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106. Adjuvant chemotherapy with cisplatin and gemcitabine versus chemotherapy at relapse in patients with muscle-invasive bladder cancer submitted to radical cystectomy: an Italian, multicenter, randomized phase III trial

Author

Cantiani, R., Aglietta, M., Bertetto, O., Cetto, G.L., Orlandini, P., Ferrazzi, E., Nardi, M., della Sofferenza, Sollievo, Manzione, L., Adamo, V., Porcile, G., Lentini, M., Breda, E., Gamucci, T., Tummarello, D., Dogliotti, L., Tumolo, S., Motta, M., Lo Russo, V., De Grande, G., Sacco, C., Gaion, F., Lavarello, A., Nuzzo, A., Clerico, M., Aragona, C., Gernone, A., Morelli, F., Olivito, V., Cupini, Mattioli, R., Marra, A., Antimi, M., Silingardi, V., Labianca, R., Martoni, A., Bortolussi, V., Luoni, M., Rosabian, A., Di Vito, F., Catalano, G., Gebbia, N., Cognetti, F., Ruggeri, E.M., Felici, A., Gallucci, M., Muto, G., Pollera, C.F., Massidda, B., Rubagotti, A., Giannarelli, D., and Boccardo, F.

Published
2012
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107. P1161: ASPEN: LONG-TERM FOLLOW-UP RESULTS OF A PHASE 3 RANDOMIZED TRIAL OF ZANUBRUTINIB (ZANU) VS IBRUTINIB (IBR) IN PATIENTS (PTS) WITH WALDENSTRÖM MACROGLOBULINEMIA (WM)

Author

Dimopoulos, M., primary, Opat, S., additional, D’Sa, S., additional, Jurczak, W., additional, Lee, H.-P., additional, Cull, G., additional, Owen, R. G., additional, Marlton, P., additional, Wahlin, B. E., additional, Garcia-Sanz, R., additional, McCarthy, H., additional, Mulligan, S., additional, Tedeschi, A., additional, Castillo, J. J., additional, Czyz, J., additional, Fernandez De Larrea Rodriguez, C., additional, Belada, D., additional, Libby, E., additional, Matous, J., additional, Motta, M., additional, Siddiqi, T., additional, Tani, M., additional, Trneny, M., additional, Minnema, M., additional, Buske, C., additional, Leblond, V., additional, Treon, S. P., additional, Trotman, J., additional, Chan, W. Y., additional, Schneider, J., additional, Allewelt, H., additional, Cohen, A., additional, Huang, J., additional, and Tam, C. S., additional

Published
2022
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109. Thrombotic and bleeding complications in patients with chronic lymphocytic leukemia and severe COVID-19: a study of ERIC, the European Research Initiative on CLL

Author

Antic D, Milic N, Chatzikonstantinou T, Scarfò L, Otasevic V, Rajovic N, Allsup D, Alonso Cabrero A, Andres M, Baile Gonzales M, Capasso A, Collado R, Cordoba R, Cuéllar-García C, Correa JG, De Paoli L, De Paolis MR, Del Poeta G, Dimou M, Doubek M, Efstathopoulou M, El-Ashwah S, Enrico A, Espinet B, Farina L, Ferrari A, Foglietta M, Lopez-Garcia A, García-Marco JA, García-Serra R, Gentile M, Gimeno E, da Silva MG, Gutwein O, Hakobyan YK, Herishanu Y, Hernández-Rivas JÁ, Herold T, Itchaki G, Jaksic O, Janssens A, Kalashnikova OB, Kalicińska E, Kater AP, Kersting S, Koren- Michowitz M, Labrador J, Lad D, Laurenti L, Fresa A, Levin MD, Mayor Bastida C, Malerba L, Marasca R, Marchetti M, Marquet J, Mihaljevic B, Milosevic I, Mirás F, Morawska M, Motta M, Munir T, Murru R, Nunes R, Olivieri J, Pavlovsky MA, Piskunova I, Popov VM, Quaglia FM, Quaresmini G, Reda G, Rigolin GM, Shrestha A, Šimkovič M, Smirnova S, Špaček M, Sportoletti P, Stanca O, Stavroyianni N, Te Raa D, Tomic K, Tonino S, Trentin L, Van Der Spek E, van Gelder M, Varettoni M, Visentin A, Vitale C, Vukovic V, Wasik-Szczepanek E, Wróbel T, Segundo LYS, Yassin M, Coscia M, Rambaldi A, Montserrat E, Foà R, Cuneo A, Carrier M, Ghia P, Stamatopoulos K.

