167 results on '"Andrea Patriarca"'
Search Results
2. S168: PELABRESIB (CPI-0610) MONOTHERAPY IN PATIENTS WITH HIGH-RISK ESSENTIAL THROMBOCYTHEMIA REFRACTORY OR INTOLERANT TO HYDROXYUREA: PRELIMINARY RESULTS FROM MANIFEST STUDY
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Francesco Passamonti, Andrea Patriarca, Steven Knapper, Candido Rivera, Joseph M Scandura, Timothy Devos, Nikki Granacher, Adam Mead, Stephen Oh, Jeanne Palmer, Raajit K Rampal, Lino Teichmann, Qing LI, Jean-Pierre Eliane, Tzuu-Wang Chang, Sandra Klein, Gozde Colak, and Claire Harrison
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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3. S298: MATERNAL AND FETAL OUTCOMES IN PREGNANCIES OF WOMEN WITH IMMUNE THROMBOCYTOPENIA: A MULTICENTER RETROSPECTIVE OBSERVATIONAL ITP-NET ITALIAN STUDY
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Monica Carpenedo, Antonella Poloni, Erika Morsia, Mattia Biondo, Giuseppina Calvaruso, Luca Frison, Livia Leuzzi, Anna Merli, Francesco Paciullo, Andrea Patriarca, Francesco Zaja, and Giuseppe Carli
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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4. P686: REAL-WORLD EFFICACY PROFILE OF ASCIMINIB IN AN ITALIAN, MULTI-RESISTANT CHRONIC-PHASE CHRONIC MYELOID LEUKEMIA (CP-CML) PATIENT POPULATION
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Massimo Breccia, Antonella Russo Rossi, Valentina Giai, Bruno Martino, Carmen Fava, Mario Annunziata, Elisabetta Abruzzese, Gianni Binotto, Claudia Baratè, Aurelio Pio Nardozza, Alessandra Misto, Paola Coco, Valeria Calafiore, Maria Cristina Carraro, Federica Cattina, Francesco Cavazzini, Maria Teresa Corsetti, Lara Crucitti, Monica Crugnola, Paolo Ditonno, Ambra DI Veroli, Anna Ermacora, Felicetto Ferrara, Angelo Genua, Antonella Gozzini, Stefana Impera, Alessandra Iurlo, Luciano Levato, Luigiana Luciano, Maria Cristina Miggiano, Marco De Gobbi, Marco Santoro, Barbara Scappini, Anna Rita Scortechini, Andrea Patriarca, Serena Rosati, Sabina Russo, Rosaria Sancetta, Grazia Sanpaolo, Teresa Maria Santeramo, Silvia Sibilla, Federica Sorà, Paolo Sportoletti, Fabio Stagno, Elena Trabacchi, and Fausto Castagnetti
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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5. P1041: LEUKOCYTOSIS SELECTS A SUBGROUP OF LOW-RISK PV PATIENTS IN WHOM PHLEBOTOMY-ALONE MAY BE INSUFFICIENT
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Alessandra Carobbio, Alessandro Vannucchi, Valerio De Stefano, Arianna Ghirardi, Greta Carioli, Arianna Masciulli, Elena Rossi, Fabio Ciceri, Massimiliano Bonifacio, Alessandra Iurlo, Francesca Palandri, Giulia Benevolo, Fabrizio Pane, Alessandra Ricco, Giuseppe Carli, Marianna Caramella, Davide Rapezzi, Caterina Musolino, Sergio Siragusa, Elisa Rumi, Andrea Patriarca, Nicola Cascavilla, Barbara Mora, Emma Cacciola, Carmela Mannarelli, Giuseppe Gaetano Loscocco, Paola Guglielmelli, Francesca Gesullo, Silvia Betti, Francesca Lunghi, Luigi Scaffidi, Cristina Bucelli, Nicola Vianelli, Marta Bellini, Maria Chiara Finazzi, Gianni Tognoni, Alessandro Rambaldi, and Tiziano Barbui
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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6. P1027: UPDATED DURABILITY OF RESPONSE AND SAFETY IN MANIFEST ARM 3: PELABRESIB (CPI-0610) COMBINED WITH RUXOLITINIB FOR JAK INHIBITOR TREATMENT-NAÏVE PATIENTS WITH MYELOFIBROSIS
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Claire Harrison, Andrea Patriarca, Vikas Gupta, Francesca Palandri, Timothy Devos, Raajit K Rampal, Moshe Talpaz, Alessandro Vannucchi, Andrew Kuykendall, Jean-Jacques Kiladjian, Srdan Verstovsek, Ruben Mesa, Gozde Colak, Soumik Dutta, Sandra Klein, Jie Cui, Tzuu-Wang Chang, and John Mascarenhas
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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7. PB2611: EVANS SYNDROME: DISEASE AWARENESS AND CLINICAL MANAGEMENT IN A NATION-WIDE ITALIAN SURVEY
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Bruno Fattizzo, Valentina Carrai, Monica Crugnola, Erminia Baldacci, Marta Bellini, Costanza Bosi, Elisa Buzzatti, Domenica Caramazza, Giuseppe Carli, Monica Carpenedo, Cristina Clissa, Cristina Danesin, Maria Rosaria De Paolis, Juri Alessandro Giannotta, Vanessa Innao, Monia Marchetti, Uros Markovic, Alessandro Morotti, Mariasanta Napolitano, Andrea Patriarca, Loredana Pettine, Antonella Poloni, Elena Rivolti, Elena Rossi, Teresa Maria Santeremo, Cristina Santoro, Maria Elena Zannier, Francesco Zaja, Silvia Cantoni, Francesca Palandri, and Valerio De Stefano
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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8. PB2670: EQOL-MDS TRIAL: PATIENT-REPORTED OUTCOMES IN PATIENTS WITH LOWER RISK MYELODYSPLASTIC SYNDROMES WITH SEVERE THROMBOCYTOPENIA.
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Esther Oliva, Giuseppe Iannì, Marta Riva, Pasquale Niscola, Valeria Santini, Massimo Breccia, Valentina Gaidano, Antonella Poloni, Andrea Patriarca, Elena Crisà, Isabella Capodanno, Prassede Salutari, Gianluigi Reda, Grazia Sanpaolo, Dario Ferrero, Attilio Guarini, Giovanni Tripepi, Andrea Castelli, Bruno Fattizzo, Germana Beltrami, Monica Bocchia, Alfredo Molteni, Pierre Fenaux, Ulrich Germing, Alessandra Ricco, Giuseppe A. Palumbo, Stefana Impera, Nicola DI Renzo, Francesco Buccisano, Aspasia Stamatoullas, Anna Marina Liberati, Anna Candoni, Ilaria Maria Delfino, Patrizia Cufari, Lorenzo Rizzo, and Roberto Latagliata
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2023
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9. Breakthrough infections in MPN-COVID vaccinated patients
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Tiziano Barbui, Alessandra Carobbio, Arianna Ghirardi, Alessandra Iurlo, Valerio De Stefano, Marta Anna Sobas, Elisa Rumi, Elena Maria Elli, Francesca Lunghi, Mercedes Gasior Kabat, Beatriz Cuevas, Paola Guglielmelli, Massimiliano Bonifacio, Monia Marchetti, Alberto Alvarez-Larran, Laura Fox, Marta Bellini, Rosa Daffini, Giulia Benevolo, Gonzalo Carreno-Tarragona, Andrea Patriarca, Haifa Kathrin Al-Ali, Maria Marcio Miguel Andrade-Campos, Francesca Palandri, Claire Harrison, Maria Angeles Foncillas, Santiago Osorio, Steffen Koschmieder, Elena Magro Mazo, Jean-Jacques Kiladjian, Estefanía Bolaños Calderón, Florian H. Heidel, Keina Quiroz Cervantes, Martin Griesshammer, Valentin Garcia-Gutierrez, Alberto Marin Sanchez, Juan Carlos Hernandez-Boluda, Emma Lopez Abadia, Giuseppe Carli, Miguel Sagues Serrano, Rajko Kusec, Blanca Xicoy Cirici, Margarita Guenova, Begona Navas Elorza, Anna Angona, Edyta Cichocka, Anna Kulikowska de Nałęcz, Daniele Cattaneo, Cristina Bucelli, Silvia Betti, Oscar Borsani, Fabrizio Cavalca, Sara Carbonell, Natalia Curto-Garcia, Lina Benajiba, Alessandro Rambaldi, and Alessandro Maria Vannucchi
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2022
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10. High reproducibility of spleen stiffness measurement by vibration‐controlled transient elastography with a spleen‐dedicated module
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Cristina Rigamonti, Micol Giulia Cittone, Giulia Francesca Manfredi, Andrea Sorge, Riccardo Moia, Andrea Patriarca, Maria Francesca Donato, Gianluca Gaidano, Mario Pirisi, and Mirella Fraquelli
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Diseases of the digestive system. Gastroenterology ,RC799-869 - Abstract
Abstract Spleen stiffness measurement (SSM) by vibration‐controlled transient elastography (VCTE) is a noninvasive technique for estimating portal hypertension in patients with chronic liver disease (CLD), with its reproducibility yet to be established and its feasibility still unknown beyond CLD. We have studied 420 participants from two tertiary referral centers for liver diseases (Novara, Milan): 297 patients with CLD (32% with cirrhosis) of different etiology (Group A), 63 Philadelphia‐negative myeloproliferative neoplasms (Group B), and 60 heathy volunteers (Group C). All underwent SSM by VCTE with a spleen‐dedicated module (SSM@100 Hz) and liver stiffness measurement (LSM), blindly performed by 2 different operators. In total, 1680 VCTE examinations for SSM were performed (1000 in Novara, 680 in Milan), with an overall 3.2% failure rate. Median SSM was 26.5 kPa (interquartile range [IQR] 20.0–42.3) in Group A, 26.3 kPa (IQR 22.3–33.6) in Group B, and 16.1 kPa (IQR 14.6–18.7) in Group C. In Group A, the median LSM was 6.8 kPa (IQR 4.9–11.3) in Novara and 8.3 kPa (IQR 7.1–10.8) in Milan, the proportion of patients with cirrhosis being 34% in Novara and 31% in Milan. The Group A interobserver agreement ICC was 0.90 (0.88–0.92), significantly lower in the absence of splenomegaly (ICC 0.87 vs. 0.91) and in absence of cirrhosis (ICC 0.84 vs. 0.90); overweight slightly, but not significantly reduced the interobserveragreement. The intra‐observer agreement ICC ranged from 0.91 to 0.96 for the four operators. The Group B interobserver agreement ICC was 0.90 (0.83–0.94). In conclusion, SSM measured by the new spleen‐dedicated VCTE module is a feasible, reliable, and highly reproducible tool in patients with CLD and hematological disorders, and in healthy volunteers.
