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1. Use of eltrombopag in aplastic anemia in Europe

Author

Ecsedi, M., Lengline, E., Knol-Bout, C., Bosman, P., Eikema, D.J., Afanasyev, B., Maschan, A., Dreger, P., Halkes, C.J.M., Drexler, B., Cortelezzi, A., Drenou, B., Patriarca, A., Bruno, B., Onofrillo, D., Lanino, E., Pulanic, D., Serventi-Seiwerth, R., Garnier, A., Ljungman, P., Bonifazi, F., Giammarco, S., Tournilhac, O., Pioltelli, P., Rovo, A., Risitano, A.M., Latour, R.P. de, Dufour, C., Passweg, J., EBMT SAA Working Party, Ecsedi, Matya, Lengline, Étienne, Knol-Bout, Cora, Bosman, Paul, Eikema, Dirk-Jan, Afanasyev, Bori, Maschan, Alexei, Dreger, Peter, Halkes, Constantijn J M, Drexler, Beatrice, Cortelezzi, Agostino, Drénou, Bernard, Patriarca, Andrea, DI BENEDETTO, Bruno, Onofrillo, Daniela, Lanino, Edoardo, Pulanic, Drazen, Serventi-Seiwerth, Ranka, Garnier, Alice, Ljungman, Per, Bonifazi, Francesca, Giammarco, Sabrina, Tournilhac, Olivier, Pioltelli, Pietro, Rovó, Alicia, Risitano, Antonio M, de Latour, Régis Peffault, Dufour, Carlo, Passweg, Jakob, Role of intra-Clonal Heterogeneity and Leukemic environment in ThErapy Resistance of chronic leukemias (CHELTER), and Université Clermont Auvergne [2017-2020] (UCA [2017-2020])

Subjects
Male, Kaplan-Meier Estimate, Benzoates, chemistry.chemical_compound, 0302 clinical medicine, Retrospective Studie, Receptors, Hydrazine, ComputingMilieux_MISCELLANEOUS, Aplastic, Anemia, Aplastic, Anemia, [SDV.MHEP.HEM]Life Sciences [q-bio]/Human health and pathology/Hematology, Hematology, General Medicine, Growth factor, Middle Aged, Aplastic anemia, Eltrombopag, Growth factors, Immunosuppression, Adult, Aged, Drug Evaluation, Drug Utilization, Europe, Female, Follow-Up Studies, Humans, Hydrazines, Myelodysplastic Syndromes, Proportional Hazards Models, Pyrazoles, Receptors, Thrombopoietin, Retrospective Studies, Young Adult, 3. Good health, Thrombopoietin, 030220 oncology & carcinogenesis, Cohort, Human, medicine.medical_specialty, Combination therapy, Myelodysplastic Syndrome, 610 Medicine & health, Benzoate, Follow-Up Studie, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, business.industry, Myelodysplastic syndromes, Retrospective cohort study, medicine.disease, Clinical trial, chemistry, Pyrazole, Proportional Hazards Model, business, 030215 immunology
Abstract

Eltrombopag (ELT), an oral thrombopoietin receptor agonist, has recently emerged as a promising new drug for the treatment of aplastic anemia (AA). How ELT is used outside of clinical trials in the real-world setting and results of this treatment are not known. We conducted therefore a retrospective survey on the use of ELT in AA among EBMT member centers. We analyzed the 134 patients reported in our survey together with 46 patients recently published by Lengline et al. The median follow-up from start of ELT treatment was 15.3 months, with 85.6% patients alive at last follow-up. Importantly, only 28.9% of our patients received ELT according to the FDA/EMA label as monotherapy in the relapsed/refractory setting, whereas 16.7% received ELT upfront. The overall response rate in our cohort was 62%, very similar to the results of the pivotal ELT trial. In multivariate analysis, combination therapy with ELT/cyclosporine/ATG and response to previous therapy were associated with response. Overall survival was favorable with a 1-year survival from ELT start of 87.4%. We identified age, AA severity before ELT start and response to ELT as variables significantly associated with OS. Two patients transformed to MDS; other adverse events were mostly benign. In sum, ELT is used widely in Europe to treat AA patients, mostly in the relapsed/refractory setting. Response to ELT is similar to the clinical trial data across different age groups, treatment lines, and treatment combinations and results in favorable survival.

