22 results on '"Barbara Loteta"'
Search Results
2. Effectiveness of CAR-T treatment toward the potential risk of second malignancies
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Massimo Martino, Gaetana Porto, Giorgia Policastro, Caterina Alati, Barbara Loteta, Maria Caterina Micó, Clizia Argiró, Maria Altomonte, Tiziana Moscato, Demetrio Labate, Vincenzo Dattola, Carmelo Massimiliano Rao, Francesca Cogliandro, Filippo Antonio Canale, Virginia Naso, Gianfranco Filippelli, Antonino Iaria, and Martina Pitea
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car-t ,follow-up ,second cancer ,malignancies ,therapy ,Immunologic diseases. Allergy ,RC581-607 - Published
- 2024
- Full Text
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3. Chimeric Antigen Receptor T-Cell Therapy: What We Expect Soon
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Massimo Martino, Virginia Naso, Barbara Loteta, Filippo Antonio Canale, Marta Pugliese, Caterina Alati, Gerardo Musuraca, Davide Nappi, Anna Gaimari, Fabio Nicolini, Massimiliano Mazza, Sara Bravaccini, Daniele Derudas, Giovanni Martinelli, and Claudio Cerchione
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CAR-T ,manufacturing ,toxicities ,solid tumor ,DRG ,cost ,Biology (General) ,QH301-705.5 ,Chemistry ,QD1-999 - Abstract
The treatment landscape for hematologic malignancies has changed since the recent approval of highly effective chimeric antigen receptor T-cell therapies (CAR-T). Moreover, more than 600 active trials are currently ongoing. However, early enthusiasm should be tempered since several issues are still unsolved and represent the challenges for the coming years. The lack of initial responses and early relapse are some hurdles to be tackled. Moreover, new strategies are needed to increase the safety profile or shorten the manufacturing process during CAR-T cells therapy production. Nowadays, most clinically evaluated CAR-T cells products are derived from autologous immune cells. The use of allogeneic CAR-T cells products generated using cells from healthy donors has the potential to change the scenario and overcome many of these limitations. In addition, CAR-T cells carry a high price tag, and there is an urgent need to understand how to pay for these therapies as many of today’s current payment systems do not feature the functionality to address the reimbursement gap. Finally, the clinical experience with CAR-T cells for solid tumors has been less encouraging, and development in this setting is desirable.
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- 2022
- Full Text
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4. Letermovir Prophylaxis for Cytomegalovirus Infection in Allogeneic Stem Cell Transplantation: A Real-World Experience
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Massimo Martino, Annalisa Pitino, Mercedes Gori, Benedetto Bruno, Alessandra Crescimanno, Vincenzo Federico, Alessandra Picardi, Stefania Tringali, Claudia Ingrosso, Paola Carluccio, Domenico Pastore, Gerardo Musuraca, Annalisa Paviglianiti, Adriana Vacca, Bianca Serio, Gabriella Storti, Nicola Mordini, Salvatore Leotta, Michele Cimminiello, Lucia Prezioso, Barbara Loteta, Anna Ferreri, Fabrizia Colasante, Emanuela Merla, Luisa Giaccone, Alessandro Busca, Maurizio Musso, Renato Scalone, Nicola Di Renzo, Serena Marotta, Patrizio Mazza, Pellegrino Musto, Immacolata Attolico, Carmine Selleri, Filippo Antonio Canale, Marta Pugliese, Giovanni Tripepi, Gaetana Porto, Giovanni Martinelli, Angelo Michele Carella, and Claudio Cerchione
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cytomegalovirus infection ,allogeneic stem cell transplantation ,prophylaxis ,real-world data ,Letermovir ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Despite effective treatments, cytomegalovirus (CMV) continues to have a significant impact on morbidity and mortality in allogeneic stem cell transplant (allo-SCT) recipients. This multicenter, retrospective, cohort study aimed to evaluate the reproducibility of the safety and efficacy of commercially available letermovir for CMV prophylaxis in a real-world setting. Endpoints were rates of clinically significant CMV infection (CSCI), defined as CMV disease or CMV viremia reactivation within day +100-+168. 204 adult CMV-seropositive allo-SCT recipients from 17 Italian centres (median age 52 years) were treated with LET 240 mg/day between day 0 and day +28. Overall, 28.9% of patients underwent a haploidentical, 32.4% a matched related, and 27.5% a matched unrelated donor (MUD) transplant. 65.7% were considered at high risk of CSCI and 65.2% had a CMV seropositive donor. Low to mild severe adverse events were observed in 40.7% of patients during treatment [gastrointestinal toxicity (36.3%) and skin rash (10.3%)]. Cumulative incidence of CSCI at day +100 and day +168 was 5.4% and 18.1%, respectively, whereas the Kaplan-Meier event rate was 5.8% (95% CI: 2.4-9.1) and 23.3% (95% CI: 16.3-29.7), respectively. Overall mortality was 6.4% at day +100 and 7.3% at day +168. This real-world experience confirms the efficacy and safety of CMV.
