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JOURNAL ARTICLE
Francesco Buccisano, Raffaele Palmieri, Alfonso Piciocchi, Valentina Arena, Anna Candoni, Lorella Melillo, Valeria Calafiore, Roberto Cairoli, Paolo De Fabritiis, Gabriella Storti, Prassede Salutari, Francesco Lanza, Giovanni Martinelli, Mario Luppi, Saveria Capria, Luca Maurillo, Maria Ilaria Del Principe, Giovangiacinto Paterno, Maria Antonietta Irno Consalvo, Tiziana Ottone, Serena Lavorgna, Maria Teresa Voso, Paola Fazi, Marco Vignetti, William Arcese, Adriano Venditti
The 2017 version of the ELN recommendations, by integrating cytogenetics and mutational status of specific genes, sort out 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 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 autologous stem cell transplant (AuSCT) if categorized as favorable-risk or allogeneic stem cell transplant (ASCT) if adverse-risk...
November 3, 2021: Blood Advances
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JOURNAL ARTICLE
Fausto Castagnetti, Gianni Binotto, Isabella Capodanno, Atto Billio, Elisabetta Calistri, Francesco Cavazzini, Monica Crugnola, Antonella Gozzini, Gabriele Gugliotta, Mauro Krampera, Alessandro Lucchesi, Anna Merli, Maria Cristina Miggiano, Claudia Minotto, Monica Poggiaspalla, Marzia Salvucci, Barbara Scappini, Mario Tiribelli, Elena Trabacchi, Gianantonio Rosti, Sara Galimberti, Massimiliano Bonifacio
In chronic-phase chronic myeloid leukemia (CML), tyrosine kinase inhibitors (TKIs) are the standard of care, and treatment-free remission (TFR) following the achievement of a stable deep molecular response (DMR) has become, alongside survival, a primary goal for virtually all patients. The GIMEMA CML working party recently suggested that the possibility of achieving TFR cannot be denied to any patient, and proposed specific treatment policies according to the patient's age and risk. However, other international recommendations (including 2020 ELN recommendations) are more focused on survival and provide less detailed suggestions on how to choose first and subsequent lines of treatment...
October 18, 2021: Targeted Oncology
#23
MULTICENTER STUDY
Giovanni Martinelli, Cristina Papayannidis, Alfonso Piciocchi, Valentina Robustelli, Simona Soverini, Carolina Terragna, Giovanni Marconi, Roberto M Lemoli, Fabio Guolo, Antonella Fornaro, Monia Lunghi, Paolo de Fabritiis, Anna Candoni, Carmine Selleri, Federico Simonetti, Monica Bocchia, Antonella Vitale, Luca Frison, Alessandra Tedeschi, Antonio Cuneo, Massimiliano Bonifacio, Maria Paola Martelli, Stefano D'Ardia, Silvia Trappolini, Patrizia Tosi, Piero Galieni, Francesco Fabbiano, Maria Chiara Abbenante, Muriel Granier, Zhaoyin Zhu, Mingyue Wang, Chiara Sartor, Stefania Paolini, Michele Cavo, Robin Foà, Paola Fazi, Marco Vignetti, Michele Baccarani
Tyrosine kinase inhibitors have improved survival for patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL). However, prognosis for old or unfit patients remains poor. In the INCB84344-201 (formerly GIMEMA LAL 1811) prospective, multicenter, phase 2 trial, we tested the efficacy and safety of ponatinib plus prednisone in newly diagnosed patients with Ph+ ALL ≥60 years, or unfit for intensive chemotherapy and stem cell transplantation. Forty-four patients received oral ponatinib 45 mg/d for 48 weeks (core phase), with prednisone tapered to 60 mg/m2/d from days-14-29...
March 22, 2022: Blood Advances
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JOURNAL ARTICLE
Caterina Giovanna Valentini, Alfonso Piciocchi, Fabio Facchetti, Fabio Guolo, Alessandro Pulsoni, Marco Vignetti, Livio Pagano
No abstract text is available yet for this article.
