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1. Longitudinal follow up of a phase 2 trial of venetoclax added to hyper-CVAD, nelarabine and pegylated asparaginase in patients with T-cell acute lymphoblastic leukemia and lymphoma

Author

Ravandi, Farhad, Senapati, Jayastu, Jain, Nitin, Short, Nicholas J., Kadia, Tapan, Borthakur, Gautam, Konopleva, Marina, Wierda, William, Huang, Xuelin, Maiti, Abhishek, Issa, Ghayas, Balkin, Hayley, Garris, Rebecca, Ferrajoli, Alessandra, Garcia-Manero, Guillermo, Alvarado, Yesid, Kebriaei, Partow, Jabbour, Elias, and Kantarjian, Hagop M.

Published
2024
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2. Menin inhibitors in pediatric acute leukemia: a comprehensive review and recommendations to accelerate progress in collaboration with adult leukemia and the international community

Author

Cuglievan, Branko, Kantarjian, Hagop, Rubnitz, Jeffrey E., Cooper, Todd M., Zwaan, C. Michel, Pollard, Jessica A., DiNardo, Courtney D., Kadia, Tapan M., Guest, Erin, Short, Nicholas J., McCall, David, Daver, Naval, Nunez, Cesar, Haddad, Fadi G., Garcia, Miriam, Bhalla, Kapil N., Maiti, Abhishek, Catueno, Samanta, Fiskus, Warren, Carter, Bing Z., Gibson, Amber, Roth, Michael, Khazal, Sajad, Tewari, Priti, Abbas, Hussein A., Bourgeois, Wallace, Andreeff, Michael, Shukla, Neerav N., Truong, Danh D., Connors, Jeremy, Ludwig, Joseph A., Stutterheim, Janine, Salzer, Elisabeth, Juul-Dam, Kristian L., Sasaki, Koji, Mahadeo, Kris M., Tasian, Sarah K., Borthakur, Gautam, Dickson, Samantha, Jain, Nitin, Jabbour, Elias, Meshinchi, Soheil, Garcia-Manero, Guillermo, Ravandi, Farhad, Stein, Eytan M., Kolb, E. Anders, and Issa, Ghayas C.

Published
2024
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5. Influence of co-mutational patterns in disease phenotype and clinical outcomes of chronic myelomonocytic leukemia

Author

Montalban-Bravo, Guillermo, Rodriguez-Sevilla, Juan Jose, Swanson, David Michael, Kanagal-Shamanna, Rashmi, Hammond, Danielle, Chien, Kelly, Sasaki, Koji, Jabbour, Elias, DiNardo, Courtney, Takahashi, Koichi, Short, Nicholas, Issa, Ghayas C., Pemmaraju, Naveen, Kadia, Tapan, Ravandi, Farhad, Daver, Naval, Borthakur, Gautam, Loghavi, Sanam, Pierce, Sherry, Bueso-Ramos, Carlos, Kantarjian, Hagop, and Garcia-Manero, Guillermo

Published
2024
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9. Decitabine, venetoclax, and ponatinib for advanced phase chronic myeloid leukaemia and Philadelphia chromosome-positive acute myeloid leukaemia: a single-arm, single-centre phase 2 trial

Author

Short, Nicholas J, Nguyen, Daniel, Jabbour, Elias, Senapati, Jayastu, Zeng, Zhihong, Issa, Ghayas C, Abbas, Hussein, Nasnas, Cedric, Qiao, Wei, Huang, Xuelin, Borthakur, Gautam, Chien, Kelly, Haddad, Fadi G, Pemmaraju, Naveen, Karrar, Omer S, Nguyen, Danielle, Konopleva, Marina, Kantarjian, Hagop, and Ravandi, Farhad

Published
2024
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10. Ziftomenib in relapsed or refractory acute myeloid leukaemia (KOMET-001): a multicentre, open-label, multi-cohort, phase 1 trial

Author

Wang, Eunice S, Issa, Ghayas C, Erba, Harry P, Altman, Jessica K, Montesinos, Pau, DeBotton, Stephane, Walter, Roland B, Pettit, Kristen, Savona, Michael R, Shah, Mithun Vinod, Kremyanskaya, Marina, Baer, Maria R, Foran, James M, Schiller, Gary, Adès, Lionel, Heiblig, Mael, Berthon, Celine, Peterlin, Pierre, Rodríguez-Arbolí, Eduardo, Salamero, Olga, Patnaik, Mrinal M, Papayannidis, Cristina, Grembecka, Jolanta, Cierpicki, Tomasz, Clegg, Bradley, Ray, Joshua, Linhares, Brian M, Nie, Kun, Mitra, Amitava, Ahsan, Julie Mackey, Tabachri, Marilyn, Soifer, Harris S, Corum, Daniel, Leoni, Mollie, Dale, Stephen, and Fathi, Amir T

Published
2024
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11. Characteristics and outcomes of children, adolescent, and young adult patients with myelodysplastic neoplasms: A single-center retrospective analysis

Author

McCall, David, Abuasab, Tareq, Rodriguez-Sevilla, Juan Jose, Mohamed, Shehab Fareed, Patnaik, Anish, Devireddy, Kirthi, Arani, Naszrin, Sheikh, Irtiza, Jamshidi, Raehannah, Gibson, Amber, Roth, Michael, Nuñez, Cesar, Garcia, Miriam, Chien, Kelly S., Loghavi, Sanam, Pierce, Sherry A., Sasaki, Koji, Issa, Ghayas, Cuglievan, Branko, Kantarjian, Hagop, and Garcia-Manero, Guillermo

