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1. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapsed/refractory follicular lymphoma: a Fondazione Italiana Linfomi multicenter, randomized, phase III trial

Author

Ladetto, M., Tavarozzi, R., Zanni, M., Evangelista, A., Ferrero, S., Tucci, A., Botto, B., Bolis, S., Volpetti, S., Zilioli, V.R., Puccini, B., Arcari, A., Pavone, V., Gaidano, G., Corradini, P., Tani, M., Cavallo, F., Milone, G., Ghiggi, C., Pinto, A., Pastore, D., Ferreri, A.J.M., Latte, G., Patti, C., Re, F., Benedetti, F., Luminari, S., Pennese, E., Bossi, E., Boccomini, C., Anastasia, A., Bottelli, C., Ciccone, G., and Vitolo, U.

Published
2024
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3. Genomic instability analysis in DNA from Papanicolaou test provides proof-of-principle early diagnosis of high-grade serous ovarian cancer

Author

Paracchini, L, Mannarino, L, Romualdi, C, Zadro, R, Beltrame, L, Nerini, I, Zola, P, Laudani, M, Pagano, E, Giordano, L, Fruscio, R, Landoni, F, Franceschi, S, Dalessandro, M, Canzonieri, V, Bocciolone, L, Lorusso, D, Bosetti, C, Raspagliesi, F, Garassino, I, D'Incalci, M, Marchini, S, Grassi, T, Bianchi, T, Cursano, G, Mangili, G, Scambia, G, Marchetti, C, Boldorini, R, De Rosa, G, Ferrero, A, Feyles, E, Goia, M, Manini, C, Orlassino, R, Surico, D, Volante, M, Greggi, S, Jaconi, M, Bella, C, Vitobello, D, di Loreto, C, Pizzolitto, S, Zanconati, F, Ciccone, G, Armaroli, P, Larato, C, Rizzolo, R, Paracchini L., Mannarino L., Romualdi C., Zadro R., Beltrame L., Nerini I. F., Zola P., Laudani M. E., Pagano E., Giordano L., Fruscio R., Landoni F., Franceschi S., Dalessandro M. L., Canzonieri V., Bocciolone L., Lorusso D., Bosetti C., Raspagliesi F., Garassino I. M. G., D'Incalci M., Marchini S., Grassi T., Bianchi T., Cursano G., Mangili G., Scambia G., Marchetti C., Boldorini R., De Rosa G., Ferrero A., Feyles E., Goia M., Manini C., Orlassino R., Surico D., Volante M., Greggi S., Jaconi M., Bella C. D., Vitobello D., di Loreto C., Pizzolitto S., Zanconati F., Ciccone G., Armaroli P., Larato C., Rizzolo R., Paracchini, L, Mannarino, L, Romualdi, C, Zadro, R, Beltrame, L, Nerini, I, Zola, P, Laudani, M, Pagano, E, Giordano, L, Fruscio, R, Landoni, F, Franceschi, S, Dalessandro, M, Canzonieri, V, Bocciolone, L, Lorusso, D, Bosetti, C, Raspagliesi, F, Garassino, I, D'Incalci, M, Marchini, S, Grassi, T, Bianchi, T, Cursano, G, Mangili, G, Scambia, G, Marchetti, C, Boldorini, R, De Rosa, G, Ferrero, A, Feyles, E, Goia, M, Manini, C, Orlassino, R, Surico, D, Volante, M, Greggi, S, Jaconi, M, Bella, C, Vitobello, D, di Loreto, C, Pizzolitto, S, Zanconati, F, Ciccone, G, Armaroli, P, Larato, C, Rizzolo, R, Paracchini L., Mannarino L., Romualdi C., Zadro R., Beltrame L., Nerini I. F., Zola P., Laudani M. E., Pagano E., Giordano L., Fruscio R., Landoni F., Franceschi S., Dalessandro M. L., Canzonieri V., Bocciolone L., Lorusso D., Bosetti C., Raspagliesi F., Garassino I. M. G., D'Incalci M., Marchini S., Grassi T., Bianchi T., Cursano G., Mangili G., Scambia G., Marchetti C., Boldorini R., De Rosa G., Ferrero A., Feyles E., Goia M., Manini C., Orlassino R., Surico D., Volante M., Greggi S., Jaconi M., Bella C. D., Vitobello D., di Loreto C., Pizzolitto S., Zanconati F., Ciccone G., Armaroli P., Larato C., and Rizzolo R.

Abstract

Late diagnosis and the lack of screening methods for early detection define high-grade serous ovarian cancer (HGSOC) as the gynecological malignancy with the highest mortality rate. In the work presented here, we investigated a retrospective and multicentric cohort of 250 archival Papanicolaou (Pap) test smears collected during routine gynecological screening. Samples were taken at different time points (from 1 month to 13.5 years before diagnosis) from 113 presymptomatic women who were subsequently diagnosed with HGSOC (pre-HGSOC) and from 77 healthy women. Genome instability was detected through low-pass whole-genome sequencing of DNA derived from Pap test samples in terms of copy number profile abnormality (CPA). CPA values of DNA extracted from Pap test samples from pre-HGSOC women were substantially higher than those in samples from healthy women. Consistently with the longitudinal analysis of clonal pathogenic TP53 mutations, this assay could detect HGSOC presence up to 9 years before diagnosis. This finding confirms the continual shedding of tumor cells from fimbriae toward the endocervical canal, suggesting a new path for the early diagnosis of HGSOC. We integrated the CPA score into the EVA (early ovarian cancer) test, the sensitivity of which was 75% (95% CI, 64.97 to 85.79), the specificity 96% (95% CI, 88.35 to 100.00), and the accuracy 81%. This proof-of-principle study indicates that the early diagnosis of HGSOC is feasible through the analysis of genomic alterations in DNA from endocervical smears.

Published
2023

4. Radioimmunotherapy versus autologous hematopoietic stem cell transplantation in relapsed/refractory follicular lymphoma: a Fondazione Italiana Linfomi multicenter, randomized, phase III trial

Author

Ladetto, M., primary, Tavarozzi, R., additional, Zanni, M., additional, Evangelista, A., additional, Ferrero, S., additional, Tucci, A., additional, Botto, B., additional, Bolis, S., additional, Volpetti, S., additional, Zilioli, V.R., additional, Puccini, B., additional, Arcari, A., additional, Pavone, V., additional, Gaidano, G., additional, Corradini, P., additional, Tani, M., additional, Cavallo, F., additional, Milone, G., additional, Ghiggi, C., additional, Pinto, A., additional, Pastore, D., additional, Ferreri, A.J.M., additional, Latte, G., additional, Patti, C., additional, Re, F., additional, Benedetti, F., additional, Luminari, S., additional, Pennese, E., additional, Bossi, E., additional, Boccomini, C., additional, Anastasia, A., additional, Bottelli, C., additional, Ciccone, G., additional, and Vitolo, U., additional

Published
2023
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7. Primary Mediastinal B‐cell Lymphoma, a nationwide real‐life retrospective study from Fondazione Italiana Linfomi (FIL)