Published
2019
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2. Musculoskeletal manifestations of childhood cancer and differential diagnosis with juvenile idiopathic arthritis (ONCOREUM): a multicentre, cross-sectional study

Author

Giovanna Russo, Valentino Conter, M Caniglia, A Garaventa, Giulia Stabile, MF Gicchino, Elisa Rossi, Annalisa Arlotta, S Ladogana, C Atzeni, Rita Consolini, Luciana Vinti, Daniela Onofrillo, Roberto Rondelli, Nicola Santoro, Loredana Lepore, F Locatelli, Elisa Coassin, Monica Ficara, Micol Romano, S Martino, Roberta Burnelli, I Fontanili, Francesca Soscia, Eleonora Prete, Francesca Santarelli, Romina Gallizzi, Patrizia Barone, MG Cefalo, E Cortis, Giovanni Filocamo, M Amatruda, Angela Miniaci, Anna Maria Caroleo, Massimo Eraldo Abate, Maria Cristina Maggio, M Mascarin, Simone Cesaro, E Fabbri, F De Benedetti, Angelo Ravelli, Alma Nunzia Olivieri, C Micalizzi, A Magnolato, B Bigucci, Francesca Ricci, Elisa Tirtei, Antonella Colombini, Luciana Breda, Tamara Belotti, Raffaela De Santis, Roberta Pericoli, Serena Pastore, Silvia Magni-Manzoni, Rosa Anna Podda, Chiara Mainardi, Donato Rigante, Federico Verzegnassi, C Messina, Adele Civino, Cristina Pizzato, M Marsili, Chiara Gorio, Rossella Mura, M Cattalini, Andrea Pession, M Cappella, A Di Cataldo, Francesco La Torre, Assunta Tornesello, Andrea Roncadori, F Porta, Maria Antonietta Pelagatti, F Fagioli, P Bertolini, Ilaria Capolsini, C Rizzari, M Cellini, Bianca Lattanzi, Alessandro De Fanti, S Davì, Carmela De Fusco, Giovanni Alighieri, Andrea Biondi, Civino, Adele, Alighieri, Giovanni, Prete, Eleonora, Maria Caroleo, Anna, SilviaMagni-Manzoni, Vinti, Luciana, Romano, Micol, Santoro, Nicola, Filocamo, Giovanni, Belotti, Tamara, Santarelli, Francesca, Gorio, Chiara, Ricci, Francesca, Colombini, Antonella, Pastore, Serena, Cesaro, Simone, Barone, Patrizia, Verzegnassi, Federico, Olivieri, Alma Nunzia, Ficara, Monica, Miniaci, Angela, Russo, Giovanna, Gallizzi, Romina, Pericoli, Roberta, Breda, Luciana, Mura, Rossella, Annapodda, Rosa, Onofrillo, Daniela, Lattanzi, Bianca, Elisatirtei, Cristina Maggio, Maria, De Santis, Raffaela, Ritaconsolini, Arlotta, Annalisa, La Torre, Francesco, Mainardi, Chiara, Antonietta Pelagatti, Maria, Coassin, Elisa, Capolsini, Ilaria, Burnelli, Roberta, Tornesello, Assunta, Soscia, Francesca, De Fanti, Alessandro, Donatorigante, Pizzato, Cristina, De Fusco, Carmela, Eraldo Abate, Massimo, Roncadori, Andrea, Rossi, Elisa, Stabile, Giulia, Biondi, Andrea, Lepore, Loredana, Conter, Valentino, Rondelli, Roberto, Pession, Andrea, Ravelli, Angelo, Association of Paediatric Haematology and Oncology†and the Italian Paediatric Rheumatology Study Group†, Italian, Amatruda, M, Atzeni, C, Pbertolini, Bigucci, B, Caniglia, M, Cappella, M, Cattalini, M, Cefalo, Mg, Cellini, M, Cortis, E, Davì, S, De Benedetti, F, Di Cataldo, A, Fabbri, E, Fagioli, F, Fontanili, I, Garaventa, A, Gicchino, MARIA FRANCESCA, Ladogana, S, Locatelli, F, Magnolato, A, Marsili, M, Martino, S, Mascarin, M, Messina, C, Micalizzi, C, Porta, F, Rizzari, C, Civino A., Alighieri G., Prete E., Caroleo A.M., Magni-Manzoni S., Vinti L., Romano M., Santoro N., Filocamo G., Belotti T., Santarelli F., Gorio C., Ricci F., Colombini A., Pastore S., Cesaro S., Barone P., Verzegnassi F., Olivieri A.N., Ficara M., Miniaci A., Russo G., Gallizzi R., Pericoli R., Breda L., Mura R., Podda R.A., Onofrillo D., Lattanzi B., Tirtei E., Maggio M.C., De Santis R., Consolini R., Arlotta A., La Torre F., Mainardi C., Pelagatti M.A., Coassin E., Capolsini I., Burnelli R., Tornesello A., Soscia F., De Fanti A., Rigante D., Pizzato C., De Fusco C., Abate M.E., Roncadori A., Rossi E., Stabile G., Biondi A., Lepore L., Conter V., Rondelli R., Pession A., Ravelli A., Amatruda M., Atzeni C., Bertolini P., Bigucci B., Caniglia M., Cappella M., Cattalini M., Cefalo M.G., Cellini M., Cortis E., Davi S., De Benedetti F., Di Cataldo A., Fabbri E., Fagioli F., Fontanili I., Garaventa A., Gicchino M.F., Ladogana S., Locatelli F., Magnolato A., Marsili M., Martino S., Mascarin M., Messina C., Micalizzi C., Porta F., Rizzari C., Civino, A, Alighieri, G, Prete, E, Caroleo, A, Magni-Manzoni, S, Vinti, L, Romano, M, Santoro, N, Filocamo, G, Belotti, T, Santarelli, F, Gorio, C, Ricci, F, Colombini, A, Pastore, S, Cesaro, S, Barone, P, Verzegnassi, F, Olivieri, A, Ficara, M, Miniaci, A, Russo, G, Gallizzi, R, Pericoli, R, Breda, L, Mura, R, Podda, R, Onofrillo, D, Lattanzi, B, Tirtei, E, Maggio, M, De Santis, R, Consolini, R, Arlotta, A, La Torre, F, Mainardi, C, Pelagatti, M, Coassin, E, Capolsini, I, Burnelli, R, Tornesello, A, Soscia, F, De Fanti, A, Rigante, D, Pizzato, C, De Fusco, C, Abate, M, Roncadori, A, Rossi, E, Stabile, G, Biondi, A, Lepore, L, Conter, V, Rondelli, R, Pession, A, Ravelli, A, Bertolini, P, Cefalo, M, Davi, S, and Gicchino, M