Published
2024
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12. Oral decitabine and cedazuridine plus venetoclax for older or unfit patients with acute myeloid leukaemia: a phase 2 study

Author

Bazinet, Alexandre, Garcia-Manero, Guillermo, Short, Nicholas, Alvarado, Yesid, Bataller, Alex, Abuasab, Tareq, Islam, Rabiul, Montalbano, Kathryn, Issa, Ghayas, Maiti, Abhishek, Yilmaz, Musa, Jain, Nitin, Masarova, Lucia, Kornblau, Steven, Jabbour, Elias, Montalban-Bravo, Guillermo, Rausch, Caitlin R, Pierce, Sherry, DiNardo, Courtney D, Kadia, Tapan, Daver, Naval, Konopleva, Marina, Huang, Xuelin, Kantarjian, Hagop, and Ravandi, Farhad

Published
2024
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13. Oral decitabine plus cedazuridine and venetoclax in patients with higher-risk myelodysplastic syndromes or chronic myelomonocytic leukaemia: a single-centre, phase 1/2 study

Author

Bataller, Alex, Montalban-Bravo, Guillermo, Bazinet, Alexandre, Alvarado, Yesid, Chien, Kelly, Venugopal, Sangeetha, Ishizawa, Jo, Hammond, Danielle, Swaminathan, Mahesh, Sasaki, Koji, Issa, Ghayas C, Short, Nicholas J, Masarova, Lucia, Daver, Naval G, Kadia, Tapan M, Colla, Simona, Qiao, Wei, Huang, Xuelin, Kanagal-Shamanna, Rashmi, Hendrickson, Stephany, Ravandi, Farhad, Jabbour, Elias, Kantarjian, Hagop, and Garcia-Manero, Guillermo

Published
2024
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14. Prognostic risk signature in patients with acute myeloid leukemia treated with hypomethylating agents and venetoclax

Author

Bataller, Alex, Bazinet, Alexandre, DiNardo, Courtney D., Maiti, Abhishek, Borthakur, Gautam, Daver, Naval G., Short, Nicholas J., Jabbour, Elias J., Issa, Ghayas C., Pemmaraju, Naveen, Yilmaz, Musa, Montalban-Bravo, Guillermo, Takahashi, Koichi, Loghavi, Sanam, Garcia-Manero, Guillermo, Ravandi, Farhad, Kantarjian, Hagop M., and Kadia, Tapan M.

Published
2024
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15. Response patterns and impact of MRD in patients with IDH1/2-mutated AML treated with venetoclax and hypomethylating agents

Author

Hammond, Danielle, Loghavi, Sanam, Wang, Sa A., Konopleva, Marina Y., Kadia, Tapan M., Daver, Naval G., Ohanian, Maro, Issa, Ghayas C., Alvarado, Yesid, Short, Nicholas J., Sasaki, Koji, Pemmaraju, Naveen, Montalban-Bravo, Guillermo, Lachowiez, Curtis A., Maiti, Abhishek, Garcia-Manero, Guillermo, Jabbour, Elias J., Borthakur, Gautam, Ravandi, Farhad, Takahashi, Koichi, Pierce, Sherry R., Kantarjian, Hagop M., and DiNardo, Courtney D.

Published
2023
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16. A Phase I study of Milademetan (DS3032b) in combination with low dose cytarabine with or without venetoclax in acute myeloid leukemia: Clinical safety, efficacy, and correlative analysis

Author

Senapati, Jayastu, Muftuoglu, Muharrem, Ishizawa, Jo, Abbas, Hussein A., Loghavi, Sanam, Borthakur, Gautam, Yilmaz, Musa, Issa, Ghayas C., Dara, Samuel I., Basyal, Mahesh, Li, Li, Naqvi, Kiran, Pourebrahim, Rasoul, Jabbour, Elias J., Kornblau, Steven M., Short, Nicholas J., Pemmaraju, Naveen, Garcia-Manero, Guillermo, Ravandi, Farhad, Khoury, Joseph, Daver, Naval, Kantarjian, Hagop M., Andreeff, Michael, and DiNardo, Courtney D.

Published
2023
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20. Venetoclax abrogates the prognostic impact of splicing factor gene mutations in newly diagnosed acute myeloid leukemia

Author

Senapati, Jayastu, Urrutia, Samuel, Loghavi, Sanam, Short, Nicholas J., Issa, Ghayas C., Maiti, Abhishek, Abbas, Hussein A., Daver, Naval G., Pemmaraju, Naveen, Pierce, Sherry, Chien, Kelly S., Sasaki, Koji, Kadia, Tapan M., Hammond, Danielle E., Borthakur, Gautam, Patel, Keyur, Ravandi, Farhad, Kantarjian, Hagop M., Garcia-Manero, Guillermo, and DiNardo, Courtney D.

Published
2023
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21. Geographic Disparity of Outcome in Patients With Cancer Over Decades: The Surveillance, Epidemiology, and End Results

Author

Sasaki, Koji, Morita, Kiyomi, Kantarjian, Hagop, Garcia-Manero, Guillermo, Jabbour, Elias, Ravandi, Farhad, Konopleva, Marina, Borthakur, Gautam, Wierda, William, Daver, Naval, Takahashi, Koichi, DiNardo, Courtney, Bravo, Guillermo Montalban, Issa, Ghayas C., Pierce, Sherry A., Soltysiak, Kelly A., Tingen, Martha S., and Cortes, Jorge E.