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- 2021
- Full Text
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5. Ibrutinib Treatment of Mantle Cell Lymphoma Relapsing at Central Nervous System: A Case Report and Literature Review
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Donato Mannina and Barbara Loteta
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
Mantle cell lymphoma (MCL) accounts for about 5% of all lymphomas. Its clinical and histological features are heterogeneous. After a frequently good initial response, the disease generally and repeatedly relapses and finally the outcome is poor. Particularly severe is the prognosis of the rare occurrence of CNSi (Central Nervous System involvement). Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has shown strong activity in relapsing patients with Chronic Lymphocytic Leukemia (CLL) and MCL. Few reports are available about treatment with ibrutinib of patients presenting CNSi by lymphoproliferative diseases (LPD). In all of them, ibrutinib, at the dosage between 420 and 560 mg/day, showed an impressive effectiveness. Here we describe a case of MCL with CNS relapse showing an excellent response to ibrutinib administered at the unusual dose of 280 mg/day because of concomitant treatment of cardiological disease.
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- 2017
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6. Impact of second-degree related donor on the outcomes of T cell-replete haploidentical transplantation with post-transplant cyclophosphamide
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Jacopo Mariotti, Anna Maria Raiola, Andrea Evangelista, Samia Harbi, Francesca Patriarca, Michele Angelo Carella, Massimo Martino, Antonio Risitano, Alessandro Busca, Luisa Giaccone, Lucia Brunello, Emanuela Merla, Lucia Savino, Barbara Loteta, Giuseppe Console, Renato Fanin, Alessandra Sperotto, Luana Marano, Serena Marotta, Camilla Frieri, Simona Sica, Patrizia Chiusolo, Christian Chabannon, Sabine Furst, Armando Santoro, Andrea Bacigalupo, Benedetto Bruno, Didier Blaise, Domenico Mavilio, Stefania Bramanti, Raynier Devillier, Emanuele Angelucci, and Luca Castagna
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Transplantation ,Transplantation Conditioning ,T-Lymphocytes ,Transplantation, Haploidentical ,Hematopoietic Stem Cell Transplantation ,Humans ,Graft vs Host Disease ,Hematology ,Cyclophosphamide ,Retrospective Studies - Abstract
Donor selection may contribute to improve clinical outcomes of T cell-replete haploidentical stem cell transplantation (Haplo-SCT) with post-transplant cyclophosphamide (PT-Cy). Impact of second-degree related donor (SRD) was not fully elucidated in this platform. We retrospectively compared the outcome of patients receiving Haplo-SCT either from a SRD (n = 31) or a first-degree related donor (FRD, n = 957). Median time to neutrophil and platelet recovery did not differ between a SRD and a FRD transplant (p = 0.599 and 0.587). Cumulative incidence of grade II-IV acute graft-versus host disease (GVHD) and moderate-severe chronic GVHD was 13% and 19% after SRD vs 24% (p = 0.126) and 13% (p = 0.395) after FRD transplant. One-year cumulative incidence of non-relapse mortality (NRM) was 19% for SRD and 20% for FRD (p = 0.435) cohort. The 3-year probability of overall survival (OS) and progression-free survival (PFS) was 42% vs 55% (p = 0.273) and 49% vs 35% (p = 0.280) after SRD and FRD transplant, respectively. After propensity score adjustment or matched pair analysis, the outcome of patients receiving Haplo-SCT from a SRD or a FRD did not differ in terms of NRM, OS, PFS, acute and chronic GVHD. Our results suggest that a SRD is a viable option for Haplo-SCT with PT-Cy when a FRD is not available.
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- 2022
7. The power of telemedicine to improve CAR-T cell therapy programs: lessons learned from COVID-19 pandemic
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Filippo A. Canale, Massimo Martino, Gaetana Porto, Chiara Verduci, Giuseppe Console, Giuseppe Irrera, Barbara Loteta, Virginia Naso, Marta Pugliese, Tiziana Moscato, Anna Ferreri, Davide Nappi, Fabio Nicolini, Massimiliano Mazza, Giovanni Martinelli, and Claudio Cerchione
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Oncology - Published
- 2023
8. Effectiveness of biosimilar pegfilgrastim in patients with multiple myeloma after high-dose melphalan and autologous stem cell transplantation
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Massimo Martino, Mercedes Gori, Gaetana Porto, Maria Pellicano, Ludovica Santoro, Chiara Verduci, Filippo Antonio Canale, Barbara Loteta, Tiziana Moscato, Caterina Alati, Maria Consuelo Ieracitano, Amelia Cuzzocrea, Maria Altomonte, Maria Teresa Florenzano, Antonella Morabito, Giuseppe Irrera, Virginia Naso, Marta Pugliese, Giuseppe Console, Anna Ferreri, Lucrezia Imbalzano, Giovanni Tripepi, and Annalisa Pitino
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Hematology ,General Medicine - Published
- 2023