October 13, 2021: Blood Advances
#25
MULTICENTER STUDY
Gian Matteo Rigolin, Ilaria Del Giudice, Antonella Bardi, Aurora Melandri, Rocio Edith García-Jacobo, Francesca Cura, Sara Raponi, Caterina Ilari, Luciana Cafforio, Alfonso Piciocchi, Valentina Arena, Gianluigi Reda, Francesco Albano, Stefano Molica, Paolo Sportoletti, Livio Trentin, Monia Marchetti, Mauro Nanni, Nadia Peragine, Paola Mariglia, Marco Vignetti, Anna Guarini, Francesca Romana Mauro, Robin Foà, Antonio Cuneo
No abstract text is available yet for this article.
December 23, 2021: Blood
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JOURNAL ARTICLE
Giorgina Specchia, Patrizia Pregno, Massimo Breccia, Fausto Castagnetti, Chiara Monagheddu, Massimiliano Bonifacio, Mario Tiribelli, Fabio Stagno, Giovanni Caocci, Bruno Martino, Luigiana Luciano, Michele Pizzuti, Antonella Gozzini, Anna Rita Scortechini, Francesco Albano, Micaela Bergamaschi, Isabella Capodanno, Andrea Patriarca, Carmen Fava, Giovanna Rege-Cambrin, Federica Sorà, Sara Galimberti, Monica Bocchia, Gianni Binotto, Giovanni Reddiconto, Paolo DiTonno, Alessandro Maggi, Grazia Sanpaolo, Maria Stella De Candia, Valentina Giai, Elisabetta Abruzzese, Maria Cristina Miggiano, Gaetano La Barba, Giuseppe Pietrantuono, Anna Guella, Luciano Levato, Olga Mulas, Fabio Saccona, Gianantonio Rosti, Pellegrino Musto, Francesco Di Raimondo, Fabrizio Pane, Michele Baccarani, Giuseppe Saglio, Giovannino Ciccone
An observational prospective study was conducted by the CML Italian network to analyze the role of baseline patient characteristics and first line treatments on overall survival and CML-related mortality in 1206 newly diagnosed CML patients, 608 treated with imatinib (IMA) and 598 with 2nd generation tyrosine kinase inhibitors (2GTKI). IMA-treated patients were much older (median age 69 years, IQR 58-77) than the 2GTKI group (52, IQR 41-63) and had more comorbidities. Estimated 4-year overall survival of the entire cohort was 89% (95%CI 85...
2021: Frontiers in Oncology
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JOURNAL ARTICLE
Michela Ansuinelli, Irene Della Starza, Alessia Lauretti, Loredana Elia, Veronica Siravo, Monica Messina, Lucia Anna De Novi, Akram Taherinasab, Martina Canichella, Anna Guarini, Robin Foà, Sabina Chiaretti
In Ph+ acute lymphoblastic leukaemia (Ph+ ALL), minimal residual disease (MRD) is the most relevant prognostic factor. Currently, its evaluation is based on quantitative real-time polymerase chain reaction (Q-RT-PCR). Digital droplet PCR (ddPCR) was successfully applied to several haematological malignancies. We analyzed 98 samples from 40 Ph+ ALL cases, the majority enrolled in the GIMEMA LAL2116 trial: 10 diagnostic samples and 88 follow-up samples, mostly focusing on positive non-quantifiable (PNQ) or negative samples by Q-RT-PCR to investigate the value of ddPCR for MRD monitoring...
August 16, 2021: Hematological Oncology
#28
JOURNAL ARTICLE
Francesco Mannelli, Giacomo Gianfaldoni, Paola Guglielmelli, Francesco Buccisano, Roberto Caporale, Marco Chiarini, Giuseppe Rossi, Adriano Venditti, Paola Fazi, Enrico Crea, Alfonso Piciocchi, Maria Teresa Voso, Marco Vignetti, Sergio Amadori, Alessandro Maria Vannucchi
AMELIORATE is a Phase III, randomized trial aiming to personalize treatment intensity in FLT3 -mutated acute myeloid leukemia. The current study provides an early appraisal of chemosensitivity based on peripheral blasts clearance, as assessed by multiparameter flow cytometry, from baseline to day 4 of induction. This biomarker was previously demonstrated to predict complete remission achievement and measurable residual disease status. For patients experiencing low peripheral blast cells (i.e., ≤2.0 logs), two major adjustments of treatment as compared with current standard of care are envisioned in the experimental arm: the immediate switch to intensified induction with high-doses cytarabine (1500 mg/m2 b...