Published
2023
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22. The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia

Author

Issa, Ghayas C., Aldoss, Ibrahim, DiPersio, John, Cuglievan, Branko, Stone, Richard, Arellano, Martha, Thirman, Michael J., Patel, Manish R., Dickens, David S., Shenoy, Shalini, Shukla, Neerav, Kantarjian, Hagop, Armstrong, Scott A., Perner, Florian, Perry, Jennifer A., Rosen, Galit, Bagley, Rebecca G., Meyers, Michael L., Ordentlich, Peter, Gu, Yu, Kumar, Vinit, Smith, Steven, McGeehan, Gerard M., and Stein, Eytan M.

Published
2023
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24. Impact of type of induction therapy on outcomes in older adults with AML after allogeneic stem cell transplantation

Author

Short, Nicholas J., Ong, Faustine, Ravandi, Farhad, Nogueras-Gonzalez, Graciela, Kadia, Tapan M., Daver, Naval, DiNardo, Courtney D., Konopleva, Marina, Borthakur, Gautam, Oran, Betul, Al-Atrash, Gheath, Mehta, Rohtesh, Jabbour, Elias J., Yilmaz, Musa, Issa, Ghayas C, Maiti, Abhishek, Champlin, Richard E, Kantarjian, Hagop, Shpall, Elizabeth J, and Popat, Uday

Published
2023
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25. Clinical outcomes associated with NPM1 mutations in patients with relapsed or refractory AML

Author

Issa, Ghayas C., Bidikian, Aram, Venugopal, Sangeetha, Konopleva, Marina, DiNardo, Courtney D., Kadia, Tapan M., Borthakur, Gautam, Jabbour, Elias, Pemmaraju, Naveen, Yilmaz, Musa, Short, Nicholas J., Maiti, Abhishek, Sasaki, Koji, Masarova, Lucia, Pierce, Sherry, Takahashi, Koichi, Tang, Guilin, Loghavi, Sanam, Patel, Keyur, Andreeff, Michael, Bhalla, Kapil, Garcia-Manero, Guillermo, Ravandi, Farhad, Kantarjian, Hagop, and Daver, Naval

Published
2023
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26. Ponatinib and blinatumomab for Philadelphia chromosome-positive acute lymphoblastic leukaemia: a US, single-centre, single-arm, phase 2 trial

Author

Jabbour, Elias, Short, Nicholas J, Jain, Nitin, Huang, Xuelin, Montalban-Bravo, Guillermo, Banerjee, Pinaki, Rezvani, Katayoun, Jiang, Xianli, Kim, Kun Hee, Kanagal-Shamanna, Rashmi, Khoury, Joseph D, Patel, Keyur, Kadia, Tapan M, Daver, Naval, Chien, Kelly, Alvarado, Yesid, Garcia-Manero, Guillermo, Issa, Ghayas C, Haddad, Fadi G, Kwari, Monica, Thankachan, Jennifer, Delumpa, Ricardo, Macaron, Walid, Garris, Rebecca, Konopleva, Marina, Ravandi, Farhad, and Kantarjian, Hagop

Published
2023
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27. Inotuzumab ozogamicin in combination with low-intensity chemotherapy (mini-HCVD) with or without blinatumomab versus standard intensive chemotherapy (HCVAD) as frontline therapy for older patients with Philadelphia chromosome-negative acute lymphoblastic leukemia: A propensity score analysis.

Author

Jabbour, Elias, Sasaki, Koji, Ravandi, Farhad, Short, Nicholas, Garcia-Manero, Guillermo, Daver, Naval, Kadia, Tapan, Konopleva, Marina, Jain, Nitin, Cortes, Jorge, Issa, Ghayas, Jacob, Jovitta, Kwari, Monica, Thompson, Philip, Garris, Rebecca, Pemmaraju, Naveen, Yilmaz, Musa, Kantarjian, Hagop, and OBrien, Susan

Subjects
blinatumomab, inotuzumab, mini-hyperfractionated cyclophosphamide, vincristine, and dexamethasone (mini-HCVD), older acute lymphoblastic leukemia (ALL), outcome, Aged, Aged, 80 and over, Antibodies, Bispecific, Antineoplastic Agents, Immunological, Female, Humans, Inotuzumab Ozogamicin, Male, Middle Aged, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Propensity Score, Survival Rate
Abstract

BACKGROUND: The outcome of older patients with newly diagnosed, Philadelphia chromosome (Ph)-negative acute lymphoblastic leukemia (ALL) is poor. The combination of targeted therapy with low-intensity chemotherapy is safe and effective. The objective of the current analysis was to compare the outcome of patients who received a combination of inotuzumab ozogamicin plus low-intensity chemotherapy (mini-hyperfractionated cyclophosphamide, vincristine, and dexamethasone [mini-HCVD]) with or without blinatumomab versus the outcome of those who received the standard, intensive, hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HCVAD) regimen. METHODS: The authors analyzed 135 older patients with newly diagnosed, Ph-negative ALL who were treated prospectively with standard HCVAD (n = 77) or with the combination of inotuzumab ozogamicin plus mini-HCVD with or without blinatumomab (n = 58). A propensity score analysis was conducted using 1:1 matching using the nearest neighbor matching method. RESULTS: Propensity score matching identified 38 patients in each cohort. The antibody plus low-intensity chemotherapy combination induced higher response rates (98% vs 88%), with lower rates of early death (0% vs 8%) and lower rates of death in complete remission (5% vs 17%). With propensity score matching, the 3-year event-free survival rates for patients who received HCVAD and those who received the combination of inotuzumab ozogamicin plus mini-HCVD with or without blinatumomab were 34% and 64%, respectively (P = .003), and the 3-year overall survival rates were 34% and 63%, respectively (P = .004). By multivariate analysis, age (P = .019; hazard ratio, 1.045) and the combination of inotuzumab plus mini-HCVD with or without blinatumomab (P = .020; hazard ratio, 0.550) were identified as independent prognostic factors for survival. CONCLUSIONS: The combination of inotuzumab ozogamicin plus mini-HCVD with or without blinatumomab is safe and effective in older patients with newly diagnosed, Ph-negative ALL and confers a better outcome compared with standard HCVAD chemotherapy.

