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Yahiya Y Syed
Lenalidomide (Revlimid®) is an immunomodulatory drug with multiple mechanisms of action against multiple myeloma. It is a thalidomide analogue, with improved potency and reduced toxicity compared with thalidomide. In the EU and USA, lenalidomide monotherapy is indicated for the maintenance treatment of patients with newly diagnosed multiple myeloma who have undergone autologous stem-cell transplantation (ASCT). In the pivotal, phase 3 IFM 2005-02 and CALGB 100104 trials, lenalidomide maintenance therapy after ASCT administered until disease progression significantly prolonged progression-free survival (PFS; primary endpoint) relative to placebo in patients with newly diagnosed multiple myeloma...
September 2017: Drugs
Gabriele Gugliotta, Fausto Castagnetti, Massimo Breccia, Francesco Albano, Alessandra Iurlo, Tamara Intermesoli, Elisabetta Abruzzese, Luciano Levato, Mariella D'Adda, Patrizia Pregno, Francesco Cavazzini, Fabio Stagno, Bruno Martino, Gaetano La Barba, Federica Sorà, Mario Tiribelli, Catia Bigazzi, Gianni Binotto, Massimiliano Bonifacio, Clementina Caracciolo, Simona Soverini, Robin Foà, Michele Cavo, Giovanni Martinelli, Fabrizio Pane, Giuseppe Saglio, Michele Baccarani, Gianantonio Rosti
The majority of patients with chronic myeloid leukemia are successfully managed with life-long treatment with tyrosine kinase inhibitors. In patients in chronic phase, other malignancies are among the most common causes of death, raising concerns on the relationship between these deaths and the off-target effects of tyrosine kinase inhibitors. We analyzed the incidence of second primary malignancies, and related mortality, in 514 chronic myeloid leukemia patients enrolled in clinical trials in which imatinib was given as first-line treatment...
September 2017: Haematologica
Fausto Castagnetti, Gabriele Gugliotta, Massimo Breccia, Alessandra Iurlo, Luciano Levato, Francesco Albano, Paolo Vigneri, Elisabetta Abruzzese, Giuseppe Rossi, Serena Rupoli, Francesco Cavazzini, Bruno Martino, Ester Orlandi, Patrizia Pregno, Mario Annunziata, Emilio Usala, Mario Tiribelli, Simona Sica, Massimiliano Bonifacio, Carmen Fava, Filippo Gherlinzoni, Monica Bocchia, Simona Soverini, Maria Teresa Bochicchio, Michele Cavo, Martinelli Giovanni, Giuseppe Saglio, Fabrizio Pane, Michele Baccarani, Gianantonio Rosti
The most frequent BCR-ABL1 fusion transcripts in chronic myeloid leukemia (CML) are the e13a2 (b2a2) and the e14a2 (b3a2) ones. In the imatinib era few studies addressing the prognostic significance of the BCR-ABL1 transcript type in early chronic phase CML have been published. Overall, these studies suggest that in e14a2 patients the response to imatinib is faster and deeper. To evaluate if the BCR-ABL1 transcript type (e13a2 compared to e14a2) affect the response to imatinib and the clinical outcome in newly diagnosed adult CML patients, 559 patients enrolled in 3 prospective studies (NCT00514488, NCT00510926, observational study CML/023) were analyzed...
August 2017: American Journal of Hematology
Giulia Dragonetti, Marianna Criscuolo, Luana Fianchi, Livio Pagano
The incidence of invasive fungal disease (IFD) has varied during the last decades. However, over the years, we have observed a progressive reduction of mortality, mainly due to wider use of prophylactic antifungal therapy (i.e., new azoles, such as posaconazole), the development of new and more effective antifungal drugs (lipid compounds of amphotericin B, candins, and azoles of the previous generation) and improvement of diagnostic tools. Based on a number of international studies across three decades, the attributable mortality rate for IFD and invasive aspergillosis (IA) among patients with acute myeloid leukemia (AML) has progressively declined...