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- 2022
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11. Patterns of neutralizing humoral response to SARS-CoV-2 infection among hematologic malignancy patients reveal a robust immune response in anti-cancer therapy-naive patients
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Cinzia Borgogna, Riccardo Bruna, Gloria Griffante, Licia Martuscelli, Marco De Andrea, Daniela Ferrante, Andrea Patriarca, Abdurraouf Mokhtar Mahmoud, Valentina Gaidano, Monia Marchetti, Davide Rapezzi, Michele Lai, Mauro Pistello, Marco Ladetto, Massimo Massaia, Gianluca Gaidano, and Marisa Gariglio
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Understanding antibody-based SARS-CoV-2 immunity in hematologic malignancy (HM) patients following infection is crucial to inform vaccination strategies for this highly vulnerable population. This cross-sectional study documents the anti-SARS-CoV-2 humoral response and serum neutralizing activity in 189 HM patients recovering from a PCR-confirmed infection. The overall seroconversion rate was 85.7%, with the lowest values in patients with lymphoid malignancies or undergoing chemotherapy. Therapy-naive patients in the “watch and wait” status were more likely to seroconvert and display increased anti-s IgG titers. Enhanced serum neutralizing activity was observed in the following SARS-CoV-2-infected HM patient groups: (i) males; (ii) severe COVID-19; and (iii) “watch and wait” or “complete/partial response”. The geometric mean (GeoMean) ID50 neutralization titers in patients analyzed before or after 6 months post-infection were 299.1 and 306.3, respectively, indicating that >50% of the patients in either group had a neutralization titer sufficient to provide 50% protection from symptomatic COVID-19. Altogether, our findings suggest that therapy-naive HM patients mount a far more robust immune response to SARS-CoV-2 infection vs. patients receiving anti-cancer treatment, raising the important question as to whether HM patients should be vaccinated before therapy and/or receive vaccine formats capable of better recapitulating the natural infection.
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- 2022
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12. Venetoclax with Hypomethylating Agents in Newly Diagnosed Acute Myeloid Leukemia: A Systematic Review and Meta-Analysis of Survival Data from Real-World Studies
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Andrealuna Ucciero, Federico Pagnoni, Lorenza Scotti, Alessia Pisterna, Francesco Barone-Adesi, Gianluca Gaidano, Andrea Patriarca, and Monia Lunghi
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acute myeloid leukemia ,hypomethylating agents ,real world studies ,survival ,venetoclax ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
In recent years, the association of venetoclax (VEN) with hypomethylating agents (HMAs) significantly improved the outcome of patients with newly diagnosed acute myeloid leukemia (AML) who were unfit for intensive chemotherapy and became the standard of care after the publication of the pivotal RCT VIALE-A. However, it is still not clear to what extent the results observed in the VIALE-A apply to a real-world setting. For this reason, we carried out a systematic review and meta-analysis of real-world studies on newly diagnosed patients with AML, ineligible for intensive induction chemotherapy, receiving first-line VEN+HMA. We then compared their results in term of survival with those from the VIALE-A. Kaplan-Meier curves were extracted from all included studies and individual survival data was reconstructed. We then estimated a pooled survival curve and compared it with the results of the VIALE-A using the log-rank test. We also conducted a secondary analysis including only studies considering VEN plus azacytidine (AZA) as treatment, as this was the schedule originally used in the VIALE-A. Nineteen real-world studies met the inclusion criteria and were included in the systematic review. Most of them reported a worse survival than the VIALE-A. The pooled survival curve was similar to that reported in the VIALE-A during the first three months of treatment but diverged thereafter (p-value = 0.0001). The pooled median survival among the real-world studies was 9.37 months (95%CI 8.81–10.5), substantially lower than that reported in the VIALE-A (14.7 months; 95%CI 11.9–18.7). Results slightly increased when the analysis was restricted to the studies using VEN+AZA as treatment (median survival: 11.5 months; 95%CI 10.2–14.8). Survival of newly diagnosed AML patients treated with VEN+HMAs in a real-world setting seems to be lower than previously reported in the VIALE-A, while the effect of VEN+AZA is more in line with expected results. Future studies are needed to evaluate whether this apparent discrepancy is due to the different characteristics of enrolled patients or to a non-optimal adherence to therapy, and whether alternative regimens can provide better results in terms of safety and effectiveness.
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- 2023
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13. High BECN1 Expression Negatively Correlates with BCL2 Expression and Predicts Better Prognosis in Diffuse Large B-Cell Lymphoma: Role of Autophagy
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Amreen Salwa, Alessandra Ferraresi, Eleonora Secomandi, Letizia Vallino, Riccardo Moia, Andrea Patriarca, Beatrice Garavaglia, Gianluca Gaidano, and Ciro Isidoro
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lymphoma ,autophagy ,BECLIN-1 ,BCL-2 ,venetoclax ,apoptosis ,Cytology ,QH573-671 - Abstract
Diffuse large B-cell lymphoma (DLBCL) is characterized by high molecular and clinical heterogeneity. Autophagy, a lysosome-driven catabolic process devoted to macromolecular turnover, is fundamental in maintaining normal hematopoietic stem cells and progenitors homeostasis, and its dysregulation plays a critical role in the initiation and progression of hematological malignancies. One main regulator of autophagy is BECLIN-1, which may interact alternatively with either BCL-2, thus allowing apoptosis, or PI3KC3, thus promoting autophagy. The altered expression of BCL2 and BECN1 correlates with lymphoma outcomes, but whether this is associated with dysregulated cross-talk between autophagy and apoptosis remains to be elucidated. Analysis of the TCGA database revealed that BCL2 and BECN1 mRNA expression were inversely correlated in DLBCL patients. In representative DLBCL cell lines exposed to doxorubicin, the cells highly expressing BCL-2 were resistant, while the ones highly expressing BECLIN-1 were sensitive, and this correlated with low and high autophagy flux, respectively. Venetoclax targeting of BCL-2 increased while the spautin-1-mediated inhibition of BECLIN-1-dependent autophagy reversed doxorubicin sensitivity in the former and in the latter, respectively. By interrogating the TCGA DLBCL dataset, we found that BCL2 and BECN1 acted as negative and positive prognostic markers for DLBCL, respectively. The differentially expressed gene analysis in the respective cohorts revealed that BCL2 positively correlated with oncogenic pathways (e.g., glucose transport, HIF1A signaling, JAK-STAT signaling, PI3K-AKT-mTOR pathway) and negatively correlated with autophagy-related transcripts, while BECN1 showed the opposite trend. Notably, patients with high BECN1 expression displayed longer survival. Our data reveal, for the first time, that the modulation of BECLIN-1-dependent autophagy influences the prognosis of DLBCL patients and provide a mechanistic explanation supporting the therapeutic use of drugs that, by stimulating autophagy, can sensitize lymphoma cells to chemotherapy.
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- 2023
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14. Immune checkpoint inhibitor therapy and outcomes from SARS-CoV-2 infection in patients with cancer: a joint analysis of OnCovid and ESMO-CoCARE registries
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Joan Brunet, Josep Tabernero, Salvatore Grisanti, Matteo Lambertini, George Pentheroudakis, Bruno Vincenzi, Dirk Arnold, Juan Aguilar-Company, Paolo Pedrazzoli, Solange Peters, Luis Castelo-Branco, Emanuela Romano, Olivier Michielin, Ramon Salazar, Alessio Cortellini, Rossana Berardi, Aleix Prat, Spyridon Gennatas, Giuseppe Tonini, Urania Dafni, Kevin J Harrington, Paola Queirolo, David J Pinato, Francesca Mazzoni, David Viñal, Gino M Dettorre, Uma Mukherjee, Mark Bower, Alexia Bertuzzi, Ailsa Sita-Lumsden, Federica Biello, Andrea Patriarca, Alessandra Gennari, Maura Rossi, Zoi Tsourti, Vasileios Angelis, Jacobo Rogado, Teresa Alonso-Gordoa, Georgia Dimopoulou, Sylvain Pradervand, Marco Tucci, Fanny Pommeret, and Marco Krengli
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background As management and prevention strategies against COVID-19 evolve, it is still uncertain whether prior exposure to immune checkpoint inhibitors (ICIs) affects COVID-19 severity in patients with cancer.Methods In a joint analysis of ICI recipients from OnCovid (NCT04393974) and European Society for Medical Oncology (ESMO) CoCARE registries, we assessed severity and mortality from SARS-CoV-2 in vaccinated and unvaccinated patients with cancer and explored whether prior immune-related adverse events (irAEs) influenced outcome from COVID-19.Findings The study population consisted of 240 patients diagnosed with COVID-19 between January 2020 and February 2022 exposed to ICI within 3 months prior to COVID-19 diagnosis, with a 30-day case fatality rate (CFR30) of 23.6% (95% CI 17.8 to 30.7%). Overall, 42 (17.5%) were fully vaccinated prior to COVID-19 and experienced decreased CFR30 (4.8% vs 28.1%, p=0.0009), hospitalization rate (27.5% vs 63.2%, p
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- 2022
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15. Long-term follow-up of recovered MPN patients with COVID-19
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Tiziano Barbui, Alessandra Iurlo, Arianna Masciulli, Alessandra Carobbio, Arianna Ghirardi, Giuseppe Rossi, Claire Harrison, Alberto Alvarez-Larran, Elena Maria Elli, Jean-Jaques Kiladjian, Mercedes Gasior Kabat, Alberto Marin Sanchez, Francesca Palandri, Marcio Miguel Andrade-Campos, Alessandro Maria Vannucchi, Gonzalo Carreno-Tarragona, Petros Papadopoulos, Keina Quiroz Cervantes, Maria Angeles Foncillas, Maria Laura Fox, Miguel Sagues Serrano, Elisa Rumi, Santiago Osorio, Giulia Benevolo, Andrea Patriarca, Begona Navas Elorza, Valentin Garcia-Gutierrez, Elena Magro Mazo, Francesca Lunghi, Massimiliano Bonifacio, Valerio De Stefano, Juan Carlos Hernandez-Boluda, Emma Lopez Abadia, Anna Angona, Blanca Xicoy Cirici, Marco Ruggeri, Steffen Koschmieder, Marta Anna Sobas, Beatriz Cuevas, Daniele Cattaneo, Rosa Daffini, Marta Bellini, Natalia Curto-Garcia, Marta Garrote, Fabrizio Cavalca, Lina Benajiba, Beatriz Bellosillo, Paola Guglielmelli, Oscar Borsani, Silvia Betti, Silvia Salmoiraghi, and Alessandro Rambaldi
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Published
- 2021
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16. A randomized clinical study on the impact of Comprehensive Geriatric Assessment (CGA) based interventions on the quality of life of elderly, frail, onco-hematologic patients candidate to anticancer therapy: protocol of the ONCO-Aging study
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Abdurraouf Mokhtar Mahmoud, Federica Biello, Paola Maria Maggiora, Riccardo Bruna, Giovanni Burrafato, Miriam Cappelli, Feba Varughese, Veronica Martini, Francesca Platini, Clara Deambrogi, Andrea Patriarca, Maura Nicolosi, Ajay ram Vachanaram, Carla Pisani, Eleonora Ferrara, Elvira Catania, Danila Azzolina, Francesco Barone-Adesi, Marco Krengli, Gianluca Gaidano, and Alessandra Gennari
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Comprehensive geriatric assessment (CGA) ,G8 questionnaire ,Quality of Life (QoL) ,Cell senescence ,Geriatrics ,RC952-954.6 - Abstract
Abstract Background Age is considered as one of the most important risk-factor for many types of solid and hematological cancers, as their incidence increases with age in parallel to the ever-growing elderly population. Moreover, cancer incidence is constantly increasing as a consequence of the increase in life expectancy that favors the process of cellular senescence. Geriatric assessment has been increasingly recognized as predictive and prognostic instrument to detect frailty in older adults with cancer. In particular, the G8 score is a simple and reproducible instrument to identify elderly patients who should undergo full geriatric evaluation. Due to their frailty, elderly patients may be often under-treated and a therapeutic choice based also on a comprehensive geriatric assessment (CGA) is recommended. With these premises, we aim to test the impact of the CGA based interventions on the quality of life (QoL) of frail elderly onco-hematological patients, identified by the G8 screening, candidate for innovative target directed drugs or treatments including the combination of radiotherapy and chemotherapy (RT + CT). Methods Patients aged > 65 years, candidate to target directed agents or to RT + CT treatments are screened for frailty by the G8 test; those patients classified as frail (G8 ≤ 14) are randomized to receive a CGA at baseline or to conventional care. The primary endpoint is QoL, assessed by EORTC QLQ-C30C. As collateral biological study, the potential prognostic/predictive role of T-cell senescence and myeloid derived suppressor cells (MDSC) are evaluated on plasma samples. Discussion This trial will contribute to define the impact of CGA on the management of frail elderly onco-hematologic patients candidate to innovative biological drugs or to integrated schedules with the association of RT + CT. Furthermore, the use of plasma samples to assess the potential prognostic value of imbalance of immune-competent cells is expected to contribute to the individualized care of elderly patients, resulting into a fine tuning of the therapeutic strategies. Trial registration ClinicalTrials.gov ID: NCT04478916 . registered July 21, 2020 – retrospectively registered.