Published
2019

28. Menin Inhibition With Revumenib for KMT2A -Rearranged Relapsed or Refractory Acute Leukemia (AUGMENT-101).

Author

Issa, Ghayas C., Aldoss, Ibrahim, Thirman, Michael J., DiPersio, John, Arellano, Martha, Blachly, James S., Mannis, Gabriel N., Perl, Alexander, Dickens, David S., McMahon, Christine M., Traer, Elie, Zwaan, C. Michel, Grove, Carolyn S., Stone, Richard, Shami, Paul J., Mantzaris, Ioannis, Greenwood, Matthew, Shukla, Neerav, Cuglievan, Branko, and Kovacsovics, Tibor

Published
2025
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29. Cladribine-Based Therapy for Acute Myeloid Leukemia in Child, Adolescent, and Early Young Adult Patients: The MD Anderson Cancer Center Experience.

Author

McCall, David, Alqahtani, Shaikha, Budak, Moriah, Sheikh, Irtiza, Fan, Aaron E., Ramakrishnan, Ramya, Nunez, Cesar, Roth, Michael, Garcia, Miriam B., Gibson, Amber, Daver, Naval, Garces, Sofia, Short, Nicholas J., Issa, Ghayas C., Ravandi, Farhad, DiNardo, Courtney D., Montalban Bravo, Guillermo, Garcia-Manero, Guillermo, Cuglievan, Branko, and Kadia, Tapan

Subjects
CANCER treatment, FEBRILE neutropenia, RESEARCH funding, ADENOSINES, SALVAGE therapy, TREATMENT effectiveness, RETROSPECTIVE studies, DESCRIPTIVE statistics, CANCER chemotherapy, MEDICAL records, ACQUISITION of data, SEPSIS, CONFIDENCE intervals, SPECIALTY hospitals, DRUG tolerance, OVERALL survival, DISEASE progression, DISEASE risk factors
Abstract

Simple Summary: Cladribine is a chemotherapy used in combination with other chemotherapy drugs in adult patients with acute myeloid leukemia (AML) who relapse or are nonresponsive to treatment. It appeared to work well and is now used for newly diagnosed adult patients. While it is commonly used in adults, it has not been used routinely in children. We looked at medical records of pediatric and adolescent patients treated for AML at MD Anderson to analyze its safety and how well it works against AML. It was found to be safe and well tolerated in these patients and also showed improved survival outcomes. About half of the patients responded to cladribine either by itself or with other chemotherapy agents. This review also highlighted its safety in combination with other agents. We found these combinations to be well tolerated and could provide additional options for pediatric providers who are treating relapsed AML. Background: Cladribine-based combination chemotherapy has demonstrated promising efficacy in patients with relapsed/refractory adult acute myeloid leukemia (AML), prompting its increased utilization in the frontline; in pediatrics, it has been typically reserved for relapsed or refractory cases. While fludarabine has been used more commonly as a purine analog in intensive regimens, cladribine may be an important alternative. Methods: We performed a retrospective study at MD Anderson Cancer Center from January 2015 to July 2023, which included patients aged 1–21 years with refractory or relapsed AML who received cladribine outside of a transplant conditioning. Results: A total of 30 patients were included, with a median age of 20 years (range, 2–21), and 55% being male. Similar to adults, cladribine exhibited good tolerability in pediatric and adolescent patients, with the most common adverse events being febrile neutropenia and myelosuppression. The most common grade 3 or 4 adverse events included febrile neutropenia (55%) and sepsis (26%), and there were no treatment discontinuations due to adverse events. Among patients with a median number of 2 (0–7) prior treatments, the overall response rate (CR/CRi) was 45%, and median event-free and overall survival were 6 and 12 months, respectively. Disease progression resulted in 4 deaths within 30 days of treatment. Conclusions: Cladribine was tolerated in pediatrics. No new safety signals were seen with cladribine regimens in this cohort. Response assessment is limited due to the heavily pretreated cohort. Further prospective studies are warranted on the safety and efficacy of cladribine and establish its role in pediatric, adolescent, and early young adult patients with AML. [ABSTRACT FROM AUTHOR]

Published
2024
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31. Impact of frontline treatment approach on outcomes in patients with secondary AML with prior hypomethylating agent exposure

Author

Short, Nicholas J., Venugopal, Sangeetha, Qiao, Wei, Kadia, Tapan M., Ravandi, Farhad, Macaron, Walid, Dinardo, Courtney D., Daver, Naval, Konopleva, Marina, Borthakur, Gautam, Shpall, Elizabeth J., Popat, Uday, Champlin, Richard E., Mehta, Rohtesh, Al-Atrash, Gheath, Oran, Betul, Jabbour, Elias, Garcia-Manero, Guillermo, Issa, Ghayas C., Montalban-Bravo, Guillermo, Yilmaz, Musa, Maiti, Abhishek, and Kantarjian, Hagop

Published
2022
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32. TP53 Y220C mutations in patients with myeloid malignancies

