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Mikkael Sekeres

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https://www.readbyqxmd.com/read/29137233/outcome-of-patients-treated-for-myelodysplastic-syndromes-with-5q-deletion-after-failure-of-lenalidomide-therapy
#1
Thomas Prebet, Thomas Cluzeau, Sophie Park, Mikkael A Sekeres, Ulrich Germing, Lionel Ades, Uwe Platzbecker, Katharina Gotze, Norbert Vey, Esther Oliva, Mary M Sugrue, Cecile Bally, Charikleia Kelaidi, Najla Al Ali, Pierre Fenaux, Steven D Gore, Rami Komrokji
While lenalidomide (LEN) is the standard of care for the lower-risk myelodysplastic syndromes (MDS) patients with deletion 5q, 35% will not respond to or do not tolerate the drug. Moreover, most of the patients will lose their response after a few years. Defining the outcome of patients with LEN failure and determining the impact of subsequent therapies is therefore important to develop alternative strategies. Based on an international collaboration, we were able to compile a total of 392 patient cases of lower-risk MDS patients with 5q deletion and to analyze their outcome after failure of lenalidomide...
October 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/29112938/impact-of-baseline-cytogenetic-findings-and-cytogenetic-response-on-outcome-of-high-risk-myelodysplastic-syndromes-and-low-blast-count-aml-treated-with-azacitidine
#2
Marie Sébert, Rami S Komrokji, Mikkael A Sekeres, Thomas Prebet, Thomas Cluzeau, Valeria Santini, Emmanuel Gyan, Alessandro Sanna, Najla HAl Ali, Sean Hobson, Virginie Eclache, Alan List, Pierre Fenaux, Lionel Adès
Karyotype according to the revised IPSS is a strong independent prognostic factor for overall survival (OS) in myelodysplastic syndromes (MDS), however established in untreated patients. The prognostic impact of cytogenetics and cytogenetic response (CyR) in MDS patients receiving azacitidine (AZA) remains uncertain. We examined the prognostic value of baseline cytogenetics and CyR for overall response rate (ORR) and OS in 702 AZA-treated higher risk MDS and low blast count acute myeloid leukemia (AML), including 493 (70%) with abnormal karyotype...
October 27, 2017: Leukemia Research
https://www.readbyqxmd.com/read/28958288/optimizing-the-use-of-hypomethylating-agents-in-myelodysplastic-syndromes-selecting-the-candidate-predicting-the-response-and-enhancing-the-activity
#3
REVIEW
Yazan Madanat, Mikkael A Sekeres
Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal hematopoietic stem cell disorders that have a substantial impact on patients' quality of life, in addition to causing significant morbidity and mortality. The hypomethylating agents (HMAs) azacitidine and decitabine are approved for use in the United States and in Europe for the treatment of MDS or acute myeloid leukemia (AML) and, in the case of azacitidine, prolong survival in higher-risk patients. Neither is curative, though, and given the lack of clear treatment guidelines after HMA treatment failure, it is imperative to optimize patient selection and identify the right timing of HMA treatment initiation and response evaluation to maximize patient benefit...
July 2017: Seminars in Hematology
https://www.readbyqxmd.com/read/28893734/origins-of-myelodysplastic-syndromes-after-aplastic-anemia
#4
LETTER
Eiju Negoro, Yasunobu Nagata, Michael J Clemente, Naoko Hosono, Wenyi Shen, Aziz Nazha, Tetsuichi Yoshizato, Cassandra Hirsch, Bartlomiej Przychodzen, Reda Z Mahfouz, Teodora Kuzmanovic, Mikkael A Sekeres, Hideki Makishima, Seishi Ogawa, Jaroslaw P Maciejewski
No abstract text is available yet for this article.
