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1. Decoding the historical tale: COVID-19 impact on haematological malignancy patients-EPICOVIDEHA insights from 2020 to 2022

Author

Arellano-Orden, Elena [0000-0003-0581-8947], Salmanton-García, Jon, Marchesi, Francesco, Farina, Francesca, Weinbergerová, Barbora, Itri, Federico, Dávila-Valls, Julio, Martín-Pérez, Sonia, Glenthøj, Andreas, Hersby, Ditte Stampe, Gomes da Silva, Maria, Nunes Rodrigues, Raquel, López-García, Alberto, Córdoba, Raúl, Bilgin, Yavuz M., Falces-Romero, Iker, El-Ashwah, Shaimaa, Emarah, Ziad, Besson, Caroline, Kohn, Milena, Van Doesum, Jaap, Ammatuna, Emanuele, Marchetti, Monia, Labrador, Jorge, Zambrotta, Giovanni Paolo Maria, Verga, Luisa, Jaksic, Ozren, Nucci, Marcio, Piukovics, Klára, Cabirta-Touzón, Alba, Jiménez, Moraima, Arellano-Orden, Elena, Espigado, Ildefonso, Blennow, Ola, Nordlander, Anna, Meers, Stef, van Praet, Jens, Aiello, Tommaso Francesco, Garcia-Vidal, Carolina, Fracchiolla, Nicola, Sciumè, Mariarita, Seval, Guldane Cengiz, Žák, Pavel, Buquicchio, Caterina, Tascini, Carlo, Gräfe, Stefanie K., Schönlein, Martin, Adžić-Vukičević, Tatjana, Bonuomo, Valentina, Cattaneo, Chiara, Nizamuddin, Summiya, Čerňan, Martin, Plantefeve, Gaëtan, Prin, Romane, Szotkovski, Tomas, Collins, Graham P., Dargenio, Michelina, Petzer, Verena, Wolf, Dominik, Čolović, Natasha, Prezioso, Lucia, Valković, Toni, Passamonti, Francesco, Méndez, Gustavo-Adolfo, Sili, Uluhan, Vena, Antonio, Bavastro, Martina, Limongelli, Alessandro, Duarte, Rafael F., Ledoux, Marie-Pierre, Cvetanoski, Milche, Stojanoski, Zlate, Machado, Marina, Batinić, Josip, Magliano, Gabriele, Biernat, Monika M., Pantić, Nikola, Poulsen, Christian Bjørn, Cuccaro, Annarosa, Del Principe, Maria Ilaria, Kulasekararaj, Austin, Ormazabal-Vélez, Irati, Busca, Alessandro, Demirkan, Fatih, Ijaz, Marriyam, Klimko, Nikolai, Stoma, Igor, Khostelidi, Sofya, Fernández, Noemí, Omrani, Ali S, Bergantim, Rui, De Jonge, Nick, Fouquet, Guillemette, Navrátil, Milan, Abu-Zeinah, Ghaith, Samarkos, Michail, Maertens, Johan, De Ramón, Cristina, Guidetti, Anna, Magyari, Ferenc, González-López, Tomás José, Lahmer, Tobias, Finizio, Olimpia, Ali, Natasha, Pinczés, László Imre, Lavilla-Rubira, Esperanza, Romano, Alessandra, Merelli, Maria, Delia, Mario, Calbacho, Maria, Meletiadis, Joseph, Antić, Darko, Hernández-Rivas, José-Ángel, Marques de Almeida, Joyce, Al-Khabori, Murtadha, Hoenigl, Martin, Tisi, Maria Chiara, Khanna, Nina, Barać, Aleksandra, Eisa, Noha, Di Blasi, Roberta, Liévin, Raphaël, Miranda-Castillo, Carolina, Bahr, Nathan C., Lamure, Sylvain, Papa, Mario Virgilio, Yahya, Ayel, Aujayeb, Avinash, Novák, Jan, Erben, Nurettin, Fernández-Galán, María, Ribera-Santa Susana, José-María, Rinaldi, Ikhwan, Fazzi, Rita, Piedimonte, Monica, Duléry, Rémy, Gonzaga, Yung, Soto-Silva, Andrés, Sapienza, Giuseppe, Serris, Alexandra, Drgoňa, Ľuboš, Groh, Ana, Serrano, Laura, Gavriilaki, Eleni, Tragiannidis, Athanasios, Prattes, Juergen, Coppola, Nicola, Otašević, Vladimir, Mladenović, Miloš, Mitrović, Mirjana, Mišković, Bojana, Jindra, Pavel, Zompi, Sofia, Sacchi, Maria Vittoria, Krekeler, Carolin, Infante, Maria Stefania, García-Bordallo, Daniel, Çolak, Gökçe Melis, Mayer, Jiří, Nygaard, Marietta, Hanáková, Michaela, Ráčil, Zdeněk, Bonanni, Matteo, Koehler, Philipp, Rahimli, Laman, Cornely, Oliver A., Pagano, Livio, Arellano-Orden, Elena [0000-0003-0581-8947], Salmanton-García, Jon, Marchesi, Francesco, Farina, Francesca, Weinbergerová, Barbora, Itri, Federico, Dávila-Valls, Julio, Martín-Pérez, Sonia, Glenthøj, Andreas, Hersby, Ditte Stampe, Gomes da Silva, Maria, Nunes Rodrigues, Raquel, López-García, Alberto, Córdoba, Raúl, Bilgin, Yavuz M., Falces-Romero, Iker, El-Ashwah, Shaimaa, Emarah, Ziad, Besson, Caroline, Kohn, Milena, Van Doesum, Jaap, Ammatuna, Emanuele, Marchetti, Monia, Labrador, Jorge, Zambrotta, Giovanni Paolo Maria, Verga, Luisa, Jaksic, Ozren, Nucci, Marcio, Piukovics, Klára, Cabirta-Touzón, Alba, Jiménez, Moraima, Arellano-Orden, Elena, Espigado, Ildefonso, Blennow, Ola, Nordlander, Anna, Meers, Stef, van Praet, Jens, Aiello, Tommaso Francesco, Garcia-Vidal, Carolina, Fracchiolla, Nicola, Sciumè, Mariarita, Seval, Guldane Cengiz, Žák, Pavel, Buquicchio, Caterina, Tascini, Carlo, Gräfe, Stefanie K., Schönlein, Martin, Adžić-Vukičević, Tatjana, Bonuomo, Valentina, Cattaneo, Chiara, Nizamuddin, Summiya, Čerňan, Martin, Plantefeve, Gaëtan, Prin, Romane, Szotkovski, Tomas, Collins, Graham P., Dargenio, Michelina, Petzer, Verena, Wolf, Dominik, Čolović, Natasha, Prezioso, Lucia, Valković, Toni, Passamonti, Francesco, Méndez, Gustavo-Adolfo, Sili, Uluhan, Vena, Antonio, Bavastro, Martina, Limongelli, Alessandro, Duarte, Rafael F., Ledoux, Marie-Pierre, Cvetanoski, Milche, Stojanoski, Zlate, Machado, Marina, Batinić, Josip, Magliano, Gabriele, Biernat, Monika M., Pantić, Nikola, Poulsen, Christian Bjørn, Cuccaro, Annarosa, Del Principe, Maria Ilaria, Kulasekararaj, Austin, Ormazabal-Vélez, Irati, Busca, Alessandro, Demirkan, Fatih, Ijaz, Marriyam, Klimko, Nikolai, Stoma, Igor, Khostelidi, Sofya, Fernández, Noemí, Omrani, Ali S, Bergantim, Rui, De Jonge, Nick, Fouquet, Guillemette, Navrátil, Milan, Abu-Zeinah, Ghaith, Samarkos, Michail, Maertens, Johan, De Ramón, Cristina, Guidetti, Anna, Magyari, Ferenc, González-López, Tomás José, Lahmer, Tobias, Finizio, Olimpia, Ali, Natasha, Pinczés, László Imre, Lavilla-Rubira, Esperanza, Romano, Alessandra, Merelli, Maria, Delia, Mario, Calbacho, Maria, Meletiadis, Joseph, Antić, Darko, Hernández-Rivas, José-Ángel, Marques de Almeida, Joyce, Al-Khabori, Murtadha, Hoenigl, Martin, Tisi, Maria Chiara, Khanna, Nina, Barać, Aleksandra, Eisa, Noha, Di Blasi, Roberta, Liévin, Raphaël, Miranda-Castillo, Carolina, Bahr, Nathan C., Lamure, Sylvain, Papa, Mario Virgilio, Yahya, Ayel, Aujayeb, Avinash, Novák, Jan, Erben, Nurettin, Fernández-Galán, María, Ribera-Santa Susana, José-María, Rinaldi, Ikhwan, Fazzi, Rita, Piedimonte, Monica, Duléry, Rémy, Gonzaga, Yung, Soto-Silva, Andrés, Sapienza, Giuseppe, Serris, Alexandra, Drgoňa, Ľuboš, Groh, Ana, Serrano, Laura, Gavriilaki, Eleni, Tragiannidis, Athanasios, Prattes, Juergen, Coppola, Nicola, Otašević, Vladimir, Mladenović, Miloš, Mitrović, Mirjana, Mišković, Bojana, Jindra, Pavel, Zompi, Sofia, Sacchi, Maria Vittoria, Krekeler, Carolin, Infante, Maria Stefania, García-Bordallo, Daniel, Çolak, Gökçe Melis, Mayer, Jiří, Nygaard, Marietta, Hanáková, Michaela, Ráčil, Zdeněk, Bonanni, Matteo, Koehler, Philipp, Rahimli, Laman, Cornely, Oliver A., and Pagano, Livio

