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1. SARS-CoV-2 infection in patients with chronic lymphocytic leukemia: The Italian Hematology Alliance on COVID-19 cohort.

Author

Merli M, Ferrarini I, Merli F, Busca A, Mina R, Falini B, Bruna R, Cairoli R, Marchetti M, Romano A, Cavo M, Arcaini L, Trentin L, Cattaneo C, Derenzini E, Fracchiolla NS, Marchesi F, Scattolin A, Billio A, Bocchia M, Massaia M, Gambacorti-Passerini C, Mauro FR, Gentile M, Mohamed S, Della Porta MG, Coviello E, Cilloni D, Visani G, Federici AB, Tisi MC, Cudillo L, Galimberti S, Gherlinzoni F, Pagano L, Guidetti A, Bertù L, Corradini P, Passamonti F, and Visco C

Subjects
Adult, Aged, Aged, 80 and over, Humans, Male, Middle Aged, COVID-19 Testing, SARS-CoV-2, COVID-19 complications, Hematology, Leukemia, Lymphocytic, Chronic, B-Cell drug therapy
Abstract

COVID-19, the disease caused by SARS-CoV-2, is still afflicting thousands of people across the globe. Few studies on COVID-19 in chronic lymphocytic leukemia (CLL) are available. Here, we analyzed data from the CLL cohort of the Italian Hematology Alliance on COVID-19 (NCT04352556), which included 256 CLL patients enrolled between 25 February 2020 and 1 February 2021. Median age was 70 years (range 38-94) with male preponderance (60.1%). Approximately half of patients (n = 127) had received at least one line of therapy for CLL, including 108 (83.7%) who were on active treatment at the time of COVID-19 or received their last therapy within 12 months. Most patients (230/256, 89.9%) were symptomatic at COVID-19 diagnosis and the majority required hospitalization (n = 176). Overall, after a median follow-up of 42 days (IQR 24-96), case fatality rate was 30.1%, and it was 37.5% and 24.4% in the first (25 February 2020-22 June 2020) and second wave (23 June 2020-1 February 2021), respectively (p = 0.03). At multivariate analysis, male sex (HR 1.82, 95% CI 1.03-3.24, p = 0.04), age over than 70 years (HR 2.23, 95% CI 1.23-4.05, p = 0.01), any treatment for CLL given in the last 12 months (HR 1.72, 95% CI 1.04-2.84, p = 0.04) and COVID-19 severity (severe: HR 5.66, 95% CI 2.62-12.33, p < 0.0001; critical: HR 15.99, 95% CI 6.93-36.90, p < 0.0001) were independently associated with poor survival. In summary, we report a dismal COVID-related outcome in a significant fraction of CLL patients, that can be nicely predicted by clinical parameters., (© 2022 John Wiley & Sons Ltd.)

Published
2023
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2. COVID-19 in adult acute myeloid leukemia patients: a long-term follow-up study from the European Hematology Association survey (EPICOVIDEHA).

Author

Marchesi F, Salmanton-García J, Emarah Z, Piukovics K, Nucci M, López-García A, Ráčil Z, Farina F, Popova M, Zompi S, Audisio E, Ledoux MP, Verga L, Weinbergerová B, Szotkovski T, Da Silva MG, Fracchiolla N, De Jonge N, Collins G, Marchetti M, Magliano G, García-Vidal C, Biernat MM, Van Doesum J, Machado M, Demirkan F, Al-Khabori M, Žák P, Víšek B, Stoma I, Méndez GA, Maertens J, Khanna N, Espigado I, Dragonetti G, Fianchi L, Del Principe MI, Cabirta A, Ormazabal-Vélez I, Jaksic O, Buquicchio C, Bonuomo V, Batinić J, Omrani AS, Lamure S, Finizio O, Fernández N, Falces-Romero I, Blennow O, Bergantim R, Ali N, Win S, Van Praet J, Tisi MC, Shirinova A, Schönlein M, Prattes J, Piedimonte M, Petzer V, Navrátil M, Kulasekararaj A, Jindra P, Sramek J, Glenthøj A, Fazzi R, De Ramón-Sánchez C, Cattaneo C, Calbacho M, Bahr NC, El-Ashwah S, Cordoba R, Hanakova M, Zambrotta G, Sciumè M, Booth S, Rodrigues RN, Sacchi MV, García-Poutón N, Martín-González JA, Khostelidi S, Gräfe S, Rahimli L, Ammatuna E, Busca A, Corradini P, Hoenigl M, Klimko N, Koehler P, Pagliuca A, Passamonti F, Cornely OA, and Pagano L

