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1. Correction: Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Author

Ossenkoppele, G. J., Breems, D. A., Stuessi, G., van Norden, Y., Bargetzi, M., Biemond, B. J., A von dem Borne, P., Chalandon, Y., Cloos, J., Deeren, D., Fehr, M., Gjertsen, B., Graux, C., Huls, G., Janssen, J. J. J. W., Jaspers, A., Jongen-Lavrencic, M., de Jongh, E., Klein, S. K., van der Klift, M., van Marwijk Kooy, M., Maertens, J., Michaux, L., van der Poel, M. W. M., van Rhenen, A., Tick, L., Valk, P., Vekemans, M. C., van der Velden, W. J. F. M., de Weerdt, O., Pabst, T., Manz, M., Löwenberg, B., Havelange, Vekemans, M-C, Moors, I., van Obberg, F., Maertens, J. A., Hodossy, B., Vansteenweghen, S., Lammertijn, L., Sonet, A., Triffet, A., Gjertsen, B. T., Passweg, J., Heim, D., Giovanni, San, Stuessi, Georg, Betticher, D., Spertini, O., Gregor, M., Hess, U., Manz, M. G., Ossenkoppele, G J, van de Loosdrecht, A., Janssen, J J W M, van Esser, J. W. J., Van der Klift, M., Brouwer, R. E., Van Lammeren-Venema, D., Levin, M. D., Tick, L. W., Legdeur, M. C. J. C., Vellenga, E., Hoogendoorn, M., Veelken, J. H., von dem Borne, P. A., Schouten, H. C., Cornelissen, J., Wouters, B., Raaijmakers, H. G. M., Kuball, J., Van Rhenen, A., Van Marwijk Kooy, M., UCL - (SLuc) Centre du cancer, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'hématologie, and UCL - SSS/DDUV/MEXP - Médecine expérimentale

Subjects
Cancer Research, Pediatrics, medicine.medical_specialty, business.industry, Intensive treatment, MEDLINE, Hematology, Oncology, Older patients, Medicine, business, Lenalidomide, medicine.drug
Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020

2. Autologous haematopoietic stem-cell transplantation versus bortezomib-melphalan-prednisone, with or without bortezomib-lenalidomide-dexamethasone consolidation therapy, and lenalidomide maintenance for newly diagnosed multiple myeloma (EMN02/HO95)

Author

Michele Cavo, Francesca Gay, Meral Beksac, Lucia Pantani, Maria Teresa Petrucci, Meletios A Dimopoulos, Luca Dozza, Bronno van der Holt, Sonja Zweegman, Stefania Oliva, Vincent H J van der Velden, Elena Zamagni, Giuseppe A Palumbo, Francesca Patriarca, Vittorio Montefusco, Monica Galli, Vladimir Maisnar, Barbara Gamberi, Markus Hansson, Angelo Belotti, Ludek Pour, Paula Ypma, Mariella Grasso, Alexsandra Croockewit, Stelvio Ballanti, Massimo Offidani, Iolanda D Vincelli, Renato Zambello, Anna Marina Liberati, Niels Frost Andersen, Annemiek Broijl, Rossella Troia, Anna Pascarella, Giulia Benevolo, Mark-David Levin, Gerard Bos, Heinz Ludwig, Sara Aquino, Anna Maria Morelli, Ka Lung Wu, Rinske Boersma, Roman Hajek, Marc Durian, Peter A von dem Borne, Tommaso Caravita di Toritto, Thilo Zander, Christoph Driessen, Giorgina Specchia, Anders Waage, Peter Gimsing, Ulf-Henrik Mellqvist, Marinus van Marwijk Kooy, Monique Minnema, Caroline Mandigers, Anna Maria Cafro, Angelo Palmas, Susanna Carvalho, Andrew Spencer, Mario Boccadoro, Pieter Sonneveld, Hematology, CCA - Cancer Treatment and quality of life, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), Immunology, Cavo M., Gay F., Beksac M., Pantani L., Petrucci M.T., Dimopoulos M.A., Dozza L., van der Holt B., Zweegman S., Oliva S., van der Velden V.H.J., Zamagni E., Palumbo G.A., Patriarca F., Montefusco V., Galli M., Maisnar V., Gamberi B., Hansson M., Belotti A., Pour L., Ypma P., Grasso M., Croockewit A., Ballanti S., Offidani M., Vincelli I.D., Zambello R., Liberati A.M., Andersen N.F., Broijl A., Troia R., Pascarella A., Benevolo G., Levin M.-D., Bos G., Ludwig H., Aquino S., Morelli A.M., Wu K.L., Boersma R., Hajek R., Durian M., von dem Borne P.A., Caravita di Toritto T., Zander T., Specchia G., Waage A., Gimsing P., Mellqvist U.-H., van Marwijk Kooy M., Minnema M., Mandigers C., Cafro A.M., Palmas A., Carvalho S., Spencer A., Boccadoro M., and Sonneveld P.