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- 2021
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17. Among classic myeloproliferative neoplasms, essential thrombocythemia is associated with the greatest risk of venous thromboembolism during COVID-19
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Tiziano Barbui, Valerio De Stefano, Alberto Alvarez-Larran, Alessandra Iurlo, Arianna Masciulli, Alessandra Carobbio, Arianna Ghirardi, Alberto Ferrari, Valeria Cancelli, Elena Maria Elli, Marcio Miguel Andrade-Campos, Mercedes Gasior Kabat, Jean-Jaques Kiladjian, Francesca Palandri, Giulia Benevolo, Valentin Garcia-Gutierrez, Maria Laura Fox, Maria Angeles Foncillas, Carmen Montoya Morcillo, Elisa Rumi, Santiago Osorio, Petros Papadopoulos, Massimiliano Bonifacio, Keina Susana Quiroz Cervantes, Miguel Sagues Serrano, Gonzalo Carreno-Tarragona, Marta Anna Sobas, Francesca Lunghi, Andrea Patriarca, Begoña Navas Elorza, Anna Angona, Elena Magro Mazo, Steffen Koschmieder, Giuseppe Carli, Beatriz Cuevas, Juan Carlos Hernandez-Boluda, Emma Lopez Abadia, Blanca Xicoy Cirici, Paola Guglielmelli, Marta Garrote, Daniele Cattaneo, Rosa Daffini, Fabrizio Cavalca, Beatriz Bellosillo, Lina Benajiba, Natalia Curto-Garcia, Marta Bellini, Silvia Betti, Claire Harrison, Alessandro Rambaldi, and Alessandro Maria Vannucchi
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract In a multicenter European retrospective study including 162 patients with COVID-19 occurring in essential thrombocythemia (ET, n = 48), polycythemia vera (PV, n = 42), myelofibrosis (MF, n = 56), and prefibrotic myelofibrosis (pre-PMF, n = 16), 15 major thromboses (3 arterial and 12 venous) were registered in 14 patients, of whom all, but one, were receiving LMW-heparin prophylaxis. After adjustment for the competing risk of death, the cumulative incidence of arterial and venous thromboembolic events (VTE) reached 8.5% after 60 days follow-up. Of note, 8 of 12 VTE were seen in ET. Interestingly, at COVID-19 diagnosis, MPN patients had significantly lower platelet count (p
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- 2021
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18. An acquired factor V inhibitor induced uncontrolled bleeding in a postsurgery patient
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Riccardo Bruna, Riccardo Moia, Alessandra Valpreda, Enrico Dosio, Roberta Rolla, Augusto Federici, Umberto Dianzani, Gianluca Gaidano, and Andrea Patriarca
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acquired hemophilia ,bypassing agents ,factor V inhibitor ,Medicine ,Medicine (General) ,R5-920 - Abstract
Abstract This case report highlights the challenges in controlling bleeding and correcting coagulation tests through the use of bypassing agents in patients with FV inhibitors.
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- 2021
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19. Predicting the probability of Gaucher disease in subjects with splenomegaly and thrombocytopenia
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Irene Motta, Dario Consonni, Marina Stroppiano, Christian Benedetto, Elena Cassinerio, Barbara Tappino, Paola Ranalli, Lorenza Borin, Luca Facchini, Andrea Patriarca, Wilma Barcellini, Federica Lanza, Mirella Filocamo, Maria Domenica Cappellini, and Splenomegaly Gaucher group
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Medicine ,Science - Abstract
Abstract Hematologists are frequently involved in the diagnostic pathway of Gaucher disease type 1 (GD1) patients since they present several hematological signs. However, GD1 is mainly underdiagnosed because of a lack of awareness. In this multicenter study, we combine the use of a diagnostic algorithm with a simple test (β-glucosidase activity on Dried Blood Spot) in order to facilitate the diagnosis in a population presenting to the hematologist with splenomegaly and/or thrombocytopenia associated with other hematological signs. In this high-risk population, the prevalence of GD1 is 3.3%. We propose an equation that predicts the probability of having GD1 according to three parameters that are routinely evaluated: platelet count, ferritin, and transferrin saturation.
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- 2021
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20. Physicians’ Perceptions of Clinical Utility of a Digital Health Tool for Electronic Patient-Reported Outcome Monitoring in Real-Life Hematology Practice. Evidence From the GIMEMA-ALLIANCE Platform
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Fabio Efficace, Andrea Patriarca, Mario Luppi, Leonardo Potenza, Giovanni Caocci, Agostino Tafuri, Francesca Fazio, Claudio Cartoni, Maria Teresa Petrucci, Ida Carmosino, Riccardo Moia, Gloria Margiotta Casaluci, Paola Boggione, Elisabetta Colaci, Davide Giusti, Valeria Pioli, Francesco Sparano, Francesco Cottone, Paolo De Fabritiis, Nicolina Rita Ardu, Pasquale Niscola, Isabella Capodanno, Anna Paola Leporace, Sabrina Pelliccia, Elisabetta Lugli, Edoardo La Sala, Luigi Rigacci, Michelina Santopietro, Claudio Fozza, Sergio Siragusa, Massimo Breccia, Paola Fazi, and Marco Vignetti
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digital health ,symptoms ,quality of life ,hematology ,patient-reported outcomes (PROs) ,leukemia ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Digital health tools are increasingly being used in cancer care and may include electronic patient-reported outcome (ePRO) monitoring systems. We examined physicians’ perceptions of usability and clinical utility of a digital health tool (GIMEMA-ALLIANCE platform) for ePRO monitoring in the real-life practice of patients with hematologic malignancies. This tool allows for the collection and assessment of ePROs with real-time graphical presentation of results to medical staff. Based on a predefined algorithm, automated alerts are sent to medical staff. Participating hematologists completed an online survey on their experience with the platform. Of the 201 patients invited to participate between December 2020 and June 2021 (cut-off date for current analysis), 180 (90%) agreed to enter the platform and had a median age of 57 years. Twenty-three hematologists with a median age of 42 years and an average of 17 years of experience in clinical practice were surveyed. All hematologists agreed or strongly agreed that the platform was easy to use, and 87%, agreed or strongly agreed that ePROs data were useful to enhance communication with their patients. The majority of physicians (78%) accessed the platform at least once per month to consult the symptom and health status profile of their patients. The frequency of access was independent of physician sex (p=0.393) and years of experience in clinical practice (p=0.404). In conclusion, our preliminary results support the clinical utility, from the perspective of the treating hematologist, of integrating ePROs into the routine cancer care of patients with hematologic malignancies.
