Clinical characteristics and risk factors associated with COVID-19 severity in patients with haematological malignancies in Italy: a retrospective, multicentre, cohort study.


Journal

The Lancet. Haematology
ISSN: 2352-3026
Titre abrégé: Lancet Haematol
Pays: England
ID NLM: 101643584

Informations de publication

Date de publication:
Oct 2020
Historique:
received: 09 06 2020
revised: 19 07 2020
accepted: 21 07 2020
pubmed: 18 8 2020
medline: 3 10 2020
entrez: 18 8 2020
Statut: ppublish

Résumé

Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19. This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing. We enrolled 536 patients with a median follow-up of 20 days (IQR 10-34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77-2·34) in our whole study cohort and 3·72 (2·86-4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1-44·9). Older age (hazard ratio 1·03, 95% CI 1·01-1·05); progressive disease status (2·10, 1·41-3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56-7·81), indolent non-Hodgin lymphoma (2·19, 1·07-4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34-4·89), or plasma cell neoplasms (2·48, 1·31-4·69), and severe or critical COVID-19 (4·08, 2·73-6·09) were associated with worse overall survival. This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available. Associazione italiana contro le leucemie, linfomi e mieloma-Varese Onlus.

Sections du résumé

BACKGROUND BACKGROUND
Several small studies on patients with COVID-19 and haematological malignancies are available showing a high mortality in this population. The Italian Hematology Alliance on COVID-19 aimed to collect data from adult patients with haematological malignancies who required hospitalisation for COVID-19.
METHODS METHODS
This multicentre, retrospective, cohort study included adult patients (aged ≥18 years) with diagnosis of a WHO-defined haematological malignancy admitted to 66 Italian hospitals between Feb 25 and May 18, 2020, with laboratory-confirmed and symptomatic COVID-19. Data cutoff for this analysis was June 22, 2020. The primary outcome was mortality and evaluation of potential predictive parameters of mortality. We calculated standardised mortality ratios between observed death in the study cohort and expected death by applying stratum-specific mortality rates of the Italian population with COVID-19 and an Italian cohort of 31 993 patients with haematological malignancies without COVID-19 (data up to March 1, 2019). Multivariable Cox proportional hazards model was used to identify factors associated with overall survival. This study is registered with ClinicalTrials.gov, NCT04352556, and the prospective part of the study is ongoing.
FINDINGS RESULTS
We enrolled 536 patients with a median follow-up of 20 days (IQR 10-34) at data cutoff, 85 (16%) of whom were managed as outpatients. 440 (98%) of 451 hospitalised patients completed their hospital course (were either discharged alive or died). 198 (37%) of 536 patients died. When compared with the general Italian population with COVID-19, the standardised mortality ratio was 2·04 (95% CI 1·77-2·34) in our whole study cohort and 3·72 (2·86-4·64) in individuals younger than 70 years. When compared with the non-COVID-19 cohort with haematological malignancies, the standardised mortality ratio was 41·3 (38·1-44·9). Older age (hazard ratio 1·03, 95% CI 1·01-1·05); progressive disease status (2·10, 1·41-3·12); diagnosis of acute myeloid leukaemia (3·49, 1·56-7·81), indolent non-Hodgin lymphoma (2·19, 1·07-4·48), aggressive non-Hodgkin lymphoma (2·56, 1·34-4·89), or plasma cell neoplasms (2·48, 1·31-4·69), and severe or critical COVID-19 (4·08, 2·73-6·09) were associated with worse overall survival.
INTERPRETATION CONCLUSIONS
This study adds to the evidence that patients with haematological malignancies have worse outcomes than both the general population with COVID-19 and patients with haematological malignancies without COVID-19. The high mortality among patients with haematological malignancies hospitalised with COVID-19 highlights the need for aggressive infection prevention strategies, at least until effective vaccination or treatment strategies are available.
FUNDING BACKGROUND
Associazione italiana contro le leucemie, linfomi e mieloma-Varese Onlus.

Identifiants

pubmed: 32798473
pii: S2352-3026(20)30251-9
doi: 10.1016/S2352-3026(20)30251-9
pmc: PMC7426107
pii:
doi:

Banques de données

ClinicalTrials.gov
['NCT04352556']

Types de publication

Journal Article Multicenter Study Observational Study

Langues

eng

Sous-ensembles de citation

IM

Pagination

e737-e745

Commentaires et corrections

Type : CommentIn
Type : CommentIn

Informations de copyright

Copyright © 2020 Elsevier Ltd. All rights reserved.