Subjects
Male, Melphalan, Gastrointestinal Diseases, multiple myeloma, ASCT, consolidation therapy, EMN02/HO95, Dexamethasone, Bortezomib, 0302 clinical medicine, Maintenance therapy, Antineoplastic Combined Chemotherapy Protocols, Medicine, Lenalidomide, Multiple myeloma, education.field_of_study, Hematopoietic Stem Cell Transplantation, Hematology, Middle Aged, daratumumab, Myeloma Proteins, SINGLE, 030220 oncology & carcinogenesis, Administration, Intravenous, Female, Multiple Myeloma, medicine.drug, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], medicine.medical_specialty, Neutropenia, Injections, Subcutaneous, Population, Infections, Transplantation, Autologous, Disease-Free Survival, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, Internal medicine, Humans, education, Neoplasm Staging, Performance status, business.industry, DELETION, medicine.disease, Thrombocytopenia, Consolidation Chemotherapy, Transplantation, Prednisone, business, Plasmacytoma, DARATUMUMAB, 030215 immunology
Abstract

Background The emergence of highly active novel agents has led some to question the role of autologous haematopoietic stem-cell transplantation (HSCT) and subsequent consolidation therapy in newly diagnosed multiple myeloma. We therefore compared autologous HSCT with bortezomib-melphalan-prednisone (VMP) as intensification therapy, and bortezomib-lenalidomide-dexamethasone (VRD) consolidation therapy with no consolidation.Methods In this randomised, open-label, phase 3 study we recruited previously untreated patients with multiple myeloma at 172 academic and community practice centres of the European Myeloma Network. Eligible patients were aged 18-65 years, had symptomatic multiple myeloma stage 1-3 according to the International Staging System (I S S), measurable disease (serum M protein >10 g/L or urine M protein >200 mg in 24 h or abnormal free light chain [FLC] ratio with involved FLC >100 mg/L, or proven plasmacytoma by biopsy), and WHO performance status grade 0-2 (grade 3 was allowed if secondary to myeloma). Patients were first randomly assigned (1:1) to receive either four 42-day cycles of bortezomib (1.3 mg/m 2 administered intravenously or subcutaneously on days 1, 4, 8, 11, 22, 25, 29, and 32) combined with melphalan (9 mg/m(2) administered orally on days 1-4) and prednisone (60 mg/m(2) administered orally on days 1-4) or autologous HSCT after high-dose melphalan (200 mg/m(2)), stratified by site and ISS disease stage. In centres with a double HS CT policy, the first randomisation (1:1:1) was to VMP or single or double HSCT. Afterwards, a second randomisation assigned patients to receive two 28-day cycles of consolidation therapy with bortezomib (1.3 mg/m(2)either intravenously or subcutaneously on days 1, 4, 8, and 11), lenalidomide (25 mg orally on days 1-21), and dexamethasone (20 mg orally on days 1, 2, 4, 5, 8, 9, 11, and 12) or no consolidation; both groups received lenalidomide maintenance therapy (10 mg orally on days 1-21 of a 28-day cycle). The primary outcomes were progression-free survival from the first and second randomisations, analysed in the intention-to-treat population, which included all patients who underwent each randomisation. All patients who received at least one dose of study drugs were included in the safety analyses. This study is registered with the EU Clinical Trials Register (EudraCT 2009-017903-28) and ClinicalTrials.gov (NCT01208766), and has completed recruitment.Findings Between Feb 25, 2011, and April 3, 2014, 1503 patients were enrolled. 1197 patients were eligible for the first randomisation, of whom 702 were assigned to autologous HSCT and 495 to VMP; 877 patients who were eligible for the first randomisation underwent the second randomisation to VRD consolidation (n=449) or no consolidation (n=428). The data cutoff date for the current analysis was Nov 26, 2018. At a median follow-up of 60.3 months (IQR 52. 2-67. 6), median progression-free survival was significantly improved with autologous HSCT compared with VMP (56.7 months [95% CI 49.3-64.5] vs 41.9 months [37.5-46.9]; hazard ratio [HR] 0.73, 0.62-0.85; p=0.0001). For the second randomisation, the number of events of progression or death at data cutoff was lower than that preplanned for the final analysis; therefore, the results from the second protocol-specified interim analysis, when 66% of events were reached, are reported (data cutoff Jan 18, 2018). At a median follow-up of 42.1 months (IQR 32.3-49.2), consolidation therapy with VRD significantly improved median progression-free survival compared with no consolidation (58.9 months [54.0-not estimable] vs 45.5 months [39.5-58.4]; HR 0.77, 0.63-0.95; p=0.014). The most common grade >= 3 adverse events in the autologous HSCT group compared to the VMP group included neutropenia (513 [79%] of 652 patients vs 137 [29%] of 472 patients), thrombocytopenia (541 [83%] vs 74 [16%]), gastrointestinal disorders (80 [12%] vs 25 [5%]), and infections (192 [30%] vs 18 [4%]). 239 (34%) of 702 patients in the autologous HSCT group and 135 (27%) of 495 in the VMP group had at least one serious adverse event. Infection was the most common serious adverse event in each of the treatment groups (206 [56%] of 368 and 70 [37%] of 189). 38 (12%) of 311 deaths from first randomisation were likely to be treatment related: 26 (68%) in the autologous HSCT group and 12 (32%) in the VMP group, most frequently due to infections (eight [21%]), cardiac events (six [16%]), and second primary malignancies (20 [53%]).Interpretation This study supports the use of autologous HSCT as intensification therapy and the use of consolidation therapy in patients with newly diagnosed multiple myeloma, even in the era of novel agents. The role of high-dose chemotherapy needs to be reassessed in future studies, in particular in patients with undetectable minimal residual disease after four-drug induction regimens including a monoclonal antiboby combined with an immunomodulatory agent and a proteasome inhibitor plus dexamethasone. Copyright (C) 2020 Elsevier Ltd. All rights reserved.