January 1, 2017: Medical Mycology: Official Publication of the International Society for Human and Animal Mycology
Francesca R Mauro, Angelo M Carella, Stefano Molica, Francesca Paoloni, Anna M Liberati, Francesco Zaja, Valeria Belsito, Agostino Cortellezzi, Rita Rizzi, Patrizia Tosi, Mauro Spriano, Antonietta Ferretti, Mauro Nanni, Marilisa Marinelli, Maria S De Propris, Sonia M Orlando, Marco Vignetti, Antonio Cuneo, Anna R Guarini, Robin Foà
The activity and safety of a regimen combining lenalidomide with fludarabine and cyclophosphamide (FC) was investigated in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Treatment consisted of six monthly courses of the FC regimen combined with 14 days of lenalidomide given at the starting dose of 2.5 mg during course 1. The maximum tolerated dose of lenalidomide was 5 mg. Forty patients were assessed for response, 66% were IGHV unmutated, 45% showed deletion 11q or 17p. The overall response and complete remission rates were 62...
July 2017: Leukemia & Lymphoma
Dominik Selleslag, Stefan Suciu, Giovanna Meloni, Petra Muus, Constantijn J M Halkes, Adriano Venditti, Safaa M Ramadan, Hans Pruijt, Liv Meert, Marco Vignetti, Jean-Pierre Marie, Sébastian Wittnebel, Theo de Witte, Sergio Amadori, Roelof Willemze, Frédéric Baron
No abstract text is available yet for this article.
February 2017: Haematologica
Sabina Chiaretti, Antonella Vitale, Marco Vignetti, Alfonso Piciocchi, Paola Fazi, Loredana Elia, Brunangelo Falini, Francesca Ronco, Felicetto Ferrara, Paolo De Fabritiis, Mario Luppi, Giorgio La Nasa, Alessandra Tedeschi, Catello Califano, Renato Fanin, Fausto Dore, Franco Mandelli, Giovanna Meloni, Robin Foà
In the GIMEMA LAL 0904 protocol, adult Philadelphia positive acute lymphoblastic leukemia patients were treated with chemotherapy for induction and consolidation, followed by maintenance with imatinib. The protocol was subsequently amended and imatinib was incorporated in the induction and post-remission phase together with chemotherapy. Due to the toxicity of this combined approach, the protocol was further amended to a sequential scheme based on imatinib plus steroids as induction, followed by consolidation with chemotherapy plus imatinib and, when applicable, by a hematopoietic stem cell transplant...
December 2016: Haematologica
Giuseppe Tagariello, Giancarlo Castaman, Anna Falanga, Rita Santoro, Mariasanta Napolitano, Sergio Storti, Dino Veneri, Marco Basso, Laura Candiotto, Cristina Tassinari, Augusto B Federici, Valerio De Stefano
BACKGROUND: Following high-dose chemotherapy/bone marrow transplantation, patients are routinely, prophylactically transfused with platelet concentrates (PC) if they have a platelet count ≤10×10(9)/L or higher in the presence of risk factors for bleeding. However, whether such transfusions are necessary in clinically stable patients with no bleeding, or whether a therapeutic transfusion strategy could be sufficient and safe, is still debated. MATERIALS AND METHODS: The GIMEMA Haemostasis and Thrombosis Working Party sent a questionnaire to Italian haematology departments to survey several aspects of daily platelet transfusion practice, such as the cut-off platelet count for transfusion, the evaluation of refractoriness and the type of PC administered...
June 24, 2016: Blood Transfusion, Trasfusione del Sangue
Francesco Lo-Coco, Laura Di Donato, Richard F Schlenk
No abstract text is available yet for this article.
