1.
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9 p, 996.2 KB |
Sustained efficacy and detailed clinical follow-up of first-line ibrutinib treatment in older patients with chronic lymphocytic leukemia : Extended phase 3 results from RESONATE-2
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Barr, Paul M. (University of Rochester) ;
Robak, Tadeusz (Medical University of Lodz) ;
Owen, Carolyn (Tom Baker Cancer Centre) ;
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda) ;
Bairey, Osnat (Sackler Faculty of Medicine. Tel Aviv University) ;
Bartlett, Nancy L. (Washington University School of Medicine) ;
Burger, Jan A. (University of Texas MD Anderson Cancer Center) ;
Hillmen, Peter (The Leeds Teaching Hospitals. St. James Institute of Oncology) ;
Coutre, Steven E (Stanford University School of Medicine) ;
Devereux, Stephen (Kings College Hospital) ;
Grosicki, Sebastian (School of Public Health. Silesian Medical University) ;
McCarthy, Helen (Royal Bournemouth Hospital) ;
Li, Jianyong (Jiangsu Province Hospital) ;
Simpson, David (North Shore Hospital) ;
Offner, Fritz (Universitair Ziekenhuis Gent) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Zhou, Cathy (Pharmacyclics. LLC an AbbVie Company) ;
Styles, Lori (Pharmacyclics. LLC an AbbVie Company) ;
James, Danelle (Pharmacyclics. LLC an AbbVie Company) ;
Kipps, Thomas J (University of California,San Diego. Moores Cancer Center) ;
Ghia, Paolo (Università Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele) ;
Universitat Autònoma de Barcelona
Results of RESONATE-2 (PCYC-1115/1116) supported approval of ibrutinib for first-line treatment of chronic lymphocytic Rleukemia. Extended analysis of RESONATE-2 was conducted to determine long-term efficacy and safety of ibrutinib in older patients with chronic lymphocytic leukemia. [...]
2018 - 10.3324/haematol.2018.192328
Haematologica, Vol. 103 Núm. 9 (31 2018) , p. 1502-1510
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2.
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19 p, 600.4 KB |
Improvement in Parameters of Hematologic and Immunologic Function and Patient Well-being in the Phase III RESONATE Study of Ibrutinib Versus Ofatumumab in Patients With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
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Barrientos, Jacqueline C. (Zucker School of Medicine at Hofstra/Northwell) ;
O'Brien, Susan (University of California Irvine) ;
Brown, Jennifer R. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica)) ;
Kay, Neil E. (Mayo Clinic) ;
Reddy, Nishitha M. (Vanderbilt-Ingram Cancer Center) ;
Coutre, Steven E (Stanford University School of Medicine) ;
Tam, Constantine (Peter MacCallum Cancer Centre and St Vincent's Hospital) ;
Mulligan, Stephen (Royal North Shore Hospital) ;
Jaeger, Ulrich (Medical University of Vienna) ;
Devereux, Stephen (King's College Hospital NHS Foundation Trust) ;
Pocock, Christopher (East Kent Hospitals University) ;
Robak, Tadeusz (Medical University of Lodz) ;
Schuster, Stephen J. (Perelman Center for Advanced Medicine) ;
Schuh, Anna (University of Oxford) ;
Gill, Devinder (Princess Alexandra Hospital) ;
Bloor, Adrian (The Christie Clinic) ;
Dearden, Claire (The Royal Marsden Hospital) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Cull, Gavin (Sir Charles Gardiner Hospital) ;
Hamblin, Mike (Colchester Hospital) ;
Jones, Jeffrey A. (The Ohio State University Comprehensive Cancer Center) ;
Eckert, Karl (Pharmacyclics LLC. an AbbVie Company) ;
Solman, Isabelle G. (Pharmacyclics LLC. an AbbVie Company) ;
Suzuki, Samuel (Pharmacyclics LLC. an AbbVie Company) ;
Hsu, Emily (Pharmacyclics LLC. an AbbVie Company) ;
James, Danelle F. (Pharmacyclics LLC. an AbbVie Company) ;
Byrd, John C. (The Ohio State University Comprehensive Cancer Center) ;
Hillmen, Peter (The Leeds Teaching Hospitals. St. James University Hospital) ;
Universitat Autònoma de Barcelona
In the phase III study RESONATE, ibrutinib reduced the risk of progression and improved overall survival versus ofatumumab in previously treated patients with CLL/SLL. In this novel analysis of patient well-being including patient-reported outcomes, ibrutinib reduced disease burden while preserving parameters of hematologic and immunologic function in RESONATE. [...]
