocytic leukaemia-retinoic acid receptor-α (PML-RARα) transcripts by real-time quantitative PCR (RQ-PCR) in bone marrow samples from 184 patients and assessed the prognostic impact of fms-related tyrosine kinase 3-internal tandem duplication (FLT3-ITD) in 159 patients enrolled in this trial in Italy. After induction therapy, the reduction of PML-RARα transcripts was significantly greater in patients receiving ATRA-CHT as compared with those treated with ATRA-ATO (3.4 vs 2.9 logs; P=0.0182). Conversely, at the end of consolidation, a greater log reduction of PML-RARα transcripts was detected in the ATRA-ATO as compared with the ATRA-CHT group (6.3 vs 5.3 logs; P=0.0024). FLT3-ITD mutations had no significant impact on either event-free survival (EFS) or cumulative incidence of relapse in patients receiving ATRA-ATO, whereas a trend for inferior EFS was observed in FLT3-ITD-positive patients receiving ATRA-CHT. Our study shows at the molecular level that ATRA-ATO exerts at least equal and probably superior antileukaemic efficacy compared with ATRA-CHT in low-intermediaterisk APL. The data also suggest that ATRA-ATO may abrogate the negative prognostic impact of FLT3-ITD.
- Published
- 2016
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11. Randomized phase III trial of retinoic acid and arsenic trioxide versus retinoic acid and chemotherapy in patients with acute promyelocytic leukemia: health-related quality-of-life outcomes.
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Efficace F, Mandelli F, Avvisati G, Cottone F, Ferrara F, Di Bona E, Specchia G, Breccia M, Levis A, Sica S, Finizio O, Kropp MG, Fioritoni G, Cerqui E, Vignetti M, Amadori S, Schlenk RF, Platzbecker U, and Lo-Coco F
- Subjects
- Arsenic Trioxide, Humans, Leukemia, Promyelocytic, Acute psychology, Prospective Studies, Antineoplastic Agents therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Arsenicals therapeutic use, Leukemia, Promyelocytic, Acute drug therapy, Oxides therapeutic use, Quality of Life, Tretinoin therapeutic use
- Abstract
Purpose: A randomized clinical trial compared efficacy and toxicity of standard all-trans-retinoic acid (ATRA) plus chemotherapy versus ATRA plus arsenic trioxide in patients with newly diagnosed, low- or intermediate-risk acute promyelocytic leukemia (APL). Here, we report health-related quality-of-life (HRQOL) results., Patients and Methods: HRQOL was a secondary end point of this trial. The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 was used to assess HRQOL at end of induction and after consolidation therapy. All analyses were based on 156 patients who received at least one dose of treatment, with groups defined according to randomly assigned treatment. Primary analysis was performed, estimating mean HRQOL score over time and differences between treatment arms using a linear mixed model., Results: Overall, 162 patients age 18 to 70 years were enrolled. Of these, 150 and 142 patients were evaluable for HRQOL after induction therapy and third consolidation course, respectively. Overall compliance with HRQOL forms was 80.1%. The largest difference, favoring patients treated with ATRA plus arsenic trioxide, was found for fatigue severity (mean score difference, -9.3; 95% CI, -17.8 to -0.7; P = .034) at end of induction therapy. This difference was also clinically relevant. HRQOL differences between treatment arms at end of consolidation showed that for several scales, differences between treatment arms were marginal., Conclusion: Overall, current HRQOL findings further support the use of ATRA plus arsenic trioxide as preferred first-line treatment in patients with low- or intermediate-risk APL., (© 2014 by American Society of Clinical Oncology.)
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- 2014
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12. Retinoic acid and arsenic trioxide for acute promyelocytic leukemia.