Subjects
Age, Anticoagulation therapy, Bleeding, CLL, COVID-19, D-dimer, LMWH, Thromboprophylaxis, Thrombosis
Abstract

Background: Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to COVID-19 related poor outcomes, including thrombosis and death, due to the advanced age, the presence of comorbidities, and the disease and treatment- related immune deficiency. The aim of this study was to assess the risk of thrombosis and bleeding in patients with CLL affected by severe COVID-19. Methods: This is a retrospective multicenter study conducted by ERIC, the European Research Initiative on CLL, including patients from 79 centers across 22 countries. Data collection was conducted between April and May 2021. The COVID-19 diagnosis was confirmed by the real-time polymerase chain reaction (RT-PCR) assay for SARS- CoV-2 on nasal or pharyngeal swabs. Severe cases of COVID-19 were defined by hospitalization and the need of oxygen or admission into ICU. Development and type of thrombotic events, presence and severity of bleeding complications were reported during treatment for COVID-19. Bleeding events were classified using ISTH definition. STROBE recommendations were used in order to enhance reporting. Results: A total of 793 patients from 79 centers were included in the study with 593 being hospitalized (74.8%). Among these, 511 were defined as having severe COVID: 162 were admitted to the ICU while 349 received oxygen supplementation outside the ICU. Most patients (90.5%) were receiving thromboprophylaxis. During COVID-19 treatment, 11.1% developed a thromboembolic event, while 5.0% experienced bleeding. Thrombosis developed in 21.6% of patients who were not receiving thromboprophylaxis, in contrast to 10.6% of patients who were on thromboprophylaxis. Bleeding episodes were more frequent in patients receiving intermediate/therapeutic versus prophylactic doses of low-molecular-weight heparin (LWMH) (8.1% vs. 3.8%, respectively) and in elderly. In multivariate analysis, peak D-dimer level and C- reactive protein to albumin ratio were poor prognostic factors for thrombosis occurrence (OR = 1.022, 95%CI 1.007‒1.038 and OR = 1.025, 95%CI 1.001‒1.051, respectively), while thromboprophylaxis use was protective (OR = 0.199, 95%CI 0.061‒0.645). Age and LMWH intermediate/therapeutic dose administration were prognostic factors in multivariate model for bleeding (OR = 1.062, 95%CI 1.017-1.109 and OR = 2.438, 95%CI 1.023-5.813, respectively). Conclusions: Patients with CLL affected by severe COVID-19 are at a high risk of thrombosis if thromboprophylaxis is not used, but also at increased risk of bleeding under the LMWH intermediate/therapeutic dose administration.

Published
2022

113. 'MOLTO', A MULTICENTER, OPEN LABEL, UNCONTROLLED, PHASE II CLINICAL TRIAL ON VENETOCLAX, ATEZOLIZUMAB, OBINUTUZUMAB (AVO) COMBINATION IN RICHTER TRANSFORMATION: SAFETY INTERIM ANALYSIS

Author

Frustaci, AM, Tedeschi, A, Zinzani, PL, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, Montillo, M, Frustaci, A, Tedeschi, A, Zinzani, P, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, and Montillo, M

Subjects
Hematology
Published
2021

116. P627 Variables associated with evolution to moderate to severe Crohn’s disease at two reference centers in Salvador, Bahia, Brazil