Abstract

The COVID-19 pandemic heightened risks for individuals with hematological malignancies due to compromised immune systems, leading to more severe outcomes and increased mortality. While interventions like vaccines, targeted antivirals, and monoclonal antibodies have been effective for the general population, their benefits for these patients may not be as pronounced.

Published
2024

2. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies: a report from the EPICOVIDEHA registry

Author

Gilead Sciences, Salmanton-García, Jon, Marchesi, Francesco, Silva, Maria Gomes da, Farina, Francesca, Dávila-Valls, Julio, Bilgin, Yavuz M., Glenthøj, Andreas, Falces-Romero, Iker, Doesum, Jaap van, Labrador, Jorge, Buquicchio, Caterina, El-Ashwah, Shaimaa, Petzer, Verena, Van Praet, Jens, Schönlein, Martin, Dargenio, Michelina, Méndez, Gustavo-Adolfo, Meers, Stef, Itri, Federico, Giordano, Antonio, Pinczés, László Imre, Espigado, Ildefonso, Stojanoski, Zlate, López-García, Alberto, Prezioso, Lucia, Jaksic, Ozren, Vena, Antonio, Fracchiolla, Nicola S., González-López, Tomás José, Čolović, Natasa, Delia, Mario, Weinbergerová, Barbora, Marchetti, Monia, Marqués de Almeida, Joyce, Finizio, Olimpia, Besson, Caroline, Biernat, Monika M., Valković, Toni, Lahmer, Tobias, Cuccaro, Annarosa, Ormazabal-Vélez, Irati, Batinić, Josip, Fernández, Noemí, Jonge, Nick de, Tascini, Carlo, Anastasopoulou, Amalia N., Duléry, Rémy, Príncipe, María Ilaria del, Plantefeve, Gaëtan, Papa, Mario Virgilio, Nucci, Marcio, Jiménez, Moraima, Aujayeb, Avinash, Hernández-Rivas, José Ángel, Merelli, Maria, Cattaneo, Chiara, Blennow, Ola, Nordlander, Anna, Cabirta, Alba, Varricchio, Gina, Sacchi, Maria Vittoria, Córdoba, Raúl, Arellano-Orden, Elena, Gräfe, Stefanie, Wolf, Dominik, Emarah, Ziad, Ammatuna, Emanuele, Hersby, Ditte Stampe, Martín-Pérez, Sonia, Nunes-Rodrigues, Raquel, Rahimli, Laman, Pagano, Livio, Cornely, Oliver A., EPICOVIDEHA registry, Gilead Sciences, Salmanton-García, Jon, Marchesi, Francesco, Silva, Maria Gomes da, Farina, Francesca, Dávila-Valls, Julio, Bilgin, Yavuz M., Glenthøj, Andreas, Falces-Romero, Iker, Doesum, Jaap van, Labrador, Jorge, Buquicchio, Caterina, El-Ashwah, Shaimaa, Petzer, Verena, Van Praet, Jens, Schönlein, Martin, Dargenio, Michelina, Méndez, Gustavo-Adolfo, Meers, Stef, Itri, Federico, Giordano, Antonio, Pinczés, László Imre, Espigado, Ildefonso, Stojanoski, Zlate, López-García, Alberto, Prezioso, Lucia, Jaksic, Ozren, Vena, Antonio, Fracchiolla, Nicola S., González-López, Tomás José, Čolović, Natasa, Delia, Mario, Weinbergerová, Barbora, Marchetti, Monia, Marqués de Almeida, Joyce, Finizio, Olimpia, Besson, Caroline, Biernat, Monika M., Valković, Toni, Lahmer, Tobias, Cuccaro, Annarosa, Ormazabal-Vélez, Irati, Batinić, Josip, Fernández, Noemí, Jonge, Nick de, Tascini, Carlo, Anastasopoulou, Amalia N., Duléry, Rémy, Príncipe, María Ilaria del, Plantefeve, Gaëtan, Papa, Mario Virgilio, Nucci, Marcio, Jiménez, Moraima, Aujayeb, Avinash, Hernández-Rivas, José Ángel, Merelli, Maria, Cattaneo, Chiara, Blennow, Ola, Nordlander, Anna, Cabirta, Alba, Varricchio, Gina, Sacchi, Maria Vittoria, Córdoba, Raúl, Arellano-Orden, Elena, Gräfe, Stefanie, Wolf, Dominik, Emarah, Ziad, Ammatuna, Emanuele, Hersby, Ditte Stampe, Martín-Pérez, Sonia, Nunes-Rodrigues, Raquel, Rahimli, Laman, Pagano, Livio, Cornely, Oliver A., and EPICOVIDEHA registry

Abstract

[Background] Nirmatrelvir/ritonavir treatment decreases the hospitalisation rate in immunocompetent patients with COVID-19, but data on efficacy in patients with haematological malignancy are scarce. Here, we describe the outcome of nirmatrelvir/ritonavir treatment in a large cohort of the latter patients., [Methods] This is a retrospective cohort study from the multicentre EPICOVIDEHA registry (NCT04733729) on patients with haematological malignancy, who were diagnosed with COVID-19 between January and September 2022. Patients receiving nirmatrelvir/ritonavir were compared to those who did not. A logistic regression was run to determine factors associated with nirmatrelvir/ritonavir administration in our sample. Mortality between treatment groups was assessed with Kaplan–Meier survival plots after matching all the patients with a propensity score. Additionally, a Cox regression was modelled to detect factors associated with mortality in patients receiving nirmatrelvir/ritonavir., [Findings] A total of 1859 patients were analysed, 117 (6%) were treated with nirmatrelvir/ritonavir, 1742 (94%) were treated otherwise. Of 117 patients receiving nirmatrelvir/ritonavir, 80% had received ≥1 anti-SARS-CoV-2 vaccine dose before COVID-19 onset, 13% of which received a 2nd vaccine booster. 5% were admitted to ICU. Nirmatrelvir/ritonavir treatment was associated with the presence of extrapulmonary symptoms at COVID-19 onset, for example anosmia, fever, rhinitis, or sinusitis (aOR 2.509, 95%CI 1.448–4.347) and 2nd vaccine booster (aOR 3.624, 95%CI 1.619–8.109). Chronic pulmonary disease (aOR 0.261, 95%CI 0.093–0.732) and obesity (aOR 0.105, 95%CI 0.014–0.776) were not associated with nirmatrelvir/ritonavir use. After propensity score matching, day-30 mortality rate in patients treated with nirmatrelvir/ritonavir was 2%, significantly lower than in patients with SARS-CoV-2 directed treatment other than nirmatrelvir/ritonavir (11%, p = 0.036). No factor was observed explaining the mortality difference in patients after nirmatrelvir/ritonavir administration., [Interpretation] Haematological malignancy patients were more likely to receive nirmatrelvir/ritonavir when reporting extrapulmonary symptoms or 2nd vaccine booster at COVID-19 onset, as opposed to chronic pulmonary disease and obesity. The mortality rate in patients treated with nirmatrelvir/ritonavir was lower than in patients with targeted drugs other than nirmatrelvir/ritonavir.

