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JOURNAL ARTICLE
Jan Philipp Bewersdorf, Kishan K Patel, Rory M Shallis, Nikolai A Podoltsev, Tariq Kewan, Jessica Stempel, Lourdes Mendez, Maximilian Stahl, Eytan M Stein, Scott F Huntington, George Goshua, Amer M Zeidan
The FLT3 inhibitor quizartinib has been shown to improve overall survival when added to intensive induction chemotherapy ("7 + 3") in patients 18-75 years old with newly diagnosed AML harboring a FLT3- ITD mutation. However, the health economic implications of this approval are unknown. We evaluated the cost-effectiveness of quizartinib using a partitioned survival analysis model. One-way and probabilistic sensitivity analyses were conducted. In the base case scenario, the addition of quizartinib to 7 + 3 resulted in incremental costs of $289,932 compared with 7 + 3 alone...
April 22, 2024: Leukemia & Lymphoma
#2
JOURNAL ARTICLE
Pau Montesinos, Amir T Fathi, Stéphane de Botton, Eytan M Stein, Amer M Zeidan, Yue Zhu, Thomas Prebet, Carlos Enrique Vigil, Iryna Bluemmert, Xin Yu, Courtney D DiNardo
Treatment with enasidenib, a selective mutant-IDH2 inhibitor, has been associated with the development of differentiation syndrome (DS) in patients with acute myeloid leukemia (AML). Studies on the incidence and clinical features of DS are limited in this setting, and diagnosis is challenging due to non-specific symptoms. This study assessed the incidence, diagnostic criteria, risk factors, and correlation with clinical response of DS based on the pooled analysis of 4 clinical trials in patients with IDH2-mutated AML treated with enasidenib as monotherapy, or in combination with azacitidine or with chemotherapy...
March 20, 2024: Blood Advances
#3
JOURNAL ARTICLE
Melissa Krystel-Whittemore, Kseniya Petrova-Drus, Ryan N Ptashkin, Mark D Ewalt, JinJuan Yao, Ying Liu, Menglei Zhu, Jamal Benhamida, Benjamin Durham, Jyoti Kumar, Khedoudja Nafa, Iwona Kiecka, Anita S Bowman, Erika Gedvilaite, Jacklyn Casanova, Yun-Te Lin, Abhinita S Mohanty, Satshil Rana, Anoop Balakrishnan Rema, Ivelise Rijo, Nelio Chaves, Paulo Salazar, Anita Yun, Sean Lachhander, Wei Wang, Mohammad S Haque, Wenbin Xiao, Mikhail Roshal, Sergio Giralt, Gilles Salles, Raajit Rampal, Eytan M Stein, Miguel-Angel Perales, Steven Horwitz, Ann Jakubowski, Doris Ponce, Alina Markova, Ozge Birsoy, Diana Mandelker, Simon Mantha, Ahmet Dogan, Ryma Benayed, Marc Ladanyi, Michael F Berger, A Rose Brannon, Ahmet Zehir, Chad Vanderbilt, Maria E Arcila
Comprehensive genomic sequencing is becoming a critical component in the assessment of hematologic malignancies, with broad implications for patient management. In this context, unequivocally discriminating somatic from germline events is challenging but greatly facilitated by matched analysis of tumor:normal pairs. In contrast to solid tumors, conventional sources of normal control (peripheral blood, buccal swabs, saliva) could be highly involved by the neoplastic process, rendering them unsuitable. In this work we describe our real-world experience using cell free DNA (cfDNA) isolated from nail clippings as an alternate source of normal control, through the dedicated review of 2,610 tumor:nail pairs comprehensively sequenced by MSK-IMPACT-heme...
March 7, 2024: Haematologica
#4
JOURNAL ARTICLE
Shai Shimony, Jan Philipp Bewersdorf, Rory M Shallis, Yiwen Liu, Eva J Schaefer, Amer M Zeidan, Aaron D Goldberg, Eytan M Stein, Guido Marcucci, R Coleman Lindsley, Evan C Chen, Jorge Ramos Perez, Anthony Stein, Daniel J DeAngelo, Donna S Neuberg, Richard M Stone, Brian Ball, Maximilian Stahl
Molecularly defined secondary acute myeloid leukemia is associated with a prior myeloid neoplasm and confers a worse prognosis. We compared outcomes of molecularly defined secondary AML patients (n = 395) treated with daunorubicin and cytarabine (7 + 3, n = 167), liposomal daunorubicin and cytarabine (CPX-351, n = 66) or hypomethylating agents (HMA) + venetoclax (VEN) (n = 162). Median overall survival (OS) was comparable between treatment groups among patients aged >60 years...