Author

Gener-Ricos, Georgina, primary, Bewersdorf, Jan P., additional, Loghavi, Sanam, additional, Bataller, Alex, additional, Goldberg, Aaron D., additional, Famulare, Christopher, additional, Takahashi, Koichi, additional, Issa, Ghayas C., additional, Borthakur, Gautam, additional, Kadia, Tapan M., additional, Short, Nicholas J., additional, Senapati, Jayastu, additional, Carter, Bing Z., additional, Patel, Keyur P., additional, Kantarjian, Hagop, additional, Andreeff, Michael, additional, Stein, Eytan M., additional, and DiNardo, Courtney D., additional

Published
2024
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33. ASC4FIRST, a pivotal phase 3 study of asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS TKIs) in newly diagnosed patients (pts) with chronic myeloid leukemia (CML): Primary results.

Author

Hughes, Timothy P., primary, Hochhaus, Andreas, additional, Takahashi, Naoto, additional, Issa, Ghayas C., additional, Larson, Richard A., additional, Bombaci, Felice, additional, Wang, Jianxiang, additional, Kim, Dong-Wook, additional, Kim, Dennis Dong Hwan, additional, Mayer, Jiri, additional, Goh, Yeow Tee, additional, Le Coutre, Phillipp D., additional, Andorsky, David Jacob, additional, Kapoor, Shruti, additional, McCulloch, Tracey, additional, Malek, Kamel, additional, Yau, Lillian, additional, Ifrah, Sophie, additional, and Cortes, Jorge E., additional

Published
2024
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34. FLAG-IDA + venetoclax in newly diagnosed (ND) or relapsed/refractory (RR) AML.

Author

Jen, Wei Ying, primary, Takahashi, Koichi, additional, Loghavi, Sanam, additional, Kadia, Tapan M., additional, Daver, Naval Guastad, additional, Xiao, Lianchun, additional, Short, Nicholas James, additional, Borthakur, Gautam, additional, Issa, Ghayas C., additional, Pemmaraju, Naveen, additional, Reville, Patrick Kevin, additional, Bravo, Guillermo Montalban, additional, Yilmaz, Musa, additional, Garcia-Manero, Guillermo, additional, Ravandi-Kashani, Farhad, additional, Konopleva, Marina, additional, Mullin, Jillian K, additional, Pierce, Sherry, additional, Kantarjian, Hagop M., additional, and Dinardo, Courtney Denton, additional

Published
2024
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35. Phase 1 Study of CK0801 in Treatment of Bone Marrow Failure Syndromes

Author

Kadia, Tapan M., primary, Huang, Meixian, additional, Pemmaraju, Naveen, additional, Abbas, Hussein A., additional, Ly, Christopher, additional, Masarova, Lucia, additional, Yilmaz, Musa, additional, Lyu, Mi-Ae, additional, Zeng, Ke, additional, Sadeghi, Tara, additional, Cook, Robin, additional, DiNardo, Courtney D., additional, Daver, Naval, additional, Issa, Ghayas C., additional, Jabbour, Elias, additional, Borthakur, Gautam, additional, Jain, Nitin, additional, Garcia-Manero, Guillermo, additional, Parmar, Simrit, additional, Flowers, Christopher, additional, Kantarjian, Hagop, additional, and Verstovsek, Srdan, additional

Published
2024
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42. Prognostic factors and survival outcomes in patients with chronic myeloid leukemia in blast phase in the tyrosine kinase inhibitor era: Cohort study of 477 patients

Author

Jain, Preetesh, Kantarjian, Hagop M, Ghorab, Ahmad, Sasaki, Koji, Jabbour, Elias J, Nogueras Gonzalez, Graciela, Kanagal-Shamanna, Rashmi, Issa, Ghayas C, Garcia-Manero, Guillermo, Kc, Devendra, Dellasala, Sara, Pierce, Sherry, Konopleva, Marina, Wierda, William G, Verstovsek, Srdan, Daver, Naval G, Kadia, Tapan M, Borthakur, Gautam, O'Brien, Susan, Estrov, Zeev, Ravandi, Farhad, and Cortes, Jorge E

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Hematology, Rare Diseases, Cancer, Clinical Research, Stem Cell Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adolescent, Adult, Aged, Aged, 80 and over, Blast Crisis, Cohort Studies, Female, Humans, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Male, Middle Aged, Prognosis, Protein Kinase Inhibitors, Protein-Tyrosine Kinases, Risk Factors, Survival Analysis, Young Adult, blast phase, bosutinib, chronic myeloid leukemia, dasatinib, imatinib, nilotinib, ponatinib, tyrosine kinase inhibitors, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundOutcomes in patients with chronic myeloid leukemia in blast phase (CML-BP) are historically dismal. Herein, the authors sought to analyze the characteristics, prognostic factors, and survival outcomes in patients with CML-BP in the tyrosine kinase inhibitor (TKI) era.MethodsA total of 477 patients with CML-BP were treated with a TKI at some point during the course of their CML. Cox proportional hazard models identified characteristics that were predictive of survival. Overall survival and failure-free survival were assessed. Optimal cutoff points for specific parameters were identified using classification and regression tree (CART) analysis.ResultsThe median age of the patients was 53 years (range, 16-84 years) and 64% were male. Approximately 80% of patients initially were diagnosed in the chronic phase of CML at a median of 41 months (range, 0.7-298 months) before transformation to CML-BP. De novo CML-BP occurred in 71 patients. Approximately 72% of patients received TKI therapy before CML-BP. The initial therapy for CML-BP included a TKI alone (35%), a TKI with chemotherapy (46%), and non-TKI therapies (19%). The median overall survival was 12 months and the median failure-free survival was 5 months. In multivariate analysis, myeloid immunophenotype, prior TKI, age ≥58 years, lactate dehydrogenase level ≥1227 IU/L, platelet count

Published
2017

43. TP53 mutation does not confer a poor outcome in adult patients with acute lymphoblastic leukemia who are treated with frontline hyper-CVAD-based regimens.