Published
2023

3. Molnupiravir compared to nirmatrelvir/ritonavir for COVID-19 in high-risk patients with haematological malignancy in Europe. A matched-paired analysis from the EPICOVIDEHA registry

Author

Gilead Sciences, Salmanton-García, Jon, Marchesi, Francesco, Koehler, Philipp, Weinbergerová, Barbora, Čolović, Natasa, Falces-Romero, Iker, Buquicchio, Caterina, Farina, Francesca, Praet, Jens van, Biernat, Monika M., Itri, Federico, Prezioso, Lucia, Tascini, Carlo, Vena, Antonio, Romano, Alessandra, Delia, Mario, Dávila-Valls, Julio, Martín-Pérez, Sonia, Lavilla-Rubira, Esperanza, Adžić-vukičević, Tatjana, García-Bordallo, Daniel, López-García, Alberto, Criscuolo, Mariana, Petzer, Verena, Fracchiolla, Nicola S., Espigado, Ildefonso, Sili, Uluhan, Meers, Stef, Erben, Nurettin, Cattaneo, Chiara, Tragiannidis, Athanasios, Gavriilaki, Eleni, Schönlein, Martin, Mitrovic, Mirjana, Pantic, Nikola, Merelli, Maria, Labrador, Jorge, Hernández-Rivas, José Ángel, Glenthøj, Andreas, Fouquet, Guillemette, Príncipe, María Ilaria del, Dargenio, Michelina, Calbacho, María, Besson, Caroline, Kohn, Milena, Gräfe, Stefanie, Hersby, Ditte Stampe, Arellano-Orden, Elena, Çolak, Gökçe Melis, Wolf, Dominik, Marchetti, Monia, Nordlander, Anna, Blennow, Ola, Córdoba, Raúl, Mišković, Bojana, Mladenović, Miloš, Bavastro, Martina, Limongelli, Alessandro, Rahimli, Laman, Pagano, Livio, Cornely, Oliver A., Gilead Sciences, Salmanton-García, Jon, Marchesi, Francesco, Koehler, Philipp, Weinbergerová, Barbora, Čolović, Natasa, Falces-Romero, Iker, Buquicchio, Caterina, Farina, Francesca, Praet, Jens van, Biernat, Monika M., Itri, Federico, Prezioso, Lucia, Tascini, Carlo, Vena, Antonio, Romano, Alessandra, Delia, Mario, Dávila-Valls, Julio, Martín-Pérez, Sonia, Lavilla-Rubira, Esperanza, Adžić-vukičević, Tatjana, García-Bordallo, Daniel, López-García, Alberto, Criscuolo, Mariana, Petzer, Verena, Fracchiolla, Nicola S., Espigado, Ildefonso, Sili, Uluhan, Meers, Stef, Erben, Nurettin, Cattaneo, Chiara, Tragiannidis, Athanasios, Gavriilaki, Eleni, Schönlein, Martin, Mitrovic, Mirjana, Pantic, Nikola, Merelli, Maria, Labrador, Jorge, Hernández-Rivas, José Ángel, Glenthøj, Andreas, Fouquet, Guillemette, Príncipe, María Ilaria del, Dargenio, Michelina, Calbacho, María, Besson, Caroline, Kohn, Milena, Gräfe, Stefanie, Hersby, Ditte Stampe, Arellano-Orden, Elena, Çolak, Gökçe Melis, Wolf, Dominik, Marchetti, Monia, Nordlander, Anna, Blennow, Ola, Córdoba, Raúl, Mišković, Bojana, Mladenović, Miloš, Bavastro, Martina, Limongelli, Alessandro, Rahimli, Laman, Pagano, Livio, and Cornely, Oliver A.

Abstract

[Introduction] Molnupiravir and nirmatrelvir/ritonavir are antivirals used to prevent progression to severe SARS-CoV-2 infections and decrease hospitalisation and mortality rates. Nirmatrelvir/ritonavir was authorised in Europe in December 2021, whereas molnupiravir is not yet licensed in Europe as of February 2022. Molnupiravir may be an alternative to nirmatrelvir/ritonavir because it is associated with fewer drug-drug interactions and contraindications. A caveat for molnupiravir is the mode of action induces viral mutations. Mortality rate reduction with molnupiravir was less pronounced than that with nirmatrelvir/ritonavir in patients without haematological malignancy. Little is known about the comparative efficacy of the two drugs in patients with haematological malignancy at high-risk of severe COVID-19. Thus, molnupiravir and nirmatrelvir/ritonavir were compared in a cohort of patients with haematological malignancies., [Methods] Clinical data from patients treated with molnupiravir or nirmatrelvir/ritonavir monotherapy for COVID-19 were retrieved from the EPICOVIDEHA registry. Patients treated with molnupiravir were matched by sex, age (±10 years), and severity of baseline haematological malignancy to controls treated with nirmatrelvir/ritonavir., [Results] A total of 116 patients receiving molnupiravir for the clinical management of COVID-19 were matched to an equal number of controls receiving nirmatrelvir/ritonavir. In each of the groups, 68 (59%) patients were male; with a median age of 64 years (interquartile range [IQR] 53-74) for molnupiravir recipients and 64 years (IQR 54-73) for nirmatrelvir/ritonavir recipients; 56.9% (n=66) of the patients had controlled baseline haematological malignancy, 12.9% (n=15) had stable disease, and 30.2% (n=35) had active disease at COVID-19 onset in each group. During COVID-19 infection, one third of patients from each group were admitted to hospital. Although a similar proportion of patients in the two groups were vaccinated (molnupiravir n=77, 66% vs. nirmatrelvir/ritonavir n=87, 75%), more of those treated with nirmatrelvir/ritonavir had received four vaccine doses (n=27, 23%) compared with those treated with molnupiravir (n=5, 4%) (P<0.001). No differences were detected in COVID-19 severity (P=0.39) or hospitalisation (P=1.0). No statistically significant differences were identified in overall mortality rate (P=0.78) or survival probability (d30 P=0.19, d60 P=0.67, d90 P=0.68, last day of follow up P=0.68). Deaths were either attributed to COVID-19, or the infection was judged by the treating physician to have contributed to death., [Conclusions] Hospitalisation and mortality rates with molnupiravir were comparable to those with nirmatrelvir/ritonavir in high-risk patients with haematological malignancies and COVID-19. Molnupiravir is a plausible alternative to nirmatrelvir/ritonavir for COVID-19 treatment in patients with haematological malignancy.