July 13, 2021: Future Oncology
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JOURNAL ARTICLE
Maria Cristina Puzzolo, Ilaria Del Giudice, Nadia Peragine, Paola Mariglia, Maria Stefania De Propris, Luca Vincenzo Cappelli, Livio Trentin, Gianluigi Reda, Antonio Cuneo, Stefano Molica, Alfonso Piciocchi, Valentina Arena, Francesca Romana Mauro, Anna Guarini, Robin Foà
Ibrutinib may revert the T-helper (Th)2 polarization observed in chronic lymphocytic leukemia (CLL) by targeting the IL-2-inducible kinase, that shows a significant homology with the Bruton tyrosine kinase. In the front-line GIMEMA LLC1114 trial (ibrutinib+rituximab for 6 months, followed by ibrutinib maintenance), we investigated the modulation of T-cell cytokine production in 208 peripheral blood paired samples from 71 CLL patients: 71 samples prior to treatment (Day 0, D0) and at day +14 (D14; n=50), at month +8 (M8; 30), +12 (M12; 25), +18 (M18; 22) and +24 (M24; 10) of treatment...
2021: Frontiers in Oncology
#30
JOURNAL ARTICLE
Fabio Efficace, Massimo Breccia, Paola Fazi, Francesco Cottone, Bernhard Holzner, Marco Vignetti
BACKGROUND: The COVID-19 pandemic has raised unprecedented challenges in the management of cancer patients and has increased the demands for digital health tools that, for example, could facilitate remote monitoring of patients. On this ground, the Gruppo Italiano Malattie Ematologiche dell'Adulto (GIMEMA) has recently developed a digital health tool dedicated to patients with hematologic malignancies: the GIMEMA-ALLIANCE platform. OBJECTIVE: The main objectives of this web-based platform are: to generate relevant data to better understand quality of life, symptoms and medication adherence during the COVID-19 pandemic and post-pandemic era; to develop a prospective real-life registry on outcomes of hematologic cancer patients, with or without a diagnosis of COVID-19; to facilitate patient-centered care in routine practice...
April 19, 2021: JMIR Research Protocols
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MULTICENTER STUDY
Gian Matteo Rigolin, Francesco Cavazzini, Alfonso Piciocchi, Valentina Arena, Andrea Visentin, Gianluigi Reda, Giulia Zamprogna, Francesca Cibien, Orsola Vitagliano, Marta Coscia, Lucia Farina, Gianluca Gaidano, Roberta Murru, Marzia Varettoni, Rossella Paolini, Paolo Sportoletti, Daniela Pietrasanta, Anna Lia Molinari, Francesca M Quaglia, Luca Laurenti, Roberto Marasca, Monia Marchetti, Francesca R Mauro, Enrico Crea, Marco Vignetti, Massimo Gentile, Marco Montillo, Robin Foà, Antonio Cuneo
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...
August 2021: Hematological Oncology
#32
MULTICENTER STUDY
Elisa Lucchini, Francesca Palandri, Stefano Volpetti, Nicola Vianelli, Giuseppe Auteri, Elena Rossi, Andrea Patriarca, Giuseppe Carli, Wilma Barcellini, Melania Celli, Ugo Consoli, Federica Valeri, Cristina Santoro, Enrico Crea, Marco Vignetti, Francesca Paoloni, Casimiro Luca Gigliotti, Elena Boggio, Umberto Dianzani, Ilaria Giardini, Monica Carpenedo, Francesco Rodeghiero, Renato Fanin, Francesco Zaja
Up to 30% immune thrombocytopenia (ITP) patients achieve a sustained remission off-treatment (SROT) after discontinuation of thrombopoietin receptor agonists (TPO-RAs). Factors predictive of response are lacking. Patients aged ≥18 years with newly diagnosed or persistent ITP were treated with eltrombopag for 24 weeks. Primary end-point was SROT: the proportion of responders that were able to taper and discontinue eltrombopag maintaining the response during a period of observation (PO) of six months...
