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1. Asciminib monotherapy in patients with chronic-phase chronic myeloid leukemia with the T315I mutation after ≥1 prior tyrosine kinase inhibitor: 2-year follow-up results

Author

Cortes, Jorge E., Sasaki, Koji, Kim, Dong-Wook, Hughes, Timothy P., Etienne, Gabriel, Mauro, Michael J., Hochhaus, Andreas, Lang, Fabian, Heinrich, Michael C., Breccia, Massimo, Deininger, Michael, Goh, Yeow Tee, Janssen, Jeroen J.W.M., Talpaz, Moshe, de Soria, Valle Gomez Garcia, le Coutre, Philipp, DeAngelo, Daniel J., Damon, Andrea, Cacciatore, Silvia, Polydoros, Fotis, Agrawal, Nithya, and Rea, Delphine

Abstract

Asciminib targets the BCR::ABL1myristoyl pocket, maintaining activity against BCR::ABL1T315I, which is resistant to most approved adenosine triphosphate–competitive tyrosine kinase inhibitors. We report updated phase I results (NCT02081378) assessing safety/tolerability and antileukemic activity of asciminib monotherapy 200 mg twice daily in 48 heavily pretreated patients with T315I-mutated chronic-phase chronic myeloid leukemia (CML-CP; data cutoff: January 6, 2021). With 2 years’ median exposure, 56.3% of patients continued receiving asciminib. Overall, 62.2% of evaluable patients achieved BCR::ABL1≤1% on the International Scale (IS); 47.6% and 81.3% of ponatinib-pretreated and -naive patients, respectively, achieved BCR::ABL1IS≤1%. Of 45 evaluable patients, 48.9% achieved a major molecular response (MMR, BCR::ABL1IS≤0.1%), including 34.6% and 68.4% of ponatinib-pretreated and -naive patients, respectively. MMR was maintained until data cutoff in 19 of 22 patients who achieved it. The most common grade ≥3 adverse events (AEs) included increased lipase level (18.8%) and thrombocytopenia (14.6%). Five (10.4%) patients experienced AEs leading to discontinuation, including 2 who discontinued asciminib and died due to COVID-19; these were the only deaths reported. These results show asciminib’s effectiveness, including in almost 50% of ponatinib pretreated patients, and confirm its risk-benefit profile, supporting its use as a treatment option for T315I-mutated CML-CP.

Published
2024
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2. How the Study of Leukemias Inspired a Decades-Long Career

Author

Cortes, Jorge E.

Subjects
Oncology, Experimental, Patients -- Care and treatment, Leukemia -- Prognosis, Antineoplastic agents, Stem cells -- Transplantation, Cancer -- Research, Antimitotic agents, Health
Abstract

'I've done a lot of work [not only with] clinical trials, but also understanding the disease, the prognostic factors, and the management of adverse effects.' A passion for patient care [...]

Published
2021

3. Eine klinische Perspektive auf die Behandlung von chronischer myeloischer Leukämie in der chronischen Phase

Author

García-Gutiérrez, Valentin, Breccia, Massimo, Jabbour, Elias, Mauro, Michael, and Cortes, Jorge E.

Abstract

Tyrosinkinase-Inhibitoren (TKIs) haben die langfristigen Behandlungsergebnisse für Patienten mit chronischer myeloischer Leukämie (CML) erheblich verbessert. Nach Imatinib (einem TKI der ersten Generation) wurden TKIs der zweiten und dritten Generation entwickelt. Mit 5 TKIs, die auf BCR::ABLabzielen und in den meisten Ländern zugelassen sind (Imatinib, Dasatinib, Bosutinib, Nilotinib und Ponatinib), und der kürzlich erfolgten Zulassung von Asciminib in den USA sind die Behandlungsentscheidungen komplex und erfordern eine Bewertung patientenspezifischer Faktoren. Optimale Behandlungsstrategien für CML entwickeln sich weiter, wobei der Schwerpunkt verstärkt darauf liegt, ein tiefes molekulares Ansprechen zu erzielen. Anhand von klinisch relevanten Fallstudien, die von den Autoren dieses Reviews entwickelt wurden, diskutieren wir 3 Hauptszenarien aus der Perspektive internationaler Experten. Erstens untersucht dieser Übersichtsartikel patientenspezifische Merkmale, die die Entscheidungsfindung zwischen TKIs der ersten und zweiten Generation bei der Erstdiagnose von CML beeinflussen, einschließlich der Begleiterkrankungen des Patienten. Zweitens wird eine gründliche Bewertung der therapeutischen Optionen im Falle eines Versagens der Erstlinienbehandlung (wie in den Richtlinien des National Comprehensive Cancer Network und des European LeukemiaNet definiert) diskutiert, zusammen mit praktischen Erwägungen zur Überwachung des optimalen Ansprechens auf die TKI-Therapie. Drittens verdeutlicht diese Übersichtsarbeit die Erwägungen zum und die Bedeutung des Erreichen(s) einer behandlungsfreien Remission als Behandlungsziel. Aufgrund des Zeitpunkts der Erstellung befasst sich dieser Review auch mit den globalen Herausforderungen, denen Hämatologen bei der Behandlung von CML-Patienten während der COVID-19-Pandemie häufig gegenüberstehen. Da bei CML weiterhin neue Behandlungsansätze erforscht werden, erörtert diese Übersichtsarbeit schließlich auch das Aufkommen neuerer Therapien wie Asciminib. Dieser Artikel kann eine nützliche Referenz für Ärzte sein, die CML-Patienten mit TKI der zweiten Generation behandeln, und kann, da er sich auf die internationalen und persönlichen Erfahrungen der Ärzte konzentriert, einen Einblick in alternative, zuvor nicht in Betracht gezogene Ansätze geben.