9. Netupitant/palonosetron without dexamethasone for preventing nausea and vomiting in patients with multiple myeloma receiving high-dose melphalan for autologous stem cell transplantation: a single-center experience
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Viviana Loddo, Giuseppe Console, Antonio Maria Rossetti, Massimo Martino, Barbara Loteta, Tiziana Gangemi, Filippo Antonio Canale, Gaetana Porto, Annalisa Paviglianiti, Nicola Meliambro, Anna Ferreri, Marta Pugliese, Letteria Russo, Pasquale Fabio Provenzano, Tiziana Moscato, Domenico Porcino, Antonella Di Costanzo, Virginia Naso, Valentina Romeo, Giuseppe Irrera, Giuseppa Cusumano, and Salvatore Gallo
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Melphalan ,Quinuclidines ,Pyridines ,Vomiting ,Nausea ,medicine.drug_class ,medicine.medical_treatment ,Transplantation, Autologous ,Dexamethasone ,chemistry.chemical_compound ,Autologous stem-cell transplantation ,Multiple myeloma ,medicine ,Humans ,Netupitant ,Antiemetic ,ASCT ,Chemotherapy ,business.industry ,Palonosetron ,Hematopoietic Stem Cell Transplantation ,Netupitant/palonosetron (NEPA) ,Oncology ,chemistry ,High-dose melphalan ,Anesthesia ,Quality of Life ,Chemotherapy-induced nausea and vomiting (CINV) ,Antiemetics ,Original Article ,medicine.symptom ,business ,medicine.drug - Abstract
Chemotherapy-induced nausea and vomiting (CINV) is one of the most frequent adverse events compromising quality of life (QoL) in patients undergoing autologous stem cell transplantation (ASCT). However, CINV prophylaxis is still lacking uniformity for high-dose melphalan (HDM), which is used to condition patients with multiple myeloma (MM). Netupitant/palonosetron (NEPA) is administered with dexamethasone (DEXA) for CINV prevention in several chemotherapy regimens. Our study aims to assess the efficacy of NEPA, without DEXA, in preventing CINV in 106 adult patients with MM receiving HDM and ASCT. All patients had antiemetic prophylaxis with multiple doses of NEPA 1 h before the start of conditioning and after 72 h and 120 h. A complete response (CR) was observed in 99 (93%) patients at 120 h (overall phase). The percentage of patients with complete control was 93%. The CR rate during the acute phase was 94% (n = 100). During the delayed phase, the CR rate was 95% (n = 101). Grade 1 nausea and vomiting were experienced by 82% and 12% of the patients, respectively. Grade 2 nausea was reported in 18% and vomiting in 10% of patients. Our results showed, for the first time, that NEPA, without DEXA, was a well-tolerated and effective antiemetic option for MM patients receiving HDM followed by ASCT. Supplementary Information The online version contains supplementary material available at 10.1007/s00520-021-06472-7.
- Published
- 2021
10. A comparative effectiveness study of lipegfilgrastim in multiple myeloma patients after high dose melphalan and autologous stem cell transplant
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Marco Rossi, Michele Cimminiello, Barbara Loteta, Giovanni Tripepi, Antonella Morabito, Vanessa Innao, Annalisa Pitino, Virginia Naso, Tiziana Moscato, Mercedes Gori, Giuseppe Alberto Gallo, Giuseppe Console, Anna Ferreri, Massimo Martino, Donato Mannina, Massimo Gentile, Iolanda Vincelli, Pasquale Fabio Provenzano, and Anna Grazia Recchia
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Male ,Melphalan ,medicine.medical_specialty ,Filgrastim ,Urology ,Neutropenia ,Polyethylene Glycols ,03 medical and health sciences ,Sex Factors ,0302 clinical medicine ,Autologous stem-cell transplantation ,medicine ,Humans ,Prospective Studies ,Autografts ,Multiple myeloma ,Aged ,business.industry ,Hematology ,General Medicine ,Middle Aged ,medicine.disease ,030220 oncology & carcinogenesis ,Autologous stem cell transplant ,G-CSF ,High dose melphalan ,Lipegfilgrastim ,Female ,Multiple Myeloma ,Stem Cell Transplantation ,Absolute neutrophil count ,business ,Pegfilgrastim ,030215 immunology ,medicine.drug - Abstract
G-CSF administration after high-dose chemotherapy and autologous stem cell transplantation (ASCT) has been shown to expedite neutrophil recovery. Several studies comparing filgrastim and pegfilgrastim in the post-ASCT setting concluded that the two are at least equally effective. Lipegfilgrastim (LIP) is a new long-acting, once-per-cycle G-CSF. This multicentric, prospective study aimed to describe the use of LIP in multiple myeloma patients receiving high-dose melphalan and autologous stem cell transplantation (ASCT) and compare LIP with historic controls of patients who received short-acting agent (filgrastim [FIL]). Overall, 125 patients with a median age of 60 years received G-CSF after ASCT (80 patients LIP on day 1 post-ASCT and 45 patients FIL on day 5 post-ASCT). The median duration of grade 4 neutropenia (absolute neutrophil count [ANC]
- Published
- 2019
11. Identifying and managing CAR T-cell-mediated toxicities: on behalf of an Italian CAR-T multidisciplinary team