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Lo-Coco F, Avvisati G, Vignetti M, Thiede C, Orlando SM, Iacobelli S, Ferrara F, Fazi P, Cicconi L, Di Bona E, Specchia G, Sica S, Divona M, Levis A, Fiedler W, Cerqui E, Breccia M, Fioritoni G, Salih HR, Cazzola M, Melillo L, Carella AM, Brandts CH, Morra E, von Lilienfeld-Toal M, Hertenstein B, Wattad M, Lübbert M, Hänel M, Schmitz N, Link H, Kropp MG, Rambaldi A, La Nasa G, Luppi M, Ciceri F, Finizio O, Venditti A, Fabbiano F, Döhner K, Sauer M, Ganser A, Amadori S, Mandelli F, Döhner H, Ehninger G, Schlenk RF, and Platzbecker U
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Arsenic Trioxide, Arsenicals adverse effects, Consolidation Chemotherapy, Disease-Free Survival, Female, Humans, Induction Chemotherapy, Leukemia, Promyelocytic, Acute genetics, Maintenance Chemotherapy, Male, Middle Aged, Neutropenia chemically induced, Oxides adverse effects, Thrombocytopenia chemically induced, Tretinoin adverse effects, Young Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Arsenicals therapeutic use, Leukemia, Promyelocytic, Acute drug therapy, Oxides therapeutic use, Tretinoin therapeutic use
- Abstract
Background: All-trans retinoic acid (ATRA) with chemotherapy is the standard of care for acute promyelocytic leukemia (APL), resulting in cure rates exceeding 80%. Pilot studies of treatment with arsenic trioxide with or without ATRA have shown high efficacy and reduced hematologic toxicity., Methods: We conducted a phase 3, multicenter trial comparing ATRA plus chemotherapy with ATRA plus arsenic trioxide in patients with APL classified as low-to-intermediate risk (white-cell count, ≤10×10(9) per liter). Patients were randomly assigned to receive either ATRA plus arsenic trioxide for induction and consolidation therapy or standard ATRA-idarubicin induction therapy followed by three cycles of consolidation therapy with ATRA plus chemotherapy and maintenance therapy with low-dose chemotherapy and ATRA. The study was designed as a noninferiority trial to show that the difference between the rates of event-free survival at 2 years in the two groups was not greater than 5%., Results: Complete remission was achieved in all 77 patients in the ATRA-arsenic trioxide group who could be evaluated (100%) and in 75 of 79 patients in the ATRA-chemotherapy group (95%) (P=0.12). The median follow-up was 34.4 months. Two-year event-free survival rates were 97% in the ATRA-arsenic trioxide group and 86% in the ATRA-chemotherapy group (95% confidence interval for the difference, 2 to 22 percentage points; P<0.001 for noninferiority and P=0.02 for superiority of ATRA-arsenic trioxide). Overall survival was also better with ATRA-arsenic trioxide (P=0.02). As compared with ATRA-chemotherapy, ATRA-arsenic trioxide was associated with less hematologic toxicity and fewer infections but with more hepatic toxicity., Conclusions: ATRA plus arsenic trioxide is at least not inferior and may be superior to ATRA plus chemotherapy in the treatment of patients with low-to-intermediate-risk APL. (Funded by Associazione Italiana contro le Leucemie and others; ClinicalTrials.gov number, NCT00482833.).
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- 2013
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13. Progressive peripheral arterial occlusive disease and other vascular events during nilotinib therapy in chronic myeloid leukemia: a single institution study.
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Levato L, Cantaffa R, Kropp MG, Magro D, Piro E, and Molica S
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- Aged, Arterial Occlusive Diseases mortality, Disease-Free Survival, Female, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive mortality, Male, Middle Aged, Peripheral Arterial Disease mortality, Pyrimidines administration & dosage, Retrospective Studies, Survival Rate, Arterial Occlusive Diseases chemically induced, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Peripheral Arterial Disease chemically induced, Pyrimidines adverse effects
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- 2013
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14. TP53 mutations are frequent in adult acute lymphoblastic leukemia cases negative for recurrent fusion genes and correlate with poor response to induction therapy.
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Chiaretti S, Brugnoletti F, Tavolaro S, Bonina S, Paoloni F, Marinelli M, Patten N, Bonifacio M, Kropp MG, Sica S, Guarini A, and Foà R
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- Adult, Humans, Oncogene Proteins, Fusion, Remission Induction, Treatment Outcome, Mutation, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma genetics, Tumor Suppressor Protein p53 genetics
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- 2013
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15. GIMEMA AIDA 0493 amended protocol for elderly patients with acute promyelocytic leukaemia. Long-term results and prognostic factors.