March 24, 2016: New England Journal of Medicine
Gabriele Gugliotta, Fausto Castagnetti, Massimo Breccia, Antonella Gozzini, Emilio Usala, Angelo M Carella, Giovanna Rege-Cambrin, Bruno Martino, Elisabetta Abruzzese, Francesco Albano, Fabio Stagno, Luigia Luciano, Mariella D'Adda, Monica Bocchia, Francesco Cavazzini, Mario Tiribelli, Monia Lunghi, Antonietta Pia Falcone, Caterina Musolino, Luciano Levato, Claudia Venturi, Simona Soverini, Michele Cavo, Giuliana Alimena, Fabrizio Pane, Giovanni Martinelli, Giuseppe Saglio, Gianantonio Rosti, Michele Baccarani
The introduction of second-generation tyrosine-kinase inhibitors (TKIs) has generated a lively debate on the choice of first-line TKI in chronic phase, chronic myeloid leukemia (CML). Despite the TKIs have different efficacy and toxicity profiles, the planned use of two TKIs has never been investigated. We report on a phase 2 study that was designed to evaluate efficacy and safety of a treatment alternating nilotinib and imatinib, in newly diagnosed BCR-ABL1 positive, chronic phase, CML patients. One hundred twenty-three patients were enrolled...
June 2016: American Journal of Hematology
Francesco Zaja, Wilma Barcellini, Silvia Cantoni, Monica Carpenedo, Giuseppe Caparrotti, Valentina Carrai, Nicola Di Renzo, Cristina Santoro, Massimo Di Nicola, Dino Veneri, Federico Simonetti, Anna M Liberati, Valeria Ferla, Francesca Paoloni, Enrico Crea, Stefano Volpetti, Enrica Tuniz, Renato Fanin
In patients with immune thrombocytopenia (ITP) refractory to corticosteroids and intravenous immunoglobulins (IVIG), splenectomy may result at higher risk of peri-operative complications and, for this reason, potentially contraindicated. The thrombopoietin receptor agonists (TPO-RAs) romiplostim and eltrombopag have shown high therapeutic activity in primary ITP, but data of efficacy and safety regarding their use in preparation for splenectomy are missing. Thirty-one adult patients, median age 50 years, with corticosteroids and/or IVIG refractory persistent and chronic ITP who were treated with TPO-RAs (romiplostim= 24; eltrombopag= 7) with the aim to increase platelet count and allow a safer execution of splenectomy were retrospectively evaluated...
May 2016: American Journal of Hematology
Sergio Amadori, Stefan Suciu, Dominik Selleslag, Franco Aversa, Gianluca Gaidano, Maurizio Musso, Luciana Annino, Adriano Venditti, Maria Teresa Voso, Carla Mazzone, Domenico Magro, Paolo De Fabritiis, Petra Muus, Giuliana Alimena, Marco Mancini, Anne Hagemeijer, Francesca Paoloni, Marco Vignetti, Paola Fazi, Liv Meert, Safaa Mahmoud Ramadan, Roel Willemze, Theo de Witte, Frédéric Baron
PURPOSE: To compare single-agent gemtuzumab ozogamicin (GO) with best supportive care (BSC) including hydroxyurea as first-line therapy in older patients with acute myeloid leukemia unsuitable for intensive chemotherapy. PATIENTS AND METHODS: In this trial, patients at least 61 years old were centrally randomized (1:1) to receive either a single induction course of GO (6 mg/m(2) on day 1 and 3 mg/m(2) on day 8) or BSC. Patients who did not progress after GO induction could receive up to eight monthly infusions of the immunoconjugate at 2 mg/m(2)...