Published
2023
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4. Olutasidenib alone or with azacitidine in IDH1-mutated acute myeloid leukaemia and myelodysplastic syndrome: phase 1 results of a phase 1/2 trial

Author

Watts, Justin M, Baer, Maria R, Yang, Jay, Prebet, Thomas, Lee, Sangmin, Schiller, Gary J, Dinner, Shira N, Pigneux, Arnaud, Montesinos, Pau, Wang, Eunice S, Seiter, Karen P, Wei, Andrew H, De Botton, Stephane, Arnan, Montserrat, Donnellan, Will, Schwarer, Anthony P, Récher, Christian, Jonas, Brian A, Ferrell, P Brent, Marzac, Christophe, Kelly, Patrick, Sweeney, Jennifer, Forsyth, Sanjeev, Guichard, Sylvie M, Brevard, Julie, Henrick, Patrick, Mohamed, Hesham, and Cortes, Jorge E

Abstract

Olutasidenib (FT-2102) is a potent, selective, oral, small-molecule inhibitor of mutant isocitrate dehydrogenase 1 (IDH1). The aims for phase 1 of this phase 1/2 study were to assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of olutasidenib, as monotherapy or in combination with azacitidine, in patients with acute myeloid leukaemia or myelodysplastic syndrome, harbouring mutant IDH1.

Published
2023
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5. Asciminib monotherapy in patients with CML-CP without BCR::ABL1T315I mutations treated with at least two prior TKIs: 4-year phase 1 safety and efficacy results

Author

Mauro, Michael J., Hughes, Timothy P., Kim, Dong-Wook, Rea, Delphine, Cortes, Jorge E., Hochhaus, Andreas, Sasaki, Koji, Breccia, Massimo, Talpaz, Moshe, Ottmann, Oliver, Minami, Hironobu, Goh, Yeow Tee, DeAngelo, Daniel J., Heinrich, Michael C., Gómez-García de Soria, Valle, le Coutre, Philipp, Mahon, Francois-Xavier, Janssen, Jeroen J. W. M., Deininger, Michael, Shanmuganathan, Naranie, Geyer, Mark B., Cacciatore, Silvia, Polydoros, Fotis, Agrawal, Nithya, Hoch, Matthias, and Lang, Fabian

Abstract

Asciminib is approved for patients with Philadelphia chromosome–positive chronic-phase chronic myeloid leukemia (CML-CP) who received ≥2 prior tyrosine kinase inhibitors or have the T315I mutation. We report updated results of a phase 1, open-label, nonrandomized trial (NCT02081378) assessing the safety, tolerability, and antileukemic activity of asciminib monotherapy 10–200 mg once or twice daily in 115 patients with CML-CP without T315I (data cutoff: January 6, 2021). After ≈4-year median exposure, 69.6% of patients remained on asciminib. The most common grade ≥3 adverse events (AEs) included increased pancreatic enzymes (22.6%), thrombocytopenia (13.9%), hypertension (13.0%), and neutropenia (12.2%); all-grade AEs (mostly grade 1/2) included musculoskeletal pain (59.1%), upper respiratory tract infection (41.7%), and fatigue (40.9%). Clinical pancreatitis and arterial occlusive events (AOEs) occurred in 7.0% and 8.7%, respectively. Most AEs occurred during year 1; the subsequent likelihood of new events, including AOEs, was low. By data cutoff, among patients without the indicated response at baseline, 61.3% achieved BCR::ABL1≤ 1%, 61.6% achieved ≤0.1% (major molecular response [MMR]), and 33.7% achieved ≤0.01% on the International Scale. MMR was maintained in 48/53 patients who achieved it and 19/20 who were in MMR at screening, supporting the long-term safety and efficacy of asciminib in this population.