Published
2023

4. Other malignancies in the history of CLL: an international multicenter study conducted by ERIC, the European Research Initiative on CLL, in HARMONY

Author

AbbVie Pharmaceuticals, European Commission, Chatzikonstantinou, Thomas, Scarfò, Lydia, Karakatsoulis, Georgios, Minga, Eva, Chamou, Dimitra, Iacoboni, Gloria, Kotaskova, Jana, Demosthenous, Christos, Smolej, Lukas, Mulligan, Stephen, Alcoceba, Miguel, Kreitman, Robert J., Labrador, Jorge, Lad, Deepesh, Levin, Mark-David, Levy, Ilana, Longval, Thomas, López-García, Alberto, Marquet, Juan, Martín-Rodríguez, Lucía, Maynadié, Marc, Tadmor, Tamar, Maslejova, Stanislava, Mayor-Bastida, Carlota, Mihaljevic, Biljana, Milosevic, Ivana, Mirás, Fátima, Moia, Riccardo, Morawska, Marta, Murru, Roberta, Nath, Uttam Kumar, Navarro-Bailón, Almudena, Tomic, Kristina, Oliveira, Ana C., Olivieri, Jacopo, Oscier, David, Panovska-Stavridis, Irina, Papaioannou, María, Papajík, Tomás, Kubova, Zuzana, Phumphukhieo, Punyarat, Pierie, Cheyenne, Puiggros, Anna, Tse, Eric, Rani, Lata, Reda, Gianluigi, Rigolin, Gian Matteo, Ruchlemer, Rosa, Daniel de Deus Santos, Marcos, Schipani, Mattia, Schiwitza, Annett, Shen, Yandong, Simkovic, Martín, Smirnova, Svetlana, Vassilakopoulos, Theodoros, Abdelrahman Soliman, Dina Sameh, Spacek, Martin, Visentin, Andrea, Vitale, Candida, von Tresckow, Julia, Vrachiolias, George, Vukovic, Vojin, Walewska, Renata, Al-Shemari, Salem, Wasik-Szczepanek, Ewa, Xu, Zhenshu, Yagci, Munci, Yañez, Lucrecia, Yassin, Mohamed, Zuchnicka, Jana, Angelopoulou, Maria, Antic, Darko, Biderman, Bella, Catherwood, Mark, Aurran-Schleinitz, Thérèse, Claus, Rainer, Coscia, Marta, Cuneo, Antonio, Demirkan, Fatih, Espinet, Blanca, Gaidano, Gianluca, Kalashnikova, Olga B., Laurenti, Luca, Nikitin, Eugene, Pangalis, Gerassimos A., Bacchiarri, Francesca, Panagiotidis, Panagiotis, Popov, Viola María, Pospisilova, Sarka, Sportoletti, Paolo, Stavroyianni, Niki, Tam, Constantine S., Trentin, Livio, Chatzidimitriou, Anastasia, Bosch, Francesc, Doubek, Michael, Bellido, Mar, Ghia, Paolo, Stamatopoulos, Kostas, Bijou, Fontanet, Calleja, Anne, Medina, Angeles, Khan, Mehreen Ali, Cassin, Ramona, Chatzileontiadou, Sofía, Collado, Rosa, Christian, Amy, Davis, Zadie, Dimou, María, Donaldson, David, Santos, Gimena Dos, Dreta, Bárbara, Efstathopoulou, María, El-Ashwah, Shaimaa, Enrico, Alicia, Fresa, Alberto, Galimberti, Sara, Galitzia, Andrea, García-Serra, Rocío, Gimeno, Eva, González-Gascón y Marín, Isabel, Gozzetti, Alessandro, Guarente, Valerio, Guieze, Romain, Gogia, Ajay, Gupta, Ritu, Harrop, Sean, Hatzimichael, Eleftheria, Herishanu, Yair, Hernández-Rivas, José Ángel, Inchiappa, Luca, Jaksic, Ozren, Janssen, Susanne, Kalicińska, Elżbieta, Kamel, Laribi, Karakus, Volkan, Kater, Arnon P., Kho, Bonnie, Kislova, María, Konstantinou, Eliana, Koren-Michowitz, Maya, Kotsianidis, Ioannis, AbbVie Pharmaceuticals, European Commission, Chatzikonstantinou, Thomas, Scarfò, Lydia, Karakatsoulis, Georgios, Minga, Eva, Chamou, Dimitra, Iacoboni, Gloria, Kotaskova, Jana, Demosthenous, Christos, Smolej, Lukas, Mulligan, Stephen, Alcoceba, Miguel, Kreitman, Robert J., Labrador, Jorge, Lad, Deepesh, Levin, Mark-David, Levy, Ilana, Longval, Thomas, López-García, Alberto, Marquet, Juan, Martín-Rodríguez, Lucía, Maynadié, Marc, Tadmor, Tamar, Maslejova, Stanislava, Mayor-Bastida, Carlota, Mihaljevic, Biljana, Milosevic, Ivana, Mirás, Fátima, Moia, Riccardo, Morawska, Marta, Murru, Roberta, Nath, Uttam Kumar, Navarro-Bailón, Almudena, Tomic, Kristina, Oliveira, Ana C., Olivieri, Jacopo, Oscier, David, Panovska-Stavridis, Irina, Papaioannou, María, Papajík, Tomás, Kubova, Zuzana, Phumphukhieo, Punyarat, Pierie, Cheyenne, Puiggros, Anna, Tse, Eric, Rani, Lata, Reda, Gianluigi, Rigolin, Gian Matteo, Ruchlemer, Rosa, Daniel de Deus Santos, Marcos, Schipani, Mattia, Schiwitza, Annett, Shen, Yandong, Simkovic, Martín, Smirnova, Svetlana, Vassilakopoulos, Theodoros, Abdelrahman Soliman, Dina Sameh, Spacek, Martin, Visentin, Andrea, Vitale, Candida, von Tresckow, Julia, Vrachiolias, George, Vukovic, Vojin, Walewska, Renata, Al-Shemari, Salem, Wasik-Szczepanek, Ewa, Xu, Zhenshu, Yagci, Munci, Yañez, Lucrecia, Yassin, Mohamed, Zuchnicka, Jana, Angelopoulou, Maria, Antic, Darko, Biderman, Bella, Catherwood, Mark, Aurran-Schleinitz, Thérèse, Claus, Rainer, Coscia, Marta, Cuneo, Antonio, Demirkan, Fatih, Espinet, Blanca, Gaidano, Gianluca, Kalashnikova, Olga B., Laurenti, Luca, Nikitin, Eugene, Pangalis, Gerassimos A., Bacchiarri, Francesca, Panagiotidis, Panagiotis, Popov, Viola María, Pospisilova, Sarka, Sportoletti, Paolo, Stavroyianni, Niki, Tam, Constantine S., Trentin, Livio, Chatzidimitriou, Anastasia, Bosch, Francesc, Doubek, Michael, Bellido, Mar, Ghia, Paolo, Stamatopoulos, Kostas, Bijou, Fontanet, Calleja, Anne, Medina, Angeles, Khan, Mehreen Ali, Cassin, Ramona, Chatzileontiadou, Sofía, Collado, Rosa, Christian, Amy, Davis, Zadie, Dimou, María, Donaldson, David, Santos, Gimena Dos, Dreta, Bárbara, Efstathopoulou, María, El-Ashwah, Shaimaa, Enrico, Alicia, Fresa, Alberto, Galimberti, Sara, Galitzia, Andrea, García-Serra, Rocío, Gimeno, Eva, González-Gascón y Marín, Isabel, Gozzetti, Alessandro, Guarente, Valerio, Guieze, Romain, Gogia, Ajay, Gupta, Ritu, Harrop, Sean, Hatzimichael, Eleftheria, Herishanu, Yair, Hernández-Rivas, José Ángel, Inchiappa, Luca, Jaksic, Ozren, Janssen, Susanne, Kalicińska, Elżbieta, Kamel, Laribi, Karakus, Volkan, Kater, Arnon P., Kho, Bonnie, Kislova, María, Konstantinou, Eliana, Koren-Michowitz, Maya, and Kotsianidis, Ioannis

Abstract

[Background]: Patients with chronic lymphocytic leukemia (CLL) have a higher risk of developing other malignancies (OMs) compared to the general population. However, the impact of CLL-related risk factors and CLL-directed treatment is still unclear and represents the focus of this work., [Methods]: We conducted a retrospective international multicenter study to assess the incidence of OMs and detect potential risk factors in 19,705 patients with CLL, small lymphocytic lymphoma, or high-count CLL-like monoclonal B-cell lymphocytosis, diagnosed between 2000 and 2016. Data collection took place between October 2020 and March 2022., [Findings]: In 129,254 years of follow-up after CLL diagnosis, 3513 OMs were diagnosed (27.2 OMs/1000 person-years). The most common hematological OMs were Richter transformation, myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). Non-melanoma skin (NMSC) and prostate cancers were the most common solid tumors (STs). The only predictor for MDS and AML development was treatment with fludarabine and cyclophosphamide with/without rituximab (FC ± R) (OR = 3.7; 95% CI = 2.79–4.91; p < 0.001). STs were more frequent in males and patients with unmutated immunoglobulin heavy variable genes (OR = 1.77; 95% CI = 1.49–2.11; p < 0.001/OR = 1.89; 95% CI = 1.6–2.24; p < 0.001). CLL-directed treatment was associated with non-melanoma skin and prostate cancers (OR = 1.8; 95% CI = 1.36–2.41; p < 0.001/OR = 2.11; 95% CI = 1.12–3.97; p = 0.021). In contrast, breast cancers were more frequent in untreated patients (OR = 0.17; 95% CI = 0.08–0.33; p < 0.001). Patients with CLL and an OM had inferior overall survival (OS) than those without. AML and MDS conferred the worst OS (p < 0.001)., [Interpretation]: OMs in CLL impact on OS. Treatment for CLL increased the risk for AML/MDS, prostate cancer, and NMSC. FCR was associated with increased risk for AML/MDS.