Author

Da Silva Beda Sacramento, C, primary, Pamponet Motta, M, additional, Oliveira Alves, C, additional, Araujo Mota, J, additional, Goes de Codes, L M, additional, Freitas Ferreira, R, additional, de Almeida Silva, P, additional, do Prado Palmiro, L, additional, Miranda Barbosa, R, additional, Nery Andrade, M, additional, Damasceno Andrade, V, additional, Brandão Vasconcelos, V, additional, Wasconcellos Thiara, B, additional, Martins Netto, E, additional, and Oliveira Santana, G, additional

Published
2022
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118. P178 Fecal incontinence and rectal anal function in Crohn’s Diseases patients

Author

Góes de Codes, L M, primary, Costa de Jeus, A C, additional, Góes de Codes, J J, additional, da Silva Beda Sacramento, C, additional, Dias Marques da Cruz, I, additional, Freitas Ferreira, R, additional, Baqueiro Sena, N, additional, Moreira Gusmão, V, additional, Araujo Mota, J, additional, Pamponet Motta, M, additional, Martins Netto, E, additional, and Oliveira santana, G, additional

Published
2022
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119. Associations between cardiac arrhythmia, incident disability in activities of daily living and physical performance: The ilsa study

Author

Noale, M., Veronese, N., Smith, L., Ungar, A., Fumagalli, S., Maggi, S., Scafato, E., Farchi, G., Galluzzo, L., Gandin, C., Capurso, A., Panza, F., Solfrizzi, V., Lepore, V., Livrea, P., Motta, L., Car-Nazzo, G., Motta, M., Bentivegna, P., Bonaiuto, S., Cruciani, G., Postacchini, D., Inzitari, D., Amaducci, L., Di Carlo, A., Baldereschi, M., Gandolfo, C., Conti, M., Canal, N., Franceschi, M., Scarlato, G., Candelise, L., Scapini, E., Rengo, F., Abete, P., Cacciatore, F., Enzi, G., Battistin, L., Sergi, G., Crepaldi, G., Minicuci, N., Grigoletto, F., Perissinotto, E., Carbonin, P., Noale, M., Veronese, N., Smith, L., Ungar, A., Fumagalli, S., Maggi, S., Scafato, E., Farchi, G., Galluzzo, L., Gandin, C., Capurso, A., Panza, F., Solfrizzi, V., Lepore, V., Livrea, P., Motta, L., Car-Nazzo, G., Motta, M., Bentivegna, P., Bonaiuto, S., Cruciani, G., Postacchini, D., Inzitari, D., Amaducci, L., Di Carlo, A., Baldereschi, M., Gandolfo, C., Conti, M., Canal, N., Franceschi, M., Scarlato, G., Candelise, L., Scapini, E., Rengo, F., Abete, P., Cacciatore, F., Enzi, G., Battistin, L., Sergi, G., Crepaldi, G., Minicuci, N., Grigoletto, F., Perissinotto, E., and Carbonin, P.

Subjects
Disability, Physical activity, Atrial fibrillation, Cardiac arrhythmia, not known, Physical performance
Abstract

Background Cardiac arrhythmias are common conditions in older people. Unfortunately, there is limited literature on associations between cardiac arrhythmias and physical performance or disability. We therefore aimed to prospectively investigate associations between cardiac arrhythmias and changes in disability and physical performance during 8 years of follow-up, using data from the Italian Longitudinal Study on Aging (ILSA). Methods Cardiac arrhythmias diagnosis was posed through a screening phase, confirmed by a physician. The onset of disability in activities of daily living (ADL) and the changes in several physical performance tests during follow-up were considered as outcomes. Fully-adjusted and propensity-score Cox Proportional Hazard models and mixed models were used for exploring associations between cardiac arrhythmia and the outcomes of interest. Results The prevalence of cardiac arrhythmia at baseline was 23.3%. People reporting cardiac arrhythmia at the baseline were significantly older, more frequently male, smokers and reported a higher presence of all medical conditions investigated (hypertension, heart failure, angina, myocardial infarction, diabetes, stroke), but no difference in dementia, Parkinsonism, cognitive or mood disorder. Cardiac arrhythmia at baseline was significantly associated with the incidence of disability in ADL (HR = 1.23; 95%: CI: 1.01-1.50; P = 0.0478 in propensity score analyses; HR = 1.28; 95% CI: 1.01-1.61; P = 0.0401 in fully adjusted models). Cardiac arrhythmia at baseline was also associated with a significant worsening in balance test (P = 0.0436). Conclusions The presence of cardiac arrhythmia at baseline was associated with a significant higher risk of disability and of worsening in some physical performance tests, particularly those relating to balance. Screening and frequently assessing physical performance in older people affected by cardiac arrhythmia can be important to prevent a loss of physical performance, with further, potential, complications of medical management. © 2020 JGC All rights reserved