Subjects
Humans, Adult, Follow-Up Studies, COVID-19 Testing, COVID-19, Leukemia, Myeloid, Acute therapy, Leukemia, Myeloid, Acute drug therapy, Hematology
Abstract

Patients with acute myeloid leukemia (AML) are at high risk of dying from coronavirus disease 2019 (COVID-19). The optimal management of AML patients with COVID-19 has not been established. Our multicenter study included 388 adult AML patients diagnosed with COVID-19 between February 2020 and October 2021. The vast majority were receiving or had received AML treatment in the preceding 3 months. COVID-19 was severe in 41.2% and critical in 21.1% of cases. The chemotherapeutic schedule was modified in 174 patients (44.8%), delayed in 68 and permanently discontinued in 106. After a median follow-up of 325 days, 180 patients (46.4%) had died; death was attributed to COVID-19 (43.3%), AML (26.1%) or to a combination of both (26.7%), whereas in 3.9% of cases the reason was unknown. Active disease, older age, and treatment discontinuation were associated with death, whereas AML treatment delay was protective. Seventy-nine patients had a simultaneous AML and COVID-19 diagnosis, with better survival when AML treatment could be delayed (80%; P<0.001). Overall survival in patients with a diagnosis of COVID-19 between January 2020 and August 2020 was significantly lower than that in patients diagnosed between September 2020 and February 2021 and between March 2021 and September 2021 (39.8% vs. 60% vs. 61.9%, respectively; P=0.006). COVID-19 in AML patients was associated with a high mortality rate and modifications of therapeutic algorithms. The best approach to improve survival was to delay AML treatment, whenever possible.

Published
2023
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3. INTERIM RESULTS OF PROSPECTIVE OBSERVATIONAL SEIFEM STUDY ON CLINICAL OUTCOME AND INFECTIOUS COMPLICATIONS IN 230 UNFIT AML PATIENTS TREATED IN FIRST-LINE WITH HYPOMETHYLATING AGENTS ALONE OR IN COMBINATION WITH VENETOCLAX

Author

Candoni A, Piccin M, Lazzarotto D, Bonuomo V, Fracchiolla N, Dargenio M, Riva M, Melillo L, Papayannidis C, Stulle M, Lessi F, Dragonetti G, Del Principe MI, Cerqui E, Pasciolla C, De Marchi R, Delia M, Tisi MC, Fanci R, Nadali G, Sciume M, Di Renzo N, Cairoli R, Valente D, Basilico, C (Basilico, C.) 18 Spadea, A (Spadea, A.) 19 Sartor, C (Sartor, C.) 8 Griguolo, D (Griguolo, D.) 9 Sarlo, C (Sarlo, C.) 20 Olivieri, A (Olivieri, A.) 21 Piccioni AL, Pagano L, Candoni, A, Piccin, M, Lazzarotto, D, Bonuomo, V, Fracchiolla, N, Dargenio, M, Riva, M, Melillo, L, Papayannidis, C, Stulle, M, Lessi, F, Dragonetti, G, Del Principe, M, Cerqui, E, Pasciolla, C, De Marchi, R, Delia, M, Tisi, M, Fanci, R, Nadali, G, Sciume, M, Di Renzo, N, Cairoli, R, Valente, D, Basilico, C,, C., ), A,, A., ), D,, D., ), and Pagano, L