Published
2023

5. Nirmatrelvir/ritonavir in COVID-19 patients with haematological malignancies

Author

Salmanton-García, Jon, Marchesi, Francesco, Gomes da Silva, Maria, Farina, Francesca, Dávila-Valls, Julio, Bilgin, Yavuz M., Glenthøj, Andreas, Falces-Romero, Iker, Van Doesum, Jaap, Labrador, Jorge, Buquicchio, Caterina, El-Ashwah, Shaimaa, Petzer, Verena, Van Praet, Jens, Schönlein, Martin, Dargenio, Michelina, Méndez, Gustavo-Adolfo, Meers, Stef, Itri, Federico, Giordano, Antonio, Pinczés, László Imre, Espigado, Ildefonso, Stojanoski, Zlate, López-García, Alberto, Prezioso, Lucia, Jaksic, Ozren, Vena, Antonio, Fracchiolla, Nicola S., González-López, Tomás José, Colović, Natasa, Delia, Mario, Weinbergerová, Barbora, Marchetti, Monia, Marques de Almeida, Joyce, Finizio, Olimpia, Besson, Caroline, Biernat, Monika M., Valković, Toni, Lahmer, Tobias, Cuccaro, Annarosa, Ormazabal-Vélez, Irati, Batinić, Josip, Fernández, Noemí, De Jonge, Nick, Tascini, Carlo, Anastasopoulou, Amalia N., Duléry, Rémy, Del Principe, Maria Ilaria, Plantefeve, Gaëtan, Papa, Mario Virgilio, Nucci, Marcio, Jiménez, Moraima, Aujayeb, Avinash, Hernández-Rivas, José-Ángel, Merelli, Maria, Cattaneo, Chiara, Blennow, Ola, Nordlander, Anna, Cabirta, Alba, Varricchio, Gina, Sacchi, Maria Vittoria, Cordoba, Raul, Arellano, Elena, Gräfe, Stefanie K., Wolf, Dominik, Emarah, Ziad, Ammatuna, Emanuele, Hersby, Ditte Stampe, Martín-Pérez, Sonia, Nunes Rodrigues, Raquel, Rahimli, Laman, Pagano, Livio, Cornely, Oliver A., Registry, EPICOVIDEHA, Piukovics, Klára, De Ramón, Cristina, Danion, François, Yahya, Ayel, Guidetti, Anna, Garcia-Vidal, Carolina, Sili, Uluhan, Meletiadis, Joseph, De Kort, Elizabeth, Verga, Luisa, Serrano, Laura, Erben, Nurettin, Di Blasi, Roberta, Tragiannidis, Athanasios, Ribera-Santa Susana, José-María, Ommen, Hans-Beier, Busca, Alessandro, Coppola, Nicola, Bergantim, Rui, Dragonetti, Giulia, Criscuolo, Marianna, Fianchi, Luana, Bonanni, Matteo, Soto-Silva, Andrés, Mikulska, Malgorzata, Machado, Marina, Shan Kho, Chi, Hassan, Nazia, Gavriilaki, Eleni, Cordini, Gregorio, Chi, Louis Yi Ann, Eggerer, Matthias, Hoenigl, Martin, Prattes, Juergen, Jiménez-Lorenzo, María-Josefa, Zompi, Sofia, Zambrotta, Giovanni Paolo Maria, Çolak, Gökçe Melis, García-Poutón, Nicole, Aiello, Tommaso Francesco, Prin, Romane, Stamouli, Maria, Samarkos, Michail, Hematology, Institut Català de la Salut, [Salmanton-García J] University of Cologne, Faculty of Medicine, and University Hospital Cologne, Chair Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany. University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Excellence Center for Medical Mycology (ECMM), Cologne, Germany. German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne, Cologne, Germany. [Marchesi F] Hematology and Stem Cell Transplant Unit, IRCCS Regina Elena National Cancer Institute, Rome, Italy. [Gomes da Silva M] Portuguese Institute of Oncology, Lisbon, Portugal. [Farina F] IRCCS Ospedale San Raffaele, Milan, Italy. [Dávila-Valls J] Hospital Nuestra Señora de Sonsoles, Ávila, Spain. [Bilgin YM] Department of Internal Medicine, ADRZ, Goes, the Netherlands. [Jiménez M] Servei d’Hematologia, Vall d’Hebron Hospital Universitari, Barcelona, Spain. Experimental Hematology, Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Departament de Medicina, Universitat Autònoma de Barcelona, Bellaterra, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Sang - Càncer, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Other subheadings::Other subheadings::/drug therapy [Other subheadings], COVID-19 (Malaltia) - Tractament, Medicine and Health Sciences, virosis::infecciones por virus ARN::infecciones por Nidovirales::infecciones por Coronaviridae::infecciones por Coronavirus [ENFERMEDADES], Medicaments antivírics - Ús terapèutic, Other subheadings::/therapeutic use [Other subheadings], 03.02. Klinikai orvostan, neoplasias::neoplasias por localización::neoplasias hematológicas [ENFERMEDADES], BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Internal Medicine, BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Interna medicina, Otros calificadores::/uso terapéutico [Otros calificadores], SARS-CoV-2, COVID-19, Malignancy, Virus Diseases::RNA Virus Infections::Nidovirales Infections::Coronaviridae Infections::Coronavirus Infections [DISEASES], General Medicine, Neoplasms::Neoplasms by Site::Hematologic Neoplasms [DISEASES], BIOMEDICINE AND HEALTHCARE. Clinical Medical Sciences. Infectology, Settore MED/15, Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Anti-Infective Agents::Antiviral Agents [CHEMICALS AND DRUGS], Settore MED/15 - MALATTIE DEL SANGUE, acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antiinfecciosos::antivíricos [COMPUESTOS QUÍMICOS Y DROGAS], BIOMEDICINA I ZDRAVSTVO. Kliničke medicinske znanosti. Infektologija, Haematology, Nirmatrelvir
Abstract