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Virginia Naso, Rosangela Surace, Frank Cirrone, Said Al Sayyad, Bruno Martino, Francesco Curmaci, Giuseppe Scappatura, Renza Monteleone, Giuseppa Cusumano, Demetrio Labate, Barbara Loteta, Maria Pellicano, Vincenzo Amalfi, Filippo Antonio Canale, Domenico Quattrone, Umberto Aguglia, Jessyca Germano, Caterina Stelitano, Viviana Loddo, Antonella Morabito, Giuseppe Console, Letteria Russo, Vittoria Borzumati, Massimo Martino, Antonella Pontari, Antonio Maria Rossetti, Alfonso Trimarchi, Claudio Franzutti, Lucrezia Imbalzano, Giulia Pucci, Sebastiano Macheda, Caterina Alati, Maria Altomonte, Luciano Arcudi, Cristina Sanguedolce, Antonio Moschella, Benedetto Bruno, Vincenzo Dattola, Carmelo Massimiliano Rao, Anna Ferreri, Tiziana Moscato, Caterina Gattuso, Giuseppe Irrera, and Maria Teresa Florenzano
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medicine.medical_specialty ,T-Lymphocytes ,Adoptive ,Clinical Biochemistry ,Multidisciplinary team ,Immunotherapy, Adoptive ,ICANS ,chemistry.chemical_compound ,Tocilizumab ,Receptors ,Drug Discovery ,medicine ,Tumor Microenvironment ,neurological toxicity ,Humans ,Intensive care medicine ,Pharmacology ,Patient Care Team ,Tumor microenvironment ,Receptors, Chimeric Antigen ,business.industry ,Mechanism (biology) ,biomarkers ,toxicity ,Chimeric Antigen ,Chimeric antigen receptor ,Blockade ,chemistry ,CAR T therapy ,Hematologic Neoplasms ,Toxicity ,Immunotherapy ,Car t cells ,business - Abstract
INTRODUCTION Chimeric antigen receptor (CAR)-T-cell therapy is a new treatment for patients with hematologic malignancies in which other therapies have failed. AREAS COVERED The review provides an overview for recognizing and managing the most acute toxicities related to CAR-T cells. EXPERT OPINION The development of immune-mediated toxicities is a common challenge of CAR-T therapy. The mechanism that determines this toxicity is still unclear, although an unfavorable tumor microenvironment and a pro-inflammatory state put patients at risk. The monitoring, diagnosis, and treatment of post-CAR-T toxicities must be determined and based on international guidelines and internal clinical practice. It is urgent to identify biomarkers that can identify patients at greater risk of developing complications. The adoption of consistent grading criteria is necessary to improve toxicity management strategies continually. The first-line therapy consists of supportive care and treatment with tocilizumab or corticosteroids. An early start of cytokine blockade therapies could mitigate toxicity. The plan will include cytokine release prophylaxis, a risk-adapted treatment, prevention of on-target/off-tumor effect, and a switch on/off CAR-T approach.
- Published
- 2021
12. Challenge to Predict Mobilized Peripheral Blood Stem Cells on the Fourth Day of Granulocyte Colony-Stimulating Factor Treatment in Healthy Donors: Predictive Value of Basal CD34+ Cell and Platelet Counts
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Barbara Loteta, Giovanni Tripepi, Massimo Gentile, Virginia Naso, Antonia Dattola, Anna Grazia Recchia, Antonella Morabito, Mercedes Gori, Giuseppe Console, Giulia Pucci, Fabio Provenzano, Massimo Martino, Anna Ferreri, Tiziana Moscato, Maria Cristina Sanguedolce, and Annalisa Pitino
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Transplantation ,medicine.diagnostic_test ,business.industry ,CD34 ,Blood volume ,Hematology ,Hematocrit ,Granulocyte colony-stimulating factor ,Andrology ,03 medical and health sciences ,Basal (phylogenetics) ,0302 clinical medicine ,Quartile ,Interquartile range ,030220 oncology & carcinogenesis ,Medicine ,Platelet ,business ,030215 immunology - Abstract
A longitudinal, prospective, observational, single-center cohort study on healthy donors was designed to identify predictors of CD34+ cell mobilization on day 4 after granulocyte colony-stimulating factor (G-CSF) administration. As potential predictors of mobilization, age, sex, body weight, height, blood volume, WBC count, peripheral blood (PB) mononuclear cell count, platelet (Plt) count, and hematocrit and hemoglobin levels were considered. Two different evaluations of CD34+ cell counts were determined for each donor: baseline (before G-CSF administration) and in PB on day 4 after G-CSF administration. One hundred twenty-two consecutive healthy donors with a median age of 47.5 years were enrolled. The median value of CD34+ on day 4 was 43 cells/µL (interquartile range, 23 to 68), and 81.1% of donors had ≥20 cells/µL. Basal WBC count, Plt count, and CD34+ were significantly higher for the subjects with CD34+ levels over median values on day 4. A multivariate quartile regression analysis, adjusted by sex, age, basal CD34+, and basal Plt count, showed a progressively stronger relationship between baseline CD34+ and Plt levels and the CD34+ levels on day 4. The basal CD34+ cut-off level to predict the levels of CD34+ on day 4 was either ≤2 cells/μL or ≥3 cells/μL and that of basal Plt count was ≤229 × 109/L or ≥230 × 109/L, respectively, to determine whether mobilization therapy should or should not be attempted. PB stem cell mobilization with G-CSF was highly effective on day 4, and herein we describe a model for predicting the probability of performing PB stem cell collection after a short course of G-CSF.