October 26, 2017: Blood
https://www.readbyqxmd.com/read/28880971/development-and-validation-of-a-novel-acute-myeloid-leukemia-composite-model-to-estimate-risks-of-mortality
#5
Mohamed L Sorror, Barry E Storer, Amir T Fathi, Aaron T Gerds, Bruno C Medeiros, Paul Shami, Andrew M Brunner, Mikkael A Sekeres, Sudipto Mukherjee, Esteban Peña, Mahmoud Elsawy, Shylo Wardyn, Jennifer Whitten, Rachelle Moore, Pamela S Becker, Jeannine S McCune, Frederick R Appelbaum, Elihu H Estey
Importance: To our knowledge, this multicenter analysis is the first to test and validate (1) the prognostic impact of comorbidities on 1-year mortality after initial therapy of acute myeloid leukemia (AML) and (2) a novel, risk-stratifying composite model incorporating comorbidities, age, and cytogenetic and molecular risks. Objective: To accurately estimate risks of mortality by developing and validating a composite model that combines the most significant patient-specific and AML-specific features...
September 7, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28774880/randomized-phase-2-study-of-low-dose-decitabine-vs-low-dose-azacitidine-in-lower-risk-mds-and-mds-mpn
#6
RANDOMIZED CONTROLLED TRIAL
Elias Jabbour, Nicholas J Short, Guillermo Montalban-Bravo, Xuelin Huang, Carlos Bueso-Ramos, Wei Qiao, Hui Yang, Chong Zhao, Tapan Kadia, Gautam Borthakur, Naveen Pemmaraju, Koji Sasaki, Zeev Estrov, Jorge Cortes, Farhad Ravandi, Yesid Alvarado, Rami Komrokji, Mikkael A Sekeres, David P Steensma, Amy DeZern, Gail Roboz, Hagop Kantarjian, Guillermo Garcia-Manero
Hypomethylating agents (HMAs) improve survival in patients with higher-risk myelodysplastic syndromes (MDS) but are less well-studied in lower-risk disease. We compared the safety and efficacy of low-dose decitabine vs low-dose azacitidine in this group of patients. Adults with low- or intermediate 1-risk MDS or MDS/myeloproliferative neoplasm (MPN), including chronic myelomonocytic leukemia, according to the International Prognostic Scoring System, were randomly assigned using a Bayesian adaptive design to receive either azacitidine 75 mg/m(2) intravenously/subcutaneously daily or decitabine 20 mg/m(2) intravenously daily for 3 consecutive days on a 28-day cycle...
September 28, 2017: Blood
https://www.readbyqxmd.com/read/28759108/a-call-for-action-increasing-enrollment-of-untreated-patients-with-higher-risk-myelodysplastic-syndromes-in-first-line-clinical-trials
#7
REVIEW
Amer M Zeidan, Maximilian Stahl, Mikkael A Sekeres, David P Steensma, Rami S Komrokji, Steven D Gore
Hypomethylating agents (HMAs) have changed the landscape of the management of patients with higher-risk myelodysplastic syndromes (HR-MDS). HMAs have improved hematopoiesis and quality of life and, in the case of azacitidine, prolonged survival in a large randomized trial. However, multiple real-life and registry analyses have demonstrated minimal survival gains at the population level after the approval of HMAs. Furthermore, the 24-month median survival observed with azacitidine in the landmark AZA-001 trial has not been replicated in population-based studies or in other clinical trials using azacitidine monotherapy arms...
October 1, 2017: Cancer
https://www.readbyqxmd.com/read/28693363/prognostic-impact-of-incomplete-hematologic-count-recovery-and-minimal-residual-disease-on-outcome-in-adult-acute-lymphoblastic-leukemia-at-the-time-of-second-complete-response
#8
Caner Saygin, Nikolaos Papadantonakis, Ryan D Cassaday, Michaela Liedtke, Katrina Fischer, Tamara Dunn, Bhumika J Patel, Ronald Sobecks, Matt Kalaycio, Mikkael A Sekeres, Sudipto Mukherjee, Aaron T Gerds, Betty K Hamilton, Hetty E Carraway, Anjali S Advani
Outcomes of relapsed adult acute lymphoblastic leukemia (ALL) have improved over time with the introduction of new therapies as well as better supportive care. However, there is still a need for easy-to-use and accurate prognostic tools for patients in first relapse. Whether complete response (CR) with incomplete count recovery (CRh) can be grouped with CR in relapsed ALL trials has not been formally studied. We analyzed 106 ALL patients at first relapse who were treated at three academic centers and achieved CR/CRh...