March 20, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
Theo de Witte, Stefan Suciu, Liv Meert, Constantijn Halkes, Dominik Selleslag, Dominique Bron, Sergio Amadori, Roel Willemze, Petra Muus, Frédéric Baron
The primary objective of this trial was to assess the feasibility, toxicity profile, and antitumor activity of gemtuzumab ozogamicin (GO) combined with a chemotherapy remission-induction regimen in adults with untreated high-risk myelodysplastic syndrome (HR-MDS) or secondary acute myeloid leukemia (sAML). In this phase II trial, 30 patients with median age of 58 years received 1 day of GO as a 1-h infusion at the dose level of 5 mg/m(2) on day 7 of the remission-induction course further consisting of a continuous infusion of cytarabine 100 mg/m(2)/day for 10 days and idarubicin 12 mg/m(2)/day on days 1, 3, and 5...
December 2015: Annals of Hematology
Gabriele Gugliotta, Fausto Castagnetti, Massimo Breccia, Luciano Levato, Mariella D'Adda, Fabio Stagno, Mario Tiribelli, Marzia Salvucci, Carmen Fava, Bruno Martino, Michele Cedrone, Monica Bocchia, Elena Trabacchi, Francesco Cavazzini, Emilio Usala, Antonella Russo Rossi, Maria Teresa Bochicchio, Simona Soverini, Giuliana Alimena, Michele Cavo, Fabrizio Pane, Giovanni Martinelli, Giuseppe Saglio, Michele Baccarani, Gianantonio Rosti
Nilotinib is a second-generation tyrosine kinase inhibitor that has been approved for the first-line treatment of chronic-phase chronic myeloid leukemia, based on the results of a prospective randomized study of nilotinib versus imatinib (ENESTnd). Apart from this registration study, very few data are currently available on first-line nilotinib treatment. We report here the long-term, 6-year results of the first investigator-sponsored, GIMEMA multicenter phase 2, single-arm trial with nilotinib 400 mg twice daily as first-line treatment in 73 patients with chronic-phase chronic myeloid leukemia...
September 2015: Haematologica
F Buccisano, L Maurillo, A Piciocchi, M I Del Principe, C Sarlo, M Cefalo, C Ditto, A Di Veroli, G De Santis, M Irno Consalvo, D Fraboni, P Panetta, P Palomba, C Attrotto, G Del Poeta, G Sconocchia, F Lo-Coco, S Amadori, A Venditti
In the present analysis, we evaluated whether in elderly acute myeloid leukemia (AML) patients (>60 years), minimal residual disease (MRD) assessed by flow cytometry may have a role in guiding choice of postremission strategies. We analyzed 149 young and 61 elderly adults who achieved morphological CR after induction course of EORTC/GIMEMA protocols. Elderly patients reached a postconsolidation MRD negative status less frequently than younger ones (11 vs 28 %, p = 0.009). MRD negativity resulted in a longer 5-year disease-free survival (DFS) both in elderly (57 vs 13 %, p = 0...
August 2015: Annals of Hematology
Giovanni Tortorella, Andrea Piccin, Alessia Tieghi, Luigi Marcheselli, Michael Steurer, Günther Gastl, Katia Codeluppi, Angelo Fama, Umberto Santoro, Chiara Birtolo, Gabriele Gugliotta, Sergio Cortelazzo, Luigi Gugliotta
In this prospective observational single-center study, 55 patients with essential thrombocythemia who were candidates for second line treatment with anagrelide (ANA) received a preliminary cardiovascular (CV) clinical, instrumental and biochemical evaluation (CV history and symptoms, CV risk factors, blood pressure, heart rate, ECG and ECHO-cardio parameters, Troponin I, NT-proBNP). After this in-depth CV screening, 54 out of 55 patients were deemed to be fit for ANA treatment. Thirty-eight of the 55 patients received ANA treatment for a median of 36 months (range 3-48), and were monitored using the same CV evaluation...