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Auteurs

Francesco Passamonti (F)

Department of Medicine and Surgery, University of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese, Varese, Italy. Electronic address: francesco.passamonti@uninsubria.it.

Chiara Cattaneo (C)

Haematology, ASST-Spedali Civili, Brescia, Italy.

Luca Arcaini (L)

Department of Molecular Medicine, University of Pavia, Pavia, Italy; Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Riccardo Bruna (R)

Division of Hematology, Department of Translational Medicine, University of Eastern Piedmont and Ospedale Maggiore della Carità, Novara, Italy.

Michele Cavo (M)

Seràgnoli Institute of Hematology, Department of Experimental, Diagnostic and Specialty Medicine, Bologna University School of Medicine, Bologna, Italy.

Francesco Merli (F)

Hematology, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.

Emanuele Angelucci (E)

Hematology, Ospedale Policlinico San Martino, Genoa, Italy.

Mauro Krampera (M)

Department of Medicine, Section of Hematology, University of Verona, Verona, Italy.

Roberto Cairoli (R)

Hematology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.

Matteo Giovanni Della Porta (MG)

Humanitas Clinical and Research Hospital-IRCCS and Department of Biomedical Sciences, Humanitas University, Milan, Italy.

Nicola Fracchiolla (N)

Fondazione IRCCS Ca' Granda-Ospedale Maggiore Policlinico, Milan, Italy.

Marco Ladetto (M)

Hematology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Carlo Gambacorti Passerini (C)

Department of Hematology, Università degli Studi di Milano-Bicocca, Milan, Italy.

Marco Salvini (M)

Department of Medicine and Surgery, University of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese, Varese, Italy.

Monia Marchetti (M)

Hematology, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy.

Roberto Lemoli (R)

Dipartimento di Medicina interna e Specialità mediche, University of Genoa, Genoa, Italy.

Alfredo Molteni (A)

Hematology, ASST Cremona, Cremona, Italy.

Alessandro Busca (A)

Stem Cell Transplant Center, AOU Citta' della Salute e della Scienza, Turin, Italy.

Antonio Cuneo (A)

Hematology, Azienda Ospedaliero Universitaria Sant'Anna, Ferrara, Italy.

Alessandra Romano (A)

Hematology, Dipartimento di Chirurgia e Specialità Medico Chirurgiche, Università degli Studi di Catania, Catania, Italy.

Nicola Giuliani (N)

Dipartimento di Medicina e Chirurgia, University of Parma, Parma, Italy.

Sara Galimberti (S)

Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy.

Alessandro Corso (A)

Hematology, ASST Ovest Milanese, Milan, Italy.

Alessandro Morotti (A)

Department of Clinical and Biological Sciences, Università di Torino, Turin, Italy.

Brunangelo Falini (B)

Department of Medicine, University of Perugia, Perugia, Italy.

Atto Billio (A)

Ospedale di Bolzano, Bolzano, Italy.

Filippo Gherlinzoni (F)

Hematology, Ospedale Ca' Foncello, Treviso, Italy.

Giuseppe Visani (G)

Dipartimento di Onco- Ematologia, Azienda Ospedaliera Ospedali Riuniti Marche Nord, Pesaro, Italy.

Maria Chiara Tisi (MC)

Hematology, Ospedale San Bortolo, Vicenza, Italy.

Agostino Tafuri (A)

Hematology, University Hospital Sant'Andrea, Sapienza, Rome, Italy; Department of Clinical and Molecular Medicine, Sapienza, University of Rome, Rome, Italy.

Patrizia Tosi (P)

Hematology, Ospedale degli Infermi di Rimini, Rimini, Italy.

Francesco Lanza (F)

Hematology, Santa Maria delle Croci, Ravenna, Italy.

Massimo Massaia (M)

Hematology, Santa Croce Hospital, Cuneo, Italy.

Mauro Turrini (M)

Hematology, Ospedale Valduce, Como, Italy.

Felicetto Ferrara (F)

Hematology, Ospedale Antonio Cardarelli, Naples, Italy.

Carmela Gurrieri (C)

Dipartimento Strutturale Aziendale Medicina, University of Padova, Padova, Italy.

Daniele Vallisa (D)

Hematology, Ospedale di Piacenza, Piacenza, Italy.

Maurizio Martelli (M)

Hematology, Department of Translational and Precision Medicine, Sapienza, University of Rome, Rome, Italy.

Enrico Derenzini (E)

Hematology, Istituto Europeo di Oncologia, Milan, Italy.

Attilio Guarini (A)

Hematology, Istituto Tumori Giovanni Paolo II, Bari, Italy.