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- 2022
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21. Stiffer Spleen Predicts Higher Bone Marrow Fibrosis and Higher JAK2 Allele Burden in Patients With Myeloproliferative Neoplasms
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Riccardo Moia, Micol Giulia Cittone, Paola Boggione, Giulia Francesca Manfredi, Chiara Favini, Bassel Awikeh, Anita Rebecca Pedrinelli, Abdurraouf Mokhtar Mahmoud, Maura Nicolosi, Mattia Bellan, Pier Paolo Sainaghi, Mario Pirisi, Gianluca Gaidano, Andrea Patriarca, and Cristina Rigamonti
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myeloproliferative neoplasms ,spleen stiffness ,JAK2 mutations ,vibration-controlled transient elastography (VCTE) ,NGS ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
A total of 63 myeloproliferative neoplasms [MPN; 9 polycythemia vera (PV), 32 essential thrombocythemia (ET), and 22 myelofibrosis (MF)] underwent spleen stiffness (SS) measurement by vibration-controlled transient elastography equipped with a novel spleen-dedicated module. Higher SS values significantly correlated with grade 2-3 bone marrow (BM) fibrosis (p=0.035), with hemoglobin level
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- 2021
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22. Prognostic Factors for Overall Survival In Chronic Myeloid Leukemia Patients: A Multicentric Cohort Study by the Italian CML GIMEMA Network
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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, and Giovannino Ciccone
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chronic myeloid leukemia ,tyrosine kinase inhibitors ,prognostic factors ,ELTs ,Sokal score ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
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 85.9-91.4). Overall, 73 patients (6.1%) died: 17 (2.8%) in the 2GTKI vs 56 (9.2%) in the IMA cohort (adjusted HR=0.50; 95% CI=0.26-0.94), but no differences were detected for CML-related mortality (10 (1.7%) vs 11 (1.8%) in the 2GTKIs vs IMA cohort (sHR=1.61; 0.52-4.96). The ELTS score was associated to CML mortality (high risk vs low, HR=9.67; 95%CI 2.94-31.74; p
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- 2021
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23. Systemic pro-inflammatory response identifies patients with cancer with adverse outcomes from SARS-CoV-2 infection: the OnCovid Inflammatory Score
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Joan Brunet, Josep Tabernero, Mieke Van Hemelrijck, Salvatore Grisanti, Bruno Vincenzi, Isabel Ruiz-Camps, Juan Aguilar-Company, Daniela Ferrante, Oriol Mirallas, Amanda Jackson, Beth Russell, Ramon Salazar, Aleix Prat, Daniele Generali, Nadia Harbeck, Alberto Zambelli, Carlo Alberto Tondini, David J Pinato, Lorenza Rimassa, Armando Santoro, Neha Chopra, Tom Newsom-Davis, Gino M Dettorre, Saoirse Dolly, Angela Loizidou, John Chester, Uma Mukherjee, Mark Bower, Christopher C T Sng, Alexia Bertuzzi, Ricard Mesia, Ailsa Sita-Lumsden, Elia Seguí, Federica Biello, Pavetha Seeva, Gianpiero Rizzo, Michela Libertini, Antonio Maconi, Charlotte Moss, Rossella Bertulli, Diego Ottaviani, Raquel Liñan, Andrea Marrari, M Carmen Carmona-García, Valeria Tovazzi, Vittoria Fotia, Claudia Andrea Cruz, Nadia Saoudi-Gonzalez, Eudald Felip, Ariadna Roqué, Alvin J X Lee, David García-Illescas, Roxana Reyes, Yien Ning Sophia Wong, Lorenza Scotti, Javier Marco-Hernández, Andrea Patriarca, Lorenzo Chiudinelli, Michela Franchi, Alessandra Gennari, and Nikolaos Diamantis
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Background Patients with cancer are particularly susceptible to SARS-CoV-2 infection. The systemic inflammatory response is a pathogenic mechanism shared by cancer progression and COVID-19. We investigated systemic inflammation as a driver of severity and mortality from COVID-19, evaluating the prognostic role of commonly used inflammatory indices in SARS-CoV-2-infected patients with cancer accrued to the OnCovid study.Methods In a multicenter cohort of SARS-CoV-2-infected patients with cancer in Europe, we evaluated dynamic changes in neutrophil:lymphocyte ratio (NLR); platelet:lymphocyte ratio (PLR); Prognostic Nutritional Index (PNI), renamed the OnCovid Inflammatory Score (OIS); modified Glasgow Prognostic Score (mGPS); and Prognostic Index (PI) in relation to oncological and COVID-19 infection features, testing their prognostic potential in independent training (n=529) and validation (n=542) sets.Results We evaluated 1071 eligible patients, of which 625 (58.3%) were men, and 420 were patients with malignancy in advanced stage (39.2%), most commonly genitourinary (n=216, 20.2%). 844 (78.8%) had ≥1 comorbidity and 754 (70.4%) had ≥1 COVID-19 complication. NLR, OIS, and mGPS worsened at COVID-19 diagnosis compared with pre-COVID-19 measurement (p
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- 2021
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24. Human hematopoietic microenvironments.
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Helene Bjoerg Kristensen, Thomas Levin Andersen, Andrea Patriarca, Klaus Kallenbach, Birgit MacDonald, Tanja Sikjaer, Charlotte Ejersted, and Jean-Marie Delaisse
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Medicine ,Science - Abstract
Dormancy of hematopoietic stem cells and formation of progenitors are directed by signals that come from the bone marrow microenvironment. Considerable knowledge has been gained on the murine hematopoietic stem cell microenvironment, while less so on the murine progenitor microenvironment and even less so on these microenvironments in humans. Characterization of these microenvironments is decisive for understanding hematopoiesis and finding new treatment modalities against bone marrow malignancies in the clinic. However, it is equally challenging, because hematopoietic stem cells are difficult to detect in the complex bone marrow landscape. In the present study we are characterizing the human hematopoietic stem cell and progenitor microenvironment. We obtained three adjacent bone marrow sections from ten healthy volunteers. One was used to identify a population of CD34+/CD38- "hematopoietic stem cells and multipotent progenitors" and a population of CD34+/CD38+ "progenitors" based on immunofluorescence pattern/intensity and cellular morphology. The other two were immunostained respectively for CD34/CD56 and for CD34/SMA. Using the combined information we performed a non-computer-assisted quantification of nine bone marrow components (adipocytes, megakaryocytes, bone surfaces, four different vessel types (arteries, capillaries, sinusoids and collecting sinuses), other "hematopoietic stem cells and multipotent progenitors" and other "progenitors") within 30 μm of "hematopoietic stem cells and multipotent progenitors", "progenitors", and "random cell profiles". We show that the microenvironment of the "hematopoietic stem cells and multipotent progenitors" is significantly enriched in sinusoids and megakaryocytes, while the microenvironment of the "progenitors" is significantly enriched in capillaries, other "progenitors", bone surfaces and arteries.
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- 2021
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25. A step ahead toward precision medicine for chronic lymphocytic leukemia
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Andrea Patriarca and Gianluca Gaidano
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2020
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26. Efficacy of recombinant erythropoietin in autoimmune hemolytic anemia: a multicenter international study
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Bruno Fattizzo, Marc Michel, Anna Zaninoni, Juri Giannotta, Stephanie Guillet, Henrik Frederiksen, Josephine M.I. Vos, Francesca R. Mauro, Bernd Jilma, Andrea Patriarca, Francesco Zaja, Anita Hill, Sigbiørn Berentsen, and Wilma Barcellini
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Published
- 2020
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27. Biological and clinical implications of BIRC3 mutations in chronic lymphocytic leukemia
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Fary Diop, Riccardo Moia, Chiara Favini, Elisa Spaccarotella, Lorenzo De Paoli, Alessio Bruscaggin, Valeria Spina, Lodovico Terzi-di-Bergamo, Francesca Arruga, Chiara Tarantelli, Clara Deambrogi, Silvia Rasi, Ramesh Adhinaveni, Andrea Patriarca, Simone Favini, Sruthi Sagiraju, Clive Jabangwe, Ahad A. Kodipad, Denise Peroni, Francesca R. Mauro, Ilaria Del Giudice, Francesco Forconi, Agostino Cortelezzi, Francesco Zaja, Riccardo Bomben, Francesca Maria Rossi, Carlo Visco, Annalisa Chiarenza, Gian Matteo Rigolin, Roberto Marasca, Marta Coscia, Omar Perbellini, Alessandra Tedeschi, Luca Laurenti, Marina Motta, David Donaldson, Phil Weir, Ken Mills, Patrick Thornton, Sarah Lawless, Francesco Bertoni, Giovanni Del Poeta, Antonio Cuneo, Antonia Follenzi, Valter Gattei, Renzo Luciano Boldorini, Mark Catherwood, Silvia Deaglio, Robin Foà, Gianluca Gaidano°, and Davide Rossi°
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Diseases of the blood and blood-forming organs ,RC633-647.5 - Abstract
BIRC3 is a recurrently mutated gene in chronic lymphocytic leukemia (CLL) but the functional implications of BIRC3 mutations are largely unexplored. Furthermore, little is known about the prognostic impact of BIRC3 mutations in CLL cohorts homogeneously treated with first-line fludarabine, cyclophosphamide, and rituximab (FCR). By immunoblotting analysis, we showed that the non-canonical nuclear factor-κB pathway is active in BIRC3-mutated cell lines and in primary CLL samples, as documented by the stabilization of MAP3K14 and by the nuclear localization of p52. In addition, BIRC3-mutated primary CLL cells are less sensitive to flu-darabine. In order to confirm in patients that BIRC3 mutations confer resistance to fludarabine-based chemoimmunotherapy, a retrospective multicenter cohort of 287 untreated patients receiving first-line FCR was analyzed by targeted next-generation sequencing of 24 recurrently mutated genes in CLL. By univariate analysis adjusted for multiple comparisons BIRC3 mutations identify a poor prognostic subgroup of patients in whom FCR treatment fails (median progression-free survival: 2.2 years, P
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- 2020
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28. Precision Medicine in Systemic Mastocytosis
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Maura Nicolosi, Andrea Patriarca, Annalisa Andorno, Abdurraouf Mokhtar Mahmoud, Alessandra Gennari, Renzo Boldorini, Gianluca Gaidano, and Elena Crisà
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systemic mastocytosis ,genetics ,KIT ,tyrosine kinase inhibitor ,precision medicine ,Medicine (General) ,R5-920 - Abstract
Mastocytosis is a rare hematological neoplasm characterized by the proliferation of abnormal clonal mast cells (MCs) in different cutaneous and extracutaneous organs. Its diagnosis is based on well-defined major and minor criteria, including the pathognomonic dense infiltrate of MCs detected in bone marrow (BM), elevated serum tryptase level, abnormal MCs CD25 expression, and the identification of KIT D816V mutation. The World Health Organization (WHO) classification subdivides mastocytosis into a cutaneous form (CM) and five systemic variants (SM), namely indolent/smoldering (ISM/SSM) and advanced SM (AdvSM) including aggressive SM (ASM), SM associated to hematological neoplasms (SM-AHN), and mast cell leukemia (MCL). More than 80% of patients with SM carry a somatic point mutation of KIT at codon 816, which may be targeted by kinase inhibitors. The presence of additional somatic mutations detected by next generation sequencing analysis may impact prognosis and drive treatment strategy, which ranges from symptomatic drugs in indolent forms to kinase-inhibitors active on KIT. Allogeneic stem cell transplant (SCT) may be considered in selected SM cases. Here, we review the clinical, diagnostic, and therapeutic issues of SM, with special emphasis on the translational implications of SM genetics for a precision medicine approach in clinical practice.
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- 2021
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29. Cerebrospinal fluid xanthochromia after pegasparaginase hepatotoxicity in B‐cell acute lymphoblastic leukemia
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Riccardo Moia, Mariangela Greco, Paola Boggione, Maura Nicolosi, Riccardo Bruna, Andrea Patriarca, Gianluca Gaidano, and Monia Lunghi
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ALL ,CSF xanthochromia ,hepatotoxicity ,pegasparaginase ,Medicine ,Medicine (General) ,R5-920 - Abstract
Key Clinical Message Patients with B‐lineage acute lymphoblastic leukemia treated with pegasparaginase‐containing regimens can develop hepatotoxicity related to it. The systemic hyperbilirubinemia due to hepatotoxicity can lead to the development of CSF xanthochromia.