Subjects
medicine.medical_specialty, business.industry, Immunology, Arthritis, Cancer, Odds ratio, Musculoskeletal manifestation, Juvenile idiopathic arthritis, medicine.disease, Histiocytosis, Rheumatology, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, Prednisone, Internal medicine, Joint pain, Arthropathy, Musculoskeletal manifestations, childhood cancer, juvenile idiopathic arthritis, medicine, childhood cancer, Immunology and Allergy, Differential diagnosis, medicine.symptom, business, medicine.drug
Abstract

Summary Background Presenting symptoms of childhood cancers might mimic those of rheumatic diseases. However, the evidence available to guide differential diagnosis remains scarce. Preventing wrong or delayed diagnosis is therefore important to avoid incorrect administration of glucocorticoid or immunosuppressive therapy and worsening of prognosis. As such, we aimed to assess the prevalence and characteristics of presenting musculoskeletal manifestations in patients at cancer onset and to identify the factors that differentiate childhood malignancies with arthropathy from juvenile idiopathic arthritis. Methods We did a multicentre, cross-sectional study at 25 paediatric haemato-oncology centres and 22 paediatric rheumatology centres in Italy. We prospectively recruited patients who were younger than 16 years that were newly diagnosed with cancer or juvenile idiopathic arthritis. We excluded patients with glucocorticoid pre-treatment (>1 mg/kg per day of oral prednisone or equivalent for ≥2 consecutive weeks). We collected data for patients with a new diagnosis of cancer or juvenile idiopathic arthritis using an electronic case report form on a web-based platform powered by the Cineca Interuniversity Consortium. The primary outcome was to describe the frequency and characteristics of musculoskeletal manifestations at cancer onset; and the secondary outcome was to identify factors that could discriminate malignancies presenting with arthropathy, with or without other musculoskeletal symptoms, from juvenile idiopathic arthritis using multivariable logistic regression analysis. Findings Between May 1, 2015, and May 31, 2018, 1957 patients were eligible, of which 1277 (65%) had cancer and 680 (35%) had juvenile idiopathic arthritis. Musculoskeletal symptoms occurred in 324 (25% [95% CI 23·0–27·8]) of 1277 patients with cancer, of whom 207 had arthropathy. Patients with malignant bone tumours had the highest frequency of musculoskeletal symptoms (53 [80%] of 66), followed by patients with Langerhans histiocytosis (16 [47%] of 34), leukaemia (189 [32%] of 582), soft-tissue sarcomas (16 [24%] of 68), and neuroblastoma (21 [19%] of 109). In the 324 patients with cancer and musculoskeletal symptoms, the most common complaints were joint pain (199 [61%]), followed by limb bone pain (112 [35%]). Joint involvement had a prevalent monoarticular pattern (100 [48%] of 207) and oligoarticular pattern (86 [42%] had 2–4 joints involved and 20 [10%] had >4 joints involved), with the most frequently involved joints being the hip (88 [43%] of 207) and knee (81 [39%]). On multivariable analysis, limb bone pain was the independent variable most strongly associated with cancer (odds ratio [OR] 87·80 [95% CI 18·89–408·12]), followed by weight loss (59·88 [6·34–565·53]), thrombocytopenia (12·67 [2·40–66·92]), monoarticular involvement (11·30 [4·09–31·19]), hip involvement (3·30 [1·13–9·61]), and male sex (2·40 [1·03–5·58]). Factors independently associated with juvenile idiopathic arthritis were morning stiffness (OR 0·04 [95% CI 0·01–0·20]), joint swelling (0·03 [0·01–0·09]), and involvement of the small hand joints (0·02 [0–1·05]). Interpretation Our study provides detailed information about presenting musculoskeletal manifestations of childhood cancers and highlights the clinical and laboratory features that are most helpful in the differential diagnosis with juvenile idiopathic arthritis. Funding Associazione Lorenzo Risolo.