Published
2020
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3. COVID-19 severity and mortality in patients with CLL: an update of the international ERIC and Campus CLL study

Author

Ellen van der Spek, Emili Montserrat, Talha Munir, Paolo Ghia, Shaimaa El-Ashwah, Andreas Glenthøj, Viola Maria Popov, Sanne H. Tonino, Ann Janssens, Michel van Gelder, Lara Malerba, Rocío García-Serra, Alberto Lopez-Garcia, Juan-Gonzalo Correa, Christos Demosthenous, Idanna Innocenti, Maria Papaioannou, Lydia Scarfò, Antonio Cuneo, Francesca Romana Mauro, Sabina Kersting, Robin Foà, David Donaldson, Livio Trentin, Roberta Murru, Panagiotis Baliakas, Marina Motta, Deepesh Lad, Yervand K Hakobyan, Paolo Sportoletti, Lucrecia Yáñez San Segundo, Alicia Enrico, Elżbieta Kalicińska, Ewa Wasik-Szczepanek, Martin Spacek, Tamar Tadmor, Enrico Lista, Roel van Kampen, Lorella Orsucci, Michael Doubek, Yair Herishanu, Blanca Espinet, Jose Angel Hernandez-Rivas, Inga Piskunova, Ozren Jakšić, Georgios Karakatsoulis, Tomasz Wróbel, Oana Stanca, Luca Laurenti, Martin Andres, Roberto Marasca, Mark-David Levin, Giovanni Del Poeta, Miguel Arturo Pavlovsky, Maria Dimou, Monia Marchetti, Ivana Milosevic, Gianluigi Reda, Tobias Herold, David Allsup, Raul Cordoba, Andrea Visentin, Maria Gomes da Silva, Angela Ferrari, Antonella Capasso, Juan Marquet, Francesca Maria Quaglia, Candida Vitale, Mattias Mattsson, Marta Coscia, Moritz Fürstenau, Lucia Farina, Niki Stavroyianni, Marta Morawska, Arnon P. Kater, Mónica Baile, Gevorg Saghumyan, Carolina Cuéllar-García, Jacopo Olivieri, Darko Antic, Raquel Nunes Rodrigues, Alejandro Alonso Cabrero, Henrik Frederiksen, Alessandro Rambaldi, Marzia Varettoni, Amit Shrestha, Оlga B Kalashnikova, Thomas Chatzikonstantinou, José A. García-Marco, Martin Simkovic, Linda Katharina Karlsson, Odit Gutwein, Mohamed A. Yassin, Rosa Ruchlemer, Eva Gimeno, Kristian Qvist, Fatima Miras, Gilad Itchaki, Maria Rosaria De Paolis, Maria Efstathopoulou, Doreen te Raa, Barbara Eichhorst, Dominique Bron, Jorge Labrador, Gian Matteo Rigolin, Myriam Foglietta, Massimo Gentile, Sofia Chatzileontiadou, Carsten Utoft Niemann, Anargyros Kapetanakis, Kostas Stamatopoulos, Lorenzo De Paoli, Giulia Quaresmini, RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, MUMC+: MA Hematologie (9), Chatzikonstantinou, T., Kapetanakis, A., Scarfo, L., Karakatsoulis, G., Allsup, D., Cabrero, A. A., Andres, M., Antic, D., Baile, M., Baliakas, P., Bron, D., Capasso, A., Chatzileontiadou, S., Cordoba, R., Correa, J. -G., Cuellar-Garcia, C., De Paoli, L., De Paolis, M. R., Del Poeta, G., Demosthenous, C., Dimou, M., Donaldson, D., Doubek, M., Efstathopoulou, M., Eichhorst, B., El-Ashwah, S., Enrico, A., Espinet, B., Farina, L., Ferrari, A., Foglietta, M., Frederiksen, H., Furstenau, M., Garcia-Marco, J. A., Garcia-Serra, R., Gentile, M., Gimeno, E., Glenthoj, A., Gomes da Silva, M., Gutwein, O., Hakobyan, Y. K., Herishanu, Y., Hernandez-Rivas, J. A., Herold, T., Innocenti, I., Itchaki, G., Jaksic, O., Janssens, A., Kalashnikova, Оb., Kalicinska, E., Karlsson, L. K., Kater, A. P., Kersting, S., Labrador, J., Lad, D., Laurenti, L., Levin, M. -D., Lista, E., Lopez-Garcia, A., Malerba, L., Marasca, R., Marchetti, M., Marquet, J., Mattsson, M., Mauro, F. R., Milosevic, I., Miras, F., Morawska, M., Motta, M., Munir, T., Murru, R., Niemann, C. U., Rodrigues, R. N., Olivieri, J., Orsucci, L., Papaioannou, M., Pavlovsky, M. A., Piskunova, I., Popov, V. M., Quaglia, F. M., Quaresmini, G., Qvist, K., Reda, G., Rigolin, G. M., Ruchlemer, R., Saghumyan, G., Shrestha, A., Simkovic, M., Spacek, M., Sportoletti, P., Stanca, O., Stavroyianni, N., Tadmor, T., Te Raa, D., Tonino, S. H., Trentin, L., Van Der Spek, E., van Gelder, M., van Kampen, R., Varettoni, M., Visentin, A., Vitale, C., Wasik-Szczepanek, E., Wrobel, T., San Segundo, L. Y., Yassin, M., Coscia, M., Rambaldi, A., Montserrat, E., Foa, R., Cuneo, A., Stamatopoulos, K., Ghia, P., Experimental Immunology, Clinical Haematology, AII - Cancer immunology, and CCA - Cancer Treatment and Quality of Life

Subjects
Chronic lymphocytic leukaemia, Cancer Research, medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), Epidemiology, medicine.medical_treatment, Chronic lymphocytic leukemia, CLL, COVID-19, 610 Medicine & health, Disease, Lower risk, COVID-19 (Malaltia), Severity of Illness Index, Article, NO, law.invention, Risk Factors, law, Internal medicine, Case fatality rate, Mortalitat, medicine, Humans, Hematologi, Chronic, Mortality, Science & Technology, Leukemia, SARS-CoV-2, business.industry, Vaccination, B-Cell, Leucèmia, COVID-19, Immunosuppression, Hematology, Prognosis, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Survival Analysis, Intensive care unit, Lymphocytic, Oncology, business, Life Sciences & Biomedicine
Abstract

Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to Coronavirus disease 2019 (COVID-19) due to age, disease, and treatment-related immunosuppression. We aimed to assess risk factors of outcome and elucidate the impact of CLL-directed treatments on the course of COVID-19. We conducted a retrospective, international study, collectively including 941 patients with CLL and confirmed COVID-19. Data from the beginning of the pandemic until March 16, 2021, were collected from 91 centers. The risk factors of case fatality rate (CFR), disease severity, and overall survival (OS) were investigated. OS analysis was restricted to patients with severe COVID-19 (definition: hospitalization with need of oxygen or admission into an intensive care unit). CFR in patients with severe COVID-19 was 38.4%. OS was inferior for patients in all treatment categories compared to untreated (p

Published
2021
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4. Consolidation and Maintenance in Newly Diagnosed Multiple Myeloma

Author

Pieter Sonneveld, Meletios A. Dimopoulos, Meral Beksac, Bronno van der Holt, Sara Aquino, Heinz Ludwig, Sonja Zweegman, Thilo Zander, Elena Zamagni, Ruth Wester, Roman Hajek, Lucia Pantani, Luca Dozza, Francesca Gay, AnneMaria Cafro, Luca De Rosa, Annamaria Morelli, Henrik Gregersen, Nina Gulbrandsen, Petra Cornelisse, Rosella Troia, Stefania Oliva, Vincent van de Velden, KaLung Wu, Paula F. Ypma, Gerard Bos, Mark-David Levin, Luca Pour, Christoph Driessen, Annemiek Broijl, Alexandra Croockewit, Monique C. Minnema, Anders Waage, Cecilie Hveding, Niels W. C. J. van de Donk, Massimo Offidani, Giuseppe A. Palumbo, Andrew Spencer, Mario Boccadoro, Michele Cavo, Interne Geneeskunde, MUMC+: MA Hematologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Hematology, Immunology, CCA - Cancer Treatment and quality of life, Sonneveld P., Dimopoulos M.A., Beksac M., van der Holt B., Aquino S., Ludwig H., Zweegman S., Zander T., Zamagni E., Wester R., Hajek R., Pantani L., Dozza L., Gay F., Cafro A., De Rosa L., Morelli A., Gregersen H., Gulbrandsen N., Cornelisse P., Troia R., Oliva S., van de Velden V., Wu K., Ypma P.F., Bos G., Levin M.-D., Pour L., Driessen C., Broijl A., Croockewit A., Minnema M.C., Waage A., Hveding C., van de Donk N.W.C.J., Offidani M., Palumbo G.A., Spencer A., Boccadoro M., and Cavo M.

Subjects
Oncology, Cancer Research, Neoplasm, Residual, Time Factors, THERAPY, Consolidation (business), Antineoplastic Combined Chemotherapy Protocols, IMPROVES, Lenalidomide/administration & dosage, Lenalidomide, Multiple myeloma, OUTCOMES, INDUCTION, Antineoplastic Combined Chemotherapy Protocols/administration & dosage, Middle Aged, OPEN-LABEL, Progression-Free Survival, DEXAMETHASONE, Europe, Residual, Multiple Myeloma, Human, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9], Adult, Dexamethasone/administration & dosage, medicine.medical_specialty, Time Factor, Adolescent, Multiple Myeloma/drug therapy, BORTEZOMIB, Newly diagnosed, Maintenance Chemotherapy, Young Adult, SDG 3 - Good Health and Well-being, Internal medicine, medicine, Humans, Aged, Neoplasm Staging, Antineoplastic Combined Chemotherapy Protocol, business.industry, STEM-CELL TRANSPLANTATION, medicine.disease, Consolidation Chemotherapy, LENALIDOMIDE MAINTENANCE, Bortezomib/administration & dosage, Neoplasm, CONSENSUS, business
Abstract