April 2021: British Journal of Haematology
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JOURNAL ARTICLE
Sabina Chiaretti, Michela Ansuinelli, Antonella Vitale, Loredana Elia, Mabel Matarazzo, Alfonso Piciocchi, Paola Fazi, Francesco Di Raimondo, Lidia Santoro, Francesco Fabbiano, Catello Califano, Giovanni Martinelli, Francesca Ronco, Felicetto Ferrara, Nicola Cascavilla, Catia Bigazzi, Alessandra Tedeschi, Simona Sica, Nicola Di Renzo, Angela Melpignano, Germana Beltrami, Marco Vignetti, Robin Foa
The GIMEMA LAL1509 protocol, designed for adult (≥18-60 years) de novo Ph+ acute lymphoblastic leukemia patients, was based on a dasatinib plus steroids induction - with central nervous system prophylaxis - followed by dasatinib alone in patients in complete molecular response or chemotherapy and/or allogeneic transplantation in patients not reaching a complete molecular response. Sixty patients (median age 41.9 years) were enrolled: 33 were p190+, 18 p210+ and 9 p190/p210+. At the end of induction (day +85), 58 patients (97%) achieved a complete hematologic remission...
July 1, 2021: Haematologica
#34
COMPARATIVE STUDY
Federico Vozella, A Siniscalchi, M Rizzo, T Za, G Antolino, U Coppetelli, A Piciocchi, A Andriani, O Annibali, L De Rosa, G Cimino, G La Verde, V De Stefano, M Cantonetti, T Caravita di Toritto, M T Petrucci
Daratumumab (DARA) is a human IgG-K monoclonal antibody (MoAb) targeting CD38 that is approved alone or in combination with bortezomib and dexamethasone or lenalidomide and dexamethasone for relapsed or refractory MM (RRMM) in patients previously exposed or double refractory to proteasome inhibitors (PI) and immunomodulatory drugs (IMiDs). However, there are limited data on its clinical activity and tolerability in real-world patients. Therefore, in the present study, we aim to determine the efficacy and toxicity profile of daratumumab in a real-life setting...
April 2021: Annals of Hematology
#35
MULTICENTER STUDY
Anna Maria Testi, Martina Canichella, Antonella Vitale, Alfonso Piciocchi, Anna Guarini, Irene Della Starza, Marzia Cavalli, Maria Stefania De Propris, Monica Messina, Loredana Elia, Maria Luisa Moleti, Bruno Martino, Mario Luppi, Marianna D'Aloisio, Anna Candoni, Valentino Conter, Paola Fazi, Marco Vignetti, Sabina Chiaretti, Roberto Foà
Adolescents and young adults (AYA) with acute lymphoblastic leukemia (ALL) represent a unique patient population with specific characteristics and needs. Growing evidences suggest that pediatric-inspired approaches improve the outcome in AYA. These results prompted the design of a pediatric AIEOP-BFM ALL 2000-based regimen - the GIMEMA LAL-1308 protocol - for newly diagnosed AYA (range 18-35 years) with Philadelphia negative (Ph-) ALL. The protocol included minimal residual disease (MRD) analysis at two different time-points (TP), that is, at the end of induction IA and consolidation IB, and a modulation in post-consolidation intensity according to MRD...
March 1, 2021: American Journal of Hematology
#36
JOURNAL ARTICLE
Nigel Russell, Richard Dillon
The introduction of all-trans retinoic acid (ATRA), and more recently of arsenic trioxide (ATO) in the treatment of Acute Promyelocytic Leukaemia (APL), has been instrumental in achieving the high cure rates recently reported. For the majority of patients, it is now possible to successfully treat this disease "chemo-free" without the use of cytotoxic chemotherapy as reflected in current clinical guidelines. The Sanz risk score developed by the GIMEMA and PETHEMA groups categorizes patients into three risk groups-low, intermediate, and high and correlates with relapse-free survival (RFS)...