- Published
- 2019
13. The use of ibrutinib before and after allogeneic stem cell transplantation
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Virginia Naso, Michele Cimminiello, Anna Grazia Recchia, Barbara Loteta, Anna Ferreri, Antonella Morabito, Tiziana Moscato, Massimo Gentile, Giuseppe Console, Massimo Martino, Angelo Michele Carella, and Fabio Provenzano
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Oncology ,medicine.medical_specialty ,Breakthrough therapy ,medicine.medical_treatment ,Chronic lymphocytic leukemia ,Hematopoietic stem cell transplantation ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,immune system diseases ,hemic and lymphatic diseases ,Internal medicine ,medicine ,Pharmacology (medical) ,neoplasms ,Pharmacology, Toxicology and Pharmaceutics (miscellaneous) ,business.industry ,Health Policy ,medicine.disease ,Transplantation ,surgical procedures, operative ,chemistry ,030220 oncology & carcinogenesis ,Ibrutinib ,Chronic gvhd ,Mantle cell lymphoma ,Stem cell ,business ,030217 neurology & neurosurgery - Abstract
Background: FDA designated ibrutinib as a breakthrough therapy in Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia (CLL). Nevertheless, patients who progress under ibrutinib still have a poor prognosis. In this setting, allogeneic hematopoietic stem cell transplantation (allo-HSCT) could induce long-term disease control.Areas covered: The purpose of the present review is to provide information on the efficacy of ibrutinib when administered before and after allo-HSCT for CLL and MCL. Moreover, we will focus on the current role of ibrutinib for chronic GVHD.Expert opinion: Ibrutinib as bridge to allo-HSCT does not appear to affect the safety of the treatment in patients with CLL and MCL. Current evidence support further evaluation of ibrutinib for the treatment of relapsed CLL and MCL after allo-HSCT. In this setting, ibrutinib should be not only highly efficient on CLL and MCL cells but might also have the ability to enhance the activity of donor T cells. Chronic GVHD is the most common ...
- Published
- 2019
14. Impact of donor age and kinship on clinical outcomes after T-cell–replete haploidentical transplantation with PT-Cy
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Samia Harbi, Alessandra Sperotto, Luca Castagna, Massimo Martino, Antonio M. Risitano, Luisa Giaccone, Andrea Bacigalupo, Lucia Savino, Alessandro Busca, Andrea Evangelista, Camilla Frieri, Sabine Furst, Luana Marano, Serena Marotta, Armando Santoro, Barbara Loteta, Emanuela Merla, Francesca Patriarca, Benedetto Bruno, Lucia Brunello, Didier Blaise, Patrizia Chiusolo, Anna Maria Raiola, Giuseppe Console, Domenico Mavilio, Stefania Bramanti, Jacopo Mariotti, Simona Sica, Angelo Michele Carella, Emanuele Angelucci, Renato Fanin, Centre de Recherche en Cancérologie de Marseille (CRCM), Aix Marseille Université (AMU)-Institut Paoli-Calmettes, and Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)
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Oncology ,Male ,medicine.medical_specialty ,Cyclophosphamide ,T-Lymphocytes ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Medicine ,Humans ,Cumulative incidence ,ComputingMilieux_MISCELLANEOUS ,Aged ,Retrospective Studies ,impact of donor age and kinship on clinical outcomes after T cell-replete haploidentical transplantation with PT-Cv ,business.industry ,Donor selection ,Incidence (epidemiology) ,Hazard ratio ,Hematopoietic Stem Cell Transplantation ,Retrospective cohort study ,Hematology ,3. Good health ,Transplantation ,Settore MED/15 - MALATTIE DEL SANGUE ,030220 oncology & carcinogenesis ,Transplantation, Haploidentical ,[SDV.IMM]Life Sciences [q-bio]/Immunology ,Female ,Stem cell ,Neoplasm Recurrence, Local ,Erratum ,business ,030215 immunology ,medicine.drug - Abstract
Donor selection contributes to improve clinical outcomes of T-cell–replete haploidentical stem cell transplantation (haplo-SCT) with posttransplant cyclophosphamide (PT-Cy). The impact of donor age and other non-HLA donor characteristics remains a matter of debate. We performed a multicenter retrospective analysis on 990 haplo-SCTs with PT-Cy. By multivariable analysis, after adjusting for donor/recipient kinship, increasing donor age and peripheral blood stem cell graft were associated with a higher risk of grade 2 to 4 acute graft-versus-host-disease (aGVHD), whereas 2-year cumulative incidence of moderate-to-severe chronic GVHD was higher for transplants from female donors into male recipients and after myeloablative conditioning. Increasing donor age was associated with a trend for higher nonrelapse mortality (NRM) (hazard ratio [HR], 1.05; P = .057) but with a significant reduced risk of disease relapse (HR, 0.92; P = .001) and improved progression-free survival (PFS) (HR, 0.97; P = .036). Increasing recipient age was a predictor of worse overall survival (OS). Risk of relapse was higher (HR, 1.39; P < .001) in patients aged ≤40 years receiving a transplant from a parent as compared with a sibling. Moreover, OS and PFS were lower when the donor was the mother rather than the father. Pretransplant active disease status was an invariably independent predictor of worse clinical outcomes, while recipient positive cytomegalovirus serostatus and hematopoietic cell transplant comorbidity index >3 were associated with worse OS and PFS. Our results suggest that younger donors may reduce the incidence of aGVHD and NRM, though at higher risk of relapse. A parent donor, particularly the mother, is not recommended in recipients ≤40 years.