Published
2023
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6. Glasdegib plus intensive or non-intensive chemotherapy for untreated acute myeloid leukemia: results from the randomized, phase 3 BRIGHT AML 1019 trial

Author

Sekeres, Mikkael A., Montesinos, Pau, Novak, Jan, Wang, Jianxiang, Jeyakumar, Deepa, Tomlinson, Benjamin, Mayer, Jiri, Jou, Erin, Robak, Tadeusz, Taussig, David C., Dombret, Hervé, Merchant, Akil, Shaik, Naveed, O’Brien, Thomas, Roh, Whijae, Liu, Xueli, Ma, Wendy, DiRienzo, Christine G., Chan, Geoffrey, and Cortes, Jorge E.

Abstract

This is the primary report of the randomized, placebo-controlled phase 3 BRIGHT AML 1019 clinical trial of glasdegib in combination with intensive chemotherapy (cytarabine and daunorubicin) or non-intensive chemotherapy (azacitidine) in patients with untreated acute myeloid leukemia. Overall survival (primary endpoint) was similar between the glasdegib and placebo arms in the intensive (n= 404; hazard ratio [HR] 1.05; 95% confidence interval [CI]: 0.782–1.408; two-sided p= 0.749) and non-intensive (n= 325; HR 0.99; 95% CI: 0.768–1.289; two-sided p= 0.969) studies. The proportion of patients who experienced treatment-emergent adverse events was similar for glasdegib versus placebo (intensive: 99.0% vs. 98.5%; non-intensive: 99.4% vs. 98.8%). The most common treatment-emergent adverse events were nausea, febrile neutropenia, and anemia in the intensive study and anemia, constipation, and nausea in the non-intensive study. The addition of glasdegib to either cytarabine and daunorubicin or azacitidine did not significantly improve overall survival and the primary efficacy endpoint for the BRIGHT AML 1019 phase 3 trial was not met. Clinical trial registration:ClinicalTrials.gov: NCT03416179.

Published
2023
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7. Asciminib vs bosutinib in chronic-phase chronic myeloid leukemia previously treated with at least two tyrosine kinase inhibitors: longer-term follow-up of ASCEMBL

Author

Hochhaus, Andreas, Réa, Delphine, Boquimpani, Carla, Minami, Yosuke, Cortes, Jorge E., Hughes, Timothy P., Apperley, Jane F., Lomaia, Elza, Voloshin, Sergey, Turkina, Anna, Kim, Dong-Wook, Abdo, Andre, Fogliatto, Laura Maria, le Coutre, Philipp, Sasaki, Koji, Kim, Dennis Dong Hwan, Saussele, Susanne, Annunziata, Mario, Chaudhri, Naeem, Chee, Lynette, García-Gutiérrez, Valentin, Kapoor, Shruti, Allepuz, Alex, Quenet, Sara, Bédoucha, Véronique, and Mauro, Michael J.

Abstract

Asciminib, the first BCR::ABL1 inhibitor that Specifically Targets the ABL Myristoyl Pocket (STAMP), is approved worldwide for the treatment of adults with Philadelphia chromosome–positive chronic myeloid leukemia in chronic phase (CML-CP) treated with ≥2 prior tyrosine kinase inhibitors (TKIs). In ASCEMBL, patients with CML-CP treated with ≥2 prior TKIs were randomized (stratified by baseline major cytogenetic response [MCyR]) 2:1 to asciminib 40 mg twice daily or bosutinib 500 mg once daily. Consistent with previously published primary analysis results, after a median follow-up of 2.3 years, asciminib continued to demonstrate superior efficacy and better safety and tolerability than bosutinib. The major molecular response (MMR) rate at week 96 (key secondary endpoint) was 37.6% with asciminib vs 15.8% with bosutinib; the MMR rate difference between the arms, after adjusting for baseline MCyR, was 21.7% (95% CI, 10.53–32.95; two-sided p= 0.001). Fewer grade ≥3 adverse events (AEs) (56.4% vs 68.4%) and AEs leading to treatment discontinuation (7.7% vs 26.3%) occurred with asciminib than with bosutinib. A higher proportion of patients on asciminib than bosutinib remained on treatment and continued to derive benefit over time, supporting asciminib as a standard of care for patients with CML-CP previously treated with ≥2 TKIs.