Annarita Conconi (A)

Hematology, Ospedale degli Infermi, Biella, Italy.

Annarosa Cuccaro (A)

Ematologia, USL 6 Livorno, Livorno, Italy.

Laura Cudillo (L)

Hematology, San Giovanni Addolorata Hospital, Rome, Italy.

Domenico Russo (D)

Dipartimento di Scienze Cliniche e Sperimentali, University of Brescia, Brescia, Italy.

Fabrizio Ciambelli (F)

Dipartimento Oncologico, ASST Valle Olona, Busto Arsizio, Italy.

Anna Maria Scattolin (AM)

Hematology, Ospedale dell'Angelo di Mestre, Venice, Italy.

Mario Luppi (M)

Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, University of Modena and Reggio Emilia, Azienda Ospedaliera Universitaria, Modena, Italy.

Carmine Selleri (C)

Hematology, Ospedale San Giovanni di Dio e Ruggi D'Aragona, Salerno, Italy.

Elettra Ortu La Barbera (E)

UOC Ematologia con Trapianto, Ospedale Santa Maria Goretti, Latina, Italy; Hematology, Ospedale Santa Maria Goretti, Latina, Italy.

Celestino Ferrandina (C)

Hematology, Ospedali Riuniti Azienda Ospedaliera Universitaria di Foggia, Foggia, Italy.

Nicola Di Renzo (N)

Hematology and Transplant Unit, Ospedale Vito Fazzi, Lecce, Italy.

Attilio Olivieri (A)

Hematology, Ospedali Riuniti di Ancona, Ancona, Italy.

Monica Bocchia (M)

Hematology Unit, University of Siena, Azienda Ospedaliero Universitaria Senese, Siena, Italy.

Massimo Gentile (M)

Hematology, Ospedale SS Annunziata, Taranto, Italy.

Francesco Marchesi (F)

Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Pellegrino Musto (P)

Department of Emergency and Organ Transplantation, "Aldo Moro" University School of Medicine and Unit of Hematology and Stem Cell Transplantation, AOU Consorziale Policlinico, Bari, Italy.

Augusto Bramante Federici (AB)

Hematology and Transfusion Medicine, L Sacco University Hospital, Milan, Italy.

Anna Candoni (A)

Dipartimento di Medicina Specialistica, University of Udine, Udine, Italy.

Adriano Venditti (A)

Hematology, Fondazione Policlinico Tor Vergata, Rome, Italy.

Carmen Fava (C)

Department of Clinical and Biological Sciences, Università di Torino, Turin, Italy.

Antonio Pinto (A)

Hematology, Istituto Nazionale Tumori IRCCS "Fondazione G Pascale", Naples, Italy.

Piero Galieni (P)

Hematology, Mazzoni Hospital, Ascoli Piceno, Italy.

Luigi Rigacci (L)

Hematology, Camillo-Forlanini Hospital, Rome, Italy.

Daniele Armiento (D)

Unit of Hematology, Stem Cell Transplantation, University Campus Bio-Medico, Rome, Italy.

Fabrizio Pane (F)

Department of Clinical Medicine and Surgery, Federico II Hospital, Naples, Italy.

Margherita Oberti (M)

Haematology, ASST-Spedali Civili, Brescia, Italy.

Patrizia Zappasodi (P)

Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.

Carlo Visco (C)

Department of Medicine, Section of Hematology, University of Verona, Verona, Italy.

Matteo Franchi (M)

Laboratory of Healthcare Research & Pharmacoepidemiology, Department of Statistics and Quantitative Methods, Università degli Studi di Milano-Bicocca, Milan, Italy; National Centre for Healthcare Research and Pharmacoepidemiology, Milan, Italy.

Paolo Antonio Grossi (PA)

Department of Medicine and Surgery, University of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese, Varese, Italy.

Lorenza Bertù (L)

Department of Medicine and Surgery, University of Insubria and ASST Sette Laghi, Ospedale di Circolo of Varese, Varese, Italy.

Giovanni Corrao (G)

Laboratory of Healthcare Research & Pharmacoepidemiology, Department of Statistics and Quantitative Methods, Università degli Studi di Milano-Bicocca, Milan, Italy; National Centre for Healthcare Research and Pharmacoepidemiology, Milan, Italy.

Livio Pagano (L)

Dipartimento di Scienze Radiologiche ed Ematologiche, Fondazione Policlinico Universitario A Gemelli-IRCCS-Università Cattolica del Sacro Cuore, Rome, Italy.

Paolo Corradini (P)

Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, University of Milano.

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