- Published
- 2020
15. CART-Cell Therapy: Recent Advances and New Evidence in Multiple Myeloma
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Barbara Loteta, Tiziana Moscato, Michela Ceccolini, Sonia Ronconi, Iolanda Vincelli, Massimo Martino, Giorgia Simonetti, Giovanni Martinelli, Caterina Alati, Massimiliano Mazza, Andrea Ghelli Luserna di Rorà, Virginia Naso, Filippo Antonio Canale, Gaetana Porto, Claudio Cerchione, Gerardo Musuraca, and Fabio Nicolini
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0301 basic medicine ,Oncology ,Cart ,relapsed multiple myeloma ,refractory myeloma ,Cancer Research ,medicine.medical_specialty ,CAR T ,Review ,Disease ,Cell therapy ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,neurologic toxicity ,Adverse effect ,RC254-282 ,Multiple myeloma ,business.industry ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,cytokine release syndrome ,medicine.disease ,Chimeric antigen receptor ,BCMA ,multiple myeloma ,Cytokine release syndrome ,030104 developmental biology ,030220 oncology & carcinogenesis ,Treatment strategy ,business - Abstract
Simple Summary Available data on anti-BCMA CART-cell therapy has demonstrated efficacy and manageable toxicity in heavily pretreated R/R MM patients. Despite this, the main issues remain to be addressed. First of all, a significant proportion of patients eventually relapse. The potential strategy to prevent relapse includes sequential or combined infusion with CAR T-cells against targets other than BCMA, CAR T-cells with novel dual-targeting vector design, and BCMA expression upregulation. Another dark side of CAR T therapy is safety. Cytokine release syndrome (CRS) and neurologic toxicity are well-described adverse effects. In MM trials, most CRS events tended to be grade 1 or 2. Another critical point is the extended timeline of the manufacturing process and that only a few academic centers can perform these procedures. Recognizing these issues, the excellent response with BCMA-targeted CAR T-cell therapy makes it a treatment strategy of great promise. Abstract Despite the improvement in survival outcomes, multiple myeloma (MM) remains an incurable disease. Chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen (BCMA) represents a new strategy for the treatment of relapsed/refractory MM (R/R). In this paper, we describe several recent advances in the field of anti-BCMA CAR T-cell therapy and MM. Currently, available data on anti-BCMA CART-cell therapy has demonstrated efficacy and manageable toxicity in heavily pretreated R/R MM patients. Despite this, the main issues remain to be addressed. First of all, a significant proportion of patients eventually relapse. The potential strategy to prevent relapse includes sequential or combined infusion with CAR T-cells against targets other than BCMA, CAR T-cells with novel dual-targeting vector design, and BCMA expression upregulation. Another dark side of CART therapy is safety. Cytokine release syndrome (CRS) andneurologic toxicity are well-described adverse effects. In the MM trials, most CRS events tended to be grade 1 or 2, with fewer patients experiencing grade 3 or higher. Another critical point is the extended timeline of the manufacturing process. Allo-CARs offers the potential for scalable manufacturing for on-demand treatment with shorter waiting days. Another issue is undoubtedly going to be access to this therapy. Currently, only a few academic centers can perform these procedures. Recognizing these issues, the excellent response with BCMA-targeted CAR T-cell therapy makes it a treatment strategy of great promise.
- Published
- 2021
16. Challenge to Predict Mobilized Peripheral Blood Stem Cells on the Fourth Day of Granulocyte Colony-Stimulating Factor Treatment in Healthy Donors: Predictive Value of Basal CD34
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Massimo, Martino, Mercedes, Gori, Tiziana, Moscato, Virginia, Naso, Anna, Ferreri, Fabio, Provenzano, Barbara, Loteta, Maria Cristina, Sanguedolce, Giuseppe, Console, Antonia, Dattola, Giulia, Pucci, Massimo, Gentile, Antonella, Morabito, Anna Grazia, Recchia, Giovanni, Tripepi, and Annalisa, Pitino
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Adult ,Male ,Time Factors ,Platelet Count ,Antigens, CD34 ,Middle Aged ,Hematopoietic Stem Cell Mobilization ,Tissue Donors ,Granulocyte Colony-Stimulating Factor ,Peripheral Blood Stem Cells ,Humans ,Female ,Longitudinal Studies ,Prospective Studies - Abstract
A longitudinal, prospective, observational, single-center cohort study on healthy donors was designed to identify predictors of CD34
- Published
- 2018
17. Granisetron transdermal system and dexamethasone for the prevention of nausea and vomiting in multiple myeloma patients receiving chemo-mobilization: An observational real-world study of effectiveness and safety
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Massimo Martino, Anna Ferreri, Pasquale Fabio Provenzano, Gaetana Porto, Antonella Morabito, Massimo Gentile, Tiziana Moscato, Annalisa Paviglianiti, Barbara Loteta, Mercedes Gori, Giuseppe Console, Marco Rossi, Anna Lisa Pitino, Virginia Naso, and Giovanni Tripepi
- Subjects
Adult ,Male ,medicine.medical_specialty ,Adolescent ,Cyclophosphamide ,Vomiting ,Nausea ,medicine.drug_class ,030204 cardiovascular system & hematology ,Administration, Cutaneous ,Granisetron ,Dexamethasone ,Young Adult ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,medicine ,Humans ,Antiemetic ,Prospective Studies ,Adverse effect ,Aged ,business.industry ,Hematology ,Middle Aged ,humanities ,Tolerability ,Female ,medicine.symptom ,Multiple Myeloma ,business ,030215 immunology ,medicine.drug - Abstract
PURPOSE Cyclophosphamide (CY) in a dose of 2–4 g/m2 is widely used for hemopoietic progenitor stem cells mobilization. CY administration is associated with several adverse effects, including chemotherapy-induced nausea and vomiting (CINV). This study aimed to evaluate the efficacy and tolerability of granisetron transdermal system (GTDS) plus dexamethasone in the management of CINV in MM patients undergoing chemo-mobilization with CY. METHODS In this single-center, prospective, observational, real world study, GTDS plus dexamethasone was administered to MM patients receiving chemo-mobilization based on CY 2 g/m2 plus G-CSF in an outpatient setting. The rate of complete response was evaluated as the main outcome. Other outcomes were rate of complete control of CINV, incidence of nausea/vomiting of any grade and safety. RESULTS A total of 88 patients were enrolled. A complete response was achieved in 45.5 % of patients; among them, 39.77 % attained complete control of CINV. Nausea and vomiting never occurred in 34.1 % and 45.5 % of patients, respectively. No episodes of grade 3–4 nausea and/or vomiting were documented. GTDS was safe and well tolerated. CONCLUSION In real world, GTDS provided an innovative, effective, and well-tolerated control of CINV in MM patients after chemo-mobilization with CY. The study found out effectiveness of a non-invasive delivery system of antiemetic.