COVID-19; Haematology; Nirmatrelvir COVID-19; Hematología; Nirmatrelvir COVID-19; Hematologia; Nirmatrelvir Background Nirmatrelvir/ritonavir treatment decreases the hospitalisation rate in immunocompetent patients with COVID-19, but data on efficacy in patients with haematological malignancy are scarce. Here, we describe the outcome of nirmatrelvir/ritonavir treatment in a large cohort of the latter patients. Methods This is a retrospective cohort study from the multicentre EPICOVIDEHA registry (NCT04733729) on patients with haematological malignancy, who were diagnosed with COVID-19 between January and September 2022. Patients receiving nirmatrelvir/ritonavir were compared to those who did not. A logistic regression was run to determine factors associated with nirmatrelvir/ritonavir administration in our sample. Mortality between treatment groups was assessed with Kaplan–Meier survival plots after matching all the patients with a propensity score. Additionally, a Cox regression was modelled to detect factors associated with mortality in patients receiving nirmatrelvir/ritonavir. Findings A total of 1859 patients were analysed, 117 (6%) were treated with nirmatrelvir/ritonavir, 1742 (94%) were treated otherwise. Of 117 patients receiving nirmatrelvir/ritonavir, 80% had received ≥1 anti-SARS-CoV-2 vaccine dose before COVID-19 onset, 13% of which received a 2nd vaccine booster. 5% were admitted to ICU. Nirmatrelvir/ritonavir treatment was associated with the presence of extrapulmonary symptoms at COVID-19 onset, for example anosmia, fever, rhinitis, or sinusitis (aOR 2.509, 95%CI 1.448–4.347) and 2nd vaccine booster (aOR 3.624, 95%CI 1.619–8.109). Chronic pulmonary disease (aOR 0.261, 95%CI 0.093–0.732) and obesity (aOR 0.105, 95%CI 0.014–0.776) were not associated with nirmatrelvir/ritonavir use. After propensity score matching, day-30 mortality rate in patients treated with nirmatrelvir/ritonavir was 2%, significantly lower than in patients with SARS-CoV-2 directed treatment other than nirmatrelvir/ritonavir (11%, p = 0.036). No factor was observed explaining the mortality difference in patients after nirmatrelvir/ritonavir administration. Interpretation Haematological malignancy patients were more likely to receive nirmatrelvir/ritonavir when reporting extrapulmonary symptoms or 2nd vaccine booster at COVID-19 onset, as opposed to chronic pulmonary disease and obesity. The mortality rate in patients treated with nirmatrelvir/ritonavir was lower than in patients with targeted drugs other than nirmatrelvir/ritonavir. EPICOVIDEHA has received funds from Optics COMMIT (COVID-19 Unmet Medical Needs and Associated Research Extension) COVID-19 RFP program by GILEAD Science, United States (Project 2020-8223).

Published
2023
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6. DNA damage response-related alterations define the genetic background of patients with chronic lymphocytic leukemia and chromosomal gains

Author

Instituto de Salud Carlos III, European Commission, Red Temática de Investigación Cooperativa en Cáncer (España), Centro de Investigación Biomédica en Red Cáncer (España), Sociedad Española de Hematología y Hemoterapia, Junta de Castilla y León, Hernández-Sánchez, María, Rodríguez-Vicente, Ana Eugenia, González-Gascón y Marín, Isabel, Quijada-Álamo, Miguel, Hernandez-Sánchez, Jesus M., Martín-Izquierdo, Marta, Hernández-Rivas, José Ángel, Benito, Rocío, Hernández, Jesús M., Instituto de Salud Carlos III, European Commission, Red Temática de Investigación Cooperativa en Cáncer (España), Centro de Investigación Biomédica en Red Cáncer (España), Sociedad Española de Hematología y Hemoterapia, Junta de Castilla y León, Hernández-Sánchez, María, Rodríguez-Vicente, Ana Eugenia, González-Gascón y Marín, Isabel, Quijada-Álamo, Miguel, Hernandez-Sánchez, Jesus M., Martín-Izquierdo, Marta, Hernández-Rivas, José Ángel, Benito, Rocío, and Hernández, Jesús M.

Abstract

The presence of chromosomal gains other than trisomy 12 suggesting a hyperdiploid karyotype is extremely rare in chronic lymphocytic leukemia (CLL) and is associated with a dismal prognosis. However, the genetic mechanisms and mutational background of these patients have not been fully explored. To improve our understanding of the genetic underpinnings of this subgroup of CLL, seven CLL patients with several chromosomal gains were sequenced using a next-generation sequencing (NGS)-targeted approach. The mutational status of 54 genes was evaluated using a custom-designed gene panel including recurrent mutated genes observed in CLL and widely associated with CLL pathogenesis. A total of 21 mutations were detected; TP53 (42.8%), ATM (28.5%), SF3B1 (28.5%), and BRAF (28.5%) were the most recurrently mutated genes. Of these mutations, 61.9% were detected in genes previously associated with a poor prognosis in CLL. Interestingly, five of the seven patients exhibited alterations in TP53 or ATM (deletion and/or mutation), genes involved in the DNA damage response (DDR), which could be related to a high genetic instability in this subgroup of patients. In conclusion, CLL patients with several chromosomal gains exhibit high genetic instability, with mutations in CLL driver genes and high-risk genetic alterations involving ATM and/or TP53 genes.

Published
2019

7. Immune response against the SARS-CoV-2 spike protein in cancer patients after COVID-19 vaccination during the Omicron wave: a prospective study.

Author

Muñoz-Gómez MJ, Ryan P, Quero-Delgado M, Martin-Vicente M, Cuevas G, Valencia J, Jiménez E, Blanca-López N, Lara-Álvarez MÁ, Hernández-Rivas JÁ, Redondo G, Mas V, Sepúlveda-Crespo D, Vázquez M, Torres-Macho J, Martínez I, and Resino S

Subjects
Humans, Prospective Studies, Male, Female, Middle Aged, Aged, T-Lymphocytes immunology, Immunization, Secondary, Vaccination, Adult, Immunity, Humoral, Immunoglobulin G blood, Immunocompromised Host, Immunity, Cellular, COVID-19 immunology, COVID-19 prevention & control, COVID-19 Vaccines immunology, COVID-19 Vaccines administration & dosage, Spike Glycoprotein, Coronavirus immunology, SARS-CoV-2 immunology, Neoplasms immunology, Antibodies, Viral blood
Abstract

Background: Cancer patients often have weakened immune systems, resulting in a lower response to vaccines, especially those receiving immunosuppressive oncological treatment (OT). We aimed to assess the impact of OT on the humoral and T-cell response to the B.1 lineage and Omicron variant following COVID-19 vaccination in patients with solid and hematological neoplasms., Methods: We conducted a prospective study on cancer patients, stratified into OT and non-OT groups, who received a two-dose series of the COVID-19 mRNA vaccine and a booster six months later. The outcomes measured were the humoral (anti-SARS-CoV-2 S IgG titers and ACE2-S interaction inhibition capacity) and cellular (SARS-CoV-2 S-specific T-cell spots per million PBMCs) responses against the B.1 lineage and Omicron variant. These responses were evaluated four weeks after the second dose (n = 98) and eight weeks after the booster dose (n = 71)., Results: The humoral response after the second vaccine dose against the B.1 lineage and Omicron variant was significantly weaker in the OT group compared to the non-OT group (q-value<0.05). A booster dose of the mRNA-1273 vaccine significantly improved the humoral response in the OT group, making it comparable to the non-OT group. The mRNA-1273 vaccine, designed for the original Wuhan strain, elicited a weaker humoral response against the Omicron variant compared to the B.1 lineage, regardless of oncological treatment or vaccine dose. In contrast, T-cell responses against SARS-CoV-2, including the Omicron variant, were already present after the second vaccine dose and were not significantly affected by oncological treatments., Conclusions: Cancer patients, particularly those receiving immunosuppressive oncological treatments, should require booster doses and adapted COVID-19 vaccines for new SARS-CoV-2 variants like Omicron. Future studies should evaluate the durability of the immune response and the efficacy of individualized regimens., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

Published
2024
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8. Geriatric assessment in hematology scale predicts treatment tolerability in older patients diagnosed with hematological malignancies: The RETROGAH study.