Published
2023
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8. Olutasidenib (FT-2102) Induces Durable Complete Remissions in Patients with Relapsed/Refractory mIDH1 Acute Myeloid Leukemia. Results from a Planned Interim Analysis of a Phase 2 Pivotal Clinical Trial

Author

Cortes, Jorge E., Fenaux, Pierre, Yee, Karen, Recher, Christian, Wei, Andrew H., Montesinos, Pau, Taussig, David C, Pigneux, Arnaud, Braun, Thorsten, Curti, Antonio, Grove, Carolyn, Jonas, Brian A., Khwaja, Asim, Peterlin, Pierre, Polyanskaya, Olga, Sweeney, Jennifer, Brevard, Julie, Barrett, Emma, and De Botton, Stephane

Published
2022
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11. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data

Author

Arber, Daniel A., Orazi, Attilio, Hasserjian, Robert P., Borowitz, Michael J., Calvo, Katherine R., Kvasnicka, Hans-Michael, Wang, Sa A., Bagg, Adam, Barbui, Tiziano, Branford, Susan, Bueso-Ramos, Carlos E., Cortes, Jorge E., Dal Cin, Paola, DiNardo, Courtney D., Dombret, Hervé, Duncavage, Eric J., Ebert, Benjamin L., Estey, Elihu H., Facchetti, Fabio, Foucar, Kathryn, Gangat, Naseema, Gianelli, Umberto, Godley, Lucy A., Gökbuget, Nicola, Gotlib, Jason, Hellström-Lindberg, Eva, Hobbs, Gabriela S., Hoffman, Ronald, Jabbour, Elias J., Kiladjian, Jean-Jacques, Larson, Richard A., Le Beau, Michelle M., Loh, Mignon L.-C., Löwenberg, Bob, Macintyre, Elizabeth, Malcovati, Luca, Mullighan, Charles G., Niemeyer, Charlotte, Odenike, Olatoyosi M., Ogawa, Seishi, Orfao, Alberto, Papaemmanuil, Elli, Passamonti, Francesco, Porkka, Kimmo, Pui, Ching-Hon, Radich, Jerald P., Reiter, Andreas, Rozman, Maria, Rudelius, Martina, Savona, Michael R., Schiffer, Charles A., Schmitt-Graeff, Annette, Shimamura, Akiko, Sierra, Jorge, Stock, Wendy A., Stone, Richard M., Tallman, Martin S., Thiele, Jürgen, Tien, Hwei-Fang, Tzankov, Alexandar, Vannucchi, Alessandro M., Vyas, Paresh, Wei, Andrew H., Weinberg, Olga K., Wierzbowska, Agnieszka, Cazzola, Mario, Döhner, Hartmut, and Tefferi, Ayalew

Abstract

The classification of myeloid neoplasms and acute leukemias was last updated in 2016 within a collaboration between the World Health Organization (WHO), the Society for Hematopathology, and the European Association for Haematopathology. This collaboration was primarily based on input from a clinical advisory committees (CACs) composed of pathologists, hematologists, oncologists, geneticists, and bioinformaticians from around the world. The recent advances in our understanding of the biology of hematologic malignancies, the experience with the use of the 2016 WHO classification in clinical practice, and the results of clinical trials have indicated the need for further revising and updating the classification. As a continuation of this CAC-based process, the authors, a group with expertise in the clinical, pathologic, and genetic aspects of these disorders, developed the International Consensus Classification (ICC) of myeloid neoplasms and acute leukemias. Using a multiparameter approach, the main objective of the consensus process was the definition of real disease entities, including the introduction of new entities and refined criteria for existing diagnostic categories, based on accumulated data. The ICC is aimed at facilitating diagnosis and prognostication of these neoplasms, improving treatment of affected patients, and allowing the design of innovative clinical trials.

Published
2022
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12. Daily palonosetron is superior to ondansetron in the prevention of delayed chemotherapy-induced nausea and vomiting in patients with acute myelogenous leukemia

Author

Mattiuzzi, Gloria N., Cortes, Jorge E., Blamble, Deborah A., Bekele, B. Nebiyou, Xiao, Lianchun, Cabanillas, Maria, Borthakur, Gautam, O'Brien, Susan, and Kantarjian, Hagop

Subjects
Palonosetron -- Dosage and administration, Palonosetron -- Research, Ondansetron -- Dosage and administration, Ondansetron -- Research, Chemotherapy -- Complications and side effects, Chemotherapy -- Research, Nausea -- Drug therapy, Nausea -- Research, Vomiting -- Drug therapy, Vomiting -- Research, Cancer -- Chemotherapy, Cancer -- Complications and side effects, Cancer -- Research, Health
Published
2010

13. Predictors and outcome of acute kidney injury in patients with acute myelogenous leukemia or high-risk myelodysplastic syndrome

Author

Lahoti, Amit, Kantarjian, Hagop, Salahudeen, Abdulla K., Ravandi, Farhad, Cortes, Jorge E., Faderl, Stefan, O'Brien, Susan, Wierda, William, and Mattiuzzi, Gloria N.