2020: Frontiers in Oncology
#37
RANDOMIZED CONTROLLED TRIAL
Paola Tacchetti, Lucia Pantani, Francesca Patriarca, Maria Teresa Petrucci, Elena Zamagni, Luca Dozza, Monica Galli, Francesco Di Raimondo, Claudia Crippa, Mario Boccadoro, Simona Barbato, Patrizia Tosi, Franco Narni, Vittorio Montefusco, Nicoletta Testoni, Antonio Spadano, Carolina Terragna, Norbert Pescosta, Giulia Marzocchi, Claudia Cellini, Piero Galieni, Sonia Ronconi, Marco Gobbi, Lucio Catalano, Antonio Lazzaro, Giovanni De Sabbata, Clotilde Cangialosi, Fabrizio Ciambelli, Pellegrino Musto, Francesca Elice, Michele Cavo
BACKGROUND: The phase 3 GIMEMA-MMY-3006 trial, which compared bortezomib, thalidomide, and dexamethasone (VTD) combination therapy with thalidomide and dexamethasone (TD) as induction therapy before and consolidation therapy after double autologous haematopoietic stem-cell transplantation (HSCT) for newly diagnosed multiple myeloma, showed the superiority of the triplet regimen over the doublet in terms of increased complete response rate and improved progression-free survival. We report the results from the final analysis of the study...
December 2020: Lancet Haematology
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JOURNAL ARTICLE
Safaa M Ramadan, Stefan Suciu, Marian J P L Stevens-Kroef, Roelof Willemze, Sergio Amadori, Theo de Witte, Bob Löwenberg, Petra Muus, Boris Labar, Liv Meert, Gaetan de Schaetzen, Giovanna Meloni, Giuseppe Leone, Marco Vignetti, Jean-Pierre Marie, Michael Lübbert, Frédéric Baron
We report the outcomes of secondary acute myeloid leukemia (s-AML) patients included in one of 13 European Organisation for Research and Treatment of Cancer (EORTC) collaborative AML trials using intensive remission-induction chemotherapy. Among 8858 patients treated between May 1986 and January 2008, 960 were identified as having s-AML, either after MDS (cohort A; n = 508), occurring after primary solid tumors or hematologic malignancies other than MDS (cohort B; n = 361), or after non-malignant conditions or with a history of toxic exposure (cohort C; n = 91)...
November 11, 2020: Cancers
#39
JOURNAL ARTICLE
Robin Foà, Renato Bassan, Antonella Vitale, Loredana Elia, Alfonso Piciocchi, Maria-Cristina Puzzolo, Martina Canichella, Piera Viero, Felicetto Ferrara, Monia Lunghi, Francesco Fabbiano, Massimiliano Bonifacio, Nicola Fracchiolla, Paolo Di Bartolomeo, Alessandra Mancino, Maria-Stefania De Propris, Marco Vignetti, Anna Guarini, Alessandro Rambaldi, Sabina Chiaretti
BACKGROUND: Outcomes in patients with Philadelphia chromosome (Ph)-positive acute lymphoblastic leukemia (ALL) have improved with the use of tyrosine kinase inhibitors. Molecular remission is a primary goal of treatment. METHODS: We conducted a phase 2 single-group trial of first-line therapy in adults with newly diagnosed Ph-positive ALL (with no upper age limit). Dasatinib plus glucocorticoids were administered, followed by two cycles of blinatumomab. The primary end point was a sustained molecular response in the bone marrow after this treatment...
October 22, 2020: New England Journal of Medicine
#40
MULTICENTER STUDY
Antonio Cuneo, Anthony R Mato, Gian Matteo Rigolin, Alfonso Piciocchi, Massimo Gentile, Luca Laurenti, John N Allan, John M Pagel, Danielle M Brander, Brian T Hill, Allison Winter, Nicole Lamanna, Constantine S Tam, Ryan Jacobs, Frederick Lansigan, Paul M Barr, Mazyar Shadman, Alan P Skarbnik, Jeffrey J Pu, Alison R Sehgal, Stephen J Schuster, Nirav N Shah, Chaitra S Ujjani, Lindsey Roeker, Ester Maria Orlandi, Atto Billio, Livio Trentin, Martin Spacek, Monia Marchetti, Alessandra Tedeschi, Fiorella Ilariucci, Gianluca Gaidano, Michael Doubek, Lucia Farina, Stefano Molica, Francesco Di Raimondo, Marta Coscia, Francesca Romana Mauro, Javier de la Serna, Angeles Medina Perez, Isacco Ferrarini, Giuseppe Cimino, Maurizio Cavallari, Rosalba Cucci, Marco Vignetti, Robin Foà, Paolo Ghia
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...
November 2020: Cancer Medicine
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