Subjects
Hematology
Published
2021

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

Author

Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta MG, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, Mc, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, Am, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, Ab, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, Pa, Bertù, L, Corrao, G, Pagano, L, Corradini, P, ITA-HEMA-COV, Investigators., Passamonti, F., Cattaneo, C., Arcaini, L., Bruna, R., Cavo, M., Merli, F., Angelucci, E., Krampera, M., Cairoli, R., Della Porta, M. G., Fracchiolla, N., Ladetto, M., Gambacorti Passerini, C., Salvini, M., Marchetti, M., Lemoli, R., Molteni, A., Busca, A., Cuneo, A., Romano, A., Giuliani, N., Galimberti, S., Corso, A., Morotti, A., Falini, B., Billio, A., Gherlinzoni, F., Visani, G., Tisi, M. C., Tafuri, A., Tosi, P., Lanza, F., Massaia, M., Turrini, M., Ferrara, F., Gurrieri, C., Vallisa, D., Martelli, M., Derenzini, E., Guarini, A., Conconi, A., Cuccaro, A., Cudillo, L., Russo, D., Ciambelli, F., Scattolin, A. M., Luppi, M., Selleri, C., Ortu La Barbera, E., Ferrandina, C., Di Renzo, N., Olivieri, A., Bocchia, M., Gentile, M., Marchesi, F., Musto, P., Federici, A. B., Candoni, A., Venditti, A., Fava, C., Pinto, A., Galieni, P., Rigacci, L., Armiento, D., Pane, F., Oberti, M., Zappasodi, P., Visco, C., Franchi, M., Grossi, P. A., Bertu, L., Corrao, G., Pagano, L., Corradini, P., Passamonti F., Cattaneo C., Arcaini L., Bruna R., Cavo M., Merli F., Angelucci E., Krampera M., Cairoli R., Della Porta M.G., Fracchiolla N., Ladetto M., Gambacorti Passerini C., Salvini M., Marchetti M., Lemoli R., Molteni A., Busca A., Cuneo A., Romano A., Giuliani N., Galimberti S., Corso A., Morotti A., Falini B., Billio A., Gherlinzoni F., Visani G., Tisi M.C., Tafuri A., Tosi P., Lanza F., Massaia M., Turrini M., Ferrara F., Gurrieri C., Vallisa D., Martelli M., Derenzini E., Guarini A., Conconi A., Cuccaro A., Cudillo L., Russo D., Ciambelli F., Scattolin A.M., Luppi M., Selleri C., Ortu La Barbera E., Ferrandina C., Di Renzo N., Olivieri A., Bocchia M., Gentile M., Marchesi F., Musto P., Federici A.B., Candoni A., Venditti A., Fava C., Pinto A., Galieni P., Rigacci L., Armiento D., Pane F., Oberti M., Zappasodi P., Visco C., Franchi M., Grossi P.A., Bertu L., Corrao G., Pagano L., Corradini P., Passamonti, F, Cattaneo, C, Arcaini, L, Bruna, R, Cavo, M, Merli, F, Angelucci, E, Krampera, M, Cairoli, R, Della Porta, M, Fracchiolla, N, Ladetto, M, Gambacorti Passerini, C, Salvini, M, Marchetti, M, Lemoli, R, Molteni, A, Busca, A, Cuneo, A, Romano, A, Giuliani, N, Galimberti, S, Corso, A, Morotti, A, Falini, B, Billio, A, Gherlinzoni, F, Visani, G, Tisi, M, Tafuri, A, Tosi, P, Lanza, F, Massaia, M, Turrini, M, Ferrara, F, Gurrieri, C, Vallisa, D, Martelli, M, Derenzini, E, Guarini, A, Conconi, A, Cuccaro, A, Cudillo, L, Russo, D, Ciambelli, F, Scattolin, A, Luppi, M, Selleri, C, Ortu La Barbera, E, Ferrandina, C, Di Renzo, N, Olivieri, A, Bocchia, M, Gentile, M, Marchesi, F, Musto, P, Federici, A, Candoni, A, Venditti, A, Fava, C, Pinto, A, Galieni, P, Rigacci, L, Armiento, D, Pane, F, Oberti, M, Zappasodi, P, Visco, C, Franchi, M, Grossi, P, Bertu, L, Corrao, G, Pagano, L, and Corradini, P