2018 - 10.1016/j.clml.2018.08.007
Clinical Lymphoma, Myeloma & Leukemia, Vol. 18 Núm. 12 (december 2018) , p. 803-813.e7
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3.
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9 p, 1.3 MB |
Single-agent ibrutinib versus chemoimmunotherapy regimens for treatment-naïve patients with chronic lymphocytic leukemia : A cross-trial comparison of phase 3 studies
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Robak, Tadeusz (Medical University of Lodz) ;
Burger, Jan A. (The University of Texas MD Anderson Cancer Center) ;
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda) ;
Barr, Paul M. (University of Rochester Cancer Center) ;
Owen, Carolyn (University of Calgary) ;
Bairey, Osnat (Tel Aviv University) ;
Hillmen, Peter (St. James's Institute of Oncology) ;
Simpson, David (North Shore Hospital) ;
Grosicki, Sebastian (Silesian Medical University) ;
Devereux, Stephen (King's College Hospital NHS Foundation Trust) ;
McCarthy, Helen (Royal Bournemouth Hospital) ;
Coutre, Steven E (Stanford University School of Medicine) ;
Quach, Hang (St. Vincent's Hospital) ;
Gaidano, Gianluca (Amedeo Avogadro University of Eastern Piedmont) ;
Maslyak, Zvenyslava (Institute of Blood Pathology and Transfusion Medicine of the Academy of Medical Sciences of Ukraine) ;
Stevens, Don A. (Norton Cancer Institute) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Gill, Devinder S. (Princess Alexandra Hospital) ;
Flinn, Ian W. (Sarah Cannon Research Institute/Tennessee Oncology) ;
Gribben, John G. (Queen Mary University of London) ;
Mokatrin, Ahmad (Pharmacyclics LLC. an AbbVie Company) ;
Cheng, Mei (Pharmacyclics LLC. an AbbVie Company) ;
Styles, Lori (Pharmacyclics LLC. an AbbVie Company) ;
James, Danelle F. (Pharmacyclics LLC. an AbbVie Company) ;
Kipps, Thomas J (University of California San Diego) ;
Ghia, Paolo (Università Vita-Salute San Raffaele and IRCCS Istituto Scientifico San Raffaele) ;
Universitat Autònoma de Barcelona
Chemoimmunotherapy (CIT) and targeted therapy with single-agent ibrutinib are both recommended first-line treatments for chronic lymphocytic leukemia (CLL), although their outcomes have not been directly compared. [...]
2018 - 10.1002/ajh.25259
American Journal of Hematology, Vol. 93 Núm. 11 (november 2018) , p. 1402-1410
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4.
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25 p, 1.7 MB |
Safety Analysis of Four Randomized Controlled Studies of Ibrutinib in Patients With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Mantle Cell Lymphoma
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O'Brien, Susan (University of California) ;
Hillmen, Peter (St. James University Hospital) ;
Coutre, Steven E (Stanford University School of Medicine) ;
Barr, Paul M (University of Rochester Cancer Center) ;
Fraser, Graeme (McMaster University (Canadà)) ;
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda) ;
Burger, Jan A. (University of Texas MD Anderson Cancer Center) ;
Dilhuydy, Marie-Sarah (Centre Hospitalier Universitaire Hopitaux de Bordeaux) ;
Hess, Georg (Universitats Medizin Mainz) ;
Moreno Atanasio, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Cramer, Paula (University of Cologne) ;
Liu, Emily (Pharmacyclics LLC. an AbbVie Company) ;
Chang, Stephen (Pharmacyclics LLC. an AbbVie Company) ;
Vermeulen, Jessica (Janssen Research & Development) ;
Styles, Lori (Pharmacyclics LLC. an AbbVie Company) ;
Howes, Angela (Janssen Research & Development) ;
James, Danelle F. (Pharmacyclics LLC. an AbbVie Company) ;
Patel, Kalpesh (Janssen Pharmaceuticals. Inc) ;
Graef, Thorsten (Pharmacyclics LLC. an AbbVie Company) ;
Valentino, Rudolph (Pharmacyclics LLC. an AbbVie Company) ;
Universitat Autònoma de Barcelona
Ibrutinib, a Bruton's tyrosine kinase inhibitor, has become a standard treatment for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The present pooled safety analysis of 4 randomized controlled studies demonstrated a favorable benefit/risk profile for ibrutinib in patients with CLL/SLL and mantle cell lymphoma. [...]