July 11, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28651604/clinical-characteristics-and-outcomes-according-to-age-in-lenalidomide-treated-patients-with-rbc-transfusion-dependent-lower-risk-mds-and-del-5q
#9
Pierre Fenaux, Aristoteles Giagounidis, Dominik Selleslag, Odile Beyne-Rauzy, Moshe Mittelman, Petra Muus, Stephen D Nimer, Eva Hellström-Lindberg, Bayard L Powell, Agnes Guerci-Bresler, Mikkael A Sekeres, H Joachim Deeg, Consuelo Del Cañizo, Peter L Greenberg, Jamile M Shammo, Barry Skikne, Xujie Yu, Alan F List
BACKGROUND: Particularly since the advent of lenalidomide, lower-risk myelodysplastic syndromes (MDS) patients with del(5q) have been the focus of many studies; however, the impact of age on disease characteristics and response to lenalidomide has not been analyzed. METHODS: We assessed the effect of age on clinical characteristics and outcomes in 286 lenalidomide-treated MDS patients with del(5q) from two multicenter trials. RESULTS: A total of 33...
June 26, 2017: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/28645118/outcome-of-patients-treated-for-myelodysplastic-syndromes-with-5q-deletion-after-failure-of-lenalidomide-therapy
#10
Thomas Prebet, Thomas Cluzeau, Sophie Park, Mikkael A Sekeres, Ulrich Germing, Lionel Ades, Uwe Platzbecker, Katharina Gotze, Norbert Vey, Esther Oliva, Mary M Sugrue, Cecile Bally, Charikleia Kelaidi, Najla Al Ali, Pierre Fenaux, Steven D Gore, Rami Komrokji
While lenalidomide (LEN) is the standard of care for the lower-risk myelodysplastic syndromes (MDS) patients with deletion 5q, 35% will not respond to or do not tolerate the drug. Moreover, most of the patients will lose their response after a few years. Defining the outcome of patients with LEN failure and determining the impact of subsequent therapies is therefore important to develop alternative strategies. Based on an international collaboration, we were able to compile a total of 392 patient cases of lower-risk MDS patients with 5q deletion and to analyze their outcome after failure of lenalidomide...
June 14, 2017: Oncotarget
https://www.readbyqxmd.com/read/28633612/clinical-features-and-treatment-outcomes-in-large-granular-lymphocytic-leukemia-lgll
#11
Srinivasa R Sanikommu, Michael J Clemente, Peter Chomczynski, Manuel G Afable, Andres Jerez, Swapna Thota, Bhumika Patel, Cassandra Hirsch, Aziz Nazha, John Desamito, Alan Lichtin, Brad Pohlman, Mikkael A Sekeres, Tomas Radivoyevitch, Jaroslaw P Maciejewski
Large granular lymphocytic leukemia (LGLL) represents a clonal/oligoclonal lymphoproliferation of cytotoxic T and natural killer cells often associated with STAT3 mutations. When symptomatic, due to mostly anemia and neutropenia, therapy choices are often empirically-based, because only few clinical trials and systematic studies have been performed. Incorporating new molecular and flow cytometry parameters, we identified 204 patients fulfilling uniform criteria for LGLL diagnoses and analyzed clinical course with median follow-up of 36 months, including responses to treatments...