Author

Iannitto, E., primary, Balzarotti, M., additional, Martelli, M., additional, Zinzani, P., additional, Tucci, A., additional, Di Rocco, A., additional, Cavallo, F., additional, Usai, S. V., additional, Guidetti, A., additional, Ravano, E., additional, Merli, F., additional, Botto, B., additional, Pelosini, M., additional, Tecchio, C., additional, Spina, M., additional, Derenzini, E., additional, Finotto, S., additional, Mola, B., additional, Pinto, A., additional, Zanni, E., additional, Battistini, R., additional, Hohaus, S., additional, Dogliotti, I., additional, Gini, G., additional, Zilioli, V. R., additional, De Lorenzo, S., additional, Dodero, A., additional, Broccoli, A., additional, Maggi, A., additional, Mannarella, C., additional, Chiarenza, A., additional, Pastore, D., additional, Cascavilla, N., additional, Musto, P., additional, Stelitano, C., additional, Di Raimondo, F., additional, Di Renzo, N., additional, Liberati, A. M., additional, Salerno, M., additional, Scalone, R., additional, Nassi, L., additional, Patti, C., additional, Polizzi, V., additional, Guarini, A., additional, Amato, G., additional, Ciccone, G., additional, Evangelista, A., additional, Lo Presti, F., additional, La Porta, A., additional, Mannina, D., additional, Calogero, R. D., additional, Musso, M., additional, and Consoli, U., additional

Published
2023
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8. FRONTLINE INTENSIFIED ABVD DEMONSTRATES SUPERIOR EFFICACY THAN PET‐ADAPTED ABVD IN ADVANCED HODGKIN LYMPHOMA: THE FIL‐ROUGE PHASE 3 TRIAL BY THE FONDAZIONE ITALIANA LINFOMI

Author

Pinto, A., primary, Corazzelli, G., additional, Evangelista, A., additional, Patti, C., additional, De Lorenzo, S., additional, Re, A., additional, Merli, F., additional, Botto, B., additional, Tarantini, G., additional, Guarini, A., additional, Leonardi, G., additional, Hohaus, S., additional, Cavallo, F., additional, Pulsoni, A., additional, Gotti, M., additional, Celli, M., additional, Gaudio, F., additional, Ricci, F., additional, Liberati, A. M., additional, Pavone, V., additional, Rota‐Scalabrini, D., additional, Flenghi, L., additional, Arcari, A., additional, Cimminiello, M., additional, Zilioli, V. R., additional, Morelli, E., additional, Mulè, A., additional, Arcamone, M., additional, Pagani, C., additional, Arletti, L., additional, Levis, M., additional, De Filippi, R., additional, Cuccaro, A., additional, Cesaretti, M., additional, Borgo, E., additional, Musto, P., additional, Vitolo, U., additional, Chauvie, S., additional, Ricardi, U., additional, Ciccone, G., additional, and Santoro, A., additional

Published
2023
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9. P07 BORTEZOMIB-MELPHALAN-PREDNISONE (VMP) VS. LENALIDOMIDE-DEXAMETHASONE (RD) IN REAL-LIFE MULTIPLE MYELOMA PATIENTS INELIGIBLE FOR TRANSPLANT: UPDATED ANALYSIS OF THE RANDOMIZED PHASE IV REAL MM TRIAL

Author

Larocca, A., primary, D’Agostino, M., additional, Giuliani, N., additional, Antonioli, E., additional, Zambello, R., additional, Ronconi, S., additional, Vincelli, I. D., additional, Ciceri, F., additional, Falcone, A. P., additional, Michieli, M., additional, Cattel, F., additional, Capra, A., additional, Grasso, M., additional, Cafro, A. M., additional, Bonello, F., additional, Floris, R., additional, Offidani, M., additional, Sciorsi, E., additional, Pietrantuono, G., additional, Curci, P., additional, Patriarca, F., additional, Cavo, M., additional, Mangiacavalli, S., additional, Benevolo, G., additional, Evangelista, A., additional, Ciccone, G., additional, Boccadoro, M., additional, Bruno, B., additional, and Bringhen, S., additional

Published
2023
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15. ffectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients With Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial

Author

Zola, P, Ciccone, G, Piovano, E, Fuso, L, Di Cuonzo, D, Castiglione, A, Pagano, E, Peirano, E, Landoni, F, Sartori, E, Narducci, F, Bertetto, O, Ferrero, A, TOTEM Collaborative, Group., Zola, P, Ciccone, G, Piovano, E, Fuso, L, Di Cuonzo, D, Castiglione, A, Pagano, E, Peirano, E, Landoni, F, Sartori, E, Narducci, F, Bertetto, O, and Ferrero, A

Subjects
Cancer Research, Oncology, multicenter trial, follow-up endometrial cancer
Abstract

PURPOSE In the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves overall survival (OS) in patients undergoing operation for endometrial cancer. METHODS The TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high), patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was powered to demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen. RESULTS In total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50, P = .380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P = .194). CONCLUSION An INT follow-up in endometrial cancer–treated patients does not improve OS, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.

Published
2022

17. Effectiveness of Intensive Versus Minimalist Follow-Up Regimen on Survival in Patients with Endometrial Cancer (TOTEM Study): A Randomized, Pragmatic, Parallel Group, Multicenter Trial

Author

Zola, P, Ciccone, G, Piovano, E, Fuso, L, Di Cuonzo, D, Castiglione, A, Pagano, E, Peirano, E, Landoni, F, Sartori, E, Narducci, F, Bertetto, O, Ferrero, A, Zola, Paolo, Ciccone, Giovannino, Piovano, Elisa, Fuso, Luca, Di Cuonzo, Daniela, Castiglione, Anna, Pagano, Eva, Peirano, Elena, Landoni, Fabio, Sartori, Enrico, Narducci, Fabrice, Bertetto, Oscar, Ferrero, Annamaria, Zola, P, Ciccone, G, Piovano, E, Fuso, L, Di Cuonzo, D, Castiglione, A, Pagano, E, Peirano, E, Landoni, F, Sartori, E, Narducci, F, Bertetto, O, Ferrero, A, Zola, Paolo, Ciccone, Giovannino, Piovano, Elisa, Fuso, Luca, Di Cuonzo, Daniela, Castiglione, Anna, Pagano, Eva, Peirano, Elena, Landoni, Fabio, Sartori, Enrico, Narducci, Fabrice, Bertetto, Oscar, and Ferrero, Annamaria

Abstract

PURPOSEIn the absence of clear evidence from randomized trials, the intensity of follow-up regimens after surgical treatment of endometrial cancer is highly variable in clinical practice. To reduce this uncertainty, we conducted a randomized trial to test whether an intensive (INT) versus a minimalist (MIN) follow-up regimen improves overall survival (OS) in patients undergoing operation for endometrial cancer.METHODSThe TOTEM study was a large, pragmatic randomized trial, conducted in 42 hospitals (in Italy and France) including patients surgically treated for endometrial cancer, in complete clinical remission, International Federation of Gynecology and Obstetrics stage I-IV. After stratification by center and risk of relapse (low or high), patients were randomly assigned (1:1) to INT or MIN hospital-based follow-up regimens. The study was powered to demonstrate an absolute improvement of 5% of the 5-year OS with the INT regimen.RESULTSIn total, 1,871 patients were randomly assigned between November 2008 and July 2018, and 1,847 patients (98.7%) were available for the final analysis (60% low risk). After a median follow-up of 69 months, the 5-year OS was 90.6% in the INT and 91.9% in the MIN arms (hazard ratio, 1.13, 95% CI, 0.86 to 1.50, P =.380). No differences in OS were found in subgroup analyses considering age, cancer treatment, risk of relapse, and degree of adherence of the center to the scheduled follow-up. The probability of detecting a relapse was slightly higher in the INT arm (hazard ratio, 1.17; 95% CI, 0.92 to 1.48; P =.194).CONCLUSIONAn INT follow-up in endometrial cancer-treated patients does not improve OS, even in high-risk patients. According to available evidence, there is no need to routinely add vaginal cytology, laboratory, or imaging investigations to the MIN regimens used in this trial.

Published
2022

19. P1144: RADIOIMMUNOTHERAPY (RIT) VERSUS AUTOLOGOUS HEMATOPOIETIC STEM-CELL TRANSPLANTATION (ASCT) IN RELAPSED/REFRACTORY (R/R) FOLLICULAR LYMPHOMA: A FONDAZIONE ITALIANA LINFOMI (FIL) PHASE III TRIAL.