February 20, 2024: Leukemia
#5
JOURNAL ARTICLE
Eytan M Stein, Amir T Fathi, Wael A Harb, Gozde Colak, Andrea Fusco, James K Mangan
Pelabresib (CPI-0610), a BET protein inhibitor, is in clinical development for hematologic malignancies, given its ability to target NF-κB gene expression. The MANIFEST phase 1 study assessed pelabresib in patients with acute leukemia, high-risk myelodysplastic (MDS) syndrome, or MDS/myeloproliferative neoplasms (MDS/MPNs) (NCT02158858). Forty-four patients received pelabresib orally once daily (QD) at various doses (24-400 mg capsule or 225-275 mg tablet) on cycles of 14 d on and 7 d off...
January 23, 2024: Leukemia & Lymphoma
#6
JOURNAL ARTICLE
Hagop Kantarjian, Amer M Zeidan, Amir T Fathi, Eytan Stein, Vincent Rajkumar, Ayalew Tefferi
Today, approximately 50% of patients eligible for Medicare have opted for Medicare Advantage as their primary coverage. Whereas Medicare Advantage is a reasonable option for healthy senior Americans, issues arise once they have serious or chronic medical problems, which are prevalent among older Americans. This review details the pros and cons of standard Medicare vs Medicare Advantage. The authors recommend considering standard Medicare as a better form of insurance coverage. In addition, patients should also enroll in Medicare Part D to get prescription drug coverage; buy a supplemental MediGap policy; and buy additional coverage for hearing, vision, and dental care...
November 27, 2023: Mayo Clinic Proceedings
#7
JOURNAL ARTICLE
Ryan N Ptashkin, Mark D Ewalt, Gowtham Jayakumaran, Iwona Kiecka, Anita S Bowman, JinJuan Yao, Jacklyn Casanova, Yun-Te David Lin, Kseniya Petrova-Drus, Abhinita S Mohanty, Ruben Bacares, Jamal Benhamida, Satshil Rana, Anna Razumova, Chad Vanderbilt, Anoop Balakrishnan Rema, Ivelise Rijo, Julie Son-Garcia, Ino de Bruijn, Menglei Zhu, Sean Lachhander, Wei Wang, Mohammad S Haque, Venkatraman E Seshan, Jiajing Wang, Ying Liu, Khedoudja Nafa, Laetitia Borsu, Yanming Zhang, Umut Aypar, Sarah P Suehnholz, Debyani Chakravarty, Jae H Park, Omar Abdel-Wahab, Anthony R Mato, Wenbin Xiao, Mikhail Roshal, Mariko Yabe, Connie Lee Batlevi, Sergio Giralt, Gilles Salles, Raajit Rampal, Martin Tallman, Eytan M Stein, Anas Younes, Ross L Levine, Miguel-Angel Perales, Marcel R M van den Brink, Ahmet Dogan, Marc Ladanyi, Michael F Berger, A Rose Brannon, Ryma Benayed, Ahmet Zehir, Maria E Arcila
Genomic profiling of hematologic malignancies has augmented our understanding of variants that contribute to disease pathogenesis and supported development of prognostic models that inform disease management in the clinic. Tumor only sequencing assays are limited in their ability to identify definitive somatic variants, which can lead to ambiguity in clinical reporting and patient management. Here, we describe the MSK-IMPACT Heme cohort, a comprehensive data set of somatic alterations from paired tumor and normal DNA using a hybridization capture-based next generation sequencing platform...