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Latagliata R, Breccia M, Fazi P, Vignetti M, Di Raimondo F, Sborgia M, Vincelli D, Candoni A, Salvi F, Rupoli S, Martinelli G, Kropp MG, Tonso A, Venditti A, Melillo L, Cimino G, Petti MC, Avvisati G, Lo-Coco F, and Mandelli F
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- Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Cytarabine, Hemorrhage chemically induced, Humans, Idarubicin administration & dosage, Idarubicin adverse effects, Leukemia, Promyelocytic, Acute complications, Leukemia, Promyelocytic, Acute mortality, Male, Middle Aged, Opportunistic Infections chemically induced, Prognosis, Remission Induction, Survival Analysis, Tretinoin administration & dosage, Tretinoin adverse effects, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Leukemia, Promyelocytic, Acute drug therapy
- Abstract
To reduce toxicity in elderly patients with acute promyelocytic leukaemia, in 1997 the Gruppo Italiano Malattie Ematologiche Dell'Adulto (GIMEMA) started an amended protocol for patients aged >60years, with the same induction [all-trans retinoic acid (ATRA)+idarubicin] as in younger patients, followed by a single consolidation course (idarubicin+ cytarabine) and maintenance with intermittent ATRA. Among 60 enrolled patients, 54 (90%) achieved haematological remission and six died during induction. Four additional patients died in complete remission (CR) from haemorrhage (2) and infection (2) prior or during consolidation therapy. Eleven patients relapsed at a median time of 17·5months from CR. The 5-year overall survival (OS), disease-free survival (DFS) and cumulative incidence of relapse (CIR) rates were 76·1%, 64·6% and 27·4%, respectively. Univariate analysis identified a performance score (PS)=2 as the only significant adverse prognostic factor for both OS (P=0·017) and DFS (P=0·0003). Male sex had an unfavourable impact on DFS (P=0·021) and on CIR (P=0·019), but not on OS (P=0·234). In multivariate analysis for DFS, only PS=2 retained prognostic significance (HR=4·5, P=0·0083). In conclusion, the amended GIMEMA protocol is effective, with similar relapse rate and inferior toxicity compared to the original AIDA 0493. However, considering the recent availability of effective new agents, a less aggressive approach should be tested in this setting., (© 2011 Blackwell Publishing Ltd.)
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- 2011
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16. AIDA 0493 protocol for newly diagnosed acute promyelocytic leukemia: very long-term results and role of maintenance.
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Avvisati G, Lo-Coco F, Paoloni FP, Petti MC, Diverio D, Vignetti M, Latagliata R, Specchia G, Baccarani M, Di Bona E, Fioritoni G, Marmont F, Rambaldi A, Di Raimondo F, Kropp MG, Pizzolo G, Pogliani EM, Rossi G, Cantore N, Nobile F, Gabbas A, Ferrara F, Fazi P, Amadori S, and Mandelli F
- Subjects
- Adolescent, Adult, Aged, Child, Child, Preschool, Clinical Protocols, Disease-Free Survival, Female, Humans, Idarubicin administration & dosage, Infant, Leukemia, Promyelocytic, Acute diagnosis, Leukemia, Promyelocytic, Acute genetics, Male, Middle Aged, Oncogene Proteins, Fusion genetics, Remission Induction, Tretinoin administration & dosage, Young Adult, Antineoplastic Combined Chemotherapy Protocols, Leukemia, Promyelocytic, Acute drug therapy
- 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.
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- 2011
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17. A common 93-kb duplicated DNA sequence at 1q21.2 in acute lymphoblastic leukemia and Burkitt lymphoma.
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La Starza R, Crescenzi B, Pierini V, Romoli S, Gorello P, Brandimarte L, Matteucci C, Kropp MG, Barba G, Martelli MF, and Mecucci C
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- Child, Child, Preschool, Chromosome Mapping, Female, Genes, Tumor Suppressor, Humans, In Situ Hybridization, Fluorescence, Karyotyping, Male, Middle Aged, RNA Splicing Factors, RNA-Binding Proteins genetics, Burkitt Lymphoma genetics, Chromosome Aberrations, Chromosomes, Human, Pair 1 genetics, Gene Duplication, Precursor Cell Lymphoblastic Leukemia-Lymphoma genetics
- Abstract
In three patients with acute lymphoblastic leukemia (ALL) and in another with Burkitt lymphoma (BL), conventional cytogenetics and fluorescence in situ hybridization (FISH), applied singly or in combination, showed 1q duplication in two cases of ALL with hyperdiploid karyotypes, 1q duplication resulting from an unbalanced translocation in a third case of ALL, and inv dup(1)(q) in a patient with BL. Centromeric or telomeric breakpoints and extension of the 1q duplicons varied in each case. FISH defined a minimal, common duplicated region of 93kb at band 1q21.2 corresponding to clone RP11-212K13. In this region three putative oncogenes or tumor suppressor genes have been mapped: SF3B4 (splicing factor 3b, subunit 4), OTUD7B (OTU domain containing 7B), and MTMR11 (myotubularin related protein 11). For the first time, a minimal common 1q21.2 duplicated sequence has been identified in lymphoid malignancies in a region where putative oncogenes or suppressor genes have been mapped. This finding elucidates the genomic background of ALL and BL with 1q duplication and provides the basis for molecular studies investigating which genes are involved in leukemogenesis or disease progression in these cases.