Published
2020

128. PO-1848 HyperArc and RapidArc dosimetric comparison for resected brain metastases stereotactic radiotherapy

Author

MUNI, R., primary, Colleoni, P., additional, Fortunato, M., additional, Benfetima, M.I., additional, Bianchi, C., additional, Motta, M., additional, Andreoli, S., additional, Cretti, F., additional, Filippone, F.R., additional, Maffioletti, L., additional, Piccoli, F., additional, Vitali, E., additional, Vukcaj, S., additional, Rinaldi, G., additional, and Cazzaniga, L.F., additional

Published
2021
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132. 'Surfing in the cell' - an investigative game for teaching cytoskeleton concepts for undergraduate students

Author

Alves Gomes, G., Melim Marques, L., Spiegel Nascimento, C., Araújo-Jorge, Tania Cremonini, and Luz Motta, M.

Subjects
ComputingMilieux_COMPUTERSANDEDUCATION
Abstract

The educational role of games becomes evident as students are more active, able to take decisions, solve problems and react to the results of their own decisions. The educative board game Discovering the Cell is based on problem-solving learning. This game challenges students to collect, discuss and interpret clues in order to decipher a question. In this work we evaluated the game as a tool for teaching health sciences undergraduate students from Rio de Janeiro. In a questionnaire-based analysis, students demonstrated great acceptance for this strategy and the majority of them were able to solve the Case tested, as well as applying the learned content to answer a related question. Taken together, our results indicate the acceptance and suitability of the game as an alternative strategy to help teaching cell and molecular biology to undergraduate students.

Published
2021

136. UPDATED RESULTS OF THE ASPEN TRIAL FROM A COHORT OF PATIENTS WITH MYD88 WILD-TYPE (MYD88(WT)) WALDENSTROM MACROGLOBULINEMIA (WM)

Author

Zinzani, P, Dimopoulos, M, Sanz, RG, Lee, H, Trneny, M, Varettoni, M, Opat, S, D'Sa, S, Owen, R, Cull, G, Mulligan, S, Czyz, J, Castillo, J, Motta, M, Siddiqi, T, Mesa, MG, Gorrochategui, MG, Talaulikar, D, Askari, E, Grosicki, S, Oriol, A, Rule, S, Kloczko, J, Tedeschi, A, Buske, C, Leblond, V, Chan, W, Schneider, J, Cohen, A, Huang, J, and Tam, C

Published
2021

137. SPRED2 loss-of-function causes a recessive Noonan syndrome-like phenotype

Author

Motta, M., Fasano, Giulia, Gredy, Sina, Brinkmann, Julia, Bonnard, Adeline Alice, Simsek-Kiper, P.O., Boer, E. de, Vissers, L.E.L.M., Zenker, M., Tartaglia, M., Motta, M., Fasano, Giulia, Gredy, Sina, Brinkmann, Julia, Bonnard, Adeline Alice, Simsek-Kiper, P.O., Boer, E. de, Vissers, L.E.L.M., Zenker, M., and Tartaglia, M.