Author

de la Rubia J, González B, Cruz-Jentoft AJ, Iglesias L, Jarque I, Persona EP, Lluch R, Marrero C, Zudaire M, Gironella M, Hernández-Rivas JÁ, Arnan M, Olivier C, Encinas C, Soler JA, Payer ÁR, Casado A, Fernández P, Vilanova D, and Bonanad S

Subjects
Humans, Aged, Geriatric Assessment methods, Retrospective Studies, Hematologic Neoplasms, Leukemia, Myeloid, Acute, Hematology
Abstract

Introduction: The GAH (Geriatric Assessment in Hematology) scale is a psychometrically valid tool aimed at identifying older patients with hematological malignancies at higher risk of treatment-related toxicity. Our objective in this study was to determine the weights for each dimension of the GAH scale and the cut-off point to reliably predict treatment tolerability in this population, estimated by a weighted receiver operating characteristic (ROC) analysis and quantified by the area under the curve (AUC)., Material and Methods: The RETROGAH was a retrospective cohort study including 126 patients who had previously participated in the GAH study. Patients were ≥ 65 years old with newly diagnosed myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), multiple myeloma (MM), or chronic lymphoid leukemia (CLL) and treated with standard front-line therapy within three months after having completed the GAH scale., Results: The optimal cut-off value of the GAH total score to discriminate patients at higher risk of treatment toxicity was 42, with 68.5% sensitivity and 55.8% specificity. Using this value, 66.1% of patients evaluated were found to develop some type of toxicity. The AUC was 0.6259 (95% CI: 0.512-0.739; p = 0.035)., Discussion: The GAH scale not only would enable clinicians to individualize therapy based on individual risk of toxicity but also discriminate patients that will benefit most from intensive treatments from those requiring an adapted approach. While futures studies in clinical practice may improve the model and overcome its limitations, the GAH scale should not be used alone when making treatment decisions., Competing Interests: Declaration of Competing Interest EPP declares consulting fees from GSK and AstraZeneca, honoraria for lectures, presentations, speakers bureaus from BMS, Incyte and Sanofi, and support for attending meetings from Janssen, Abbvie and Novartis; CM declares support for attending meetings from Janssen, Abbvie, Novartis, Roche, AstraZeneca and for participating in advisory boards from Janssen; MG declares honoraria for lectures, presentations, speakers bureaus from Celgene, Janssen and Amgen, and for advisory board from Sanofi, Janssen and Amgen; MA declares support for meetings from Novartis and Jazz, and for advisory board from Jazz. CE declares honoraria for lectures, presentations, speakers bureaus from BMS, Sanofi, Janssen, GSK and Amgen, support for meetings from Janssen, BMS, Amgen, Sanofi and GSK, and for participating in advisory boards from Janssen, BMS, Sanofi, GSK. ARP declares honoraria for lectures, presentations, speakers bureaus from Novartis, Janssen, Amgen, BMS, Abbvie and AstraZeneca and for advisory board from BMS, Abbvie, Janssen, Amgen, Sanofi and AstraZeneca. PF, and DV are Celgene employees, and the rest of the authors declare no competing financial conflict outside the submitted work., (Copyright © 2022 The Authors. Published by Elsevier Ltd.. All rights reserved.)

Published
2023
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9. Breakthrough COVID-19 in vaccinated patients with hematologic malignancies: results from the EPICOVIDEHA survey.

Author

Pagano L, Salmanton-García J, Marchesi F, Blennow O, Gomes da Silva M, Glenthøj A, van Doesum J, Bilgin YM, López-García A, Itri F, Nunes Rodrigues R, Weinbergerová B, Farina F, Dragonetti G, Berg Venemyr C, van Praet J, Jaksic O, Valković T, Falces-Romero I, Martín-Pérez S, Jiménez M, Dávila-Valls J, Schönlein M, Ammatuna E, Meers S, Delia M, Stojanoski Z, Nordlander A, Lahmer T, Imre Pinczés L, Buquicchio C, Piukovics K, Ormazabal-Vélez I, Fracchiolla N, Samarkos M, Méndez GA, Hernández-Rivas JÁ, Espigado I, Cernan M, Petzer V, Lamure S, di Blasi R, Marques de Almedia J, Dargenio M, Biernat MM, Sciumè M, de Ramón C, de Jonge N, Batinić J, Aujayeb A, Marchetti M, Fouquet G, Fernández N, Zambrotta G, Sacchi MV, Guidetti A, Demirkan F, Prezioso L, Ráčil Z, Nucci M, Mladenović M, Liévin R, Hanáková M, Gräfe S, Sili U, Machado M, Cattaneo C, Adžić-Vukičević T, Verga L, Labrador J, Rahimli L, Bonanni M, Passamonti F, Pagliuca A, Corradini P, Hoenigl M, Koehler P, Busca A, and Cornely OA

Subjects
Adult, Humans, SARS-CoV-2, COVID-19 Testing, Antibodies, Monoclonal, Antiviral Agents, Antibodies, Viral, COVID-19 epidemiology, COVID-19 prevention & control, Hematologic Neoplasms complications, Hematologic Neoplasms therapy
Abstract

Limited data are available on breakthrough COVID-19 in patients with hematologic malignancy (HM) after anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination. Adult patients with HM, ≥1 dose of anti-SARS-CoV-2 vaccine, and breakthrough COVID-19 between January 2021 and March 2022 were analyzed. A total of 1548 cases were included, mainly lymphoid malignancies (1181 cases, 76%). After viral sequencing in 753 cases (49%), the Omicron variant was prevalent (517, 68.7%). Most of the patients received ≤2 vaccine doses before COVID-19 (1419, 91%), mostly mRNA-based (1377, 89%). Overall, 906 patients (59%) received COVID-19-specific treatment. After 30-day follow-up from COVID-19 diagnosis, 143 patients (9%) died. The mortality rate in patients with the Omicron variant was 7.9%, comparable to other variants, with a significantly lower 30-day mortality rate than in the prevaccine era (31%). In the univariable analysis, older age (P < .001), active HM (P < .001), and severe and critical COVID-19 (P = .007 and P < .001, respectively) were associated with mortality. Conversely, patients receiving monoclonal antibodies, even for severe or critical COVID-19, had a lower mortality rate (P < .001). In the multivariable model, older age, active disease, critical COVID-19, and 2-3 comorbidities were correlated with a higher mortality, whereas monoclonal antibody administration, alone (P < .001) or combined with antivirals (P = .009), was protective. Although mortality is significantly lower than in the prevaccination era, breakthrough COVID-19 in HM is still associated with considerable mortality. Death rate was lower in patients who received monoclonal antibodies, alone or in combination with antivirals., (© 2022 by The American Society of Hematology.)

Published
2022
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10. COVID-19 in vaccinated adult patients with hematological malignancies: preliminary results from EPICOVIDEHA.

Author

Pagano L, Salmanton-García J, Marchesi F, López-García A, Lamure S, Itri F, Gomes-Silva M, Dragonetti G, Falces-Romero I, van Doesum J, Sili U, Labrador J, Calbacho M, Bilgin YM, Weinbergerová B, Serrano L, Ribera-Santa Susana JM, Malak S, Loureiro-Amigo J, Glenthøj A, Córdoba-Mascuñano R, Nunes-Rodrigues R, González-López TJ, Karlsson LK, Jiménez-Lorenzo MJ, Hernández-Rivas JÁ, Jaksic O, Ráčil Z, Busca A, Corradini P, Hoenigl M, Klimko N, Koehler P, Pagliuca A, Passamonti F, and Cornely OA

Subjects
Adult, Aged, Aged, 80 and over, Female, Humans, Male, Middle Aged, 2019-nCoV Vaccine mRNA-1273 administration & dosage, BNT162 Vaccine administration & dosage, COVID-19 immunology, COVID-19 mortality, COVID-19 prevention & control, Hematologic Neoplasms immunology, Hematologic Neoplasms mortality, SARS-CoV-2 immunology
Published
2022
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11. Real-World Characteristics and Outcome of Patients Treated With Single-Agent Ibrutinib for Chronic Lymphocytic Leukemia in Spain (IBRORS-LLC Study).