PURPOSE To address the role of consolidation treatment for newly diagnosed, transplant eligible patients with multiple myeloma in a controlled clinical trial. PATIENTS AND METHODS The EMN02/HOVON95 trial compared consolidation treatment with two cycles of bortezomib, lenalidomide, and dexamethasone (VRD) or no consolidation after induction and intensification therapy, followed by continuous lenalidomide maintenance. Primary study end point was progression-free survival (PFS). RESULTS Eight hundred seventy-eight eligible patients were randomly assigned to receive VRD consolidation (451 patients) or no consolidation (427 patients). At a median follow-up of 74.8 months, median PFS with adjustment for pretreatment was prolonged in patients randomly assigned to VRD consolidation (59.3 v 42.9 months, hazard ratio [HR] = 0.81; 95% CI, 0.68 to 0.96; P = .016). The PFS benefit was observed across most predefined subgroups, including revised International Staging System (ISS) stage, cytogenetics, and prior treatment. Revised ISS3 stage (HR, 2.00; 95% CI, 1.41 to 2.86) and ampl1q (HR, 1.67; 95% CI, 1.37 to 2.04) were significant adverse prognostic factors. The median duration of maintenance was 33 months (interquartile range 13-86 months). Response ≥ complete response (CR) after consolidation versus no consolidation before start of maintenance was 34% versus 18%, respectively ( P < .001). Response ≥ CR on protocol including maintenance was 59% with consolidation and 46% without ( P < .001). Minimal residual disease analysis by flow cytometry in a subgroup of 226 patients with CR or stringent complete response or very good partial response before start of maintenance demonstrated a 74% minimal residual disease–negativity rate in VRD-treated patients. Toxicity from VRD was acceptable and manageable. CONCLUSION Consolidation treatment with VRD followed by lenalidomide maintenance improves PFS and depth of response in newly diagnosed patients with multiple myeloma as compared to maintenance alone.

Published
2021
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5. Daratumumab, bortezomib, and dexamethasone in relapsed or refractory multiple myeloma: Subgroup analysis of CASTOR based on cytogenetic risk

Author

Markus Munder, Katja Weisel, Ho Jin Shin, Cindy Lee, Tomer M Mark, Tamás Masszi, Maria-Victoria Mateos, Meral Beksac, Andrew Spencer, Birgitta Lauri, Paolo Corradini, Je-Jung Lee, Asher Chanan-Khan, Tineke Casneuf, Hang Quach, Suzanne Lentzsch, Roberto Ovilla, Jon Ukropec, Jae Cheol Jo, Noemi Horvath, Wolney Barreto, Mark-David Levin, Himal Amin, Marcelo Capra, Ivan Spicka, Pieter Sonneveld, Nikki A. Deangelis, Vania Hungria, Chang-Ki Min, Michele Cavo, Alberto Bosi, Ajay K. Nooka, Hervé Avet-Loiseau, Rachel Kobos, Hematology, Janssen Research and Development, Weisel K., Spencer A., Lentzsch S., Avet-Loiseau H., Mark T.M., Spicka I., Masszi T., Lauri B., Levin M.-D., Bosi A., Hungria V., Cavo M., Lee J.-J., Nooka A., Quach H., Munder M., Lee C., Barreto W., Corradini P., Min C.-K., Chanan-Khan A.A., Horvath N., Capra M., Beksac M., Ovilla R., Jo J.-C., Shin H.-J., Sonneveld P., Casneuf T., Deangelis N., Amin H., Ukropec J., Kobos R., and Mateos M.-V.

Subjects
Oncology, Male, Cancer Research, Neoplasm, Residual, Abnormal Karyotype, Kaplan-Meier Estimate, Dexamethasone, Bortezomib, Clinical trials, Recurrence, Multiple myeloma, Antineoplastic Combined Chemotherapy Protocols, In Situ Hybridization, Fluorescence, Aged, 80 and over, education.field_of_study, Antibodies, Monoclonal, Hematology, lcsh:Diseases of the blood and blood-forming organs, Middle Aged, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Progression-Free Survival, Clinical trial, Tolerability, Female, medicine.drug, Adult, Risk, medicine.medical_specialty, Population, lcsh:RC254-282, Internal medicine, medicine, Humans, Progression-free survival, education, Molecular Biology, Aged, business.industry, lcsh:RC633-647.5, Research, Daratumumab, Myeloma therapy, medicine.disease, Minimal residual disease, business, Follow-Up Studies
Abstract