Abstract

Item does not contain fulltext

Published
2021

138. SPEN haploinsufficiency causes a neurodevelopmental disorder overlapping proximal 1p36 deletion syndrome with an episignature of X chromosomes in females

Author

Radio, F.C., Pang, K., Ciolfi, A., Levy, M.A., Hernández-García, A., Pedace, L., Pantaleoni, F., Liu, Z, Boer, E. de, Jackson, A., Bruselles, A., McConkey, H., Stellacci, E., Cicero, S. Lo, Motta, M., Carrozzo, R., Dentici, M.L., McWalter, K., Desai, M., Monaghan, K.G., Telegrafi, A., Philippe, C., Vitobello, A., Au, M., Grand, K., Sanchez-Lara, P.A., Baez, J., Lindstrom, K., Kulch, P., Sebastian, J., Madan-Khetarpal, S., Roadhouse, C., MacKenzie, J.J., Monteleone, B., Saunders, C.J., Cuevas, J.K. Jean, Cross, L., Zhou, D., Hartley, T., Sawyer, S.L., Monteiro, F.P., Secches, T.V., Kok, F., Schultz-Rogers, L.E., Macke, E.L., Morava, E., Klee, E.W., Kemppainen, J., Iascone, M., Selicorni, A., Tenconi, R., Amor, D.J., Pais, L., Gallacher, L., Turnpenny, P.D., Stals, K., Ellard, S., Cabet, S., Lesca, G., Pascal, J., Steindl, K., Ravid, S., Weiss, K., Castle, A.M.R., Carter, M.T., Kalsner, L., Vries, B.B.A. de, Bon, B.W. van, Wevers, M.R., Pfundt, R.P., Stegmann, A.P.A., Kerr, B., Kingston, H.M., Chandler, K.E., Sheehan, W., Elias, A.F., Shinde, D.N., Towne, M.C., Robin, N.H., Goodloe, D., Vanderver, A., Sherbini, O., Bluske, K., Hagelstrom, R.T., Zanus, C., Faletra, F., Musante, L., Kurtz-Nelson, E.C., Earl, R.K., Anderlid, B.M., Morin, G., Slegtenhorst, M. van, Diderich, K.E.M., Brooks, A.S., Gribnau, J., Boers, R.G., Finestra, T.R., Carter, L.B., Rauch, A., Gasparini, P., Vissers, L.E.L.M., Lloyd Holder, J., Tartaglia, M., Radio, F.C., Pang, K., Ciolfi, A., Levy, M.A., Hernández-García, A., Pedace, L., Pantaleoni, F., Liu, Z, Boer, E. de, Jackson, A., Bruselles, A., McConkey, H., Stellacci, E., Cicero, S. Lo, Motta, M., Carrozzo, R., Dentici, M.L., McWalter, K., Desai, M., Monaghan, K.G., Telegrafi, A., Philippe, C., Vitobello, A., Au, M., Grand, K., Sanchez-Lara, P.A., Baez, J., Lindstrom, K., Kulch, P., Sebastian, J., Madan-Khetarpal, S., Roadhouse, C., MacKenzie, J.J., Monteleone, B., Saunders, C.J., Cuevas, J.K. Jean, Cross, L., Zhou, D., Hartley, T., Sawyer, S.L., Monteiro, F.P., Secches, T.V., Kok, F., Schultz-Rogers, L.E., Macke, E.L., Morava, E., Klee, E.W., Kemppainen, J., Iascone, M., Selicorni, A., Tenconi, R., Amor, D.J., Pais, L., Gallacher, L., Turnpenny, P.D., Stals, K., Ellard, S., Cabet, S., Lesca, G., Pascal, J., Steindl, K., Ravid, S., Weiss, K., Castle, A.M.R., Carter, M.T., Kalsner, L., Vries, B.B.A. de, Bon, B.W. van, Wevers, M.R., Pfundt, R.P., Stegmann, A.P.A., Kerr, B., Kingston, H.M., Chandler, K.E., Sheehan, W., Elias, A.F., Shinde, D.N., Towne, M.C., Robin, N.H., Goodloe, D., Vanderver, A., Sherbini, O., Bluske, K., Hagelstrom, R.T., Zanus, C., Faletra, F., Musante, L., Kurtz-Nelson, E.C., Earl, R.K., Anderlid, B.M., Morin, G., Slegtenhorst, M. van, Diderich, K.E.M., Brooks, A.S., Gribnau, J., Boers, R.G., Finestra, T.R., Carter, L.B., Rauch, A., Gasparini, P., Vissers, L.E.L.M., Lloyd Holder, J., and Tartaglia, M.