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- 2020
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30. Genetic Predisposition to Myelodysplastic Syndromes: A Challenge for Adult Hematologists
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Elena Crisà, Paola Boggione, Maura Nicolosi, Abdurraouf Mokhtar Mahmoud, Wael Al Essa, Bassel Awikeh, Anna Aspesi, Annalisa Andorno, Renzo Boldorini, Irma Dianzani, Gianluca Gaidano, and Andrea Patriarca
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genetic predisposition ,myelodysplastic syndromes ,inherited bone marrow failure ,Biology (General) ,QH301-705.5 ,Chemistry ,QD1-999 - Abstract
Myelodysplastic syndromes (MDS) arising in the context of inherited bone marrow failure syndromes (IBMFS) differ in terms of prognosis and treatment strategy compared to MDS occurring in the adult population without an inherited genetic predisposition. The main molecular pathways affected in IBMFS involve telomere maintenance, DNA repair, biogenesis of ribosomes, control of proliferation and others. The increased knowledge on the genes involved in MDS pathogenesis and the wider availability of molecular diagnostic assessment have led to an improvement in the detection of IBMFS genetic predisposition in MDS patients. A punctual recognition of these disorders implies a strict surveillance of the patient in order to detect early signs of progression and promptly offer allogeneic hematopoietic stem cell transplantation, which is the only curative treatment. Moreover, identifying an inherited mutation allows the screening and counseling of family members and directs the choice of donors in case of need for transplantation. Here we provide an overview of the most recent data on MDS with genetic predisposition highlighting the main steps of the diagnostic and therapeutic management. In order to highlight the pitfalls of detecting IBMFS in adults, we report the case of a 27-year-old man affected by MDS with an underlying telomeropathy.
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- 2021
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31. Atypical Chronic Myeloid Leukemia: Where Are We Now?
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Elena Crisà, Maura Nicolosi, Valentina Ferri, Chiara Favini, Gianluca Gaidano, and Andrea Patriarca
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Atypical CML ,next generation sequencing ,target therapy ,Biology (General) ,QH301-705.5 ,Chemistry ,QD1-999 - Abstract
Atypical chronic myeloid leukemia, BCR-ABL1 negative (aCML) is a rare myelodysplastic syndrome (MDS)/myeloproliferative neoplasm (MPN) with a high rate of transformation to acute myeloid leukemia, and poor survival. Until now, the diagnosis has been based on morphological grounds only, possibly making the real frequency of the disease underestimated. Only recently, new insights in the molecular biology of MDS/MPN syndromes have deepened our knowledge of aCML, enabling us to have a better molecular profile of the disease. The knowledge gleaned from next generation sequencing has complemented morphologic and laboratory WHO criteria for myeloid neoplasms and can provide greater specificity in distinguishing aCML from alternative MDS/MPN or MPNs. The most commonly mutated genes (>20%) in aCML are SETBP1, ASXL1, N/K-RAS, SRSF2, and TET2, and less frequently (< 10%) CBL, CSFR3, JAK2, EZH2, and ETNK1. Several of these mutations affect the JAK-STAT, MAPK, and ROCK signaling pathways, which are targetable by inhibitors that are already in clinical use and may lead to a personalized treatment of aCML patients unfit for allogeneic transplant, which is currently the only curative option for fit patients. In this review, we present two emblematic clinical cases and address the new molecular findings in aCML and the available treatment options.
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- 2020
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32. Presenting Features and Early Mortality from SARS-CoV-2 Infection in Cancer Patients during the Initial Stage of the COVID-19 Pandemic in Europe
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David J. Pinato, Alvin J. X. Lee, Federica Biello, Elia Seguí, Juan Aguilar-Company, Anna Carbó, Riccardo Bruna, Mark Bower, Gianpiero Rizzo, Sarah Benafif, Carme Carmona, Neha Chopra, Claudia Andrea Cruz, Francesca D’Avanzo, Joanne S. Evans, Myria Galazi, Isabel Garcia-Fructuoso, Alessia Dalla Pria, Thomas Newsom-Davis, Diego Ottaviani, Andrea Patriarca, Roxana Reyes, Rachel Sharkey, Christopher C. T. Sng, Yien Ning Sophia Wong, Daniela Ferrante, Lorenza Scotti, Gian Carlo Avanzi, Mattia Bellan, Luigi Mario Castello, Javier Marco-Hernández, Meritxell Mollà, Mario Pirisi, Isabel Ruiz-Camps, Pier Paolo Sainaghi, Gianluca Gaidano, Joan Brunet, Josep Tabernero, Aleix Prat, and Alessandra Gennari
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COVID-19 ,coronavirus ,SARS-CoV-2 ,cancer ,survival ,outcomes ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
We describe the outcomes in cancer patients during the initial outbreak of the COVID-19 in Europe from the retrospective, multi-center observational OnCovid study. We identified 204 cancer patients from eight centers in the United Kingdom, Italy, and Spain aged >18 (mean = 69) and diagnosed with COVID-19 between 26 February and 1 April 2020. A total of 127 (62%) were male, 184 (91%) had a diagnosis of solid malignancy, and 103 (51%) had non-metastatic disease. A total of 161 (79%) had >1 co-morbidity. A total of 141 (69%) patients had >1 COVID-19 complication. A total of 36 (19%) were escalated to high-dependency or intensive care. A total of 59 (29%) died, 53 (26%) were discharged, and 92 (45%) were in-hospital survivors. Mortality was higher in patients aged >65 (36% vs. 16%), in those with >2 co-morbidities (40% vs. 18%) and developing >1 complication from COVID-19 (38% vs. 4%, p = 0.004). Multi-variable analyses confirmed age > 65 and >2 co-morbidities to predict for patient mortality independent of tumor stage, active malignancy, or anticancer therapy. During the early outbreak of SARS-CoV-2 infection in Europe co-morbid burden and advancing age predicted for adverse disease course in cancer patients. The ongoing OnCovid study will allow us to compare risks and outcomes in cancer patients between the initial and later stages of the COVID-19 pandemic.
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- 2020
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33. Precision Medicine Management of Chronic Lymphocytic Leukemia
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Riccardo Moia, Andrea Patriarca, Mattia Schipani, Valentina Ferri, Chiara Favini, Sruthi Sagiraju, Wael Al Essa, and Gianluca Gaidano
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chronic lymphocytic leukemia ,target therapy ,precision medicine ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Chronic lymphocytic leukemia (CLL) is the most common type of leukemia in western countries, with an incidence of approximately 5.1/100,000 new cases per year. Some patients may never require treatment, whereas others relapse early after front line therapeutic approaches. Recent whole genome and whole exome sequencing studies have allowed a better understanding of CLL pathogenesis and the identification of genetic lesions with potential clinical relevance. Consistently, precision medicine plays a pivotal role in the treatment algorithm of CLL, since the integration of molecular biomarkers with the clinical features of the disease may guide treatment choices. Most CLL patients present at the time of diagnosis with an early stage disease and are managed with a watch and wait strategy. For CLL patients requiring therapy, the CLL treatment armamentarium includes both chemoimmunotherapy strategies and biological drugs. The efficacy of these treatment strategies relies upon specific molecular features of the disease. TP53 disruption (including both TP53 mutation and 17p deletion) is the strongest predictor of chemo-refractoriness, and the assessment of TP53 status is the first and most important decisional node in the first line treatment algorithm. The presence of TP53 disruption mandates treatment with biological drugs that inhibit the B cell receptor or, alternatively, the B-cell lymphoma 2 (BCL2) pathway and can, at least in part, circumvent the chemorefractoriness of TP53-disrupted patients. Beside TP53 disruption, the mutational status of immunoglobulin heavy variable (IGHV) genes also helps clinicians to improve treatment tailoring. In fact, patients carrying mutated IGHV genes in the absence of TP53 disruption experience a long-lasting and durable response to chemoimmunotherapy after fludarabine, cyclophosphamide, and rituximab (FCR) treatment with a survival superimposable to that of a matched general population. In contrast, patients with unmutated IGHV genes respond poorly to chemoimmunotherapy and deserve treatment with B cell receptor inhibitors. Minimal residual disease is also emerging as a relevant biomarker with potential clinical implications. Overall, precision medicine is now a mainstay in the management and treatment stratification of CLL. The identification of novel predictive biomarkers will allow further improvements in the treatment tailoring of this leukemia.
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- 2020
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34. Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network
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Raphael Itzykson, Valeria Santini, Sylvain Thepot, Lionel Ades, Cendrine Chaffaut, Aristoteles Giagounidis, Margot Morabito, Nathalie Droin, Michael Lübbert, Rosa Sapena, Stanislas Nimubona, Jean Goasguen, Eric Wattel, Gina Zini, Jose Miguel Torregrosa Diaz, Ulrich Germing, Anna Maria Pelizzari, Sophie Park, Nadja Jaekel, Georgia Metzgeroth, Francesco Onida, Robert Navarro, Andrea Patriarca, Aspasia Stamatoullas, Katharina Götze, Martin Puttrich, Sandra Mossuto, Eric Solary, Silke Gloaguen, Sylvie Chevret, Fatiha Chermat, Uwe Platzbecker, and Pierre Fenaux
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Cancer Research ,Oncology - Abstract
PURPOSE Hydroxyurea (HY) is a reference treatment of advanced myeloproliferative neoplasms. We conducted a randomized phase III trial comparing decitabine (DAC) and HY in advanced myeloproliferative chronic myelomonocytic leukemias (CMML). PATIENTS AND METHODS Newly diagnosed myeloproliferative CMML patients with advanced disease were randomly assigned 1:1 to intravenous DAC (20 mg/m2/d days 1-5) or HY (1-4 g/d) in 28-day cycles. The primary end point was event-free survival (EFS), events being death and acute myelomonocytic leukemia (AML) transformation or progression. RESULTS One-hundred seventy patients received DAC (n = 84) or HY (n = 86). Median age was 72 and 74 years, and median WBC count 32.5 × 109/L and 31.2 × 109/L in the DAC and HY arms, respectively. Thirty-three percent of DAC and 31% of HY patients had CMML-2. Patients received a median of five DAC and six HY cycles. With a median follow-up of 17.5 months, median EFS was 12.1 months in the DAC arm and 10.3 months in the HY arm (hazard ratio [HR], 0.83; 95% CI, 0.59 to 1.16; P = .27). There was no significant interaction between treatment effect and blast or platelet count, anemia, CMML Prognostic Scoring System, Groupe Francophone des Myelodysplasies, or CMML Prognostic Scoring System–mol risk. Fifty-three (63%) DAC patients achieved a response compared with 30 (35%) HY patients ( P = .0004). Median duration of response was similar in both arms (DAC, 16.3 months; HY, 17.4 months; P = .90). Median overall survival was 18.4 months in the DAC arm and 21.9 months in the HY arm ( P = .67). Compared with HY, DAC significantly reduced the risk of CMML progression or transformation to acute myelomonocytic leukemia (cause-specific HR, 0.62; 95% CI, 0.41 to 0.94; P = .005) at the expense of death without progression or transformation (cause-specific HR, 1.55; 95% CI, 0.82 to 2.9; P = .04). CONCLUSION Compared with HY, frontline treatment with DAC did not improve EFS in patients with advanced myeloproliferative CMML (ClinicalTrials.gov identifier: NCT02214407 ).