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- 2007
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18. Adult T-cell acute lymphoblastic leukemia: biologic profile at presentation and correlation with response to induction treatment in patients enrolled in the GIMEMA LAL 0496 protocol.
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Vitale A, Guarini A, Ariola C, Mancini M, Mecucci C, Cuneo A, Pane F, Saglio G, Cimino G, Tafuri A, Meloni G, Fabbiano F, Recchia A, Kropp MG, Krampera M, Cascavilla N, Ferrara F, Romano A, Mazza P, Fozza C, Paoloni F, Vignetti M, and Foà R
- Subjects
- Adolescent, Adult, Cytogenetic Analysis, Drug Resistance, Multiple, Female, Humans, Immunophenotyping, Male, Middle Aged, Oncogene Proteins, Fusion genetics, Precursor Cell Lymphoblastic Leukemia-Lymphoma diagnosis, Precursor Cell Lymphoblastic Leukemia-Lymphoma drug therapy, Precursor Cell Lymphoblastic Leukemia-Lymphoma immunology, Prognosis, Remission Induction, Treatment Outcome, ATP Binding Cassette Transporter, Subfamily B, Member 1 metabolism, Chromosome Aberrations, Leukemia-Lymphoma, Adult T-Cell diagnosis, Leukemia-Lymphoma, Adult T-Cell drug therapy, Leukemia-Lymphoma, Adult T-Cell immunology, Oncogene Proteins, Fusion metabolism
- Abstract
Between 1996 and 2000, 90 newly diagnosed adult patients with T-acute lymphoblastic leukemia (T-ALL) were registered in the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) Leucemia Acuta Limfoide (LAL) 0496 protocol. Cases were centrally processed for morphology, immunophenotype, cytogenetics, molecular biology, and multidrug resistance (MDR). Twenty-two patients were females and 68 were males. Four percent of cases were pro-T, 47% pre-T, 39% cortical T, and 10% mature T-ALL. Fifty-six percent of patients with pro-T + pre-T-ALL achieved complete remission (CR) compared with 91% for cortical + mature cases (P = .002). CD34 expression was associated with a significantly lower CR rate: 54% versus 84% (P = .009). Thirty-one (36.5%) of 85 patients had an abnormal karyotype, the most common abnormality (15%) being a partial del(6q). The cytogenetic profile did not impact on CR achievement. MDR1 function, present in 26% of cases, correlated significantly with CR achievement (P = .004). A highly significant (P = .001) difference in CR rate was observed between patients who did not express the CD13/CD33/CD34 antigens and were MDR functionally negative (96%) compared with patients positive for at least one of these markers (57%). Multivariate analysis showed an impact on CR achievement for CD33 expression and MDR1 function. An extensive biologic workup of adult T-ALL cases at presentation is recommended in order to design tailored therapeutic strategies aimed at improving CR rates.
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- 2006
- Full Text
- View/download PDF
19. A comprehensive genetic classification of adult acute lymphoblastic leukemia (ALL): analysis of the GIMEMA 0496 protocol.