Abstract

Contains fulltext : 231702.pdf (Publisher’s version ) (Closed access), Deletion 1p36 (del1p36) syndrome is the most common human disorder resulting from a terminal autosomal deletion. This condition is molecularly and clinically heterogeneous. Deletions involving two non-overlapping regions, known as the distal (telomeric) and proximal (centromeric) critical regions, are sufficient to cause the majority of the recurrent clinical features, although with different facial features and dysmorphisms. SPEN encodes a transcriptional repressor commonly deleted in proximal del1p36 syndrome and is located centromeric to the proximal 1p36 critical region. Here, we used clinical data from 34 individuals with truncating variants in SPEN to define a neurodevelopmental disorder presenting with features that overlap considerably with those of proximal del1p36 syndrome. The clinical profile of this disease includes developmental delay/intellectual disability, autism spectrum disorder, anxiety, aggressive behavior, attention deficit disorder, hypotonia, brain and spine anomalies, congenital heart defects, high/narrow palate, facial dysmorphisms, and obesity/increased BMI, especially in females. SPEN also emerges as a relevant gene for del1p36 syndrome by co-expression analyses. Finally, we show that haploinsufficiency of SPEN is associated with a distinctive DNA methylation episignature of the X chromosome in affected females, providing further evidence of a specific contribution of the protein to the epigenetic control of this chromosome, and a paradigm of an X chromosome-specific episignature that classifies syndromic traits. We conclude that SPEN is required for multiple developmental processes and SPEN haploinsufficiency is a major contributor to a disorder associated with deletions centromeric to the previously established 1p36 critical regions.

Published
2021

139. Zanubrutinib for the treatment of MYD88 wild-type Waldenstrom macroglobulinemia: A substudy of the phase 3 ASPEN trial.

Author

Trotman J., Rule S., Kloczko J., Tedeschi A., Buske C., Leblond V., Chan W.Y., Michel J., Schneider J., Tan Z., Cohen A., Huang J., Tam C.S., Opat S., Dimopoulos M., Sanz R.G., Lee H.-P., Trneny M., Varettoni M., D'Sa S., Owen R.G., Cull G., Mulligan S., Czyz J., Castillo J.J., Motta M., Siddiqi T., Mesa M.G., Gorrochategui M.G., Talaulikar D., Zinzani P.L., Askari E., Grosicki S., Oriol A., Trotman J., Rule S., Kloczko J., Tedeschi A., Buske C., Leblond V., Chan W.Y., Michel J., Schneider J., Tan Z., Cohen A., Huang J., Tam C.S., Opat S., Dimopoulos M., Sanz R.G., Lee H.-P., Trneny M., Varettoni M., D'Sa S., Owen R.G., Cull G., Mulligan S., Czyz J., Castillo J.J., Motta M., Siddiqi T., Mesa M.G., Gorrochategui M.G., Talaulikar D., Zinzani P.L., Askari E., Grosicki S., and Oriol A.