October 28, 2023: Nature Communications
#8
JOURNAL ARTICLE
Sheng F Cai, Ying Huang, Jennie R Lance, Hsiao-Yin Charlene Charlene Mao, Andrew Dunbar, Samantha McNulty, Todd E Druley, Yan Li, Maria R Baer, Wendy Stock, Tibor Kovacsovics, William Blum, Gary J Schiller, Rebecca L Olin, James M Foran, Mark R Litzow, Tara L Lin, Prapti Arvind Patel, Matthew C Foster, Michael Boyiadzis, Robert H Collins, Jordan Chervin, Abigail B Shoben, Jo-Anne Vergilio, Nyla A Heerema, Leonard Rosenberg, Timothy L Chen, Ashley O Yocum, Franchesca Druggan, Sonja Marcus, Mona Stefanos, Brian J Druker, Alice S Mims, Uma Borate, Amy Burd, John C Byrd, Ross L Levine, Eytan M Stein
Enasidenib is an inhibitor of isocitrate dehydrogenase 2 (IDH2) approved for the treatment of patients with IDH2-mutant relapsed/refractory acute myeloid leukemia (AML). In this phase 2/1b Beat AML sub-study, we applied a risk-adapted approach to assess the efficacy of enasidenib monotherapy for patients 60 years and older with newly diagnosed IDH2-mutant AML in whom genomic profiling demonstrated mutant IDH2 was in the dominant leukemic clone. Patients for whom enasidenib monotherapy did not induce a complete response (CR) or CR with incomplete blood count recovery (CRi) enrolled on a phase 1b cohort with the addition of azacitidine...
October 23, 2023: Blood Advances
#9
JOURNAL ARTICLE
Jan Philipp Bewersdorf, Maximilian Stahl, Justin Taylor, Xiaoli Mi, Namrata Sonia Chandhok, Justin Watts, Andriy Derkach, Mateusz Wysocki, Sydney X Lu, Jessie Bourcier, Simon J Hogg, Jahan Rahman, Sana Chaudhry, Tulasigeri M Totiger, Omar Abdel-Wahab, Eytan M Stein
No abstract text is available yet for this article.
October 9, 2023: Leukemia
#10
JOURNAL ARTICLE
Karthik Nath, Jasme Lee, Theresa A Elko, Lauren Levy, Elaina Preston, Sean M Devlin, Doris M Ponce, Richard J Lin, Brian C Shaffer, Christina Cho, Ioannis Politikos, Ann A Jakubowski, Jae H Park, Raajit Rampal, Miguel-Angel Perales, Martin S Tallman, Juliet N Barker, Ellin Berman, Roni Tamari, Eytan Stein, Sergio A Giralt, Boglarka Gyurkocza
Allogeneic hematopoietic cell transplantation (allo-HCT) is a potentially curative treatment for patients with acute leukemia. Despite this, studies have shown that only a minority of patients ultimately proceed to allo-HCT. The primary objective of this prospective, observational study was to identify the rate of allo-HCT in patients for whom it was recommended, and reasons why patients deemed appropriate and eligible for HCT did not subsequently undergo transplant. Between April 2016 and April 2021, adult patients with newly diagnosed or relapsed/refractory acute leukemia were enrolled at the time of induction/reinduction therapy...
September 9, 2023: American Journal of Hematology
#11
JOURNAL ARTICLE
Eytan M Stein, Stephane de Botton, Thomas Cluzeau, Arnaud Pigneux, Jane L Liesveld, Rachel J Cook, Philippe Rousselot, David A Rizzieri, Thorsten Braun, Gail J Roboz, Delphine Lebon, Mael Heiblig, Kristen Baker, Angela Volkert, Sofia Paul, Nisha Rajagopal, David A Roth, Michael Kelly, Pierre Peterlin
Tamibarotene-based therapy is a novel targeted approach for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) with retinoic acid receptor alpha ( RARA ) gene overexpression. Approximately, 50% of higher-risk myelodysplastic syndrome (MDS) patients and approximately 30% of AML patients are positive for RARA overexpression using a blood-based biomarker test that measures RARA expression in peripheral blasts. A phase 2 study investigating the activity of tamibarotene in patients with RARA overexpression was conducted in patients with AML and MDS (NCT02807558)...
August 12, 2023: Leukemia & Lymphoma
#12
JOURNAL ARTICLE
Uma Borate, Fei Yang, Richard Press, Amy S Ruppert, Dan Jones, Sean Caruthers, Weiqiang Zhao, Jo-Anne Vergilio, Dean C Pavlick, Luke Juckett, Brianna Norris, Taylor Bucy, Amy Burd, Eytan M Stein, Prapti Patel, Maria R Baer, Wendy Stock, Gary Schiller, William Blum, Tibor Kovacsovics, Mark Litzow, James Foran, Nyla A Heerema, Leonard Rosenberg, Sonja Marcus, Ashley Yocum, Mona Stefanos, Brian Druker, John C Byrd, Ross L Levine, Alice Mims
Next-generation sequencing (NGS) to identify pathogenic mutations is an integral part of acute myeloid leukemia (AML) therapeutic decision-making. The concordance in identifying pathogenic mutations among different NGS platforms at different diagnostic laboratories has been studied in solid tumors but not in myeloid malignancies to date. To determine this interlaboratory concordance, we collected a total of 194 AML bone marrow or peripheral blood samples from newly diagnosed patients with AML enrolled in the Beat AML Master Trial (BAMT) at 2 academic institutions...