Author

Ladetto, M., primary, Tavarozzi, R., additional, Evangelista, A., additional, Zanni, M., additional, Tucci, A., additional, Anastasia, A., additional, Botto, B., additional, Boccomini, C., additional, Bolis, S., additional, Volpetti, S., additional, Zilioli, V. R., additional, Puccini, B., additional, Arcari, A., additional, Pavone, V., additional, Gaidano, G., additional, Corradini, P., additional, Tani, M., additional, Ferrero, S., additional, Cavallo, F., additional, Milone, G., additional, Ghiggi, C., additional, Pinto, A., additional, Pastore, D., additional, Ferreri, A. J., additional, Latte, G., additional, Patti, C., additional, Re, F., additional, Arcaini, L., additional, Benedetti, F., additional, Usai, S. V., additional, Luminari, S., additional, Mannina, D., additional, Pulsoni, A., additional, Stelitano, C., additional, Pennese, E., additional, Pietrantuono, G., additional, Gherlinzoni, F., additional, Pomponi, F., additional, Olivieri, A., additional, Perrone, T., additional, Rota Scalabrini, D., additional, Califano, C., additional, Falini, B., additional, Ciccone, G., additional, and Vitolo, U., additional

Published
2022
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20. S221: BORTEZOMIB TO R-DHAP COMPARED TO R-DHAP IN RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA ELIGIBLE TO STEM CELL TRANPLANTATION: FINAL RESULTS OF PHASE II RANDOMIZED FIL-VERAL12

Author

Chiappella, A., primary, Balzarotti, M., additional, Botto, B, additional, Castiglione, A., additional, Cavallo, F., additional, Usai, S. V., additional, Zanni, M., additional, Califano, C., additional, Re, F., additional, Ghiggi, C., additional, Olivieri, A., additional, Corradini, P., additional, Liberati, A. M., additional, Volpetti, S., additional, Michieli, M. G., additional, Tucci, A, additional, Gaidano, G., additional, Tani, M., additional, Ciambelli, F., additional, Musuraca, G., additional, Vallisa, D., additional, Merli, F., additional, Molinari, A. L., additional, Tafuri, A., additional, Zilioli, V. R., additional, Marino, D., additional, Stelitano, C., additional, Pileri, S. A., additional, Ciccone, G., additional, and Vitolo, U., additional

Published
2022
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21. PB2132: COPANLISIB PLUS RITUXIMAB-BENDAMUSTINE FOR RELAPSED-REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA: RECRUITMENT UPDATE ON AN ONGOING PHASE II TRIAL OF THE FONDAZIONE ITALIANA LINFOMI (FIL_COPA-RB)

Author

Novo, M., primary, Castellino, A., additional, Chiappella, A., additional, Ciccone, G., additional, Balzarotti, M., additional, Arcari, A., additional, Scarpa, E., additional, Tucci, A., additional, Di Renzo, N., additional, Tarantini, G., additional, Gini, G., additional, Moretti, M., additional, Mannina, D., additional, Di Rocco, A., additional, Spina, M., additional, and Vitolo, U., additional

Published
2022
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24. B13 - Start (active surveillance or radical treatment for newly diagnosed patients with a localized, low risk, prostate cancer): an epidemiological study of the Oncology Network of Piemonte and Valle d’Aosta. Update 2017

Author

Galassi, C., Ceccarelli, M., Monagheddu, C., Pagano, E., Rosato, R., Ivaldi, P., Bollito, E., Zitella, A., De Luca, S., Camilli, M., Munoz, F., Bellissimo, A.R., Bongiovanni, F., Ponti di Sant'Angelo, F., Mistrangelo, M., Ciccone, G., and Bertetto, O.

Published
2017
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25. O004/#393 Does intensive follow-up improve overall survivalin endometrial cancer patients? Results from the totem randomized controlled trial

Author

Zola, P, primary, Ciccone, G, additional, Angioli, R, additional, Terranova, C, additional, Piovano, E, additional, Fuso, L, additional, Di Cuonzo, D, additional, Peirano, E, additional, Perrone, AM, additional, Mandato, VD, additional, Zavallone, L, additional, Chiudinelli, F, additional, Berretta, R, additional, Loda, S, additional, Greggi, S, additional, Adorni, M, additional, Busato, E, additional, Comerci, G, additional, Fambrini, M, additional, and Ferrero, A, additional

Published
2021
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26. 673 An audit and feedback intervention to monitor quality of care of ovarian cancer according to ESGO guidelines in the Piemonte cancer network

Author

Ferrero, A, primary, Pagano, E, additional, Mistrangelo, M, additional, Fuso, L, additional, Martins, VH, additional, Valabrega, G, additional, Laudani, ME, additional, Marocco, F, additional, Surico, D, additional, Piovano, E, additional, Barbero, M, additional, Camanni, M, additional, Delpiano, EM, additional, Puppo, A, additional, Daniele, A, additional, Zavallone, L, additional, Aguggia, V, additional, Fiorentino, R, additional, Ciccone, G, additional, and Zola, P, additional

Published
2021
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29. 259 The impact of intensive follow-up on health-related quality of life and costs in endometrial cancer patients: data from the TOTEM trial NCT00916708

Author

Zola, P, primary, Ciccone, G, additional, Piovano, E, additional, Fuso, L, additional, Peirano, E, additional, Cuonzo, DDI, additional, Pagano, E, additional, Castiglione, A, additional, Perrone, AM, additional, Mandato, VD, additional, Zavallone, L, additional, Chiudinelli, F, additional, Berretta, R, additional, Loda, S, additional, Valenzano Menada, M, additional, Greggi, S, additional, Adorni, M, additional, Comerci, G, additional, Fambrini, M, additional, and Ferrero, A, additional

Published
2021
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32. OC-0207 Long-term results of peri-transplant RT in Hodgkin’s lymphomas: results from a multi-center study

Author

Levis, M., primary, Campbell, B., additional, Matrone, F., additional, Furfaro, G., additional, Grapulin, L., additional, Di Russo, A., additional, Buglione, M., additional, Iamundo De Cumis, I., additional, Simontacchi, G., additional, Ciammella, P., additional, Magli, A., additional, Pascale, G., additional, Meregalli, S., additional, MacManus, M., additional, Fanetti, G., additional, De Felice, F., additional, Alghisi, A., additional, Deidda, M.A., additional, Manicone, M., additional, Ciccone, G., additional, Filippi, A.R., additional, and Ricardi, U., additional

Published
2021
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33. Clinical and epidemiological characteristics associated with pneumonia at disease onset in patients admitted for COVID-19 to the Emergency Department of a large Hospital in Piedmont (North-Western Italy)

Author

Sacerdote, C., Castiglione, A., Pagano, E., Migliore, E., Pivetta, E., Auzzas, G. M., Brentisci, C., Brunetti, F., Defile, C., Gangemi, M., Giacometti, L., Gilardetti, M., Martins, V. H., Saccona, F., Stura, A., Turco, D., Balestro, C., Zozzoli, S., Fiandra, U., Roggero, S., Silvestre, C., Scozzari, G., Scarmozzino, A., and Ciccone, G.