Abstract

Patients with Waldenstrom macroglobulinemia (WM) lacking activating mutations in the MYD88 gene (MYD88WT) have demonstrated relatively poor outcomes to ibrutinib monotherapy, with no major responses reported in a phase 2 pivotal study. Zanubrutinib is a novel, selective Bruton tyrosine kinase (BTK) inhibitor designed to maximize BTK occupancy and minimize off-target activity. The ASPEN study consisted of a randomized comparison of zanubrutinib and ibrutinib efficacy and safety in patients with WM who have the MYD88 mutation, as well as a separate cohort of patients without MYD88 mutation (MYD88WT) or with unknown mutational status who received zanubrutinib. Results from the latter single-arm cohort are reported herein. Efficacy endpoints included overall, major and complete (CR) or very good partial response (VGPR) rates, progression-free survival (PFS), duration of response (DOR), and overall survival (OS). Twenty-eight patients (23 relapsed/ refractory; 5 treatment-naive) were enrolled, including 26 with centrally confirmed MYD88WT disease and 2 with unknown MYD88 mutational status. At a median follow-up of 17.9 months, 7 of 26 MYD88WT patients (27%) had achieved a VGPR and 50% a major response (partial response or better); there were no CRs. At 18 months, the estimated PFS and OS rates were 68% and 88%, respectively, while the median DOR had not been reached. Two patients discontinued zanubrutinib due to adverse events. Treatment-emergent hypertension, atrial fibrillation, and major hemorrhages were reported in 3, 1 and 2 patients (including 1 concurrent with enoxaparin therapy), respectively. Results of this substudy demonstrate that zanubrutinib monotherapy can induce high quality responses in patients with MYD88WT WM. This trial is registered on www.clinicaltrials.gov as NCT #03053440.Copyright © 2020 by The American Society of Hematology

Published
2021

140. A randomized phase 3 trial of zanubrutinib vs ibrutinib in symptomatic Waldenstrom macroglobulinemia: The ASPEN study.

Author

Sanz R.G., Tam C.S., Opat S., D'Sa S., Jurczak W., Lee H.-P., Cull G., Owen R.G., Marlton P., Ewahlin B., Motta M., Siddiqi T., Tani M., Trneny M., Minnema M.C., Buske C., Leblond V., Trotman J., Chan W.Y., Schneider J., Ro S., Cohen A., Huang J., McCarthy H., Mulligan S., Tedeschi A., Castillo J.J., Czyz J., De Larrea C.F., Belada D., Libby E., Matous J.V., Sanz R.G., Tam C.S., Opat S., D'Sa S., Jurczak W., Lee H.-P., Cull G., Owen R.G., Marlton P., Ewahlin B., Motta M., Siddiqi T., Tani M., Trneny M., Minnema M.C., Buske C., Leblond V., Trotman J., Chan W.Y., Schneider J., Ro S., Cohen A., Huang J., McCarthy H., Mulligan S., Tedeschi A., Castillo J.J., Czyz J., De Larrea C.F., Belada D., Libby E., and Matous J.V.

Abstract

Bruton tyrosine kinase (BTK) inhibition is an effective treatment approach for patients with Waldenstrom macroglobulinemia (WM). The phase 3 ASPEN study compared the efficacy and safety of ibrutinib, a first-generation BTK inhibitor, with zanubrutinib, a novel highly selective BTK inhibitor, in patients with WM. Patients with MYD88L265P disease were randomly assigned 1:1 to treatment with ibrutinib or zanubrutinib. The primary end point was the proportion of patients achieving a complete response (CR) or a very good partial response (VGPR) by independent review. Key secondary end points included major response rate (MRR), progression-free survival (PFS), duration of response (DOR), disease burden, and safety. A total of 201 patients were randomized, and 199 received ++1 dose of study treatment. No patient achieved a CR. Twenty-nine (28%) zanubrutinib patients and 19 (19%) ibrutinib patients achieved a VGPR, a nonstatistically significant difference (P 5 .09). MRRs were 77% and 78%, respectively. Median DOR and PFS were not reached 84% and 85% of ibrutinib and zanubrutinib patients were progression free at 18 months. Atrial fibrillation, contusion, diarrhea, peripheral edema, hemorrhage, muscle spasms, and pneumonia, as well as adverse events leading to treatment discontinuation, were less common among zanubrutinib recipients. Incidence of neutropenia was higher with zanubrutinib, although grade ++3 infection rates were similar in both arms (1.2 and 1.1 events per 100 person-months). These results demonstrate that zanubrutinib and ibrutinib are highly effective in the treatment of WM, but zanubrutinib treatment was associated with a trend toward better response quality and less toxicity, particularly cardiovascular toxicity.Copyright © 2020 American Society of Hematology. All rights reserved.