2018 - 10.1016/j.clml.2018.06.016
Clinical Lymphoma, Myeloma & Leukemia, Vol. 18 Núm. 10 (october 2018) , p. 648-657.e15
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5.
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14 p, 1.1 MB |
Long-Term Studies Assessing Outcomes of Ibrutinib Therapy in Patients With Del(11q) Chronic Lymphocytic Leukemia
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Kipps, Thomas J. (UC San Diego Moores Cancer Center) ;
Fraser, Graeme (McMaster University (Canadà)) ;
Coutre, Steven E (Stanford University School of Medicine) ;
Brown, Jennifer R. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica)) ;
Barrientos, Jacqueline C. (Northwell Health Cancer Institute) ;
Barr, Paul M. (University of Rochester) ;
Byrd, John C. (The Ohio State University Comprehensive Cancer Center) ;
O'Brien, Susan M. (University of California) ;
Dilhuydy, Marie-Sarah (Hôpital Haut-Lévêque) ;
Hillmen, Peter (University of Leeds) ;
Jaeger, Ulrich (Medical University of Vienna) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Cramer, Paula (University of Cologne) ;
Stilgenbauer, Stephan (University of Ulm) ;
Chanan-Khan, Asher A. (Mayo Clinic Cancer Center) ;
Mahler, Michelle (Janssen Research and Development) ;
Salman, Mariya (Janssen Research and Development) ;
Eckert, Karl (Pharmacyclics LLC. an AbbVie Company) ;
Solman, Isabelle G. (Pharmacyclics LLC. an AbbVie Company) ;
Balasubramanian, Sriram (Janssen Research and Development) ;
Cheng, Mei (Pharmacyclics LLC. an AbbVie Company) ;
Londhe, Anil (Janssen Research and Development) ;
Ninomoto, Joi (Pharmacyclics LLC. an AbbVie Company) ;
Howes, Angela (Janssen Research and Development) ;
James, Danelle F. (Pharmacyclics LLC. an AbbVie Company) ;
Hallek, Michael (University of Cologne) ;
Universitat Autònoma de Barcelona
Certain genomic features, such as del(11q), expression of unmutated immunoglobulin heavy-chain variable region (IGHV) gene, or complex karyotype, predict poorer outcomes to chemotherapy in patients with chronic lymphocytic leukemia (CLL). [...]
2019 - 10.1016/j.clml.2019.07.004
Clinical Lymphoma, Myeloma & Leukemia, Vol. 19 Núm. 11 (november 2019) , p. 715-722.e6
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6.
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11 p, 1.4 MB |
Up to 8-year follow-up from RESONATE-2 : first-line ibrutinib treatment for patients with chronic lymphocytic leukemia
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Barr, Paul M. (Clinical Trials Office. Wilmot Cancer Institute. University of Rochester Medical Center) ;
Owen, Carolyn (Division of Hematology & Hematological Malignancies. Tom Baker Cancer Centre. University of Calgary) ;
Robak, Tadeusz (Medical University of Lodz) ;
Tedeschi, Alessandra (Department of Hematology. Azienda Socio Sanitaria Territoriali Grande Ospedale Metropolitano Niguarda) ;
Bairey, Osnat (Department of Hematology. Rabin Medical Center) ;
Burger, Jan A (Department of Leukemia. University of Texas MD Anderson Cancer Center) ;
Hillmen, Peter (Department of Haematology. The Leeds Teaching Hospitals. St. James Institute of Oncology) ;
Coutre, Steven E. (Stanford University School of Medicine. Stanford Cancer Cente) ;
Dearden, Claire (Haemato-Oncology Department. The Royal Marsden Hospital) ;
Grosicki, Sebastian (Department of Hematology and Cancer Prevention. School of Public Health. Silesian Medical University) ;
McCarthy, Helen (Royal Bournemouth General Hospital. Haematology Department) ;
Li, Jian-Yong (Jiangsu Province Hospital. Department of Hematology) ;
Offner, Fritz (Universitair Ziekenhuis Gent. Department of Clinical Hematology) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Zhou, Ccathy (Biostatistics. Pharmacyclics LLC. An AbbVie Company) ;
Hsu, Emily (Clinical Sciences. Pharmacyclics LLC. An AbbVie Company) ;
Szoke, Anita (Clinical Sciences. Pharmacyclics LLC. An AbbVie Company) ;
Kipps, Thomas J. (University of California San Diego. Department of Medicine. Moores Cancer Center) ;
Ghia, Paolo (Università Vita-Salute San Raffaele. Department of Onco-Hematology. Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele) ;
Universitat Autònoma de Barcelona
2022 - 10.1182/bloodadvances.2021006434
Blood advances, Vol. 6 Núm. 11 (june 2022) , p. 3440-3450
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7.