- Published
- 2020
18. Ibrutinib Treatment of Mantle Cell Lymphoma Relapsing at Central Nervous System: A Case Report and Literature Review
- Author
-
Barbara Loteta and Donato Mannina
- Subjects
0301 basic medicine ,Oncology ,medicine.medical_specialty ,Chronic lymphocytic leukemia ,Central nervous system ,Case Report ,Disease ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,immune system diseases ,Internal medicine ,hemic and lymphatic diseases ,medicine ,Bruton's tyrosine kinase ,biology ,business.industry ,lcsh:RC633-647.5 ,General Medicine ,lcsh:Diseases of the blood and blood-forming organs ,medicine.disease ,030104 developmental biology ,medicine.anatomical_structure ,chemistry ,030220 oncology & carcinogenesis ,Concomitant ,Ibrutinib ,Immunology ,biology.protein ,Mantle cell lymphoma ,business - Abstract
Mantle cell lymphoma (MCL) accounts for about 5% of all lymphomas. Its clinical and histological features are heterogeneous. After a frequently good initial response, the disease generally and repeatedly relapses and finally the outcome is poor. Particularly severe is the prognosis of the rare occurrence of CNSi (Central Nervous System involvement). Ibrutinib, an oral inhibitor of Bruton tyrosine kinase (BTK), has shown strong activity in relapsing patients with Chronic Lymphocytic Leukemia (CLL) and MCL. Few reports are available about treatment with ibrutinib of patients presenting CNSi by lymphoproliferative diseases (LPD). In all of them, ibrutinib, at the dosage between 420 and 560 mg/day, showed an impressive effectiveness. Here we describe a case of MCL with CNS relapse showing an excellent response to ibrutinib administered at the unusual dose of 280 mg/day because of concomitant treatment of cardiological disease.
- Published
- 2017
19. Levels of soluble angiogenin in chronic myeloid malignancies: clinical implications
- Author
-
Luana Calabrò, Domenica Gangemi, Eugenia Quartarone, Elisabetta Massara, Andrea Alonci, Giacomo Bellomo, Caterina Musolino, and Barbara Loteta
- Subjects
medicine.medical_specialty ,Myeloid ,Angiogenin ,Angiogenesis ,business.industry ,Myelodysplastic syndromes ,Hematology ,General Medicine ,medicine.disease ,Gastroenterology ,Pathogenesis ,Haematopoiesis ,medicine.anatomical_structure ,Internal medicine ,Cancer research ,medicine ,Clinical significance ,Platelet ,business - Abstract
Angiogenesis is critical for the clinical progression of haematopoietic malignancies and depends on angiogenic factors. Angiogenin is a powerful factor produced by neoplastic cells and host microenvironment. High levels of soluble angiogenin (sAng) correlate with a poor prognosis in patients affected by acute myeloid leukaemia and myelodysplastic syndromes, but no data are available on sAng in chronic myeloproliferative disorders (CMD). Therefore, in this study we investigated the clinical significance of the angiogenin in sera of patients with chronic myeloid leukaemia (CML) (n = 14) or essential thrombocythaemia (ET) (n = 20), and correlated them with those of soluble transforming growth factor-beta(1) (sTGF beta(1)). Enzyme-linked immunosorbent assay detected (P < 0.05) higher levels of sAng in CMD compared with healthy subjects (1026.74 +/- 464.60 pg/mL and 196.00 +/- 39.90 pg/mL, respectively). The highest levels of sAng were detected in CML patients (1349.23 +/- 549.55 pg/mL). Interestingly, CML patients who achieved haematological remission after interferon therapy showed circulating levels of angiogenin significantly (P < 0.05) decreased when compared with those at diagnosis. In ET patients, levels of angiogenin (889.34 +/- 267.66 pg/mL) and sTGF beta(1) (76.69 +/-6.08 pg/mL) were higher (P < 0.05) compared with healthy controls (57.93 +/- 19.39 pg/mL). No correlation was found between levels of sAng and levels of sTGF beta(1) or platelet count among ET patients. Our results show for the first time that elevated blood levels of angiogenin feature chronic myeloid malignancies, suggesting a role of angiogenin in the pathogenesis of these diseases.