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- 2023
35. The life and works of Professor Naresh Magan
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John E. Hallsworth, Allen Y. Mswaka, Andrea Patriarca, Carol Verheecke-Vaessen, and Angel Medina
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Public Health, Environmental and Occupational Health ,Toxicology ,Food Science - Published
- 2023
36. Pelabresib (CPI-0610) Combined with Ruxolitinib for JAK Inhibitor Treatment-Naïve Patients with Myelofibrosis: Durability of Response and Safety Beyond Week 24
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John Mascarenhas, Marina Kremyanskaya, Andrea Patriarca, Vikas Gupta, Francesca Palandri, Timothy Devos, Raajit K Rampal, Moshe Talpaz, Alessandro Vannucchi, Andrew Kuykendall, Jean-Jacques Kiladjian, Srdan Verstovsek, Ruben Mesa, Gozde Colak, Qing Li, Sandra Klein, and Claire Harrison
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
37. Protection Against Breakthrough Delta/Omicron Variants in Vaccinated Patients with Myeloproliferative Neoplasms (MPN)
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Tiziano Barbui, Alessandra Carobbio, Arianna Ghirardi, Alessandra Iurlo, Valerio De Stefano, Marta Anna Sobas, Elisa Rumi, Elena Maria Elli, Francesca Lunghi, Mercedes Gasior Kabat, Beatriz Cuevas, Paola Guglielmelli, Massimiliano Bonifacio, Monia Marchetti, Alberto Alvarez-Larran, Laura Maria Fox, Marta Bellini, Rosa Daffini, Giulia Benevolo, Gonzalo Carreño, Andrea Patriarca, Haifa Kathrin Al-Ali, Marcio Andrade, Francesca Palandri, Claire Harrison, Maria Angeles Foncillas, Santiago Osorio, Steffen Koschmieder, Elena Magro, Jean-Jacques Kiladjian, Estefanía Bolaños, Florian H. Heidel, Keina Quiroz, Martin Griesshammer, Valentín García Gutiérrez, Alberto Marin Sanchez, Juan Carlos Hernandez Boluda, Emma Lopez Abadia, Giuseppe Carli, Miguel Sagüés, Rajko Kusec, Blanca Xicoy, Margarita Guenova, Begoña Navas, Anna Angona, Edyta Cichocka, Anna Masternak, Daniele Cattaneo, Cristina Bucelli, Silvia Betti, Oscar Borsani, Fabrizio Cavalca, Sara Carbonell, Natalia Curto-Garcia, Lina Benajiba, Alessandro Rambaldi, and Alessandro M. Vannucchi
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
38. Improvement in Individual Symptoms and Total Symptom Score (TSS) and Matching-Adjusted Indirect Comparison (MAIC) Analysis to Compare TSS As a Continuous Endpoint in Patients with Myelofibrosis Treated with Pelabresib in Combination with Ruxolitinib Versus Janus Kinase Inhibitor Monotherapy
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Ruben Mesa, Marina Kremyanskaya, Andrea Patriarca, Vikas Gupta, Francesca Palandri, Timothy Devos, Claire Harrison, Raajit K. Rampal, Moshe Talpaz, Alessandro Vannucchi, Andrew Kuykendall, Jean-Jacques Kiladjian, Srdan Verstovsek, Gozde Colak, Debarshi Dey, and John Mascarenhas
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
39. Diversity and metabolomic characterization of Penicillium expansum isolated from apples grown in Argentina and Spain
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María Luisa Maldonado, Andrea Patriarca, Patricia Mc Cargo, Leopoldo Iannone, Vicente Sanchis, Kristian Fog Nielsen, and Virginia Fernández Pinto
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Genomic diversity ,Apple ,Argentina ,Penicillium ,Patulin ,Infectious Diseases ,Spain ,Fruit ,Malus ,Secondary metabolite profiles ,Genetics ,Penicillium expansum ,Phylogeny ,Ecology, Evolution, Behavior and Systematics - Abstract
Apples (Malus domestica) are one of the most consumed fruits globally. It is a relevant crop in Argentina and Spain, and one of the main fruits for export and industrialization in these countries. Quality control of apples, fundamentally in the postharvest stage, is critical to prevent fungal diseases. The blue mould, caused by Penicillium expansum, is responsible for great economic losses due to the deterioration of the fruit and mycotoxin production. Many studies have characterized this pathogen; however, little is known about the differences between populations from distant geographical origins. The objective of the present study was to characterize two P. expansum populations, from Argentina and Spain, through morphological, metabolomic and molecular approaches, and to evaluate the existence of differences related to their geographical source. A total of 103 isolates, 53 from Argentina and 50 from Spain were studied. Their morphological features were consistent with the species description. The secondary metabolite profiles revealed low chemical diversity. All 103 isolates shared the production of 13 compounds, namely andrastins, aurantioclavine, chaetoglobosins, communesins, expansolides, roquefortine C and patulin. Penostatins and citrinin were produced by 102 and 101 isolates, respectively. A region of the β-tubulin gene was selected to analyse the diversity of the P. expansum isolates. No substantial differences were observed between isolates of different geographical origins through morphology, patulin accumulation, secondary metabolite profiles and phylogenetic analysis. However, the analysis of polymorphisms revealed 29 haplotypes with a relative separation between isolates of both populations; 13 haplotypes contained Argentinean isolates, while Spanish isolates were separated into 16 haplotypes. The diversity indices of Shannon (H´=2.075; H´=2.402) and Simpson (SiD = 0.850; SiD = 0.895) for isolates from Argentina and Spain, respectively, indicated that the diversity of P. expansum is greater in Spain than in Argentina. This distribution could be explained both by the existence of haplotype exchange between both countries, with the ancestral haplotypes originating in Spain, and the subsequent adaptation to the environmental conditions or apples varieties grown in each region.
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- 2022
40. Ropeginterferon versus Standard Therapy for Low-Risk Patients with Polycythemia Vera
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Tiziano Barbui, Alessandro Maria Vannucchi, Valerio De Stefano, Alessandra Carobbio, Arianna Ghirardi, Greta Carioli, Arianna Masciulli, Elena Rossi, Fabio Ciceri, Massimiliano Bonifacio, Alessandra Iurlo, Francesca Palandri, Giulia Benevolo, Fabrizio Pane, Alessandra Ricco, Giuseppe Carli, Marianna Caramella, Davide Rapezzi, Caterina Musolino, Sergio Siragusa, Elisa Rumi, Andrea Patriarca, Nicola Cascavilla, Barbara Mora, Emma Cacciola, Carmela Mannarelli, Giuseppe Gaetano Loscocco, Paola Guglielmelli, Francesca Gesullo, Silvia Betti, Francesca Lunghi, Luigi Scaffidi, Cristina Bucelli, Nicola Vianelli, Marta Bellini, Maria Chiara Finazzi, Gianni Tognoni, and Alessandro Rambaldi
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- 2023
41. Supplementary Data from Clinical Portrait of the SARS-CoV-2 Epidemic in European Patients with Cancer
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Judith Swallow, Lorenza Scotti, Mario Pirisi, Meritxell Mollà, Maria Martinez, Luigi Mario Castello, Mattia Bellan, Gian Carlo Avanzi, Alessandra Gennari, Josep Tabernero, Aleix Prat, Armando Santoro, Michela Franchi, Alba Cabirta, Macarena Izuzquiza, Lorenzo Chiudinelli, Lorenza Rimassa, Gianluca Gaidano, Isabel Ruiz-Camps, Clara Maluquer, Anna Sureda, Javier Marco-Hernández, Daniela Ferrante, Yien Ning Sophia Wong, Rachel Sharkey, Palma Dileo, Roxana Reyes, David García-Illescas, Andrea Patriarca, Thomas Newsom-Davis, Alvin J.X. Lee, Isabel Garcia-Fructuoso, Myria Galazi, Eudald Felip, Nadia Saoudi-Gonzalez, Joanne S. Evans, Francesca D'Avanzo, Alessia Dalla Pria, Claudia Andrea Cruz, Vittoria Fotia, Salvatore Provenzano, Marta Betti, Valeria Tovazzi, Oriol Mirallas, Carlo Tondini, Neha Chopra, M. Carmen Carmona-Garcia, Rachel Wuerstlein, Andrea Marrari, Sarah Benafif, Riccardo Bruna, Anna Carbó, Diego Ottaviani, Rossella Bertulli, Bruno Vincenzi, Nadia Harbeck, Antonio Maconi, Michela Libertini, Gianpiero Rizzo, Salvatore Grisanti, Daniele Generali, Federica Biello, Elia Seguí, Ricard Mesia, Joan Brunet, Alexia Bertuzzi, Ramon Salazar, Christopher C.T. Sng, Mark Bower, Juan Aguilar-Company, Alberto Zambelli, and David J. Pinato
- Abstract
Supplementary Tables and Figures
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- 2023
42. Data from Clinical Portrait of the SARS-CoV-2 Epidemic in European Patients with Cancer
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Judith Swallow, Lorenza Scotti, Mario Pirisi, Meritxell Mollà, Maria Martinez, Luigi Mario Castello, Mattia Bellan, Gian Carlo Avanzi, Alessandra Gennari, Josep Tabernero, Aleix Prat, Armando Santoro, Michela Franchi, Alba Cabirta, Macarena Izuzquiza, Lorenzo Chiudinelli, Lorenza Rimassa, Gianluca Gaidano, Isabel Ruiz-Camps, Clara Maluquer, Anna Sureda, Javier Marco-Hernández, Daniela Ferrante, Yien Ning Sophia Wong, Rachel Sharkey, Palma Dileo, Roxana Reyes, David García-Illescas, Andrea Patriarca, Thomas Newsom-Davis, Alvin J.X. Lee, Isabel Garcia-Fructuoso, Myria Galazi, Eudald Felip, Nadia Saoudi-Gonzalez, Joanne S. Evans, Francesca D'Avanzo, Alessia Dalla Pria, Claudia Andrea Cruz, Vittoria Fotia, Salvatore Provenzano, Marta Betti, Valeria Tovazzi, Oriol Mirallas, Carlo Tondini, Neha Chopra, M. Carmen Carmona-Garcia, Rachel Wuerstlein, Andrea Marrari, Sarah Benafif, Riccardo Bruna, Anna Carbó, Diego Ottaviani, Rossella Bertulli, Bruno Vincenzi, Nadia Harbeck, Antonio Maconi, Michela Libertini, Gianpiero Rizzo, Salvatore Grisanti, Daniele Generali, Federica Biello, Elia Seguí, Ricard Mesia, Joan Brunet, Alexia Bertuzzi, Ramon Salazar, Christopher C.T. Sng, Mark Bower, Juan Aguilar-Company, Alberto Zambelli, and David J. Pinato
- Abstract
The SARS-CoV-2 pandemic significantly affected oncology practice across the globe. There is uncertainty as to the contribution of patients' demographics and oncologic features to severity and mortality from COVID-19 and little guidance as to the role of anticancer and anti–COVID-19 therapy in this population. In a multicenter study of 890 patients with cancer with confirmed COVID-19, we demonstrated a worsening gradient of mortality from breast cancer to hematologic malignancies and showed that male gender, older age, and number of comorbidities identify a subset of patients with significantly worse mortality rates from COVID-19. Provision of chemotherapy, targeted therapy, or immunotherapy did not worsen mortality. Exposure to antimalarials was associated with improved mortality rates independent of baseline prognostic factors. This study highlights the clinical utility of demographic factors for individualized risk stratification of patients and supports further research into emerging anti–COVID-19 therapeutics in SARS-CoV-2–infected patients with cancer.Significance:In this observational study of 890 patients with cancer diagnosed with SARS-CoV-2, mortality was 33.6% and predicted by male gender, age ≥65, and comorbidity burden. Delivery of cancer therapy was not detrimental to severity or mortality from COVID-19. These patients should be the focus of shielding efforts during the SARS-CoV-2 pandemic.This article is highlighted in the In This Issue feature, p. 1426
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- 2023
43. Natural Occurrence, Exposure Assessment & Risk Characterization of Alternaria Mycotoxins in Apple By-Products in Argentina
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María Agustina Pavicich, Marthe De Boevre, Arnau Vidal, Hannes Mikula, Benedikt Warth, Doris Marko, Sarah De Saeger, and Andrea Patriarca
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Alternariol ,Infant foods ,Health, Toxicology and Mutagenesis ,Public Health, Environmental and Occupational Health ,Modified mycotoxins ,Consumer’s risk ,Pollution ,Food safety ,Water Science and Technology - Abstract
Data on the natural occurrence of Alternaria mycotoxins in apple by-products is lacking in Argentina and the risk of exposure to these mycotoxins has not been characterized before. The levels of alternariol (AOH), alternariol monomethyl ether (AME), altenuene (ALT), tenuazonic acid (TeA), tentoxin (TEN), altertoxin-I (ATX-I), altertoxin-II (ATX-II), alternariol 3-sulfate (AOH-3-S), alternariol 3-glucoside (AOH-3-G), alternariol monomethyl ether 3-sulfate (AME-3-S), and alternariol monomethyl ether 3-glucoside (AME-3-G) were determined in clarified and cloudy apple juices, marmalades, and apple-based infant food from the Argentinean market, and the risk of exposure was characterized. Detectable levels of AME, TEN, TeA, AME-3-S and AOH-3-G were found in clarified juices, while the same mycotoxins plus AOH were found in cloudy apple juices in higher concentrations. AME, TEN, TeA and AOH-3G were detected in marmalades, and AOH, AME, TEN and TeA in apple infant food. Probabilistic exposure assessment and risk characterization were carried out for children between 6 months and 5 years old in Argentina. The highest risk of exposure affected children between 6 and 23 months from the consumption of apple infant food and mainly associated with the alternariols. Better control strategies to prevent the incorporation of Alternaria mouldy core into the process line and the establishment of legislation for Alternaria mycotoxins are needed in Argentina.