Author

Kanagal-Shamanna, Rashmi, Jain, Preetesh, Takahashi, Koichi, Short, Nicholas, Tang, Guilin, Issa, Ghayas, Ravandi, Farhad, Garcia-Manero, Guillermo, Yin, Cameron, Luthra, Rajyalakshmi, Patel, Keyur, Khoury, Joseph, Montalban-Bravo, Guillermo, Sasaki, Koji, Kadia, Tapan, Borthakur, Gautam, Konopleva, Marina, Jain, Nitin, Garris, Rebecca, Pierce, Sherry, Wierda, William, Estrov, Zeev, Cortes, Jorge, Kantarjian, Hagop, Jabbour, Elias, and OBrien, Susan

Subjects
acute lymphoblastic leukemia (ALL), hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD), next-generation sequencing, tumor protein 53 (TP53), Adult, Age Factors, Aged, Aged, 80 and over, Alleles, Antineoplastic Combined Chemotherapy Protocols, Cyclophosphamide, Dexamethasone, Doxorubicin, Female, Genes, p53, Humans, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Male, Middle Aged, Mutation, Mutation, Missense, Precursor B-Cell Lymphoblastic Leukemia-Lymphoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Sequence Analysis, DNA, Treatment Outcome, Tumor Suppressor Protein p53, Vincristine
Abstract

BACKGROUND: Tumor protein 53 (TP53) mutations are uncommon in adult patients with acute lymphoblastic leukemia (ALL) and predict a poor outcome. METHODS: TP53 mutation analysis was performed in 164 newly diagnosed adult patients with ALL using a combination of targeted amplicon-based next-generation sequencing and Sanger sequencing. RESULTS: TP53 mutations were detected in 25 patients (15%), with a median allelic frequency of 42.2% (range, 5.6%-93.8%). The majority of mutations were single-nucleotide variants of missense type and involved the DNA-binding domain. TP53-mutated (TP53mut ) ALL was found to be significantly associated with older age, lower median white blood cell and platelet counts, lower frequency of Philadelphia chromosome and a higher frequency of low hypodiploid karyotype compared with ALL with wild-type TP53 (TP53wt ). To evaluate the prognostic effect of TP53 mutations, the authors selected 146 patients with B-cell immunophenotype ALL (24 with TP53mut and 122 with TP53wt ) who were uniformly treated with frontline hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (hyper-CVAD)-based regimens; >90% of these individuals also received a monoclonal antibody. Over a median follow-up duration of 15 months, there was no significant difference in the median overall survival, event-free survival, and duration of complete remission noted between patients with TP53mut ALL and those with TP53wt ALL. CONCLUSIONS: Hyper-CVAD-based regimens appear to negate the poor prognostic impact of TP53 mutations in patients with adult B-cell immunophenotype ALL. Cancer 2017;123:3717-24. © 2017 American Cancer Society.

Published
2017

44. Poor outcomes associated with +der(22)t(9;22) and −9/9p in patients with Philadelphia chromosome‐positive acute lymphoblastic leukemia receiving chemotherapy plus a tyrosine kinase inhibitor

Author

Short, Nicholas J, Kantarjian, Hagop M, Sasaki, Koji, Ravandi, Farhad, Ko, Heidi, Yin, C Cameron, Garcia‐Manero, Guillermo, Cortes, Jorge E, Garris, Rebecca, O'Brien, Susan M, Patel, Keyur, Khouri, Maria, Thomas, Deborah, Jain, Nitin, Kadia, Tapan M, Daver, Naval G, Benton, Christopher B, Issa, Ghayas C, Konopleva, Marina, and Jabbour, Elias

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Pediatric Cancer, Cancer, Hematology, Clinical Research, Childhood Leukemia, Rare Diseases, Pediatric, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Chromosome Aberrations, Chromosomes, Human, Pair 22, Chromosomes, Human, Pair 9, Dasatinib, Disease-Free Survival, Female, Gene Deletion, Humans, Imatinib Mesylate, Imidazoles, Male, Middle Aged, Philadelphia Chromosome, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prognosis, Protein Kinase Inhibitors, Pyridazines, Survival Rate, Translocation, Genetic, Treatment Outcome, Young Adult, Cardiorespiratory Medicine and Haematology, Immunology, Cardiovascular medicine and haematology
Abstract

In patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) treated with chemotherapy plus a tyrosine kinase inhibitor (TKI), the prognostic impact of additional chromosomal abnormalities (ACAs) is not well-established. We evaluated the prognostic impact of individual ACAs in 152 patients with Ph+ ALL receiving first-line intensive chemotherapy plus either imatinib (n = 36), dasatinib (n = 74), or ponatinib (n = 42). ACAs were identified in 118 patients (78%). Compared to outcomes of patients without ACAs, ACAs were not associated with differences in either relapse-free survival (RFS; P = 0.42) or overall survival (OS; P = 0.51). When individual ACAs were evaluated, +der(22)t(9;22) and/or -9/9p in the absence of high hyperdiploidy (HeH) was present in 16% of patients and constituted a poor-risk ACA group. Patients with one or more poor-risk ACAs in the absence of HeH had significantly shorter RFS (5-year RFS rate 33% versus 59%, P = 0.01) and OS (5-year OS rate 24% versus 63%, P = 0.003). Poor-risk ACAs were prognostic in patients who received imatinib and dasatinib but not in those who received ponatinib. By multivariate analysis, this poor-risk ACA group was independently associated with worse RFS (HR 2.03 [95% CI 1.08-3.30], P = 0.03) and OS (HR 2.02 [95% CI 1.10-3.71], P = 0.02). Patients with Ph+ ALL who have +der(22)t(9;22) and/or -9/9p in the absence of HeH have relatively poor outcomes when treated with chemotherapy plus a TKI.