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12 p, 1.8 MB |
Long-term efficacy and safety of first-line ibrutinib treatment for patients with CLL/SLL : 5 years of follow-up from the phase 3 RESONATE-2 study
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Burger, Jan A. (University of Texas MD Anderson Cancer Center. Department of Leukemia) ;
Barr, Paul M. (Wilmot Cancer Institute, University of Rochester Medical Center) ;
Robak, Tadeusz (Medical University of Lodz, Copernicus Memorial Hospital) ;
Owen, Carolyn (University of Calgary. Tom Baker Cancer Centre) ;
Ghia, Paolo (Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele) ;
Tedeschi, Alessandra (ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy) ;
Bairey, Osnat (Tel Aviv University. Rabin Medical Center, Petah Tikva, Israel and Sackler Faculty of Medicine) ;
Hillmen, Peter (University of Leeds. The Leeds Teaching Hospitals, St. James Institute of Oncology) ;
Coutre, Steven E. (Stanford University School of Medicine. Stanford Cancer Center) ;
Devereux, Stephen (NHS Foundation Trust. Kings College Hospital) ;
Grosicki, Sebastian (Silesiam Medical University. Department of Hematology and Cancer Prevention) ;
McCarthy, Helen (Royal Bournemouth General Hospital (Dorset, Regne Unit)) ;
Simpson, David (North Shore Hospital) ;
Offner, Fritz (Universitair Ziekenhuis Gent) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Dai, Sandra (Pharmacyclics LLC, an AbbVie Company) ;
Lal, Indu (Pharmacyclics LLC, an AbbVie Company) ;
Dean, James P. (Pharmacyclics LLC, an AbbVie Company) ;
Kipps, Thomas J. (UCSD Moores Cancer Center) ;
Universitat Autònoma de Barcelona
RESONATE-2 is a phase 3 study of first-line ibrutinib versus chlorambucil in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Patients aged ≥65 years (n = 269) were randomized 1:1 to once-daily ibrutinib 420 mg continuously or chlorambucil 0. [...]
2019 - 10.1038/s41375-019-0602-x
Leukemia, Vol. 34 (october 2019) , p. 787-798
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8.
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11 p, 1.8 MB |
Final analysis from RESONATE : Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma
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Munir, Talha (St. James's Hospital ( Dublín, Irlanda)) ;
Brown, J. R. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica)) ;
O'Brien, Susan (UC Irvine. Chao Family Comprehensive Cancer Center) ;
Barrientos, Jacqueline C. (Northwell Health Cancer Institute (Estats Units d'Amèrica)) ;
Barr, Paul M (Wilmot Cancer Institute. University of Rochester Medical Center) ;
Reddy, N. M. (Vanderbilt-Ingram Cancer Center) ;
Coutre, Steven E. (Stanford Cancer Center. Stanford University School of Medicine) ;
Tam, C. S. (Peter MacCallum Cancer Centre. St. Vincent's Hospital and University of Melbourne) ;
Mulligan, S. P. (Royal North Shore Hospital) ;
Jaeger, Ulrich (Division of Hematology and Hemostaseology. Medical University of Vienna) ;
Kipps, T. J. (UCSD Moores Cancer Center) ;
Moreno, Carol (Institut d'Investigació Biomèdica Sant Pau) ;
Montillo, M. (Niguarda Ca' Granda Hospital) ;
Burger, Jan A (Department of Leukemia. University of Texas MD Anderson Cancer Center) ;
Byrd, J. C. (The Ohio State University Comprehensive Cancer Center) ;
Hillmen, Peter (The Leeds Teaching Hospitals. St. James Institute of Oncology) ;
Dai, Sandra (Pharmacyclics LLC. an AbbVie Company) ;
Szoke, A. (Pharmacyclics LLC. an AbbVie Company) ;
Dean, James P. (Pharmacyclics LLC. an AbbVie Company) ;
Woyach, J. A. (The Ohio State University Comprehensive Cancer Center) ;
Universitat Autònoma de Barcelona
Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). [...]
2019 - 10.1002/ajh.25638
American Journal of Hematology, Vol. 94 Núm. 12 (january 2019) , p. 1353-1363
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