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- 2023
44. Health-Related Quality of Life of Patients with Philadelphia-Negative Myeloproliferative Neoplasms Compared with the General Population: A Preliminary Report from the Gimema Prophecy Study
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Giovanni Caocci, Francesca Palandri, Giuseppe Gaetano Loscocco, Alfonso Piciocchi, Alessandra Iurlo, Alessia Tieghi, Andrea Patriarca, Elisabetta Abruzzese, Simona Tomassetti, Monia Marchetti, Daniele Vanni, Mario Luppi, Fabrizio Pane, Massimo Breccia, Sergio Siragusa, Elena Maria Elli, Alessandra Ricco, Claudio Fozza, Maria Teresa Corsetti, Carmen Fava, Camilla Mazzoni, Paola Fazi, Giorgio La Nasa, Marco Vignetti, Alessandro M. Vannucchi, and Fabio Efficace
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
45. Clinical Benefit Associated with Biomarker Changes Indicative of Disease Modification in Patients with Myelofibrosis Treated with the BET Inhibitor Pelabresib As Monotherapy or in Combination with Ruxolitinib
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Joseph Scandura, Srdan Verstovsek, Marina Kremyanskaya, Moshe Talpaz, Raajit K Rampal, Alessandro Vannucchi, Vikas Gupta, Francesca Palandri, Andrea Patriarca, Prithviraj Bose, Dong Chen, Oksana Zavidij, Jike Cui, Tzuu-Wang Chang, Pietro Taverna, John Mascarenhas, and Claire Harrison
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
46. Ropeginterferon Alfa-2b Versus Standard Therapy for Low-Risk Patients with Polycythemia Vera. Final Results of Low-PV Randomized Phase II Trial
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Tiziano, Barbui, Alessandro Maria Vannucchi, Valerio De Stefano, Arianna, Masciulli, Alessandra, Carobbio, Arianna, Ghirardi, Greta, Carioli, Elena, Rossi, Fabio, Ciceri, Massimiliano, Bonifacio, Alessandra, Iurlo, Francesca, Palandri, Giulia, Benevolo, Fabrizio, Pane, Alessandra, Ricco, Giuseppe, Carli, Marianna, Caramella, Davide, Rapezzi, Caterina, Musolini, Sergio, Siragusa, Elisa, Rumi, Andrea, Patriarca, Nicola, Cascavilla, Barbara, Mora, Cacciola, Emma, Carmela, Mannarelli, Giuseppe Gaetano Loscocco, Paola, Guglielmelli, Francesca, Gesullo, Silvia, Betti, Francesca, Lunghi, Luigi, Scaffidi, Cristina, Bucelli, Nicola, Vianelli, Marta, Bellini, Maria Chiara Finazzi, Giovanni, Tognoni, and Alessandro, Rambaldi.
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
47. Autoimmune Hemolytic Anemia during Pregnancy or Post-Partum: An International Multi-Center Experience
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Marta Bortolotti, Norma Fantini, Andreas Glenthøj, Marc Michel, Mariasanta Napolitano, Simona Raso, Frederick Chen, Vickie McDonald, Irina Murakhovskaya, Josephine M.I. Vos, Andrea Patriarca, Maria Eva Mingot, Giulio Giordano, Margherita Scarrone, Laura Trespidi, Daniele Prati, Wilma Barcellini, and Bruno Fattizzo
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Immunology ,Cell Biology ,Hematology ,Biochemistry - Published
- 2022
48. MANIFEST: Pelabresib in Combination With Ruxolitinib for Janus Kinase Inhibitor Treatment-Naïve Myelofibrosis
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John Mascarenhas, Marina Kremyanskaya, Andrea Patriarca, Francesca Palandri, Timothy Devos, Francesco Passamonti, Raajit K. Rampal, Adam J. Mead, Gabriella Hobbs, Joseph M. Scandura, Moshe Talpaz, Nikki Granacher, Tim C. P. Somervaille, Ronald Hoffman, Marielle J. Wondergem, Mohamed E. Salama, Gozde Colak, Jike Cui, Jean-Jacques Kiladjian, Alessandro M. Vannucchi, Srdan Verstovsek, Natalia Curto-García, Claire Harrison, and Vikas Gupta
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Cancer Research ,Oncology - Abstract
PURPOSE Standard therapy for myelofibrosis comprises Janus kinase inhibitors (JAKis), yet spleen response rates of 30%-40%, high discontinuation rates, and a lack of disease modification highlight an unmet need. Pelabresib (CPI-0610) is an investigational, selective oral bromodomain and extraterminal domain inhibitor (BETi). METHODS MANIFEST (ClinicalTrails.gov identifier: NCT02158858 ), a global, open-label, nonrandomized, multicohort, phase II study, includes a cohort of JAKi-naïve patients with myelofibrosis treated with pelabresib and ruxolitinib. The primary end point is a spleen volume reduction of ≥ 35% (SVR35) at 24 weeks. RESULTS Eighty-four patients received ≥ 1 dose of pelabresib and ruxolitinib. The median age was 68 (range, 37-85) years; 24% of patients were intermediate-1 risk, 61% were intermediate-2 risk, and 16% were high risk as per the Dynamic International Prognostic Scoring System; 66% (55 of 84) of patients had a hemoglobin level of < 10 g/dL at baseline. At 24 weeks, 68% (57 of 84) achieved SVR35, and 56% (46 of 82) achieved a total symptom score reduction of ≥ 50% (TSS50). Additional benefits at week 24 included 36% (29 of 84) of patients with improved hemoglobin levels (mean, 1.3 g/dL; median, 0.8 g/dL), 28% (16 of 57) with ≥ 1 grade improvement in fibrosis, and 29.5% (13 of 44) with > 25% reduction in JAK2V617F-mutant allele fraction, which was associated with SVR35 response ( P = .018, Fisher's exact test). At 48 weeks, 60% (47 of 79) of patients had SVR35 response. Grade 3 or 4 toxicities seen in ≥ 10% patients were thrombocytopenia (12%) and anemia (35%), leading to treatment discontinuation in three patients. 95% (80 of 84) of the study participants continued combination therapy beyond 24 weeks. CONCLUSION The rational combination of the BETi pelabresib and ruxolitinib in JAKi-naïve patients with myelofibrosis was well tolerated and showed durable improvements in spleen and symptom burden, with associated biomarker findings of potential disease-modifying activity.