Subjects
Adult, Diarrhea, Male, Time Factors, Vomiting, Pneumonia, Viral, Cohort study, COVID-19, Pneumonia, Aged, Aged, 80 and over, Comorbidity, Dyspnea, Emergency Service, Hospital, Female, Hospitals, University, Humans, Italy, Leukocyte Count, Middle Aged, Nervous System Diseases, Oxygen, Prospective Studies, Respiratory Rate, Retrospective Studies, Symptom Assessment, Pandemics, Hospital, 80 and over, Viral, Emergency Service, University, Hospitals
Abstract

to explore clinical and epidemiological characteristics associated with an imaging feature of COVID-19 pneumonia at disease onset, in order to identify factors that may be evaluable by general practitioners at patient's home, and which may lead to identify a more severe disease, needing hospitalization.this is a retrospective/prospective observational hospital cohort.the study population includes all patients consecutively admitted to the emergency department of Città della salute e della scienza University Hospital from 01.03 to 31.05.2020 with a confirmed diagnosis of SARS-CoV-2 infection.patients were classified in two groups according to the findings of X-ray imaging, lung ultrasound and chest computer tomography, as pneumonia or not pneumonia patients.in multivariable analysis, factors most strongly associated with emergency department admission with pneumonia were age, oxygen saturation90% (adj OR 4.16 ;95%CI 1.44-12.07), respiratory rate24 breaths/min (adj OR 6.50; 95%CI 2.36-17.87), fever ≥38° (adj OR 3.05; 95%CI 1.53-6.08) and the presence of gastroenteric symptoms (vomiting and diarrhea). A delay (7 days) between the appearance of the initial lung symptoms (cough and dyspnea) and the admission to the emergency department was also related to a higher probability of receiving a positive imaging report (OR 4.99; 95%CI 2,02-12,34).in order to reorganize the management of COVID-19 patients in Italy, in view of the risk of a second wave of epidemic or of local outbreaks, it would be desirable to relocate the triage, and possibly the patient's care, from hospital to home. In this scenario it is important to identify all symptoms and signs associated with COVID-19 pneumonia that would facilitate the decision-making process of GPs leading to patients hospitalization.

Published
2021

34. Implementation of the ERAS (Enhanced Recovery After Surgery) protocol for colorectal cancer surgery in the Piemonte Region with an Audit and Feedback approach: study protocol for a stepped wedge cluster randomised trial: a study of the EASY-NET project

Author

Pagano, E, Pellegrino, L, Rinaldi, F, Palazzo, V, Donati, D, Meineri, M, Palmisano, S, Rolfo, M, Bachini, I, Bertetto, O, Borghi, F, Ciccone, G, ERAS Colon-Rectum Piemonte study group members. ERAS Colon-Rectum Piemonte study group members: Site investigators: Federica Borromeo, Fabio Priora, Sergio Gentilli, Luca Portigliotti, Paolo Massucco, Marco Palisi, Felice Borghi, Luca Pellegrino, Maurizio De Giuli, Aridai Resendiz, Paola Bellomo, Silvia Marola, IRCCS Candiolo Alfredo Mellano, Dario Ribero, Roberto, Polastri, Andrea Muratore, Nicoletta Sveva Pipitone, Garino, Mauro, Ospedale Cardinal Massaia, Asti: Elisabetta Castagna, Pozzo, Gabriele, Ospedale Castelli, Verbania: Andrea Caneparo, Adriana Ginardi, Reggina Lagana, Monica Carrera, Stefania Muzio, Ospedale, Civile, Ivrea: Luca Panier Suffat, Ivan, Lettini, Alberto Kiss, Valentina Gentile, Roberto Saracco, Donatella Scaglione, Andrea Gattolin, Roberto Rimonda, Francesco Battafarano, Luigi Oragano, Luca Lorenzin, Carlo Palenzona, Carmine Gianfranco Di Somma, Eliana Giaminardi, Marco Calgaro, Marco Naddeo, Piero Cumbo, Emma Marchigiano, Francesca, Cravero, Amisano, Marco Francesco, Francesco, Lemut, Tiziana Viora, Luciano Bonaccorsi, Silvio Testa, Clemente De Rosa, Marco, Brunetti, Matteo, Gatti, Carlo Bima, Enrico Gibin, Quaglino, Francesco, Festa, Federico, Luca, Bonatti, Morino, Mario, Allaix, Marco Ettore, Paolo De Paolis, Ida Marina Raciti, Mauro, Santarelli, Gitana, Scozzari, Felice, Borghi, Donati, Danilo, Maurizio, Meineri, Palmisano, Sarah, Pellegrino, Luca, Ciccone, Giovannino, Rosalba, Galletti, Pagano, Eva, Sandrucci, Sergio, Ilaria, Bachini, Anna De Magistris, Barbara, Mitola, Paolo, Massucco, Alessio, Rizzo, Caironi, Pietro, Monica, Rolfo, Anna, Orlando, Bertetto, Oscar, Francesco, Brunetti, Corinna, Defilè, DIAS MARTINS, VITOR HUGO, Lisa, Giacometti, Papurello, Matteo, Fabio, Saccona, and Danila, Turco.

Subjects
medicine.medical_specialty, audit, Audit, Disease cluster, quality in health care, Feedback, 03 medical and health sciences, 0302 clinical medicine, Postoperative Complications, Medicine, Humans, Multicenter Studies as Topic, Duration (project management), Enhanced recovery after surgery, Pandemics, Randomized Controlled Trials as Topic, Protocol (science), business.industry, SARS-CoV-2, Incidence (epidemiology), COVID-19, General Medicine, Length of Stay, Colorectal surgery, Italy, Sample size determination, 030220 oncology & carcinogenesis, Emergency medicine, 030211 gastroenterology & hepatology, Surgery, colorectal surgery, business, Colorectal Neoplasms, Enhanced Recovery After Surgery
Abstract

IntroductionThe ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population.MethodsA multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients’ recovery, control of pain and patients’ satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints.Ethics and disseminationThe study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals.Trial registration numberNCT04037787.

Published
2021

35. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials.