Author

Abrisqueta P, Loscertales J, Terol MJ, Ramírez Payer Á, Ortiz M, Pérez I, Cuellar-García C, Fernández de la Mata M, Rodríguez A, Lario A, Delgado J, Godoy A, Arguiñano Pérez JM, Berruezo MJ, Oliveira A, Hernández-Rivas JÁ, García Malo MD, Medina Á, García Martin P, Osorio S, Baltasar P, Fernández-Zarzoso M, Marco F, Vidal Manceñido MJ, Smucler Simonovich A, López Rubio M, Jarque I, Suarez A, Fernández Álvarez R, Lancharro Anchel A, Ríos E, Losada Castillo MDC, Pérez Persona E, García Muñoz R, Ramos R, Yáñez L, Bello JL, Loriente C, Acha D, and Villanueva M

Subjects
Adenine analogs & derivatives, Aged, Humans, Piperidines, Pyrazoles adverse effects, Pyrimidines adverse effects, Retrospective Studies, Spain epidemiology, Leukemia, Lymphocytic, Chronic, B-Cell
Abstract

Background: Ibrutinib demonstrated remarkable efficacy and favorable tolerability in patients with untreated or relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL), including those with high-risk genetic alterations. The IBRORS-CLL study assessed the characteristics, clinical management and outcome of CLL patients receiving ibrutinib in routine clinical practice in Spain., Patients: Observational, retrospective, multicenter study in CLL patients who started single-agent ibrutinib as first-line treatment or at first or second relapse between January 2016 and January 2019., Results: A total of 269 patients were included (median age: 70.9 years; cardiovascular comorbidity: 55.4%, including hypertension [47.6%] and atrial fibrillation [AF] [7.1%]). Overall, 96.7% and 69% of patients underwent molecular testing for del(17p)/TP53 mutation and IGHV mutation status. High-risk genetic features included unmutated IGHV (79%) and del(17p)/TP53 mutation (first-line: 66.3%; second-line: 23.1%). Overall, 84 (31.2%) patients received ibrutinib as first-line treatment, and it was used as second- and third-line therapy in 121 (45.0%) and 64 (23.8%) patients. The median progression-free survival and overall survival were not reached irrespective of del(17p)/TP53, or unmutated IGHV. Common grade ≥3 adverse events were infections (12.2%) and bleeding (3%). Grade ≥3 AF occurred in 1.5% of patients., Conclusion: This real-world study shows that single-agent ibrutinib is an effective therapy for CLL, regardless of age and high-risk molecular features, consistent with clinical trials. Additionally, single-agent ibrutinib was well tolerated, with a low rate of cardiovascular events. This study also emphasized a high molecular testing rate of del(17p)/TP53 mutation and IGHV mutation status in clinical practice according to guideline recommendations., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2021
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12. Outcomes of COVID-19 in patients with CLL: a multicenter international experience.

Author

Mato AR, Roeker LE, Lamanna N, Allan JN, Leslie L, Pagel JM, Patel K, Osterborg A, Wojenski D, Kamdar M, Huntington SF, Davids MS, Brown JR, Antic D, Jacobs R, Ahn IE, Pu J, Isaac KM, Barr PM, Ujjani CS, Geyer MB, Berman E, Zelenetz AD, Malakhov N, Furman RR, Koropsak M, Bailey N, Hanson L, Perini GF, Ma S, Ryan CE, Wiestner A, Portell CA, Shadman M, Chong EA, Brander DM, Sundaram S, Seddon AN, Seymour E, Patel M, Martinez-Calle N, Munir T, Walewska R, Broom A, Walter H, El-Sharkawi D, Parry H, Wilson MR, Patten PEM, Hernández-Rivas JÁ, Miras F, Fernández Escalada N, Ghione P, Nabhan C, Lebowitz S, Bhavsar E, López-Jiménez J, Naya D, Garcia-Marco JA, Skånland SS, Cordoba R, and Eyre TA

Subjects
Adult, Agammaglobulinaemia Tyrosine Kinase antagonists & inhibitors, Aged, Aged, 80 and over, Anti-Inflammatory Agents therapeutic use, Antiviral Agents therapeutic use, Betacoronavirus isolation & purification, COVID-19, Coronavirus Infections therapy, Female, Humans, Immunization, Passive, Leukemia, Lymphocytic, Chronic, B-Cell therapy, Male, Middle Aged, Pandemics, Pneumonia, Viral therapy, Protein Kinase Inhibitors therapeutic use, SARS-CoV-2, Survival Analysis, Treatment Outcome, COVID-19 Serotherapy, Coronavirus Infections complications, Leukemia, Lymphocytic, Chronic, B-Cell complications, Pneumonia, Viral complications
Abstract

Given advanced age, comorbidities, and immune dysfunction, chronic lymphocytic leukemia (CLL) patients may be at particularly high risk of infection and poor outcomes related to coronavirus disease 2019 (COVID-19). Robust analysis of outcomes for CLL patients, particularly examining effects of baseline characteristics and CLL-directed therapy, is critical to optimally manage CLL patients through this evolving pandemic. CLL patients diagnosed with symptomatic COVID-19 across 43 international centers (n = 198) were included. Hospital admission occurred in 90%. Median age at COVID-19 diagnosis was 70.5 years. Median Cumulative Illness Rating Scale score was 8 (range, 4-32). Thirty-nine percent were treatment naive ("watch and wait"), while 61% had received ≥1 CLL-directed therapy (median, 2; range, 1-8). Ninety patients (45%) were receiving active CLL therapy at COVID-19 diagnosis, most commonly Bruton tyrosine kinase inhibitors (BTKi's; n = 68/90 [76%]). At a median follow-up of 16 days, the overall case fatality rate was 33%, though 25% remain admitted. Watch-and-wait and treated cohorts had similar rates of admission (89% vs 90%), intensive care unit admission (35% vs 36%), intubation (33% vs 25%), and mortality (37% vs 32%). CLL-directed treatment with BTKi's at COVID-19 diagnosis did not impact survival (case fatality rate, 34% vs 35%), though the BTKi was held during the COVID-19 course for most patients. These data suggest that the subgroup of CLL patients admitted with COVID-19, regardless of disease phase or treatment status, are at high risk of death. Future epidemiologic studies are needed to assess severe acute respiratory syndrome coronavirus 2 infection risk, these data should be validated independently, and randomized studies of BTKi's in COVID-19 are needed to provide definitive evidence of benefit.

Published
2020
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13. Further psychometric validation of the GAH scale: Responsiveness and effect size.

Author

Cruz-Jentoft AJ, González B, de la Rubia J, Hernández Rivas JÁ, Soler JA, Fernández Lago C, Arnao M, Gironella M, Pérez Persona E, Zudaire MT, Olivier C, Altés A, García Guiñón A, Nomdedeu B, Arnan M, Ramírez Payer Á, Sánchez-Godoy P, Pajuelo N, Vilanova D, Monjil DF, and Bonanad S

Subjects
Activities of Daily Living, Aged, Disease Progression, Female, Humans, Karnofsky Performance Status, Male, Middle Aged, Prospective Studies, Psychometrics, Sensitivity and Specificity, Visual Analog Scale, Geriatric Assessment methods, Hematologic Neoplasms psychology
Abstract

Objectives: The purpose of this study was to assess the responsiveness of the newly developed Geriatric Assessment in Hematology (GAH) scale to clinical change in older patients diagnosed with hematologic malignancies., Methods: A prospective observational study conducted in 164 patients aged ≥65years and diagnosed with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML), multiple myeloma (MM), or chronic lymphocytic leukemia (CLL). Responsiveness of the GAH scales was studied by means of the Eastern Cooperative Oncology Group (ECOG) score, the Karnofsky performance status (KPS) score, the visual analog scale (VAS), and the physician's subjective assessment, used as clinical anchors to identify whether patients had changed clinically (either improved or worsened) or not since the baseline visit. Responsiveness was evaluated on the basis of effect size (ES)., Results: 164 patients (men, 63.7%; median age, 77.0 (72.8-81.4) participated. Statistically significant correlations were obtained between the investigator's qualitative assessment and changes in ECOG, KPS, and VAS scores. Likewise, a statistically significant correlation was obtained between the investigator's qualitative assessment and changes in the GAH scale score. Responsiveness of the GAH scale to detect clinical change was satisfactory (ES 0.34)., Conclusion: Findings confirm that the GAH scale is responsive to clinical changes in patients' health status. Additionally, the GAH scale is a promising tool to improve clinical decision-making in older patients with hematological malignancies., (Copyright © 2016 Elsevier Ltd. All rights reserved.)

Published
2017
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