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- 2023
49. SARS-CoV-2 omicron (B.1.1.529)-related COVID-19 sequelae in vaccinated and unvaccinated patients with cancer: results from the OnCovid registry
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Alessio Cortellini, Josep Tabernero, Uma Mukherjee, Ramon Salazar, Anna Sureda, Clara Maluquer, Daniela Ferrante, Mark Bower, Rachel Sharkey, Oriol Mirallas, Andrea Plaja, Marc Cucurull, Ricard Mesia, Alessia Dalla Pria, Thomas Newsom-Davis, Mieke Van Hemelrijck, Ailsa Sita-Lumsden, Eleanor Apthorp, Bruno Vincenzi, Giuseppina Rita Di Fazio, Giuseppe Tonini, Francesco Pantano, Alexia Bertuzzi, Sabrina Rossi, Joan Brunet, Matteo Lambertini, Paolo Pedrazzoli, Federica Biello, Francesca D'Avanzo, Alvin J X Lee, Marianne Shawe-Taylor, Lucy Rogers, Cian Murphy, Lee Cooper, Ramis Andaleeb, Saira Khalique, Samira Bawany, Sarah Ahmed, M Carmen Carmona-García, Roser Fort-Culillas, Raquel Liñan, Federica Zoratto, Gianpiero Rizzo, Marta Perachino, Kris Doonga, Gianluca Gaidano, Riccardo Bruna, Andrea Patriarca, Clara Martinez-Vila, Ignacio Pérez Criado, Raffaele Giusti, Francesca Mazzoni, Lorenzo Antonuzzo, Armando Santoro, Alessandro Parisi, Paola Queirolo, Avinash Aujayeb, Lorenza Rimassa, Nikolaos Diamantis, Rossella Bertulli, Claudia A M Fulgenzi, Antonio D'Alessio, Isabel Ruiz-Camps, Nadia Saoudi-Gonzalez, David Garcia Illescas, Irene Medina, Laura Fox, Alessandra Gennari, Juan Aguilar-Company, David J Pinato, Joanne S Evans, Judith Swallow, Georgina Hanbury, Chris Chung, Meera Patel, Gino Dettorre, Katherine Belessiotis, Dolly Saorise, Eleanor Jones, Charlotte Moss, Beth Russell, Sarah Townsend, Amanda Jackson, Angela Loizidou, Martine Piccart, Fanny Pommeret, Emeline Colomba-Blameble, Aleix Prat, Claudia A Cruz, Roxana Reyes, Elia Segui, Javier Marco-Hernández, Margarita Viladot, Nadia Harbeck, Rachel Wuerstlein, Franziska Henze, Sven Mahner, Eudald Felip, Lorenza Scotti, Andrea Marrari, Federica Grosso, Vittorio Fusco, Sara Delfanti, Maura Rossi, Alberto Zambelli, Carlo Tondini, Lorenzo Chiudinelli, Michela Franchi, Michela Libertini, Salvatore Provenzano, Daniele Generali, Salvatore Grisanti, Alice Baggi, Valeria Tovazzi, Corrado Ficorella, Giampiero Porzio, Maristella Saponara, Marco Filetti, Marco Tucci, Rossana Berardi, Luca Cantini, Francesco Paoloni, Annalisa Guida, Sergio Bracarda, Maria Iglesias, Ana Sanchez de Torre, and Marco Tagliamento
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Malalts de càncer ,Oncology ,SARS-CoV-2 ,Vaccination ,COVID-19 ,Cancer patients ,Vacunació - Abstract
Background COVID-19 sequelae can affect about 15% of patients with cancer who survive the acute phase of SARS-CoV-2 infection and can substantially impair their survival and continuity of oncological care. We aimed to investigate whether previous immunisation affects long-term sequelae in the context of evolving variants of concern of SARS-CoV-2. Methods OnCovid is an active registry that includes patients aged 18 years or older from 37 institutions across Belgium, France, Germany, Italy, Spain, and the UK with a laboratory-confirmed diagnosis of COVID-19 and a history of solid or haematological malignancy, either active or in remission, followed up from COVID-19 diagnosis until death. We evaluated the prevalence of COVID-19 sequelae in patients who survived COVID-19 and underwent a formal clinical reassessment, categorising infection according to the date of diagnosis as the omicron (B.1.1.529) phase from Dec 15, 2021, to Jan 31, 2022; the alpha (B.1.1.7)-delta (B.1.617.2) phase from Dec 1, 2020, to Dec 14, 2021; and the pre-vaccination phase from Feb 27 to Nov 30, 2020. The prevalence of overall COVID-19 sequelae was compared according to SARS-CoV-2 immunisation status and in relation to post-COVID-19 survival and resumption of systemic anticancer therapy. This study is registered with ClinicalTrials.gov, NCT04393974. Findings At the follow-up update on June 20, 2022, 1909 eligible patients, evaluated after a median of 39 days (IQR 24-68) from COVID-19 diagnosis, were included (964 [ 50 center dot 7%] of 1902 patients with sex data were female and 938 [49 center dot 3%] were male). Overall, 317 (16 center dot 6%; 95% CI 14 center dot 8-18 center dot 5) of 1909 patients had at least one sequela from COVID-19 at the first oncological reassessment. The prevalence of COVID-19 sequelae was highest in the prevaccination phase (191 [19 center dot 1%; 95% CI 16 center dot 4-22 center dot 0] of 1000 patients). The prevalence was similar in the alpha-delta phase (110 [16 center dot 8%; 13 center dot 8- 20 center dot 3] of 653 patients, p=0 center dot 24), but significantly lower in the omicron phase (16 [6 center dot 2%; 3 center dot 5-10 center dot 2] of 256 patients, p
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- 2023
50. Momelotinib versus danazol in symptomatic patients with anaemia and myelofibrosis (MOMENTUM):results from an international, double-blind, randomised, controlled, phase 3 study
- Author
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Srdan Verstovsek, Aaron T Gerds, Alessandro M Vannucchi, Haifa Kathrin Al-Ali, David Lavie, Andrew T Kuykendall, Sebastian Grosicki, Alessandra Iurlo, Yeow Tee Goh, Mihaela C Lazaroiu, Miklos Egyed, Maria Laura Fox, Donal McLornan, Andrew Perkins, Sung-Soo Yoon, Vikas Gupta, Jean-Jacques Kiladjian, Nikki Granacher, Sung-Eun Lee, Luminita Ocroteala, Francesco Passamonti, Claire N Harrison, Barbara J Klencke, Sunhee Ro, Rafe Donahue, Jun Kawashima, Ruben Mesa, Adi Shacham Abulafia, Bjorn Andreasson, Anna Angona, Rosa Ayala, Soo-Mee Bang, Bruce Bank, Fiorenza Barraco, Eloise Beggiato, Fleur Samantha Benghiat, MassimiliaNo Bonifacio, Claire Bories, Gabriela Borsaru, Mette Brabrand, Andrei Braester, Andes Broliden, Veronika Buxhofer-Ausch, Nathalie Cambier, Marianna Caramella, Benjamin Carpentier, Nicola Cascavilla, Maria Giraldo Castellano, Hung Chang, Chih-Cheng Chen, June-Won Cheong, Yunsuk Choi, Philip Choi, Maria Teresa Corsetti, Isabel Montero Cuadrado, Julia Cunningham, Gandhi Laurent Damaj, Valerio De Stefano, Robert Delage, Regina Garcĺa Delgado, Jose Miguel Torregrosa Diaz, Péter Dombi, Viviane Dubruille, Miklós Egyed, Daniel El Fassi, Anna Elinder-Camburn, Elena Maria Elli, Martin Ellis, Carmen Fava, Salman Fazal, Angela Fleischman, Lynda Foltz, Laura Fox, Nashat Gabrail, Jose Valentĺn Garcĺa-Gutiérrez, Aaron Gerds, Stephane Girault, Heinz Gisslinger, Alexandru Gluvacov, Joachim Göthert, Evgeni (Evgueniy) Hadjiev (Hadzhiev), Kaoutar Hafraoui, Aryan Hamed, Claire Harrison, Hans Hasselbalch, Hanns Hauser, Mark Heaney, Holger Hebart, Jesus Maria Hernandez Rivas, Victor Higuero Saavedra, Christopher Hillis, Hsin-An Hou, Jonathan How, Daniel Huang, Marek Hus, Arpad Illés, Alessandro Isidori, Vadim Ivanov, Peter Johansson, Chul Won Jung, Ilya Kirgner, Maya Koren-Michowitz, Steffen Koschmieder, Szabolcs Ors Kosztolanyi, Natalia Kreiniz, Andrew Kuykendall, Jonathan Lambert, Kamel Laribi, Axelle Lascaux, Noa Lavie, Mihaela Lazaroiu, Michael Leahy, Ewa Lech-Maranda, Won Sik Lee, Ollivier Legrand, Roberto Lemoli, James Liang, Sung-Nam Lim, Michael Loschi, Alessandro Lucchesi, Ioan Macarie, Jean-Pierre Marolleau, Maurizio Martelli, Jiri Mayer, James McCloskey, Christopher McDermott, Brandon McMahon, Priyanka Mehta, Gábor Mikala, Dragana Milojkovic, Philippe Mineur, Elena Mishchenko, Joon Ho Moon, Zsolt Nagy, Srinivasan Narayanan, Casey O'Connell, Stephen Oh, Mario Ojeda-Uribe, Kiat Hoe Ong, Folashade Otegbeye, Jeanne Palmer, Fabrizio Pane, Andrea Patriarca, Giuseppe Pietrantuono, Mark Plander, Uwe Platzbecker, Ritam Prasad, Witold Prejzner, Tobias Rachow, Atanas Radinoff, László Rejtő, Ciro Rinaldi, Tadeusz Robak, Maria Angeles Fernandez Rodriguez, Aaron Ronson, David Ross, Tomasz Sacha, Parvis Sadjadian, Antonio Salar, Guillermo Sanz Santillana, Christof Scheid, Aline Schmidt, Marianne Tang Severinsen, Vera Stoeva, Paweł Szwedyk, Mario Tiribelli, Karolin Trautmann-Grill, Amy Trottier, Nikolay Tzvetkov, Janusz van Droogenbroeck, Alessandro Vannucchi, Nicola Vianelli, Nikolas von Bubnoff, Dominik Wolf, Dariusz Woszczyk, Tomasz Woźny, Tomasz Wróbel, Blanca Xicoy, and Su-Peng Yeh
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Anemia/drug therapy ,Treatment Outcome ,Double-Blind Method ,Janus Kinase Inhibitors/therapeutic use ,Danazol/adverse effects ,Humans ,Primary Myelofibrosis/complications ,General Medicine - Abstract
BACKGROUND: Janus kinase (JAK) inhibitors approved for myelofibrosis provide spleen and symptom improvements but do not meaningfully improve anaemia. Momelotinib, a first-in-class inhibitor of activin A receptor type 1 as well as JAK1 and JAK2, has shown symptom, spleen, and anaemia benefits in myelofibrosis. We aimed to confirm the differentiated clinical benefits of momelotinib versus the active comparator danazol in JAK-inhibitor-exposed, symptomatic patients with anaemia and intermediate-risk or high-risk myelofibrosis.METHODS: MOMENTUM is an international, double-blind, randomised, controlled, phase 3 study that enrolled patients at 107 sites across 21 countries worldwide. Eligible patients were 18 years or older with a confirmed diagnosis of primary myelofibrosis or post-polycythaemia vera or post-essential thrombocythaemia myelofibrosis. Patients were randomly assigned (2:1) to receive momelotinib (200 mg orally once per day) plus danazol placebo (ie, the momelotinib group) or danazol (300 mg orally twice per day) plus momelotinib placebo (ie, the danazol group), stratified by total symptom score (TSS; FINDINGS: 195 patients were randomly assigned to either the momelotinib group (130 [67%]) or danazol group (65 [33%]) and received study treatment in the 24-week randomised treatment period between April 24, 2020, and Dec 3, 2021. A significantly greater proportion of patients in the momelotinib group reported a 50% or more reduction in TSS than in the danazol group (32 [25%] of 130 vs six [9%] of 65; proportion difference 16% [95% CI 6-26], p=0·0095). The most frequent grade 3 or higher treatment-emergent adverse events with momelotinib and danazol were haematological abnormalities by laboratory values: anaemia (79 [61%] of 130 vs 49 [75%] of 65) and thrombocytopenia (36 [28%] vs 17 [26%]). The most frequent non-haematological grade 3 or higher treatment-emergent adverse events with momelotinib and danazol were acute kidney injury (four [3%] of 130 vs six [9%] of 65) and pneumonia (three [2%] vs six [9%]).INTERPRETATION: Treatment with momelotinib, compared with danazol, resulted in clinically significant improvements in myelofibrosis-associated symptoms, anaemia measures, and spleen response, with favourable safety. These findings support the future use of momelotinib as an effective treatment in patients with myelofibrosis, especially in those with anaemia.FUNDING: Sierra Oncology.
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- 2023
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