October 24, 2023: Blood Advances
#13
JOURNAL ARTICLE
Daniel A Pollyea, Jessica K Altman, Rita Assi, Dale Bixby, Amir T Fathi, James M Foran, Ivana Gojo, Aric C Hall, Brian A Jonas, Ashwin Kishtagari, Jeffrey Lancet, Lori Maness, James Mangan, Gabriel Mannis, Guido Marcucci, Alice Mims, Kelsey Moriarty, Moaath Mustafa Ali, Jadee Neff, Reza Nejati, Rebecca Olin, Mary-Elizabeth Percival, Alexander Perl, Amanda Przespolewski, Dinesh Rao, Farhad Ravandi, Rory Shallis, Paul J Shami, Eytan Stein, Richard M Stone, Kendra Sweet, Swapna Thota, Geoffrey Uy, Pankit Vachhani, Carly J Cassara, Deborah A Freedman-Cass, Katie Stehman
Acute myeloid leukemia (AML) is a heterogeneous hematologic malignancy characterized by the clonal expansion of myeloid blasts in the peripheral blood, bone marrow, and/or other tissues. It is the most common form of acute leukemia among adults and accounts for the largest number of annual deaths from leukemias in the United States. Like AML, blastic plasmacytoid dendritic cell neoplasm (BPDCN) is a myeloid malignancy. It is a rare malignancy characterized by the aggressive proliferation of precursors of plasmacytoid dendritic cells that frequently involves the bone marrow, skin, central nervous system, and other organs and tissues...
May 2023: Journal of the National Comprehensive Cancer Network: JNCCN
#14
JOURNAL ARTICLE
Joseph G W McCarter, David Nemirovsky, Christopher A Famulare, Noushin Farnoud, Abhinita S Mohanty, Zoe S Stone-Molloy, Jordan Chervin, Brian J Ball, Zachary D Epstein-Peterson, Maria E Arcila, Aaron J Stonestrom, Andrew Dunbar, Sheng F Cai, Jacob L Glass, Mark B Geyer, Raajit K Rampal, Ellin Berman, Omar I Abdel-Wahab, Eytan M Stein, Martin S Tallman, Ross L Levine, Aaron D Goldberg, Elli Papaemmanuil, Yanming Zhang, Mikhail Roshal, Andriy Derkach, Wenbin Xiao
Accurate classification and risk stratification is critical for clinical decision making in AML patients. In the newly proposed World Health Organization (WHO) and International Consensus classifications (ICC) of hematolymphoid neoplasms, the presence of myelodysplasia-related (MR) gene mutations is included as one of the diagnostic criteria of AML, myelodysplasia-related (AML-MR), largely based on the assumption that these mutations are specific for AML with an antecedent myelodysplastic syndrome. ICC also prioritizes MR gene mutations over ontogeny (as defined by clinical history)...
May 4, 2023: Blood Advances
#15
MULTICENTER STUDY
Vu H Duong, Amy S Ruppert, Alice S Mims, Uma Borate, Eytan M Stein, Maria R Baer, Wendy Stock, Tibor Kovacsovics, William Blum, Martha L Arellano, Gary J Schiller, Rebecca L Olin, James M Foran, Mark R Litzow, Tara L Lin, Prapti A Patel, Matthew C Foster, Robert L Redner, Zeina Al-Mansour, Christopher R Cogle, Ronan T Swords, Robert H Collins, Jo-Anne Vergilio, Nyla A Heerema, Leonard Rosenberg, Ashley O Yocum, Sonja Marcus, Timothy Chen, Franchesca Druggan, Mona Stefanos, Theophilus J Gana, Abigail B Shoben, Brian J Druker, Amy Burd, John C Byrd, Ross L Levine, Michael M Boyiadzis
BACKGROUND: Patients with acute myeloid leukemia (AML) who have tumor protein p53 (TP53) mutations or a complex karyotype have a poor prognosis, and hypomethylating agents are often used. The authors evaluated the efficacy of entospletinib, an oral inhibitor of spleen tyrosine kinase, combined with decitabine in this patient population. METHODS: This was a multicenter, open-label, phase 2 substudy of the Beat AML Master Trial (ClinicalTrials.gov identifier NCT03013998) using a Simon two-stage design...