- Author
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Mancini M, Scappaticci D, Cimino G, Nanni M, Derme V, Elia L, Tafuri A, Vignetti M, Vitale A, Cuneo A, Castoldi G, Saglio G, Pane F, Mecucci C, Camera A, Specchia G, Tedeschi A, Di Raimondo F, Fioritoni G, Fabbiano F, Marmont F, Ferrara F, Cascavilla N, Todeschini G, Nobile F, Kropp MG, Leoni P, Tabilio A, Luppi M, Annino L, Mandelli F, and Foà R
- Subjects
- Adolescent, Adult, Analysis of Variance, Chromosome Aberrations, Classification, Cytogenetic Analysis, Female, Humans, Karyotyping, Male, Middle Aged, Oncogene Proteins, Fusion analysis, Ploidies, Precursor Cell Lymphoblastic Leukemia-Lymphoma mortality, Prognosis, Risk Factors, Survival Analysis, Treatment Outcome, Precursor Cell Lymphoblastic Leukemia-Lymphoma genetics, Precursor Cell Lymphoblastic Leukemia-Lymphoma pathology
- Abstract
The Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) 0496 protocol, through the central handling of bone marrow samples at presentation, allowed us to combine cytogenetic and molecular information on a large series of adults with acute lymphoblastic leukemia (ALL) treated homogeneously, enabling us to define as broadly as possible their genetic profile and to determine the impact on outcome of the cytogenetic-molecular signature. Of 414 patients centrally processed, 325 were considered for the categorization into the following cytogenetic-molecular subgroups: normal, t(9;22)/BCR-ABL, t(4;11)/MLL-AF4, t(1;19)/E2A-PBX1, 9p/p15-p16 deletions, 6q deletions, miscellaneous structural abnormalities, and hyperdiploid. The inclusion into each subgroup was based on a hierarchical approach: molecular abnormalities with adverse prognosis had precedence over karyotypic changes with less-defined prognosis and the latter over ploidy. Patients without abnormalities and those with isolated 9p/p15-p16 deletions showed a relatively favorable outcome (median disease-free survival [DFS], > 3 years). The t(9;22)/BCR-ABL, t(4;11)/MLL-AF4, t(1; 19)/E2A-PBX1 defined a group with dismal prognosis (median DFS, 7 months), whereas 6q deletions, miscellaneous aberrations, and hyperdiploidy predicted an intermediate prognosis (median DFS, 19 months). This study highlights the importance of a combined cytogenetic-molecular profiling of adult ALL at presentation as a critical independent determinant of their outcome, providing further evidence of the necessity of a risk-adapted therapeutic algorithm for an optimal management of these patients.
- Published
- 2005
- Full Text
- View/download PDF
20. Fludarabine treatment in B-cell chronic lymphocytic leukemia: response, toxicity and survival analysis in 47 cases.
- Author
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Stelitano C, Morabito F, Kropp MG, Callea V, Iuliano F, Oriana V, Levato D, Nobile F, Molica S, and Brugiatelli M
- Subjects
- Adult, Aged, Aged, 80 and over, Antineoplastic Agents adverse effects, Drug Resistance, Neoplasm, Female, Humans, Leukemia, Lymphocytic, Chronic, B-Cell mortality, Leukemia, Lymphocytic, Chronic, B-Cell pathology, Male, Middle Aged, Recurrence, Survival Analysis, Vidarabine administration & dosage, Vidarabine adverse effects, Antineoplastic Agents administration & dosage, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy, Vidarabine analogs & derivatives
- Abstract
Background and Objective: Fludarabine monophosphate (FAMP) is a purine analog with specific therapeutic activity in B-cell chronic lymphocytic leukemia (CLL). Its current use as front-line therapy of CLL is still a matter of debate both because of the controversial results of the clinical trials so far reported and because of the toxicity profile of the drug. In order to contribute to clarifying the possible role of FAMP, we report a retrospective analysis of the results obtained with the purine analog in CLL patients in different phases of the disease., Design and Methods: Forty-seven patients affected by advanced CLL, 36% untreated, 31.9% relapsed and 31.9% resistant, were treated with FAMP 25 mg/m2/day, either for 4 days every 3 weeks in 29 cases, or for 5 days every 4 weeks in 18. The median number of FAMP cycles was 6 (range 2-11). Response was defined according to total tumor mass (TTM) score reduction and toxicity was expressed according to WHO grading criteria. The median follow-up of the series was 13 months from the beginning of FAMP therapy., Results: Out of 47 evaluable patients the response rate was 74.4%, with 34% complete response (CR). The overall response rate was 94%, 80% and 46.6% in untreated, relapsed and resistant cases, respectively; a significantly higher number of responses was associated with no previous treatment and number of FAMP cycles. Fifty-three percent of all cases and 58.8% of untreated ones did not experience any toxicity. Treatment-related side effects were mainly autoimmune phenomena in untreated patients and infectious complications in treated ones. One heavily pre-treated patient died because of neurologic complications. Median time to re-treatment was18 months (range 1-30) and was influenced by age and previous treatment. The overall median survival was 35.7 months with a significantly higher proportion of surviving cases among RAI 0-II stages, responders and patients receiving more than 5 FAMP cycles., Interpretation and Conclusions: The present report confirms the high efficacy of FAMP in previously pre-treated cases with acceptable toxicity and encourages its use as front-line treatment provided that the results of randomized trials demonstrate its superiority over conventional chemotherapy. The possible development of autoimmune phenomena should, however, be considered seriously.
- Published
- 1999
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