Subjects
Kidney diseases -- Risk factors, Kidney diseases -- Patient outcomes, Kidney diseases -- Demographic aspects, Kidney diseases -- Research, Myelodysplastic syndromes -- Care and treatment, Myelodysplastic syndromes -- Complications and side effects, Myelodysplastic syndromes -- Research, Health
Published
2010

14. Cause of death in patients with lower-risk myelodysplastic syndrome

Author

Dayyani, Farshid, Conley, Anthony P., Strom, Sara S., Stevensson, William, Cortes, Jorge E., Borthakur, Gautam, Faderl, Stefan, O'Brien, Susan, Pierce, Sherry, Kantarjian, Hagop, and Garcia-Manero, Guillermo

Subjects
Myelodysplastic syndromes -- Patient outcomes, Myelodysplastic syndromes -- Research, Mortality -- United States, Mortality -- Research, Health
Published
2010

15. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion

Author

Porkka, Kimmo, Khoury, H. Jean, Paquette, Ronald L., Matloub, Yousif, Sinha, Ritwik, and Cortes, Jorge E.

Subjects
Dasatinib -- Dosage and administration, Dasatinib -- Research, Pleural effusions -- Prevention, Pleural effusions -- Demographic aspects, Pleural effusions -- Research, Chronic myeloid leukemia -- Drug therapy, Chronic myeloid leukemia -- Patient outcomes, Chronic myeloid leukemia -- Research, Health
Published
2010

16. Rapid and reliable confirmation of acute promyelocytic leukemia by immunofluorescence staining with an antipromyelocytic leukemia antibody: The M.D. Anderson Cancer Center Experience of 349 Patients

Author

Dimov, Nikolay D., Medeiros, L. Jeffrey, Kantarjian, Hagop M., Cortes, Jorge E., Chang, Kun-Sang, Bueso-Ramos, Carlos E., and Ravandi, Farhad

Subjects
Myelocytic leukemia -- Diagnosis, Myelocytic leukemia -- Research, Nonlymphoid leukemia -- Diagnosis, Nonlymphoid leukemia -- Research, Fluorescent antibody technique -- Usage, Fluorescent antibody technique -- Research, Immunofluorescence -- Usage, Immunofluorescence -- Research, Tumor staging -- Research, Health
Published
2010

17. Survival is poorer in patients with secondary core-binding factor acute myelogenous leukemia compared with de novo core-binding factor leukemia

Author

Borthakur, Gautam, Lin, E., Jain, Nitin, Estey, Elihu E., Cortes, Jorge E., O'Brien, Susan, Faderl, Stefan, Ravandi, Farhad, Pierce, Sherry, and Kantarjian, Hagop

Subjects
Leukemia -- Comparative analysis, Leukemia -- Care and treatment, Leukemia -- Patient outcomes, Cancer -- Care and treatment, Cancer -- Comparative analysis, Cancer -- Patient outcomes, Stem cells -- Transplantation, Stem cells -- Usage, Stem cells -- Patient outcomes, Health
Published
2009

18. Dasatinib early intervention after cytogenetic or hematologic resistance to imatinib in patients with chronic myeloid leukemia

Author

Quintas-Cardama, Alfonso, Cortes, Jorge E., O'brien, Susan, Ravandi, Farhad, Borthakur, Gautam, Liu, David, Bleickardt, Eric, Chen, Tai-Tsang, and Kantarjian, Hagop M.

Subjects
Chronic myeloid leukemia -- Care and treatment, Chronic myeloid leukemia -- Patient outcomes, Chronic myeloid leukemia -- Research, Dasatinib -- Dosage and administration, Dasatinib -- Research, Drug resistance -- Research, Health
Published
2009

20. Kinase domain point mutations in Philadelphia chromosome-positive acute lymphoblastic leukemia emerge after therapy with BCR-ABL kinase inhibitors

Author

Jones, Dan, Thomas, Deborah, Yin, C. Cameron, O'Brien, Susan, Cortes, Jorge E., Jabbour, Elias, Breeden, Megan, Giles, Francis J., Zhao, Weiqiang, and Kantarjian, Hagop M.

Subjects
Acute lymphocytic leukemia -- Genetic aspects, Acute lymphocytic leukemia -- Care and treatment, Acute lymphocytic leukemia -- Research, Phosphotransferases -- Genetic aspects, Gene mutations -- Research, Enzyme inhibitors -- Dosage and administration, Enzyme inhibitors -- Research, Health
Published
2008

22. Current and emerging treatment options in chronic myeloid leukemia

Author

Jabbour, Elias, Cortes, Jorge E., Giles, Francis J., O'Brien, Susan, and Kantarjian, Hagop M.