Published
2017

45. Poor outcomes associated with +der(22)t(9;22) and -9/9p in patients with Philadelphia chromosome-positive acute lymphoblastic leukemia receiving chemotherapy plus a tyrosine kinase inhibitor.

Author

Short, Nicholas J, Kantarjian, Hagop M, Sasaki, Koji, Ravandi, Farhad, Ko, Heidi, Cameron Yin, C, Garcia-Manero, Guillermo, Cortes, Jorge E, Garris, Rebecca, O'Brien, Susan M, Patel, Keyur, Khouri, Maria, Thomas, Deborah, Jain, Nitin, Kadia, Tapan M, Daver, Naval G, Benton, Christopher B, Issa, Ghayas C, Konopleva, Marina, and Jabbour, Elias

Subjects
Chromosomes, Human, Pair 9, Philadelphia Chromosome, Chromosomes, Human, Pair 22, Humans, Chromosome Aberrations, Translocation, Genetic, Imidazoles, Pyridazines, Antineoplastic Combined Chemotherapy Protocols, Protein Kinase Inhibitors, Prognosis, Disease-Free Survival, Treatment Outcome, Survival Rate, Gene Deletion, Adult, Aged, Aged, 80 and over, Middle Aged, Female, Male, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Young Adult, Imatinib Mesylate, Dasatinib, Rare Diseases, Pediatric Cancer, Pediatric, Hematology, Clinical Research, Cancer, Childhood Leukemia, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Cardiorespiratory Medicine and Haematology, Immunology
Abstract

In patients with Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL) treated with chemotherapy plus a tyrosine kinase inhibitor (TKI), the prognostic impact of additional chromosomal abnormalities (ACAs) is not well-established. We evaluated the prognostic impact of individual ACAs in 152 patients with Ph+ ALL receiving first-line intensive chemotherapy plus either imatinib (n = 36), dasatinib (n = 74), or ponatinib (n = 42). ACAs were identified in 118 patients (78%). Compared to outcomes of patients without ACAs, ACAs were not associated with differences in either relapse-free survival (RFS; P = 0.42) or overall survival (OS; P = 0.51). When individual ACAs were evaluated, +der(22)t(9;22) and/or -9/9p in the absence of high hyperdiploidy (HeH) was present in 16% of patients and constituted a poor-risk ACA group. Patients with one or more poor-risk ACAs in the absence of HeH had significantly shorter RFS (5-year RFS rate 33% versus 59%, P = 0.01) and OS (5-year OS rate 24% versus 63%, P = 0.003). Poor-risk ACAs were prognostic in patients who received imatinib and dasatinib but not in those who received ponatinib. By multivariate analysis, this poor-risk ACA group was independently associated with worse RFS (HR 2.03 [95% CI 1.08-3.30], P = 0.03) and OS (HR 2.02 [95% CI 1.10-3.71], P = 0.02). Patients with Ph+ ALL who have +der(22)t(9;22) and/or -9/9p in the absence of HeH have relatively poor outcomes when treated with chemotherapy plus a TKI.

Published
2017

46. Prognostic impact of pretreatment cytogenetics in adult Philadelphia chromosome–negative acute lymphoblastic leukemia in the era of minimal residual disease

Author

Issa, Ghayas C, Kantarjian, Hagop M, Yin, C Cameron, Qiao, Wei, Ravandi, Farhad, Thomas, Deborah, Short, Nicholas J, Sasaki, Koji, Garcia‐Manero, Guillermo, Kadia, Tapan M, Cortes, Jorge E, Daver, Naval, Borthakur, Gautam, Jain, Nitin, Konopleva, Marina, Khouri, Issa, Kebriaei, Partow, Champlin, Richard E, Pierce, Sherry, O’Brien, Susan M, and Jabbour, Elias

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Oncology and Carcinogenesis, Hematology, Childhood Leukemia, Cancer, Pediatric, Rare Diseases, Pediatric Cancer, Adolescent, Adult, Aged, Aged, 80 and over, Cytarabine, Cytodiagnosis, Disease-Free Survival, Doxorubicin, Female, Humans, Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative, Male, Middle Aged, Neoplasm, Residual, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Prognosis, Remission Induction, Treatment Outcome, Vincristine, acute lymphoblastic leukemia, complex, cytogenetics, hypodiploidy, minimal residual disease, prognosis, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis, Public health
Abstract