Author

Axfors C., Janiaud P., Schmitt A.M., van't Hooft J., Smith E.R., Haber N.A., Abayomi A., Abduljalil M., Abdulrahman A., Acosta-Ampudia Y., Aguilar-Guisado M., Al-Beidh F., Alejandria M.M., Alfonso R.N., Ali M., AlQahtani M., AlZamrooni A., Anaya J.-M., Ang M.A.C., Aomar I.F., Argumanis L.E., Averyanov A., Baklaushev V.P., Balionis O., Benfield T., Berry S., Birocco N., Bonifacio L.B., Bowen A.C., Bown A., Cabello-Gutierrez C., Camacho B., Camacho-Ortiz A., Campbell-Lee S., Cao D.H., Cardesa A., Carnate J.M., Castillo G.J.J., Cavallo R., Chowdhury F.R., Chowdhury F.U.H., Ciccone G., Cingolani A., Climacosa F.M.M., Compernolle V., Cortez C.F.N., Costa Neto A., D'Antico S., Daly J., Danielle F., Davis J.S., De Rosa F.G., Denholm J.T., Denkinger C.M., Desmecht D., Diaz-Coronado J.C., Diaz Ponce-Medrano J.A., Donneau A.-F., Dumagay T.E., Dunachie S., Dungog C.C., Erinoso O., Escasa I.M.S., Estcourt L.J., Evans A., Evasan A.L.M., Fareli C.J., Fernandez-Sanchez V., Galassi C., Gallo J.E., Garcia P.J., Garcia P.L., Garcia J.A., Garigliany M., Garza-Gonzalez E., Gauiran D.T.V., Gaviria Garcia P.A., Giron-Gonzalez J.-A., Gomez-Almaguer D., Gordon A.C., Gothot A., Grass Guaqueta J.S., Green C., Grimaldi D., Hammond N.E., Harvala H., Heralde F.M., Herrick J., Higgins A.M., Hills T.E., Hines J., Holm K., Hoque A., Hoste E., Ignacio J.M., Ivanov A.V., Janssen M., Jennings J.H., Jha V., King R.A.N., Kjeldsen-Kragh J., Klenerman P., Kotecha A., Krapp F., Labanca L., Laing E., Landin-Olsson M., Laterre P.-F., Lim L.-L., Lim J., Ljungquist O., Llaca-Diaz J.M., Lopez-Robles C., Lopez-Cardenas S., Lopez-Plaza I., Lucero J.A.C., Lundgren M., Macias J., Maganito S.C., Malundo A.F.G., Manrique R.D., Manzini P.M., Marcos M., Marquez I., Martinez-Marcos F.J., Mata A.M., McArthur C.J., McQuilten Z.K., McVerry B.J., Menon D.K., Meyfroidt G., Mirasol M.A.L., Misset B., Molton J.S., Mondragon A.V., Monsalve D.M., Moradi Choghakabodi P., Morpeth S.C., Mouncey P.R., Moutschen M., Muller-Tidow C., Murphy E., Najdovski T., Nichol A.D., Nielsen H., Novak R.M., O'Sullivan M.V.N., Olalla J., Osibogun A., Osikomaiya B., Oyonarte S., Pardo-Oviedo J.M., Patel M.C., Paterson D.L., Pena-Perez C.A., Perez-Calatayud A.A., Perez-Alba E., Perkina A., Perry N., Pouladzadeh M., Poyato I., Price D.J., Quero A.K.H., Rahman M.M., Rahman M.S., Ramesh M., Ramirez-Santana C., Rasmussen M., Rees M.A., Rego E., Roberts J.A., Roberts D.J., Rodriguez Y., Rodriguez-Bano J., Rogers B.A., Rojas M., Romero A., Rowan K.M., Saccona F., Safdarian M., Santos M.C.M., Sasadeusz J., Scozzari G., Shankar-Hari M., Sharma G., Snelling T., Soto A., Tagayuna P.Y., Tang A., Tatem G., Teofili L., Tong S.Y.C., Turgeon A.F., Veloso J.D., Venkatesh B., Ventura-Enriquez Y., Webb S.A., Wiese L., Wiken C., Wood E.M., Yusubalieva G.M., Zacharowski K., Zarychanski R., Khanna N., Moher D., Goodman S.N., Ioannidis J.P.A., Hemkens L.G., Axfors C., Janiaud P., Schmitt A.M., van't Hooft J., Smith E.R., Haber N.A., Abayomi A., Abduljalil M., Abdulrahman A., Acosta-Ampudia Y., Aguilar-Guisado M., Al-Beidh F., Alejandria M.M., Alfonso R.N., Ali M., AlQahtani M., AlZamrooni A., Anaya J.-M., Ang M.A.C., Aomar I.F., Argumanis L.E., Averyanov A., Baklaushev V.P., Balionis O., Benfield T., Berry S., Birocco N., Bonifacio L.B., Bowen A.C., Bown A., Cabello-Gutierrez C., Camacho B., Camacho-Ortiz A., Campbell-Lee S., Cao D.H., Cardesa A., Carnate J.M., Castillo G.J.J., Cavallo R., Chowdhury F.R., Chowdhury F.U.H., Ciccone G., Cingolani A., Climacosa F.M.M., Compernolle V., Cortez C.F.N., Costa Neto A., D'Antico S., Daly J., Danielle F., Davis J.S., De Rosa F.G., Denholm J.T., Denkinger C.M., Desmecht D., Diaz-Coronado J.C., Diaz Ponce-Medrano J.A., Donneau A.-F., Dumagay T.E., Dunachie S., Dungog C.C., Erinoso O., Escasa I.M.S., Estcourt L.J., Evans A., Evasan A.L.M., Fareli C.J., Fernandez-Sanchez V., Galassi C., Gallo J.E., Garcia P.J., Garcia P.L., Garcia J.A., Garigliany M., Garza-Gonzalez E., Gauiran D.T.V., Gaviria Garcia P.A., Giron-Gonzalez J.-A., Gomez-Almaguer D., Gordon A.C., Gothot A., Grass Guaqueta J.S., Green C., Grimaldi D., Hammond N.E., Harvala H., Heralde F.M., Herrick J., Higgins A.M., Hills T.E., Hines J., Holm K., Hoque A., Hoste E., Ignacio J.M., Ivanov A.V., Janssen M., Jennings J.H., Jha V., King R.A.N., Kjeldsen-Kragh J., Klenerman P., Kotecha A., Krapp F., Labanca L., Laing E., Landin-Olsson M., Laterre P.-F., Lim L.-L., Lim J., Ljungquist O., Llaca-Diaz J.M., Lopez-Robles C., Lopez-Cardenas S., Lopez-Plaza I., Lucero J.A.C., Lundgren M., Macias J., Maganito S.C., Malundo A.F.G., Manrique R.D., Manzini P.M., Marcos M., Marquez I., Martinez-Marcos F.J., Mata A.M., McArthur C.J., McQuilten Z.K., McVerry B.J., Menon D.K., Meyfroidt G., Mirasol M.A.L., Misset B., Molton J.S., Mondragon A.V., Monsalve D.M., Moradi Choghakabodi P., Morpeth S.C., Mouncey P.R., Moutschen M., Muller-Tidow C., Murphy E., Najdovski T., Nichol A.D., Nielsen H., Novak R.M., O'Sullivan M.V.N., Olalla J., Osibogun A., Osikomaiya B., Oyonarte S., Pardo-Oviedo J.M., Patel M.C., Paterson D.L., Pena-Perez C.A., Perez-Calatayud A.A., Perez-Alba E., Perkina A., Perry N., Pouladzadeh M., Poyato I., Price D.J., Quero A.K.H., Rahman M.M., Rahman M.S., Ramesh M., Ramirez-Santana C., Rasmussen M., Rees M.A., Rego E., Roberts J.A., Roberts D.J., Rodriguez Y., Rodriguez-Bano J., Rogers B.A., Rojas M., Romero A., Rowan K.M., Saccona F., Safdarian M., Santos M.C.M., Sasadeusz J., Scozzari G., Shankar-Hari M., Sharma G., Snelling T., Soto A., Tagayuna P.Y., Tang A., Tatem G., Teofili L., Tong S.Y.C., Turgeon A.F., Veloso J.D., Venkatesh B., Ventura-Enriquez Y., Webb S.A., Wiese L., Wiken C., Wood E.M., Yusubalieva G.M., Zacharowski K., Zarychanski R., Khanna N., Moher D., Goodman S.N., Ioannidis J.P.A., and Hemkens L.G.

Abstract

Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Method(s): In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Result(s): A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3