February 2018: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28616874/romiplostim-monotherapy-in-thrombocytopenic-patients-with-myelodysplastic-syndromes-long-term-safety-and-efficacy
#12
MULTICENTER STUDY
Pierre Fenaux, Petra Muus, Hagop Kantarjian, Roger M Lyons, Richard A Larson, Mikkael A Sekeres, Pamela S Becker, Amelia Orejudos, Janet Franklin
Romiplostim can improve platelet counts in about 50% of patients with low- or intermediate 1-risk (lower risk) myelodysplastic syndromes (MDS) and thrombocytopenia, but its long-term toxicity and efficacy are not known. This open-label extension study evaluated the long-term safety and efficacy of romiplostim in 60 patients with lower risk MDS and platelet counts ≤50 × 10(9) /l. The primary endpoint was adverse event (AE) incidence. Secondary endpoints were efficacy parameters, including bleeding events and platelet response...
September 2017: British Journal of Haematology
https://www.readbyqxmd.com/read/28588020/enasidenib-in-mutant-idh2-relapsed-or-refractory-acute-myeloid-leukemia
#13
Eytan M Stein, Courtney D DiNardo, Daniel A Pollyea, Amir T Fathi, Gail J Roboz, Jessica K Altman, Richard M Stone, Daniel J DeAngelo, Ross L Levine, Ian W Flinn, Hagop M Kantarjian, Robert Collins, Manish R Patel, Arthur E Frankel, Anthony Stein, Mikkael A Sekeres, Ronan T Swords, Bruno C Medeiros, Christophe Willekens, Paresh Vyas, Alessandra Tosolini, Qiang Xu, Robert D Knight, Katharine E Yen, Sam Agresta, Stephane de Botton, Martin S Tallman
Recurrent mutations in isocitrate dehydrogenase 2 (IDH2) occur in ∼12% of patients with acute myeloid leukemia (AML). Mutated IDH2 proteins neomorphically synthesize 2-hydroxyglutarate resulting in DNA and histone hypermethylation, which leads to blocked cellular differentiation. Enasidenib (AG-221/CC-90007) is a first-in-class, oral, selective inhibitor of mutant-IDH2 enzymes. This first-in-human phase 1/2 study assessed the maximum tolerated dose (MTD), pharmacokinetic and pharmacodynamic profiles, safety, and clinical activity of enasidenib in patients with mutant-IDH2 advanced myeloid malignancies...
August 10, 2017: Blood
https://www.readbyqxmd.com/read/28486043/randomized-phase-ii-study-of-azacitidine-alone-or-in-combination-with-lenalidomide-or-with-vorinostat-in-higher-risk-myelodysplastic-syndromes-and-chronic-myelomonocytic-leukemia-north-american-intergroup-study-swog-s1117
#14
RANDOMIZED CONTROLLED TRIAL
Mikkael A Sekeres, Megan Othus, Alan F List, Olatoyosi Odenike, Richard M Stone, Steven D Gore, Mark R Litzow, Rena Buckstein, Min Fang, Diane Roulston, Clara D Bloomfield, Anna Moseley, Aziz Nazha, Yanming Zhang, Mario R Velasco, Rakesh Gaur, Ehab Atallah, Eyal C Attar, Elina K Cook, Alyssa H Cull, Michael J Rauh, Frederick R Appelbaum, Harry P Erba
Purpose Azacitidine is standard, first-line therapy in higher-risk myelodysplastic syndromes (MDS). Whether azacitidine-based combinations with lenalidomide or vorinostat produce superior overall response rates (ORRs) to azacitidine is not known. Patients and Methods North American Intergroup Study S1117 is a phase II/III trial that randomly assigned patients with higher-risk MDS and chronic myelomonocytic leukemia (CMML) 1:1:1 to azacitidine (75 mg/m(2)/day on days 1 to 7 of a 28-day cycle); azacitidine plus lenalidomide (10 mg/day on days 1 to 21); or azacitidine plus vorinostat (300 mg twice daily on days 3 to 9)...