Subjects
Male, Lymphoma, Comorbidity, 0302 clinical medicine, COVID-19, risk factors, death's rates, haematological malignancies, Retrospective Studie, Risk Factors, Neoplasms, 80 and over, haematological malignancies, Viral, Aged, 80 and over, education.field_of_study, Leukemia, Mortality rate, Lymphoma, Non-Hodgkin, Hazard ratio, Hematology, Plasma cell neoplasm, Middle Aged, Italy, 030220 oncology & carcinogenesis, Hematologic Neoplasms, Cohort, Plasma Cell, Female, Inpatient, Coronavirus Infections, Cohort study, Human, Adult, medicine.medical_specialty, Population, Pneumonia, Viral, Non-Hodgkin, Article, NO, Follow-Up Studie, 03 medical and health sciences, Betacoronavirus, Young Adult, COVID-19 haematological malignancies, Internal medicine, COVID-19, haematological malignancies, multicentre, retrospective, cohort study, Multivariable Cox, medicine, Humans, education, Hematologic Neoplasm, Neoplasms, Plasma Cell, Pandemics, Myeloproliferative Disorder, Aged, Retrospective Studies, Inpatients, Follow-Up Studies, Myeloproliferative Disorders, death's rates, Betacoronaviru, business.industry, Coronavirus Infection, SARS-CoV-2, Risk Factor, COVID-19, haematological malignancies, risk factors, COVID-19, Retrospective cohort study, Pneumonia, Settore MED/15, COVID-19 Drug Treatment, Settore MED/15 - MALATTIE DEL SANGUE, Standardized mortality ratio, business, 030215 immunology
Abstract

Summary 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 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 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 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 Associazione italiana contro le leucemie, linfomi e mieloma–Varese Onlus.

Published
2020

5. Real-world Outcomes of Relapsed/Refractory Diffuse Large B-cell Lymphoma Treated With Polatuzumab Vedotin-based Therapy

Author

Lisa Argnani, Alessandro Broccoli, Cinzia Pellegrini, Alberto Fabbri, Benedetta Puccini, Riccardo Bruna, Maria Chiara Tisi, Francesco Masia, Leonardo Flenghi, Maria Elena Nizzoli, Maurizio Musso, Marilena Salerno, Potito Rosario Scalzulli, Daniela Dessi’, Isacco Ferrarini, Elsa Pennese, Elisa Lucchini, Francesca Gaia Rossi, Carla Minoia, Filippo Gherlinzoni, Pellegrino Musto, Caterina Patti, Vittorio Stefoni, Pier Luigi Zinzani, and Argnani L, Broccoli A, Pellegrini C, Fabbri A, Puccini B, Bruna R, Tisi MC, Masia F, Flenghi L, Nizzoli ME, Musso M, Salerno M, Scalzulli PR, Dessi' D, Ferrarini I, Pennese E, Lucchini E, Rossi FG, Minoia C, Gherlinzoni F, Musto P, Patti C, Stefoni V, Zinzani PL.

Subjects
Diffuse Large B-cell Lymphoma, real world, Hematology, diffuse large B cell lymphoma, polatuzumab vedotin, real world, polatuzumab vedotin, diffuse large B cell lymphoma
Abstract

After FDA and EMA approval of the regimen containing polatuzumab vedotin plus rituximab and bendamustine (PolaBR), eligible relapsed/refractory diffuse large B-cell lymphoma (DLBCL) patients in Italy were granted early access through a Named Patient Program. A multicentric observational retrospective study was conducted focusing on the effectiveness and safety of PolaBR in everyday clinical practice. Fifty-five patients were enrolled. There were 26 females (47.3%), 32 patients were primary refractory and 45 (81.8%) resulted refractory to their last therapy. The decision to add or not bendamustine was at physician's discretion. Thirty-six patients underwent PolaBR, and 19 PolaR. The 2 groups did not differ in most of baseline characteristics. The final overall response rate was 32.7% (18.2% complete response rate), with a best response rate of 49.1%. Median disease-free survival was reached at 12 months, median progression-free survival at 4.9 months and median overall survival at 9 months, respectively. Overall, 88 adverse events (AEs) were registered during treatment in 31 patients, 22 of grade ≥3. Eight cases of neuropathy occurred, all of grades 1-2 and all related to polatuzumab. The two groups of treatment did not differ for effectiveness endpoints but presented statistically significant difference in AEs occurrence, especially in hematological AEs, in AEs of grade equal or greater than 3 and in incidence of neuropathy. Our data add useful information on the effectiveness of Pola(B)R in the setting of heavily pretreated DLBCL and may also suggest a better tolerability in absence of bendamustine without compromise of efficacy.

Published
2022

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