Published
2021

36. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, C, Janiaud, P, Schmitt, AM, Van't Hooft, J, Smith, ER, Haber, NA, Abayomi, A, Abduljalil, M, Abdulrahman, A, Acosta-Ampudia, Y, Aguilar-Guisado, M, Al-Beidh, F, Alejandria, MM, Alfonso, RN, Ali, M, AlQahtani, M, AlZamrooni, A, Anaya, J-M, Ang, MAC, Aomar, IF, Argumanis, LE, Averyanov, A, Baklaushev, VP, Balionis, O, Benfield, T, Berry, S, Birocco, N, Bonifacio, LB, Bowen, AC, Bown, A, Cabello-Gutierrez, C, Camacho, B, Camacho-Ortiz, A, Campbell-Lee, S, Cao, DH, Cardesa, A, Carnate, JM, Castillo, GJJ, Cavallo, R, Chowdhury, FR, Chowdhury, FUH, Ciccone, G, Cingolani, A, Climacosa, FMM, Compernolle, V, Cortez, CFN, Neto, AC, D'Antico, S, Daly, J, Danielle, F, Davis, JS, De Rosa, FG, Denholm, JT, Denkinger, CM, Desmecht, D, Diaz-Coronado, JC, Diaz Ponce-Medrano, JA, Donneau, A-F, Dumagay, TE, Dunachie, S, Dungog, CC, Erinoso, O, Escasa, IMS, Estcourt, LJ, Evans, A, Evasan, ALM, Fareli, CJ, Fernandez-Sanchez, V, Galassi, C, Gallo, JE, Garcia, PJ, Garcia, PL, Garcia, JA, Garigliany, M, Garza-Gonzalez, E, Gauiran, DT, Gaviria Garcia, PA, Giron-Gonzalez, J-A, Gomez-Almaguer, D, Gordon, AC, Gothot, A, Grass Guaqueta, JS, Green, C, Grimaldi, D, Hammond, NE, Harvala, H, Heralde, FM, Herrick, J, Higgins, AM, Hills, TE, Hines, J, Holm, K, Hoque, A, Hoste, E, Ignacio, JM, Ivanov, A, Janssen, M, Jennings, JH, Jha, V, King, RAN, Kjeldsen-Kragh, J, Klenerman, P, Kotecha, A, Krapp, F, Labanca, L, Laing, E, Landin-Olsson, M, Laterre, P-F, Lim, L-L, Lim, J, Ljungquist, O, Llaca-Diaz, JM, Lopez-Robles, C, Lopez-Cardenas, S, Lopez-Plaza, I, Lucero, JAC, Lundgren, M, Macias, J, Maganito, SC, Malundo, AFG, Manrique, RD, Manzini, PM, Marcos, M, Marquez, I, Javier Martinez-Marcos, F, Mata, AM, McArthur, CJ, McQuilten, ZK, McVerry, BJ, Menon, DK, Meyfroidt, G, Mirasol, MAL, Misset, B, Molton, JS, Mondragon, A, Monsalve, DM, Choghakabodi, PM, Morpeth, SC, Mouncey, PR, Moutschen, M, Muller-Tidow, C, Murphy, E, Najdovski, T, Nichol, AD, Nielsen, H, Novak, RM, O'Sullivan, MVN, Olalla, J, Osibogun, A, Osikomaiya, B, Oyonarte, S, Pardo-Oviedo, JM, Patel, MC, Paterson, DL, Pena-Perez, CA, Perez-Calatayud, AA, Perez-Alba, E, Perkina, A, Perry, N, Pouladzadeh, M, Poyato, I, Price, DJ, Quero, AKH, Rahman, MM, Rahman, MS, Ramesh, M, Ramirez-Santana, C, Rasmussen, M, Rees, MA, Rego, E, Roberts, JA, Roberts, DJ, Rodriguez, Y, Rodriguez-Bano, J, Rogers, BA, Rojas, M, Romero, A, Rowan, KM, Saccona, F, Safdarian, M, Santos, MCM, Sasadeusz, J, Scozzari, G, Shankar-Hari, M, Sharma, G, Snelling, T, Soto, A, Tagayuna, PY, Tang, A, Tatem, G, Teofili, L, Tong, SYC, Turgeon, AF, Veloso, JD, Venkatesh, B, Ventura-Enriquez, Y, Webb, SA, Wiese, L, Wiken, C, Wood, EM, Yusubalieva, GM, Zacharowski, K, Zarychanski, R, Khanna, N, Moher, D, Goodman, SN, Ioannidis, JPA, Hemkens, LG, Axfors, C, Janiaud, P, Schmitt, AM, Van't Hooft, J, Smith, ER, Haber, NA, Abayomi, A, Abduljalil, M, Abdulrahman, A, Acosta-Ampudia, Y, Aguilar-Guisado, M, Al-Beidh, F, Alejandria, MM, Alfonso, RN, Ali, M, AlQahtani, M, AlZamrooni, A, Anaya, J-M, Ang, MAC, Aomar, IF, Argumanis, LE, Averyanov, A, Baklaushev, VP, Balionis, O, Benfield, T, Berry, S, Birocco, N, Bonifacio, LB, Bowen, AC, Bown, A, Cabello-Gutierrez, C, Camacho, B, Camacho-Ortiz, A, Campbell-Lee, S, Cao, DH, Cardesa, A, Carnate, JM, Castillo, GJJ, Cavallo, R, Chowdhury, FR, Chowdhury, FUH, Ciccone, G, Cingolani, A, Climacosa, FMM, Compernolle, V, Cortez, CFN, Neto, AC, D'Antico, S, Daly, J, Danielle, F, Davis, JS, De Rosa, FG, Denholm, JT, Denkinger, CM, Desmecht, D, Diaz-Coronado, JC, Diaz Ponce-Medrano, JA, Donneau, A-F, Dumagay, TE, Dunachie, S, Dungog, CC, Erinoso, O, Escasa, IMS, Estcourt, LJ, Evans, A, Evasan, ALM, Fareli, CJ, Fernandez-Sanchez, V, Galassi, C, Gallo, JE, Garcia, PJ, Garcia, PL, Garcia, JA, Garigliany, M, Garza-Gonzalez, E, Gauiran, DT, Gaviria Garcia, PA, Giron-Gonzalez, J-A, Gomez-Almaguer, D, Gordon, AC, Gothot, A, Grass Guaqueta, JS, Green, C, Grimaldi, D, Hammond, NE, Harvala, H, Heralde, FM, Herrick, J, Higgins, AM, Hills, TE, Hines, J, Holm, K, Hoque, A, Hoste, E, Ignacio, JM, Ivanov, A, Janssen, M, Jennings, JH, Jha, V, King, RAN, Kjeldsen-Kragh, J, Klenerman, P, Kotecha, A, Krapp, F, Labanca, L, Laing, E, Landin-Olsson, M, Laterre, P-F, Lim, L-L, Lim, J, Ljungquist, O, Llaca-Diaz, JM, Lopez-Robles, C, Lopez-Cardenas, S, Lopez-Plaza, I, Lucero, JAC, Lundgren, M, Macias, J, Maganito, SC, Malundo, AFG, Manrique, RD, Manzini, PM, Marcos, M, Marquez, I, Javier Martinez-Marcos, F, Mata, AM, McArthur, CJ, McQuilten, ZK, McVerry, BJ, Menon, DK, Meyfroidt, G, Mirasol, MAL, Misset, B, Molton, JS, Mondragon, A, Monsalve, DM, Choghakabodi, PM, Morpeth, SC, Mouncey, PR, Moutschen, M, Muller-Tidow, C, Murphy, E, Najdovski, T, Nichol, AD, Nielsen, H, Novak, RM, O'Sullivan, MVN, Olalla, J, Osibogun, A, Osikomaiya, B, Oyonarte, S, Pardo-Oviedo, JM, Patel, MC, Paterson, DL, Pena-Perez, CA, Perez-Calatayud, AA, Perez-Alba, E, Perkina, A, Perry, N, Pouladzadeh, M, Poyato, I, Price, DJ, Quero, AKH, Rahman, MM, Rahman, MS, Ramesh, M, Ramirez-Santana, C, Rasmussen, M, Rees, MA, Rego, E, Roberts, JA, Roberts, DJ, Rodriguez, Y, Rodriguez-Bano, J, Rogers, BA, Rojas, M, Romero, A, Rowan, KM, Saccona, F, Safdarian, M, Santos, MCM, Sasadeusz, J, Scozzari, G, Shankar-Hari, M, Sharma, G, Snelling, T, Soto, A, Tagayuna, PY, Tang, A, Tatem, G, Teofili, L, Tong, SYC, Turgeon, AF, Veloso, JD, Venkatesh, B, Ventura-Enriquez, Y, Webb, SA, Wiese, L, Wiken, C, Wood, EM, Yusubalieva, GM, Zacharowski, K, Zarychanski, R, Khanna, N, Moher, D, Goodman, SN, Ioannidis, JPA, and Hemkens, LG

Abstract

BACKGROUND: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX ). METHODS: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung-Knapp-Sidik-Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. RESULTS: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% o