Subjects
Chronic myeloid leukemia -- Care and treatment, Cancer -- Care and treatment, Cancer -- Forecasts and trends, Market trend/market analysis, Health
Published
2007

25. Thalidomide therapy for myelofibrosis with myeloid metaplasia

Author

Thomas, Deborah A., Giles, Francis J., Albitar, Maher, Cortes, Jorge E., Verstovsek, Srdan, Faderl, Stefan, O'Brien, Susan M., Garcia-Manero, Guillermo, Keating, Michael J., Pierce, Sherry, Zeldis, Jerome, and Kantarjian, Hagop M.

Subjects
Myelofibrosis -- Drug therapy, Myelodysplastic syndromes -- Drug therapy, Thalidomide -- Research, Health
Published
2006

27. Phase I and pharmacokinetic study of a low-clearance, unilamellar liposomal formulation of Lurtotecan, a Topoisomerase 1 inhibitor, in patients with advanced leukemia

Author

Giles, Francis J., Tallman, Martin S., Garcia-Manero, Guillermo, Cortes, Jorge E., Thomas, Deborah A., Wierda, William G., Verstovsek, Srdan, Hamilton, Marta, Barett, Emma, Albitar, Maher, and Kantarijan, Hagop M.

Subjects
Pharmacokinetics -- Dosage and administration, Pharmacokinetics -- Observations, Pharmacokinetics -- Evaluation, Leukemia -- Drug therapy, Leukemia -- Observations, Leukemia -- Prognosis, Health
Published
2004

29. Phase ll study of alemtuzumab in chronic lymphoproliferative disorders

Author

Ferrajoli, Alessandra, O'Brien, Susan M., Cortes, Jorge E., Giles, Francis J., Thomas, Deborah A., Faderl, Stefan, Kurzrock, Razelle, Lerner, Susan, Kontoyiannis, Dimitrios P., and Keating, Michael J.

Subjects
Chronic lymphocytic leukemia -- Case studies, Lymphoproliferative disorders -- Case studies, Health
Published
2003

30. Complete cytogenetic and molecular responses to interferon-alpha-based therapy for chronic myelogenous leukemia are associated with excellent long-term prognosis

Author

Kantarjian, Hagop M., O'Brien, Susan, Cortes, Jorge E., Jianqin Shan, Giles, Francis J., Rios, Mary Beth, Federl, Stefan H., Wierda, William G., Ferrajoli, Alessandra, Verstovsek, Srdan, Keating, Michael J., Freireich, Emil J., and Talpaz, Moshe

Subjects
Myeloid leukemia, Philadelphia-positive -- Prognosis, Myeloid leukemia, Philadelphia-positive -- Drug therapy, Myeloid leukemia, Philadelphia-positive -- Patient outcomes, Interferon alpha -- Dosage and administration, Interferon alpha -- Evaluation, Cytogenetics -- Research, Molecular biology -- Research, Health
Published
2003

31. Bosutinib versus imatinib for newly diagnosed chronic phase chronic myeloid leukemia: final results from the BFORE trial

Author

Brümmendorf, Tim H., Cortes, Jorge E., Milojkovic, Dragana, Gambacorti-Passerini, Carlo, Clark, Richard E., le Coutre, Philipp, Garcia-Gutierrez, Valentin, Chuah, Charles, Kota, Vamsi, Lipton, Jeffrey H., Rousselot, Philippe, Mauro, Michael J., Hochhaus, Andreas, Hurtado Monroy, Rafael, Leip, Eric, Purcell, Simon, Yver, Anne, Viqueira, Andrea, and Deininger, Michael W.

Abstract

This analysis from the multicenter, open-label, phase 3 BFORE trial reports efficacy and safety of bosutinib in patients with newly diagnosed chronic phase (CP) chronic myeloid leukemia (CML) after five years’ follow-up. Patients were randomized to 400-mg once-daily bosutinib (n= 268) or imatinib (n= 268; three untreated). At study completion, 59.7% of bosutinib- and 58.1% of imatinib-treated patients remained on study treatment. Median duration of treatment and time on study was 55 months in both groups. Cumulative major molecular response (MMR) rate by 5 years was higher with bosutinib versus imatinib (73.9% vs. 64.6%; odds ratio, 1.57 [95% CI, 1.08–2.28]), as were cumulative MR4(58.2% vs. 48.1%; 1.50 [1.07–2.12]) and MR4.5(47.4% vs. 36.6%; 1.57 [1.11–2.22]) rates. Superior MR with bosutinib versus imatinib was consistent across Sokal risk groups, with greatest benefit seen in patients with high risk. Treatment-emergent adverse events (TEAEs) were consistent with 12-month data. After 5 years of follow-up there was an increase in the incidence of cardiac, effusion, renal, and vascular TEAEs in bosutinib- and imatinib-treated patients, but overall, no new safety signals were identified. These final results support 400-mg once-daily bosutinib as standard-of-care in patients with newly diagnosed CP CML.