August 20, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28420120/clinical-outcomes-of-217-patients-with-acute-erythroleukemia-according-to-treatment-type-and-line-a-retrospective-multinational-study
#15
MULTICENTER STUDY
Antonio M Almeida, Thomas Prebet, Raphael Itzykson, Fernando Ramos, Haifa Al-Ali, Jamile Shammo, Ricardo Pinto, Luca Maurillo, Jaime Wetzel, Pellegrino Musto, Arjan A Van De Loosdrecht, Maria Joao Costa, Susana Esteves, Sonja Burgstaller, Reinhard Stauder, Eva M Autzinger, Alois Lang, Peter Krippl, Dietmar Geissler, Jose Francisco Falantes, Carmen Pedro, Joan Bargay, Guillermo Deben, Ana Garrido, Santiago Bonanad, Maria Diez-Campelo, Sylvain Thepot, Lionel Ades, Wolfgang R Sperr, Peter Valent, Pierre Fenaux, Mikkael A Sekeres, Richard Greil, Lisa Pleyer
Acute erythroleukemia (AEL) is a rare disease typically associated with a poor prognosis. The median survival ranges between 3-9 months from initial diagnosis. Hypomethylating agents (HMAs) have been shown to prolong survival in patients with myelodysplastic syndromes (MDS) and AML, but there is limited data of their efficacy in AEL. We collected data from 210 AEL patients treated at 28 international sites. Overall survival (OS) and PFS were estimated using the Kaplan-Meier method and the log-rank test was used for subgroup comparisons...
April 14, 2017: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/28370201/a-phase-1-study-of-amg-900-an-orally-administered-pan-aurora-kinase-inhibitor-in-adult-patients-with-acute-myeloid-leukemia
#16
MULTICENTER STUDY
Hagop M Kantarjian, Michael W Schuster, Nitin Jain, Anjali Advani, Elias Jabbour, Erick Gamelin, Erik Rasmussen, Gloria Juan, Abraham Anderson, Vincent F Chow, Gregory Friberg, Florian D Vogl, Mikkael A Sekeres
Aurora kinases are involved in the pathophysiology of several cancers including acute myeloid leukemia (AML). In this phase 1 study, we investigated the safety and efficacy of AMG 900, an orally administered, highly potent, selective, small-molecule inhibitor of both Aurora kinase A and B, in patients with AML . Patients with pathologically documented AML who either declined standard treatments or had relapsed from or were refractory to previous therapies were enrolled. Two every-2-week dose-escalation schedules using a modified 3 + 3 + 3 design were evaluated AMG 900 given daily for 4 days with 10 days off (4/10 schedule), and AMG 900 given daily for 7 days with 7 days off (7/7 schedule)...
July 2017: American Journal of Hematology
https://www.readbyqxmd.com/read/28351181/prognostic-models-in-predicting-outcomes-in-myelodysplastic-syndromes-after-hypomethylating-agent-failure
#17
Sagar S Patel, Mikkael A Sekeres, Aziz Nazha
Myelodysplastic syndromes (MDS) are clonal stem cell disorders marked by bone marrow failure with varying degrees of cytopenias. MDS are characterized by the accumulation of complex genetic alterations that influence disease pathogenesis and outcomes. Given the heterogeneity of MDS patients, multiple prognostic scoring systems have been developed to predict patient outcomes. Most focus primarily on untreated patients in whom outcomes are predicted accurately only at diagnosis; their application dynamically, during the disease course and especially after hypomethylating agent (HMA) failure, may not be accurate...