Published
2021

37. Association between convalescent plasma treatment and mortality in COVID-19: a collaborative systematic review and meta-analysis of randomized clinical trials

Author

Axfors, C., Janiaud, P., Schmitt, A. M., van't Hooft, J., Smith, E. R., Haber, N. A., Abayomi, A., Abduljalil, M., Abdulrahman, A., Acosta-Ampudia, Y., Aguilar-Guisado, M., Al-Beidh, F., Alejandria, M. M., Alfonso, R. N., Ali, M., Alqahtani, M., Alzamrooni, A., Anaya, J. -M., Ang, M. A. C., Aomar, I. F., Argumanis, L. E., Averyanov, A., Baklaushev, V. P., Balionis, O., Benfield, T., Berry, S., Birocco, N., Bonifacio, L. B., Bowen, A. C., Bown, A., Cabello-Gutierrez, C., Camacho, B., Camacho-Ortiz, A., Campbell-Lee, S., Cao, D. H., Cardesa, A., Carnate, J. M., Castillo, G. J. J., Cavallo, R., Chowdhury, F. R., Chowdhury, F. U. H., Ciccone, G., Cingolani, Antonella, Climacosa, F. M. M., Compernolle, V., Cortez, C. F. N., Costa Neto, A., D'Antico, S., Daly, J., Danielle, F., Davis, J. S., De Rosa, F. G., Denholm, J. T., Denkinger, C. M., Desmecht, D., Diaz-Coronado, J. C., Diaz Ponce-Medrano, J. A., Donneau, A. -F., Dumagay, T. E., Dunachie, S., Dungog, C. C., Erinoso, O., Escasa, I. M. S., Estcourt, L. J., Evans, A., Evasan, A. L. M., Fareli, C. J., Fernandez-Sanchez, V., Galassi, C., Gallo, J. E., Garcia, P. J., Garcia, P. L., Garcia, J. A., Garigliany, M., Garza-Gonzalez, E., Gauiran, D. T. V., Gaviria Garcia, P. A., Giron-Gonzalez, J. -A., Gomez-Almaguer, D., Gordon, A. C., Gothot, A., Grass Guaqueta, J. S., Green, C., Grimaldi, D., Hammond, N. E., Harvala, H., Heralde, F. M., Herrick, J., Higgins, A. M., Hills, T. E., Hines, J., Holm, K., Hoque, A., Hoste, E., Ignacio, J. M., Ivanov, A. V., Janssen, M., Jennings, J. H., Jha, V., King, R. A. N., Kjeldsen-Kragh, J., Klenerman, P., Kotecha, A., Krapp, F., Labanca, L., Laing, E., Landin-Olsson, M., Laterre, P. -F., Lim, L. -L., Lim, J., Ljungquist, O., Llaca-Diaz, J. M., Lopez-Robles, C., Lopez-Cardenas, S., Lopez-Plaza, I., Lucero, J. A. C., Lundgren, M., Macias, J., Maganito, S. C., Malundo, A. F. G., Manrique, R. D., Manzini, P. M., Marcos, M., Marquez, I., Martinez-Marcos, F. J., Mata, A. M., Mcarthur, C. J., Mcquilten, Z. K., Mcverry, B. J., Menon, D. K., Meyfroidt, G., Mirasol, M. A. L., Misset, B., Molton, J. S., Mondragon, A. V., Monsalve, D. M., Moradi Choghakabodi, P., Morpeth, S. C., Mouncey, P. R., Moutschen, M., Muller-Tidow, C., Murphy, E., Najdovski, T., Nichol, A. D., Nielsen, H., Novak, R. M., O'Sullivan, M. V. N., Olalla, J., Osibogun, A., Osikomaiya, B., Oyonarte, S., Pardo-Oviedo, J. M., Patel, M. C., Paterson, D. L., Pena-Perez, C. A., Perez-Calatayud, A. A., Perez-Alba, E., Perkina, A., Perry, N., Pouladzadeh, M., Poyato, I., Price, D. J., Quero, A. K. H., Rahman, M. M., Rahman, M. S., Ramesh, M., Ramirez-Santana, C., Rasmussen, M., Rees, M. A., Rego, E., Roberts, J. A., Roberts, D. J., Rodriguez, Y., Rodriguez-Bano, J., Rogers, B. A., Rojas, M., Romero, A., Rowan, K. M., Saccona, F., Safdarian, M., Santos, M. C. M., Sasadeusz, J., Scozzari, G., Shankar-Hari, M., Sharma, G., Snelling, T., Soto, A., Tagayuna, P. Y., Tang, A., Tatem, G., Teofili, Luciana, Tong, S. Y. C., Turgeon, A. F., Veloso, J. D., Venkatesh, B., Ventura-Enriquez, Y., Webb, S. A., Wiese, L., Wiken, C., Wood, E. M., Yusubalieva, G. M., Zacharowski, K., Zarychanski, R., Khanna, N., Moher, D., Goodman, S. N., Ioannidis, J. P. A., Hemkens, L. G., Cingolani A. (ORCID:0000-0002-3793-2755), Teofili L. (ORCID:0000-0002-7214-1561), Axfors, C., Janiaud, P., Schmitt, A. M., van't Hooft, J., Smith, E. R., Haber, N. A., Abayomi, A., Abduljalil, M., Abdulrahman, A., Acosta-Ampudia, Y., Aguilar-Guisado, M., Al-Beidh, F., Alejandria, M. M., Alfonso, R. N., Ali, M., Alqahtani, M., Alzamrooni, A., Anaya, J. -M., Ang, M. A. C., Aomar, I. F., Argumanis, L. E., Averyanov, A., Baklaushev, V. P., Balionis, O., Benfield, T., Berry, S., Birocco, N., Bonifacio, L. B., Bowen, A. C., Bown, A., Cabello-Gutierrez, C., Camacho, B., Camacho-Ortiz, A., Campbell-Lee, S., Cao, D. H., Cardesa, A., Carnate, J. M., Castillo, G. J. J., Cavallo, R., Chowdhury, F. R., Chowdhury, F. U. H., Ciccone, G., Cingolani, Antonella, Climacosa, F. M. M., Compernolle, V., Cortez, C. F. N., Costa Neto, A., D'Antico, S., Daly, J., Danielle, F., Davis, J. S., De Rosa, F. G., Denholm, J. T., Denkinger, C. M., Desmecht, D., Diaz-Coronado, J. C., Diaz Ponce-Medrano, J. A., Donneau, A. -F., Dumagay, T. E., Dunachie, S., Dungog, C. C., Erinoso, O., Escasa, I. M. S., Estcourt, L. J., Evans, A., Evasan, A. L. M., Fareli, C. J., Fernandez-Sanchez, V., Galassi, C., Gallo, J. E., Garcia, P. J., Garcia, P. L., Garcia, J. A., Garigliany, M., Garza-Gonzalez, E., Gauiran, D. T. V., Gaviria Garcia, P. A., Giron-Gonzalez, J. -A., Gomez-Almaguer, D., Gordon, A. C., Gothot, A., Grass Guaqueta, J. S., Green, C., Grimaldi, D., Hammond, N. E., Harvala, H., Heralde, F. M., Herrick, J., Higgins, A. M., Hills, T. E., Hines, J., Holm, K., Hoque, A., Hoste, E., Ignacio, J. M., Ivanov, A. V., Janssen, M., Jennings, J. H., Jha, V., King, R. A. N., Kjeldsen-Kragh, J., Klenerman, P., Kotecha, A., Krapp, F., Labanca, L., Laing, E., Landin-Olsson, M., Laterre, P. -F., Lim, L. -L., Lim, J., Ljungquist, O., Llaca-Diaz, J. M., Lopez-Robles, C., Lopez-Cardenas, S., Lopez-Plaza, I., Lucero, J. A. C., Lundgren, M., Macias, J., Maganito, S. C., Malundo, A. F. G., Manrique, R. D., Manzini, P. M., Marcos, M., Marquez, I., Martinez-Marcos, F. J., Mata, A. M., Mcarthur, C. J., Mcquilten, Z. K., Mcverry, B. J., Menon, D. K., Meyfroidt, G., Mirasol, M. A. L., Misset, B., Molton, J. S., Mondragon, A. V., Monsalve, D. M., Moradi Choghakabodi, P., Morpeth, S. C., Mouncey, P. R., Moutschen, M., Muller-Tidow, C., Murphy, E., Najdovski, T., Nichol, A. D., Nielsen, H., Novak, R. M., O'Sullivan, M. V. N., Olalla, J., Osibogun, A., Osikomaiya, B., Oyonarte, S., Pardo-Oviedo, J. M., Patel, M. C., Paterson, D. L., Pena-Perez, C. A., Perez-Calatayud, A. A., Perez-Alba, E., Perkina, A., Perry, N., Pouladzadeh, M., Poyato, I., Price, D. J., Quero, A. K. H., Rahman, M. M., Rahman, M. S., Ramesh, M., Ramirez-Santana, C., Rasmussen, M., Rees, M. A., Rego, E., Roberts, J. A., Roberts, D. J., Rodriguez, Y., Rodriguez-Bano, J., Rogers, B. A., Rojas, M., Romero, A., Rowan, K. M., Saccona, F., Safdarian, M., Santos, M. C. M., Sasadeusz, J., Scozzari, G., Shankar-Hari, M., Sharma, G., Snelling, T., Soto, A., Tagayuna, P. Y., Tang, A., Tatem, G., Teofili, Luciana, Tong, S. Y. C., Turgeon, A. F., Veloso, J. D., Venkatesh, B., Ventura-Enriquez, Y., Webb, S. A., Wiese, L., Wiken, C., Wood, E. M., Yusubalieva, G. M., Zacharowski, K., Zarychanski, R., Khanna, N., Moher, D., Goodman, S. N., Ioannidis, J. P. A., Hemkens, L. G., Cingolani A. (ORCID:0000-0002-3793-2755), and Teofili L. (ORCID:0000-0002-7214-1561)