- Published
- 2004
20. B-cell chronic lymphocytic leukemia: clinical impact of biological prognostic factors and updated treatment strategies
- Author
-
Maura, Brugiatelli, Barbara, Loteta, Laura, Nocilli, and Donato, Mannina
- Subjects
Humans ,Prognosis ,Leukemia, Lymphocytic, Chronic, B-Cell - Published
- 2008
21. Levels of solubile angiogenin in chronic myeloid malignancies: clinical implications
- Author
-
Caterina, Musolino, Andrea, Alonci, Giacomo, Bellomo, Barbara, Loteta, Eugenia, Quartarone, Domenica, Gangemi, Elisabetta, Massara, and Luana, Calabrò
- Subjects
Adult ,Aged, 80 and over ,Male ,Myeloproliferative Disorders ,Adolescent ,Remission Induction ,Ribonuclease, Pancreatic ,Chronic myeloid malignancies ,Middle Aged ,Angiogenin ,Prognosis ,Angiogenesis ,Neoplasm Proteins ,NO ,Solubility ,Transforming Growth Factor beta ,Case-Control Studies ,Leukemia, Myelogenous, Chronic, BCR-ABL Positive ,Chronic Disease ,Humans ,Female ,Aged ,Thrombocythemia, Essential - Abstract
Angiogenesis is critical for the clinical progression of haematopoietic malignancies and depends on angiogenic factors. Angiogenin is a powerful factor produced by neoplastic cells and host microenvironment. High levels of soluble angiogenin (sAng) correlate with a poor prognosis in patients affected by acute myeloid leukaemia and myelodysplastic syndromes, but no data are available on sAng in chronic myeloproliferative disorders (CMD). Therefore, in this study we investigated the clinical significance of the angiogenin in sera of patients with chronic myeloid leukaemia (CML) (n = 14) or essential thrombocythaemia (ET) (n = 20), and correlated them with those of soluble transforming growth factor-beta(1) (sTGF beta(1)). Enzyme-linked immunosorbent assay detected (P0.05) higher levels of sAng in CMD compared with healthy subjects (1026.74 +/- 464.60 pg/mL and 196.00 +/- 39.90 pg/mL, respectively). The highest levels of sAng were detected in CML patients (1349.23 +/- 549.55 pg/mL). Interestingly, CML patients who achieved haematological remission after interferon therapy showed circulating levels of angiogenin significantly (P0.05) decreased when compared with those at diagnosis. In ET patients, levels of angiogenin (889.34 +/- 267.66 pg/mL) and sTGF beta(1) (76.69 +/-6.08 pg/mL) were higher (P0.05) compared with healthy controls (57.93 +/- 19.39 pg/mL). No correlation was found between levels of sAng and levels of sTGF beta(1) or platelet count among ET patients. Our results show for the first time that elevated blood levels of angiogenin feature chronic myeloid malignancies, suggesting a role of angiogenin in the pathogenesis of these diseases.
- Published
- 2004
22. [Lipid profile in hematologic neoplasms]
- Author
-
Caterina, Musolino, Luana, Calabrò, Giacomo, Bellomo, Maria, Cincotta, Valeria, Di Giacomo, Caterina, Pezzano, Barbara, Loteta, Vincenzo, Rizzo, Salvatore, Guglielmo, and Andrea, Alonci
- Subjects
Male ,Apolipoproteins ,Cholesterol ,Hematologic Neoplasms ,Humans ,Female ,Middle Aged - Abstract
Abnormal blood lipid profiles have been reported in human malignancies. So, it is likely an overall involvement of tumoral cell metabolism. The aim of this study was to evaluate clinico-biological implications of altered lipid profiles in oncohaematologic patients.The plasma lipids, lipoproteins and apolipoproteins were determined at the time of diagnosis in 48 previously untreated patients (35M, 13F, median age 60 years), 11 with multiple myeloma (MM), 11 with non-Hodgkin's lymphoma (NHL), 11 with acute leukemia (AL), 10 with chronic myeloproliferative disorders (CMD) and 5 with B-chronic lymphocytic leukemia (B-CLL). The results were correlated with known prognostic serum markers, such as lactate dehydrogenase (LDH), beta-2-microglobulin (beta 2m), and soluble molecule ICAM1 (sICAM1).Altered blood lipid profiles were observed in all concohaematologic patients. Statistically significant values included reduced cholesterol (155 +/- 47.36 vs 205 +/- 35 mg/dl; p0.001), HDL-C (30.47 +/- 13.36 vs 45 +/- 10 mg/dl; p0.003) and apo A (118.86 +/- 49.98 vs 182.69 mg/dl; p0.0001) levels. No correlations were found between cholesterol levels and clinico-biological features representative of tumor mass (LDH, beta 2m, sICAM-1). A significant increase of cholesterol levels was observed in all patients responding to therapy.These results support the idea that the cholesterol, its fractions and the apolipoproteins determinations might be considered as useful biochemical and prognostic markers in hematologic neoplasms.
- Published
- 2002
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