© The Author(s)., Background: Multiple myeloma (MM) patients with high cytogenetic risk have poor outcomes. In CASTOR, daratumumab plus bortezomib/dexamethasone (D-Vd) prolonged progression-free survival (PFS) versus bortezomib/dexamethasone (Vd) alone and exhibited tolerability in patients with relapsed or refractory MM (RRMM). [Methods]: This subgroup analysis evaluated D-Vd versus Vd in CASTOR based on cytogenetic risk, determined using fluorescence in situ hybridization and/or karyotype testing performed locally. High-risk patients had t(4;14), t(14;16), and/or del17p abnormalities. Minimal residual disease (MRD; 10-5 sensitivity threshold) was assessed via the clonoSEQ® assay V2.0. Of the 498 patients randomized, 40 (16%) in the D-Vd group and 35 (14%) in the Vd group were categorized as high risk. [Results]: After a median follow-up of 40.0 months, D-Vd prolonged median PFS versus Vd in patients with standard (16.6 vs 6.6 months; HR, 0.26; 95% CI, 0.19-0.37; P < 0.0001) and high (12.6 vs 6.2 months; HR, 0.41; 95% CI, 0.21-0.83; P = 0.0106) cytogenetic risk. D-Vd achieved deep responses, including higher rates of MRD negativity and sustained MRD negativity versus Vd, regardless of cytogenetic risk. The safety profile was consistent with the overall population of CASTOR. [Conclusion]: These updated data reinforce the effectiveness and tolerability of daratumumab-based regimens for RRMM, regardless of cytogenetic risk status. Trial registration: ClinicalTrials.gov, NCT02136134. Registered 12 May 2014, This CASTOR study was sponsored by Janssen Research & Development, LLC. Open access funding provided by Projekt DEAL.

Published
2020

6. COVID-19 severity and mortality in patients with chronic lymphocytic leukemia: a joint study by ERIC, the European Research Initiative on CLL, and CLL Campus

Author

Tobias Herold, Martin Andres, Gimena Dos Santos, Livio Trentin, Monia Marchetti, Antonio Cuneo, Robin Foà, Vladimir Strugov, Sunil Iyengar, Ozren Jakšić, Mark-David Levin, Angela Ferrari, Francesca Romana Mauro, Candida Vitale, Martin Spacek, Olga Kalashnikova, Eugene Nikitin, Ann Janssens, Constantine S. Tam, Julio Delgado, Maria Papaioannou, Barbara Pocali, Davide Rossi, Marina Motta, Niki Stavroyianni, Myriam Foglietta, Alicia Enrico, Carolina Cuéllar-García, Lara Malerba, Mónica Baile, Lydia Scarfò, Ellen van der Spek, Paolo Sportoletti, Maria Rosaria De Paolis, Mihnea Zdrenghea, Macarena Ortiz Pareja, Annalisa Chiarenza, Sabina Kersting, Fatima Miras, Yair Herishanu, Emili Montserrat, Marta Coscia, Giuseppe Rossi, Jose Angel Hernandez-Rivas, Carsten Utoft Niemann, Alessandro Rambaldi, Amit Shrestha, Roberto Marasca, Rosa Ruchlemer, Marzia Varettoni, Dominique Bron, Juan Marquet, Eva Gimeno, Viola Maria Popov, Massimo Gentile, Mohamed A. Yassin, Kostas Stamatopoulos, Lorenzo De Paoli, Thomas Chatzikonstantinou, Giulia Quaresmini, Luca Laurenti, Lucia Farina, Arnon P. Kater, Nimish Shah, Elisabeth Vandenberghe, José A. García-Marco, Oana Stanca, Giovanni Del Poeta, Martin Simkovic, Yervand K Hakobyan, Enrico Lista, Michael Doubek, Gilad Itchaki, Talha Munir, Paolo Ghia, Ewa Wasik-Szczepanek, Gianluigi Reda, Francesca Maria Quaglia, Maria Dimou, Gábor Barna, Lorella Orsucci, Gian Matteo Rigolin, Scarfo', L., Chatzikonstantinou, T., Rigolin, G. M., Quaresmini, G., Motta, M., Vitale, C., Garcia-Marco, J. A., Hernandez-Rivas, J. A., Miras, F., Baile, M., Marquet, J., Niemann, C. U., Reda, G., Munir, T., Gimeno, E., Marchetti, M., Quaglia, F. M., Varettoni, M., Delgado, J., Iyengar, S., Janssens, A., Marasca, R., Ferrari, A., Cuellar-Garcia, C., Itchaki, G., Spacek, M., De Paoli, L., Laurenti, L., Levin, M. -D., Lista, E., Mauro, F. R., Simkovic, M., Van Der Spek, E., Vandenberghe, E., Trentin, L., Wasik-Szczepanek, E., Ruchlemer, R., Bron, D., De Paolis, M. R., Del Poeta, G., Farina, L., Foglietta, M., Gentile, M., Herishanu, Y., Herold, T., Jaksic, O., Kater, A. P., Kersting, S., Malerba, L., Orsucci, L., Popov, V. M., Sportoletti, P., Yassin, M., Pocali, B., Barna, G., Chiarenza, A., dos Santos, G., Nikitin, E., Andres, M., Dimou, M., Doubek, M., Enrico, A., Hakobyan, Y., Kalashnikova, O., Ortiz Pareja, M., Papaioannou, M., Rossi, D., Shah, N., Shrestha, A., Stanca, O., Stavroyianni, N., Strugov, V., Tam, C., Zdrenghea, M., Coscia, M., Stamatopoulos, K., Rossi, G., Rambaldi, A., Montserrat, E., Foa, R., Cuneo, A., Ghia, P., Experimental Immunology, Clinical Haematology, and CCA - Cancer Treatment and Quality of Life