Published
2021

3. Outcome of relapsed/refractory acute promyelocytic leukaemia in children, adolescents and young adult patients — a 25-year Italian experience

Author

Concetta Micalizzi, Luca Lo Nigro, Alfonso Piciocchi, Giuseppe Menna, Nicola Santoro, C. Putti, Anna Maria Testi, Saverio Ladogana, Robin Foà, Riccardo Masetti, Marco Zecca, Paolo Pierani, Ottavio Ziino, Valentina Arena, Daniela Onofrillo, Franco Locatelli, Carmelo Rizzari, Maria Vittoria Micheletti, Fabio Timeus, Daniela Diverio, Sara Mohamed, Testi, A, Mohamed, S, Diverio, D, Piciocchi, A, Menna, G, Rizzari, C, Timeus, F, Micalizzi, C, Lo Nigro, L, Santoro, N, Masetti, R, Micheletti, M, Ziino, O, Onofrillo, D, Ladogana, S, Putti, C, Pierani, P, Arena, V, Zecca, M, Foa, R, Locatelli, F, Testi A.M., Mohamed S., Diverio D., Piciocchi A., Menna G., Rizzari C., Timeus F., Micalizzi C., Lo Nigro L., Santoro N., Masetti R., Micheletti M.V., Ziino O., Onofrillo D., Ladogana S., Putti C., Pierani P., Arena V., Zecca M., Foa R., and Locatelli F.

Subjects
Male, Pediatrics, medicine.medical_specialty, Adolescent, acute promyelocytic leukaemia, Salvage treatment, salvage treatment, Antineoplastic Agents, Tretinoin, Young Adult, Antineoplastic Agents, Immunological, Arsenic Trioxide, Leukemia, Promyelocytic, Acute, immune system diseases, medicine, Humans, Anthracyclines, Young adult, Child, neoplasms, Retrospective Studies, Salvage Therapy, business.industry, Remission Induction, Hematopoietic Stem Cell Transplantation, Hematology, Prognosis, Combined Modality Therapy, Gemtuzumab, Progression-Free Survival, Treatment Outcome, Italy, Settore MED/38 - PEDIATRIA GENERALE E SPECIALISTICA, adolescent children, Case-Control Studies, Child, Preschool, Relapsed refractory, relapsed/refractory disease, Early adolescents, Female, Acute promyelocytic leukaemia, Neoplasm Recurrence, Local, business
Abstract

Acute promyelocytic leukaemia (APL) is a rare subtype ofchildhood acute myeloid leukaemia (AML), accounting for5–12% of all AML cases. Treatment with all-trans-retinoicacid (ATRA) and anthracyclines yields complete remission(CR) rates >90% and 10-year event-free survival (EFS) ratesaround 80%.1–3The recent front-line arsenic trioxide(ATO)-based regimens have further improved the APL out-come by reducing toxicity and preventing relapse.4–6Relapsed APL patients are a rare and heterogeneous group,whose prognosis depends on front-line treatment and timeelapsing between diagnosis and recurrence. Currently, ATOis the treatment of choice for relapsed APL. Due to the rarityof relapsed childhood APL, 17–27% in ATRA- andchemotherapy-1,3,7–9and 4% in ATO-containing regimens,10it will be difficult, in the future, to design future prospectivecomparative trials for these patients. In an attempt to designtherapeutic guidelines, recommendations on management ofrelapsed/refractory paediatric APL have been publishedrecently