June 2015: Leukemia Research
Meral Beksac, Anders Waage, Sara Bringhen, Sigurdur Y Kristinsson, Gülsan Türköz Sucak, Peter Gimsing, Giulia Lupparelli, Tulin Fıratlı-Tuğlular, Gunnar Juliusson, Ingemar Turesson, Antonio Palumbo
BACKGROUND/AIM: Low-molecular-weight heparin (LMWH) has been shown to prolong survival among patients with solid tumors, but its role among myeloma patients is unknown. PATIENTS: Data from the GIMEMA (Gruppo Italiano Malattie Ematologiche dell'Adulto), Nordic and Turkish myeloma study groups comparing melphalan and prednisolone with (MPT, n: 404) or without thalidomide (MP, n: 393) are analyzed for effects of LMWH. Forty percent (159/394) of the patients on MPT and 7...
2015: Acta Haematologica
F Castagnetti, G Gugliotta, M Baccarani, M Breccia, G Specchia, L Levato, E Abruzzese, G Rossi, A Iurlo, B Martino, P Pregno, F Stagno, A Cuneo, M Bonifacio, M Gobbi, D Russo, A Gozzini, M Tiribelli, A de Vivo, G Alimena, M Cavo, G Martinelli, F Pane, G Saglio, G Rosti
BACKGROUND: The incidence of chronic myeloid leukemia (CML) increases with age, but it is unclear how the characteristics of the disease vary with age. In children, where CML is very rare, it presents with more aggressive features, including huge splenomegaly, higher cell count and higher blast cell percentage. PATIENTS AND METHODS: To investigate if after childhood the disease maintains or loses these characteristics of aggressiveness, we analyzed 2784 adult patients, at least 18 years old, registered by GIMEMA CML WP over a 40-year period...
January 2015: Annals of Oncology: Official Journal of the European Society for Medical Oncology
Wilma Barcellini, Bruno Fattizzo, Anna Zaninoni, Tommaso Radice, Ilaria Nichele, Eros Di Bona, Monia Lunghi, Cristina Tassinari, Fiorella Alfinito, Antonella Ferrari, Anna Paola Leporace, Pasquale Niscola, Monica Carpenedo, Carla Boschetti, Nicoletta Revelli, Maria Antonietta Villa, Dario Consonni, Laura Scaramucci, Paolo De Fabritiis, Giuseppe Tagariello, Gianluca Gaidano, Francesco Rodeghiero, Agostino Cortelezzi, Alberto Zanella
The clinical outcome, response to treatment, and occurrence of acute complications were retrospectively investigated in 308 primary autoimmune hemolytic anemia (AIHA) cases and correlated with serological characteristics and severity of anemia at onset. Patients had been followed up for a median of 33 months (range 12-372); 60% were warm AIHA, 27% cold hemagglutinin disease, 8% mixed, and 5% atypical (mostly direct antiglobulin test negative). The latter 2 categories more frequently showed a severe onset (hemoglobin [Hb] levels ≤6 g/dL) along with reticulocytopenia...
November 6, 2014: Blood
Paola Tacchetti, Carolina Terragna, Monica Galli, Elena Zamagni, Maria Teresa Petrucci, Annalisa Pezzi, Vittorio Montefusco, Marina Martello, Patrizia Tosi, Luca Baldini, Jacopo Peccatori, Miriana Ruggieri, Lucia Pantani, Antonio Lazzaro, Francesca Elice, Serena Rocchi, Alessandro Gozzetti, Guido Cavaletti, Antonio Palumbo, Michele Cavo
A subanalysis of the GIMEMA-MMY-3006 trial was performed to characterize treatment-emergent peripheral neuropathy (PN) in patients randomized to thalidomide-dexamethasone (TD) or bortezomib-TD (VTD) before and after double autologous transplantation (ASCT) for multiple myeloma (MM). A total of 236 patients randomized to VTD and 238 to TD were stratified according to the emergence of grade ≥2 PN. Gene expression profiles (GEP) of CD138+ plasma cells were analyzed in 120 VTD-treated patients. The incidence of grade ≥2 PN was 35% in the VTD arm and 10% in the TD arm (P < 0...
December 2014: American Journal of Hematology
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