Published
2022
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33. A Phase I/II Study of Combination of Azacitidine, Venetoclax and Pevonedistat in Patients with Newly-Diagnosed Secondary Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) with Hypomethylating Agent (HMA) Failure

Author

Ong, Faustine, Garcia-Manero, Guillermo, Montalban-Bravo, Guillermo, Alvarado, Yesid, Ohanian, Maro, Konopleva, Marina, Jabbour, Elias, Jain, Nitin, Borthakur, Gautam, DiNardo, Courtney D., Daver, Naval, Issa, Ghayas C., Sasaki, Koji, Chien, Kelly S., Takahashi, Koichi, Andreeff, Michael, Muftuoglu, Muharrem, Delumpa, Ricardo, Mayor, Ejiroghene, Loiselle, Christopher, Waller, Lourdes, Banks, Glenda, Kantarjian, Hagop, Cortes, Jorge E., and Short, Nicholas

Published
2022
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36. Molecular Response of ≤10% BCR::ABL1IS Is Predictive of Positive Outcomes in Treatment-Resistant Patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML) Treated with Ponatinib from the Phase 2 Optic Trial

Author

Apperley, Jane F., Cortes, Jorge E., Jabbour, Elias, Hochhaus, Andreas, Hughes, Timothy, Chuah, Charles, de Lavallade, Hugues, Deininger, Michael W., Lipton, Jeffrey H., Lomaia, Elza, Maness, Lori, Mauro, Michael, McCloskey, James, Moiraghi, Beatriz, Pavlovsky, Carolina, Rojas, Christine, Rousselot, Philippe, Sacha, Tomasz, Talpaz, Moshe, Turkina, Anna, Sutton, Maria Undurraga, Ren, Xiaowei, Vorog, Alexander, and Rosti, Gianantonio

Published
2022
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37. Efficacy and Safety Results from ASC4MORE, a Randomized Study of Asciminib (ASC) Add-on to Imatinib (IMA), Continued IMA, or Switch to Nilotinib (NIL) in Patients (Pts) with Chronic-Phase Chronic Myeloid Leukemia (CML-CP) Not Achieving Deep Molecular Responses (DMRs) with ≥1 Year of IMA

Author

Cortes, Jorge E., Hughes, Timothy, Geissler, Jan, Kim, Dong-Wook, Lomaia, Elza, Mayer, Jiri, Turkina, Anna G., Hurwicz Kogut, Sarah, Torres Cardoso, Ana Paula, Sura, Monali, and Saglio, Giuseppe

Published
2022
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38. Efficacy and Safety of Vodobatinib in Patients (pts) with Chronic Phase Philadelphia Positive Chronic Myeloid Leukemia (Ph+ CML): A Sub Group Analysis By Lines of Tyrosine Kinase Inhibitor (TKI) Therapy

Author

Cortes, Jorge E., Saikia, Tapan, Kim, Dong-Wook, Alvarado, Yesid, Nicolini, Franck E., Rathnam, Krishnakumar, Khattry, Navin, Punatar, Sachin, Apperley, Jane F., Charbonnier, Aude, Deininger, Michael, de Lavallade, Hugues, Granacher, Nikki, Gambacorti-Passerini, Carlo, Lucchesi, Alessandro, Mauro, Michael, Vandenberghe, Peter, Verhoef, Gregor, Whiteley, Andrew R., Nag, Arijit, Apte, Shashikant, Yao, Siu-Long, Inamdar, Sandeep, Dillu, Ruchika Irene, Sreenivasan, Jayasree, and Chimote, Geetanjali

Published
2022
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39. Impact of Allogeneic Hematopoietic Cell Transplantation in First Complete Remission in Addition to FLT3 Inhibition with Quizartinib in Acute Myeloid Leukemia with FLT3-Internal Tandem Duplication: Results from the Quantum-First Trial

Author

Schlenk, Richard F., Montesinos, Pau, Romero-Aguilar, Antonio, Vrhovac, Radovan, Patkowska, Elżbieta, Kim, Hee-Je, Zak, Pavel, Wang, Po-Nan, Hanyok, James, Liu, Li, Kamel, Yasser Mostafa, Benzohra, Aziz, Lesegretain, Arnaud, Cortes, Jorge E., Sekeres, Mikkael A., Dombret, Hervé, Amadori, Sergio, Wang, Jianxiang, Perl, Alexander E., Levis, Mark J., and Erba, Harry P.