August 1, 2023: Cancer
#16
JOURNAL ARTICLE
Ghayas C Issa, Ibrahim Aldoss, John DiPersio, Branko Cuglievan, Richard Stone, Martha Arellano, Michael J Thirman, Manish R Patel, David S Dickens, Shalini Shenoy, Neerav Shukla, Hagop Kantarjian, Scott A Armstrong, Florian Perner, Jennifer A Perry, Galit Rosen, Rebecca G Bagley, Michael L Meyers, Peter Ordentlich, Yu Gu, Vinit Kumar, Steven Smith, Gerard M McGeehan, Eytan M Stein
Targeting critical epigenetic regulators reverses aberrant transcription in cancer, thereby restoring normal tissue function1-3 . The interaction of menin with lysine methyltransferase 2A (KMT2A), an epigenetic regulator, is a dependence in acute leukaemia caused by either rearrangement of KMT2A or mutation of the nucleophosmin 1 gene (NPM1)4-6 . KMT2A rearrangements occur in up to 10% of acute leukaemias and have an adverse prognosis, whereas NPM1 mutations occur in up to 30%, forming the most common genetic alteration in acute myeloid leukaemia7,8 ...
March 2023: Nature
#17
JOURNAL ARTICLE
Florian Perner, Eytan M Stein, Daniela V Wenge, Sukrit Singh, Jeonghyeon Kim, Athina Apazidis, Homa Rahnamoun, Disha Anand, Christian Marinaccio, Charlie Hatton, Yanhe Wen, Richard M Stone, David Schaller, Shoron Mowla, Wenbin Xiao, Holly A Gamlen, Aaron J Stonestrom, Sonali Persaud, Elizabeth Ener, Jevon A Cutler, John G Doench, Gerard M McGeehan, Andrea Volkamer, John D Chodera, Radosław P Nowak, Eric S Fischer, Ross L Levine, Scott A Armstrong, Sheng F Cai
Chromatin-binding proteins are critical regulators of cell state in haematopoiesis1,2 . Acute leukaemias driven by rearrangement of the mixed lineage leukaemia 1 gene (KMT2Ar) or mutation of the nucleophosmin gene (NPM1) require the chromatin adapter protein menin, encoded by the MEN1 gene, to sustain aberrant leukaemogenic gene expression programs3-5 . In a phase 1 first-in-human clinical trial, the menin inhibitor revumenib, which is designed to disrupt the menin-MLL1 interaction, induced clinical responses in patients with leukaemia with KMT2Ar or mutated NPM1 (ref...
March 2023: Nature
#18
EDITORIAL
Eytan M Stein
No abstract text is available yet for this article.
January 12, 2023: Blood
#19
REVIEW
Hetty E Carraway, Daniel A Pollyea, Eytan M Stein
The advances and progress in the understanding and management of acute leukemia and myelodysplasia continue to occur at an exponential rate. While this has led to more therapy options, clinicians and researchers are now facing more challenges in terms of clinical decision-making and more unanswered questions. This paper has outlined some conundrums in acute leukemia and myelodysplasia, and the efforts that are underway to address these.
December 2022: Best Practice & Research. Clinical Haematology
#20
JOURNAL ARTICLE
Jan Philipp Bewersdorf, Kishan K Patel, George Goshua, Rory M Shallis, Nikolai A Podoltsev, Maximilian Stahl, Eytan M Stein, Scott F Huntington, Amer M Zeidan
Ivosidenib + azacitidine (IVO/AZA) is approved in the United States for newly diagnosed, older or intensive chemotherapy-ineligible patients with IDH1 -mutated acute myeloid leukemia. We created a partitioned survival analysis model to evaluate the health economic implications of this approval. Model outputs were used to calculate the incremental cost-effectiveness ratio (ICER) of IVO/AZA versus AZA. One-way and probabilistic sensitivity analyses were conducted. In the base case scenario, IVO/AZA and AZA resulted in life-time costs of $403,062 and $161,887, respectively...
December 9, 2022: Leukemia & Lymphoma
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