Published
2021

141. 'MOLTO', A MULTICENTER, OPEN LABEL, UNCONTROLLED, PHASE II CLINICAL TRIAL ON VENETOCLAX, ATEZOLIZUMAB, OBINUTUZUMAB (AVO) COMBINATION IN RICHTER TRANSFORMATION: SAFETY INTERIM ANALYSIS

Author

Frustaci, A, Tedeschi, A, Zinzani, P, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, Montillo, M, Frustaci, AM, Zinzani, PL, Frustaci, A, Tedeschi, A, Zinzani, P, Pietrasanta, D, Coscia, M, Zenz, T, Motta, M, Gaidano, G, Scarfo, L, Deodato, M, Zamprogna, G, Vitale, C, Cairoli, R, Rossi, D, Montillo, M, Frustaci, AM, and Zinzani, PL

Published
2021

142. The death of Raphael: a reflection on bloodletting in the Renaissance

Author

Riva, M, Paladino, M, Motta, M, Belingheri, M, Riva, Michele Augusto, Paladino, Maria Emilia, Motta, Marco, Belingheri, Michael, Riva, M, Paladino, M, Motta, M, Belingheri, M, Riva, Michele Augusto, Paladino, Maria Emilia, Motta, Marco, and Belingheri, Michael

Published
2021

143. Management of chronic lymphocytic leukemia in Italy during a one year of the COVID-19 pandemic and at the start of the vaccination program. A Campus CLL report

Author

Cuneo, A., Rigolin, G. M., Coscia, M., Quaresmini, G., Scarfo, L., Mauro, F. R., Motta, M., Quaglia, F. M., Trentin, L., Ferrario, Alberto Alfredo, Laurenti, Luca, Reda, G., Ferrari, A., Pietrasanta, D., Sportoletti, P., Re, F., De Paoli, L., Foglietta, M., Giordano, A., Marchetti, M., Farina, L., Del Poeta, G., Varettoni, M., Chiurazzi, F., Marasca, R., Malerba, L., Ibatici, A., Tisi, Maria Chiara, Stefoni, V., Leone, M., Barate, C., Olivieri, J., Murru, R., Gentile, Marino, Sanna, A., Gozzetti, A., Gattei, V., Gottardi, D., Derenzini, E., Levato, L., Orsucci, L., Penna, G., Chiarenza, A., Foa, Robin, Ferrario A., Laurenti L. (ORCID:0000-0002-8327-1396), Tisi M. C., Gentile M., Foa R., Cuneo, A., Rigolin, G. M., Coscia, M., Quaresmini, G., Scarfo, L., Mauro, F. R., Motta, M., Quaglia, F. M., Trentin, L., Ferrario, Alberto Alfredo, Laurenti, Luca, Reda, G., Ferrari, A., Pietrasanta, D., Sportoletti, P., Re, F., De Paoli, L., Foglietta, M., Giordano, A., Marchetti, M., Farina, L., Del Poeta, G., Varettoni, M., Chiurazzi, F., Marasca, R., Malerba, L., Ibatici, A., Tisi, Maria Chiara, Stefoni, V., Leone, M., Barate, C., Olivieri, J., Murru, R., Gentile, Marino, Sanna, A., Gozzetti, A., Gattei, V., Gottardi, D., Derenzini, E., Levato, L., Orsucci, L., Penna, G., Chiarenza, A., Foa, Robin, Ferrario A., Laurenti L. (ORCID:0000-0002-8327-1396), Tisi M. C., Gentile M., and Foa R.

Abstract

n/a

Published
2021

Catalog

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