Abstract

Background: Convalescent plasma has been widely used to treat COVID-19 and is under investigation in numerous randomized clinical trials, but results are publicly available only for a small number of trials. The objective of this study was to assess the benefits of convalescent plasma treatment compared to placebo or no treatment and all-cause mortality in patients with COVID-19, using data from all available randomized clinical trials, including unpublished and ongoing trials (Open Science Framework, https://doi.org/10.17605/OSF.IO/GEHFX). Methods: In this collaborative systematic review and meta-analysis, clinical trial registries (ClinicalTrials.gov, WHO International Clinical Trials Registry Platform), the Cochrane COVID-19 register, the LOVE database, and PubMed were searched until April 8, 2021. Investigators of trials registered by March 1, 2021, without published results were contacted via email. Eligible were ongoing, discontinued and completed randomized clinical trials that compared convalescent plasma with placebo or no treatment in COVID-19 patients, regardless of setting or treatment schedule. Aggregated mortality data were extracted from publications or provided by investigators of unpublished trials and combined using the Hartung–Knapp–Sidik–Jonkman random effects model. We investigated the contribution of unpublished trials to the overall evidence. Results: A total of 16,477 patients were included in 33 trials (20 unpublished with 3190 patients, 13 published with 13,287 patients). 32 trials enrolled only hospitalized patients (including 3 with only intensive care unit patients). Risk of bias was low for 29/33 trials. Of 8495 patients who received convalescent plasma, 1997 died (23%), and of 7982 control patients, 1952 died (24%). The combined risk ratio for all-cause mortality was 0.97 (95% confidence interval: 0.92; 1.02) with between-study heterogeneity not beyond chance (I2 = 0%). The RECOVERY trial had 69.8% and the unpublished evidence 25.3% of

Published
2021

42. IMPACT OF DIFFERENT INDUCTION REGIMENS ON THE OUTCOME OF PRIMARY MEDIASTINAL B CELL LYMPHOMA IN THE PROSPECTIVE IELSG 37 TRIAL

Author

Martelli, M., primary, Zucca, E., additional, Botto, B., additional, Kryachok, I., additional, Ceriani, L., additional, Balzarotti, M., additional, Tucci, A., additional, Cabras, M. G., additional, Zilioli, V. R., additional, Rusconi, C., additional, Angrilli, F., additional, Arcaini, L., additional, Iwanicka, A. Dabrowska, additional, Ferreri, A.J.M., additional, Merli, F., additional, Zhao, W., additional, Hodgson, D., additional, Ionescu, C., additional, Fosså, A., additional, Cwynarski, K., additional, Mikhaeel, G., additional, Jerkeman, M., additional, Janikova, A., additional, Hüttmann, A., additional, Ciccone, G., additional, Metser, U., additional, Barrington, S., additional, Malkowski, B., additional, Versari, A., additional, Esposito, F., additional, Cozens, K., additional, Ielmini, N., additional, Ricardi, R., additional, Cavalli, F., additional, Johnson, P., additional, and Davies, A., additional

Published
2021
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43. ROMIDEPSIN‐CHOEP PLUS UP‐FRONT STEM‐CELL TRANSPLANTATION IN PERIPHERAL T‐CELL LYMPHOMA (PTCL): FIRST ANALYSIS OF THE PHASE II FIL‐PTCL13 STUDY

Author

Chiappella, A., primary, Carniti, C., additional, Re, A., additional, Castellino, C., additional, Evangelista, A., additional, Ciancia, R., additional, Orsucci, L., additional, Pinto, A., additional, Usai, S. V., additional, Arcari, A., additional, Ilariucci, F., additional, Rossi, F. G., additional, Benedetti, F., additional, Flenghi, L., additional, Ghiggi, C., additional, Molinari, A. L., additional, Stefoni, V., additional, Volpetti, S., additional, Zilioli, V. R., additional, Ballerini, F., additional, Bruna, R., additional, Cavallo, F., additional, Musuraca, G., additional, Patti, C., additional, Re, F., additional, Tani, M., additional, Varettoni, M., additional, Zanni, M., additional, Dodero, A., additional, Pileri, S. A., additional, Ciccone, G., additional, and Corradini, P., additional

Published
2021
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45. A RANDOMIZED TRIAL OF OBSERVATION VERSUS RADIOTHERAPY IN PRIMARY MEDIASTINAL B‐CELL LYMPHOMA PATIENTS WITH COMPLETE METABOLIC RESPONSE AFTER STANDARD IMMUNOCHEMOTHERAPY.

Author

Davies, A. J., Zucca, E., Ceriani, L., Kryachok, I., Ciccone, G., Botto, B., Balzarotti, M., Tucci, A., Rusconi, C., Usai, S. V., Pennese, E., Arcaini, L., Dabrowska‐Iwanicka, A., Ferreri, A. J. M., Merli, F., Zhao, W., Hodgson, D., Rigacci, L., Cellini, C., and Stelitano, C.

Subjects
LYMPHOMAS
Abstract

The IELSG37 (NCT01599559) randomized trial was planned with a non-inferiority design to test whether RT can be omitted in PMBCL patients who achieve a complete metabolic response (CMR) after immunochemotherapy. Mediastinal radiotherapy (RT) may consolidate responses to dose-intensive immunochemotherapy; however, it increases the risk of second malignancies and coronary or valvular heart disease. B Introduction: b Primary mediastinal B-cell lymphoma (PMBCL) has a poor prognosis if remission is not rapidly achieved, or the disease recurs. [Extracted from the article]

Published
2023
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