Subjects
0301 basic medicine, Male, Chronic lymphocytic leukaemia, Cancer Research, Chronic Lymphocytic Leukemia, COVID-19, Chronic lymphocytic leukemia, Comorbidity, Severity of Illness Index, chemistry.chemical_compound, 0302 clinical medicine, Piperidines, Obinutuzumab, Surveys and Questionnaires, hemic and lymphatic diseases, 80 and over, Viral, Chronic, 610 Medicine & health, Immunodeficiency, Aged, 80 and over, Leukemia, Mortality rate, Age Factors, Hematology, Middle Aged, Prognosis, Lymphocytic, Oncology, 030220 oncology & carcinogenesis, Infectious diseases, Female, Coronavirus Infections, medicine.drug, Bendamustine, medicine.medical_specialty, Pneumonia, Viral, Antineoplastic Agents, Article, NO, 03 medical and health sciences, Betacoronavirus, Internal medicine, Severity of illness, medicine, Humans, Chronic Lymphocytic Leukemia, Pandemics, Protein Kinase Inhibitors, Aged, Retrospective Studies, SARS-CoV-2, Venetoclax, business.industry, Adenine, B-Cell, COVID-19, Odds ratio, Pneumonia, medicine.disease, Leukemia, Lymphocytic, Chronic, B-Cell, Settore MED/15 - MALATTIE DEL SANGUE, 030104 developmental biology, Pyrazoles, Pyrimidines, chemistry, business
Abstract

Chronic lymphocytic leukemia (CLL) is a disease of the elderly, characterized by immunodeficiency. Hence, patients with CLL might be considered more susceptible to severe complications from COVID-19. We undertook this retrospective international multicenter study to characterize the course of COVID-19 in patients with CLL and identify potential predictors of outcome. Of 190 patients with CLL and confirmed COVID-19 diagnosed between 28/03/2020 and 22/05/2020, 151 (79%) presented with severe COVID-19 (need of oxygen and/or intensive care admission). Severe COVID-19 was associated with more advanced age (≥65 years) (odds ratio 3.72 [95% CI 1.79–7.71]). Only 60 patients (39.7%) with severe COVID-19 were receiving or had recent (≤12 months) treatment for CLL at the time of COVID-19 versus 30/39 (76.9%) patients with mild disease. Hospitalization rate for severe COVID-19 was lower (p < 0.05) for patients on ibrutinib versus those on other regimens or off treatment. Of 151 patients with severe disease, 55 (36.4%) succumbed versus only 1/38 (2.6%) with mild disease; age and comorbidities did not impact on mortality. In CLL, (1) COVID-19 severity increases with age; (2) antileukemic treatment (particularly BTK inhibitors) appears to exert a protective effect; (3) age and comorbidities did not impact on mortality, alluding to a relevant role of CLL and immunodeficiency.

Published
2020

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