Published
2021

4. Human Fibrinogen Concentrate and Fresh Frozen Plasma in the Management of Severe Acquired Hypofibrinogenemia in Children With Acute Lymphoblastic Leukemia: Results of a Retrospective Survey

Author

Matteo Luciani, Anna Maria Testi, Concetta Micalizzi, Silvio Tafuri, Carmelo Rizzari, Nicola Santoro, Maria C. Putti, Caterina Consarino, Paola Giordano, Berardino Pollio, Antonella Colombini, Lucia Dora Notarangelo, Elena Mastrodicasa, Paola Carmela Corallo, Fara Petruzziello, Fiorina Casale, Rosa M. Mura, Daniela Onofrillo, Francesco De Leonardis, Paola Saracco, Massimo Grassi, Giordano, P, Grassi, M, Saracco, P, Luciani, M, Colombini, A, Testi, A, Micalizzi, C, Petruzziello, F, Putti, M, Casale, F, Consarino, C, Mura, R, Mastrodicasa, E, Notarangelo, L, Onofrillo, D, Pollio, B, Rizzari, C, Tafuri, S, De Leonardis, F, Corallo, P, and Santoro, N

Subjects
Male, Pediatrics, medicine.medical_specialty, Adolescent, Lymphoblastic Leukemia, fresh frozen plasma, hypofibrinogenemia, acute lymphoblastic leukemia, Fibrinogen, Plasma, 03 medical and health sciences, 0302 clinical medicine, medicine, Humans, Child, hemostasi, Acquired hypofibrinogenemia, Retrospective Studies, business.industry, Retrospective cohort study, Hematology, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Hypofibrinogenemia, Afibrinogenemia, medicine.disease, Thrombosis, Oncology, Child, Preschool, 030220 oncology & carcinogenesis, Hemostasis, Pediatrics, Perinatology and Child Health, Female, Fresh frozen plasma, ALL, business, 030215 immunology, medicine.drug
Abstract

Objective of the Study:In this study we aimed to retrospectively evaluate how centers, belonging to the Associazione Italiana Ematologia e Oncologia Pediatrica (AIEOP), manage severe acquired hypofibrinogenemia in children with acute lymphoblastic leukemia, particularly evaluating the therapeutic role of human fibrinogen concentrate (HFC) and fresh frozen plasma (FFP).Methods:We conducted a survey among AIEOP centers; thereafter, we collected and analyzed data with regard to the treatment of episodes of severe acquired hypofibrinogenemia occurring during the induction and reinduction phases of the AIEOP-BFM ALL 2009 protocol.Results:In total, 15 of the 37 AIEOP centers invited to join the survey agreed to collect the data, with 10 and 5 centers declaring to react to severe acquired hypofibrinogenemia (

Published
2019
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5. Screening for SARS-CoV-2 infection in pediatric oncology patients during the epidemic peak in Italy

Author

Daniela Onofrillo, Elena Soncini, Raffaella De Santis, Angelica Barone, Laura Sainati, Linda Meneghello, Katia Perruccio, Maria Grazia Petris, Valentina Baretta, Federico Mercolini, Nagua Giurici, Simone Cesaro, Antonella Colombini, Francesca Compagno, Daniele Zama, R. Mura, Cesaro S., Compagno F., Zama D., Meneghello L., Giurici N., Soncini E., Onofrillo D., Mercolini F., Mura R., Perruccio K., De Santis R., Colombini A., Barone A., Sainati L., Baretta V., and Petris M.G.

Subjects
2019-20 coronavirus outbreak, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Coronaviru, Pneumonia, Viral, medicine.disease_cause, Betacoronavirus, Neoplasms, Pandemic, medicine, Pediatric oncology, Humans, Viral, Pediatrics, Perinatology, and Child Health, Child, Pandemics, Coronavirus, biology, Betacoronaviru, business.industry, Coronavirus Infection, SARS-CoV-2, COVID-19, Pneumonia, Hematology, biology.organism_classification, medicine.disease, Virology, Oncology, Italy, Pediatrics, Perinatology and Child Health, business, Coronavirus Infections, Human
Abstract

NA

Published
2020

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