Published
2022
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42. Molecular Response of ≤10% BCR::ABL1ISIs Predictive of Positive Outcomes in Treatment-Resistant Patients with Chronic Phase Chronic Myeloid Leukemia (CP-CML) Treated with Ponatinib from the Phase 2 Optic Trial

Author

Apperley, Jane F., Cortes, Jorge E., Jabbour, Elias, Hochhaus, Andreas, Hughes, Timothy, Chuah, Charles, de Lavallade, Hugues, Deininger, Michael W., Lipton, Jeffrey H., Lomaia, Elza, Maness, Lori, Mauro, Michael, McCloskey, James, Moiraghi, Beatriz, Pavlovsky, Carolina, Rojas, Christine, Rousselot, Philippe, Sacha, Tomasz, Talpaz, Moshe, Turkina, Anna, Sutton, Maria Undurraga, Ren, Xiaowei, Vorog, Alexander, and Rosti, Gianantonio

Published
2022
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46. Three-Year Update from the Optic Trial: A Dose-Optimization Study of 3 Starting Doses of Ponatinib

Author

Cortes, Jorge E., Deininger, Michael W., Lomaia, Elza, Moiraghi, Beatriz, Sutton, Maria Undurraga, Pavlovsky, Carolina, Chuah, Charles, Sacha, Tomasz, Lipton, Jeffrey H., McCloskey, James, Hochhaus, Andreas, Rousselot, Philippe, Rosti, Gianantonio, de Lavallade, Hugues, Rojas, Christine, Turkina, Anna, Maness, Lori, Talpaz, Moshe, Mauro, Michael, Lu, Vickie, Vorog, Alexander, and Apperley, Jane F.

Published
2022
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47. Quantum-First Trial: FLT3-ITD-Specific MRD Clearance Is Associated with Improved Overall Survival

Author

Levis, Mark J., Erba, Harry P., Montesinos, Pau, Vrhovac, Radovan, Patkowska, Elzbieta, Kim, Heeje, Zak, Pavel, Wang, Po-Nan, Rohrbach, Jaime E. Connolly, Chang, Ken CN, Hanyok, James, Liu, Li, Kamel, Yasser Mostafa, Lesegretain, Arnaud, Cortes, Jorge E., Sekeres, Mikkael A., Dombret, Hervé, Amadori, Sergio, Wang, Jianxiang, Schlenk, Richard F., and Perl, Alexander

Published
2022
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50. A phase 3, open-label, randomized study of asciminib, a STAMP inhibitor, vs bosutinib in CML after 2 or more prior TKIs

Author

Réa, Delphine, Mauro, Michael J., Boquimpani, Carla, Minami, Yosuke, Lomaia, Elza, Voloshin, Sergey, Turkina, Anna, Kim, Dong-Wook, Apperley, Jane F., Abdo, Andre, Fogliatto, Laura Maria, Kim, Dennis Dong Hwan, le Coutre, Philipp, Saussele, Susanne, Annunziata, Mario, Hughes, Timothy P., Chaudhri, Naeem, Sasaki, Koji, Chee, Lynette, García-Gutiérrez, Valentin, Cortes, Jorge E., Aimone, Paola, Allepuz, Alex, Quenet, Sara, Bédoucha, Véronique, and Hochhaus, Andreas

Abstract

Patients with chronic myeloid leukemia in chronic phase (CML-CP) resistant/intolerant to ≥2 tyrosine kinase inhibitors (TKIs) are at high risk of experiencing poor outcomes because of disease biology and inadequate efficacy and/or safety of current therapies. Asciminib, a first-in-class BCR-ABL1 inhibitor Specifically Targeting the ABL Myristoyl Pocket (STAMP), has the potential to overcome resistance/intolerance to approved TKIs. In this phase 3, open-label study, patients with CML-CP previously treated with ≥2 TKIs were randomized (2:1) to receive asciminib 40 mg twice daily vs bosutinib 500 mg once daily. Randomization was stratified by major cytogenetic response (MCyR) status at baseline. The primary objective was to compare the major molecular response (MMR) rate at week 24 for asciminib vs bosutinib. A total of 233 patients were randomized to asciminib (n = 157) or bosutinib (n = 76). Median follow-up was 14.9 months. The MMR rate at week 24 was 25.5% with asciminib and 13.2% with bosutinib. The difference in MMR rate between treatment arms, after adjusting for MCyR at baseline, was 12.2% (95% confidence interval, 2.19-22.30; 2-sided P = .029). Fewer grade ≥3 adverse events (50.6% vs 60.5%) and adverse events leading to treatment discontinuation (5.8% vs 21.1%) occurred with asciminib than with bosutinib. The study showed a superior efficacy of asciminib compared with that of bosutinib, together with a favorable safety profile. These results support the use of asciminib as a new therapy in patients with CML-CP who are resistant/intolerant to ≥2 prior TKIs. This trial was registered at www.clinicaltrials.gov as #NCT03106779.

Published
2021
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