BackgroundThe introduction of novel prognostic factors such as minimal residual disease (MRD) and genomic profiling has led to the reevaluation of the role of cytogenetics and other conventional factors in risk stratification for acute lymphoblastic leukemia (ALL).MethodsThis study assessed the impact of baseline cytogenetics on the outcomes of 428 adult patients with Philadelphia chromosome-negative ALL who were receiving frontline chemotherapy. Three hundred thirty patients (77%) were treated with hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone-based regimens, and 98 (23%) were treated with the augmented Berlin-Frankfurt-Munster regimen.ResultsThe median age was 40 years (range, 13-86 years). One hundred eighty-six patients (43%) had diploid cytogenetics, 32 (7%) had complex cytogenetics (defined as ≥ 5 chromosomal abnormalities), 27 (6%) had low hypodiploidy/near-triploidy (Ho-Tr), 24 (6%) had high hyperdiploidy, and 24 (6%) had a mixed-lineage leukemia (MLL) rearrangement. Patients with an MLL rearrangement, Ho-Tr, or a complex karyotype had significantly worse relapse-free survival (RFS) and overall survival (OS) than the diploid group. According to a multivariate analysis including all the baseline characteristics and MRD status, Ho-Tr and a complex karyotype were independent predictive factors for worse RFS and OS. Furthermore, survival among all cytogenetic groups was similar, regardless of the treatment received.ConclusionsA complex karyotype and Ho-Tr are adverse prognostic factors for adults with ALL independently of the MRD status. These findings suggest that pretreatment cytogenetics remain a valuable prognostic tool in this population. Cancer 2017;123:459-467. © 2016 American Cancer Society.

Published
2017

48. Prognostic value of measurable residual disease after venetoclax and decitabine in acute myeloid leukemia

Author

Maiti, Abhishek, DiNardo, Courtney D., Wang, Sa A., Jorgensen, Jeffrey, Kadia, Tapan M., Daver, Naval G., Short, Nicholas J., Yilmaz, Musa, Pemmaraju, Naveen, Borthakur, Gautam, Bose, Prithviraj, Issa, Ghayas C., Ferrajoli, Alessandra, Jabbour, Elias J., Jain, Nitin, Garcia-Manero, Guillermo, Ohanian, Maro, Takahashi, Koichi, Montalban-Bravo, Guillermo, Masarova, Lucia, Burger, Jan A., Thompson, Philip A., Verstovsek, Srdan, Sasaki, Koji, Andreeff, Michael, Rausch, Caitlin R., Montalbano, Kathryn S., Pierce, Sherry, Qiao, Wei, Ning, Jing, Kantarjian, Hagop M., Konopleva, Marina Y., and Ravandi, Farhad

Published
2021
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49. NPM1‐mutated myeloid neoplasms are a unique entity not defined by bone marrow blast percentage.

Author

Gener‐Ricos, Georgina, Bataller, Alex, Rodriguez‐Sevilla, Juan Jose, Chien, Kelly S., Quesada, Andres E., Almanza‐Huante, Emmanuel, Hammond, Danielle, Sasaki, Koji, DiNardo, Courtney, Kadia, Tapan, Daver, Naval, Borthakur, Gautam, Issa, Ghayas C., Short, Nicholas J., Kanagal‐Shamanna, Rashmi, Kantarjian, Hagop M., Garcia‐Manero, Guillermo, and Montalban‐Bravo, Guillermo

Subjects
STEM cell transplantation, BONE marrow, MYELODYSPLASTIC syndromes, OVERALL survival, CLINICAL pathology
Abstract

Introduction: NPM1‐mutated (NPM1mut) myeloid neoplasms (MNs) with <20% bone marrow (BM) blasts (NPM1mut MNs<20) are uncommon, and their classification remains inconsistent. Methods: The clinicopathologic features of 54 patients with NPM1mut MNs <20 were evaluated and compared with wild‐type NPM1 MNs <20 and NPM1mut MNs≥20, respectively. Results: NPM1mut MNs had similar features regardless of blast percentage, except for higher IDH2 (29% vs 7%, p =.023) and FLT3 (70% vs 11%, p <.001) frequency in patients with ≥20% BM blasts. Thirty‐three (61%) patients with NPM1mut MNs <20 received low‐intensity chemotherapy (LIC) and 12 (22%) received intensive chemotherapy (IC). Higher complete remission rates (75% vs 27%, p =.006) and median overall survival (mOS) (not reached vs 30.4 months, p =.06) were observed with IC compared to LIC. Young patients (age <60 years) did not reach mOS either when treated with LIC or IC. Stem cell transplant was associated with increased survival only in patients treated with LIC (HR, 0.24; p =.025). No differences in mOS were observed by BM blast strata (32.2 months, not reached and 46.9 months for <10%, 10%–19%, and ≥20% blasts, p =.700) regardless of treatment modality (LIC: p =.900; IC: p =.360). Twenty‐three patients (43%) with NPM1mut MNs <20 had marrow blast progression to ≥20%. Conclusions: Overall, NPM1mut MNs define a unique entity independent of BM blast percentage. NPM1 mutations define a unique leukemia entity regardless of bone marrow blast percentage. Patients with NPM1‐mutated myeloid neoplasms benefit from intensive chemotherapy approaches even in the setting of low bone marrow blast percentage. [ABSTRACT FROM AUTHOR]

Published
2024
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50. Optical genome mapping improves the accuracy of classification, risk stratification, and personalized treatment strategies for patients with acute myeloid leukemia.

Author

Loghavi, Sanam, Wei, Qing, Ravandi, Farhad, Quesada, Andres E., Routbort, Mark J., Hu, Shimin, Toruner, Gokce A., Wang, Sa A., Wang, Wei, Miranda, Roberto N., Li, Shaoying, Xu, Jie, DiNardo, Courtney D., Daver, Naval, Kadia, Tapan M., Issa, Ghayas C., Kantarjian, Hagop M., Medeiros, L. Jeffrey, and Tang, Guilin

Published
2024
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