March 28, 2017: Leukemia & Lymphoma
https://www.readbyqxmd.com/read/28350519/outcome-of-lower-risk-patients-with-myelodysplastic-syndromes-without-5q-deletion-after-failure-of-erythropoiesis-stimulating-agents
#18
Sophie Park, Jean-François Hamel, Andrea Toma, Charikleia Kelaidi, Sylvain Thépot, Maria Diez Campelo, Valeria Santini, Mikkael A Sekeres, Enrico Balleari, Jennifer Kaivers, Rosa Sapena, Katharina Götze, Catharina Müller-Thomas, Odile Beyne-Rauzy, Aspasia Stamatoullas, Ioannis Kotsianidis, Rami Komrokji, David P Steensma, Jaime Fensterl, Gail J Roboz, Teresa Bernal, Fernando Ramos, Marisa Calabuig, Agnès Guerci-Bresler, Dominique Bordessoule, Pascale Cony-Makhoul, Stéphane Cheze, Eric Wattel, Christian Rose, Norbert Vey, Daniela Gioia, Dario Ferrero, Gianluca Gaidano, Giovanni Cametti, Fabrizio Pane, Alessandro Sanna, Ulrich Germing, Guillermo F Sanz, François Dreyfus, Pierre Fenaux
Purpose Most anemic patients with non-deleted 5q lower-risk myelodysplastic syndromes (MDS) are treated with erythropoiesis-stimulating agents (ESAs), with a response rate of approximately 50%. Second-line treatments, including hypomethylating agents (HMAs), lenalidomide (LEN), and investigational drugs, may be used after ESA failure in some countries, but their effect on disease progression and overall survival (OS) is unknown. Here, we analyzed outcome after ESA failure and the effect of second-line treatments...
May 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28255022/molecular-features-of-early-onset-adult-myelodysplastic-syndrome
#19
Cassandra M Hirsch, Bartlomiej P Przychodzen, Tomas Radivoyevitch, Bhumika Patel, Swapna Thota, Michael J Clemente, Yasunobu Nagata, Thomas LaFramboise, Hetty E Carraway, Aziz Nazha, Mikkael A Sekeres, Hideki Makishima, Jaroslaw P Maciejewski
Myelodysplastic syndromes are typically diseases of older adults. Patients in whom the onset is early may have distinct molecular and clinical features or reflect a demographic continuum. The identification of differences between "early onset" patients and those diagnosed at a traditional age has the potential to advance understanding of the pathogenesis of myelodysplasia and may lead to formation of distinct morphological subcategories. We studied a cohort of 634 patients with various subcategories of myelodysplastic syndrome and secondary acute myeloid leukemia, stratifying them based on age at presentation and clinical parameters...
June 2017: Haematologica
https://www.readbyqxmd.com/read/28223278/genetic-abnormalities-in-myelodysplasia-and-secondary-acute-myeloid-leukemia-impact-on-outcome-of-stem-cell-transplantation
#20
Tetsuichi Yoshizato, Yasuhito Nannya, Yoshiko Atsuta, Yusuke Shiozawa, Yuka Iijima-Yamashita, Kenichi Yoshida, Yuichi Shiraishi, Hiromichi Suzuki, Yasunobu Nagata, Yusuke Sato, Nobuyuki Kakiuchi, Keitaro Matsuo, Makoto Onizuka, Keisuke Kataoka, Kenichi Chiba, Hiroko Tanaka, Hiroo Ueno, Masahiro M Nakagawa, Bartlomiej Przychodzen, Claudia Haferlach, Wolfgang Kern, Kosuke Aoki, Hidehiro Itonaga, Yoshinobu Kanda, Mikkael A Sekeres, Jaroslaw P Maciejewski, Torsten Haferlach, Yasushi Miyazaki, Keizo Horibe, Masashi Sanada, Satoru Miyano, Hideki Makishima, Seishi Ogawa
Genetic alterations, including mutations and copy-number alterations, are central to the pathogenesis of myelodysplastic syndromes and related diseases (myelodysplasia), but their roles in allogeneic stem cell transplantation have not fully been studied in a large cohort of patients. We enrolled 797 patients who had been diagnosed with myelodysplasia at initial presentation and received transplantation via the Japan Marrow Donor Program. Targeted-capture sequencing was performed to identify mutations in 69 genes, together with copy-number alterations, whose effects on transplantation outcomes were investigated...
April 27, 2017: Blood
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