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Bosutinib for pretr...
Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia : primary results of the phase 4 BYOND study
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- Hochhaus, Andreas (author)
- Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany
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- Gambacorti-Passerini, Carlo (author)
- Univ Milano Bicocca, Monza, Italy
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- Abboud, Camille (author)
- Washington Univ, Sch Med, St Louis, MO USA
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- Gjertsen, Bjørn Tore (author)
- Haukeland Hosp, Helse Bergen, Norway; Univ Bergen, Bergen, Norway
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- Brümmendorf, Tim H. (author)
- Univ Klinikum RWTH Aachen, Aachen, Germany
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- Smith, B. Douglas (author)
- Johns Hopkins Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
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- Ernst, Thomas (author)
- Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany
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- Giraldo-Castellano, Pilar (author)
- Miguel Servet Univ Hosp, CIBER Enfermedades Raras, Zaragoza, Spain
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- Olsson-Strömberg, Ulla (author)
- Uppsala universitet,Hematologi
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- Saussele, Susanne (author)
- Heidelberg Univ, Univ Med Mannheim, Mannheim, Germany
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- Bardy-Bouxin, Nathalie (author)
- Pfizer Int Operat Oncol, Paris, France
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- Viqueira, Andrea (author)
- Pfizer SLU, Madrid, Spain
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- Leip, Eric (author)
- Pfizer Inc, Cambridge, MA USA
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- Russell-Smith, T. Alexander (author)
- Pfizer Inc, New York, NY USA
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- Leone, Jocelyn (author)
- Pfizer Inc, Cambridge, MA USA
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- Rosti, Gianantonio (author)
- Univ Bologna, Univ Hosp, Bologna, Italy
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- Watts, Justin (author)
- Univ Miami, Sylvester Comprehens Canc Ctr, Miami, FL USA
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- Giles, Francis J. (author)
- Dev Therapeut Consortium, Chicago, IL USA
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(creator_code:org_t)
- 2020-06-22
- 2020
- English.
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In: Leukemia. - : Springer Science and Business Media LLC. - 0887-6924 .- 1476-5551. ; 34:8, s. 2125-2137
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Abstract
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- Bosutinib is approved for newly diagnosed Philadelphia chromosome-positive (Ph+) chronic phase (CP) chronic myeloid leukemia (CML) and for Ph+ CP, accelerated (AP), or blast (BP) phase CML after prior treatment with tyrosine kinase inhibitors (TKIs). In the ongoing phase 4 BYOND study (NCT02228382), 163 CML patients resistant/intolerant to prior TKIs (n = 156 Ph+ CP CML, n = 4 Ph+ AP CML, n = 3 Ph-negative/BCR-ABL1+ CML) received bosutinib 500 mg once daily (starting dose). As of ≥1 year after last enrolled patient (median treatment duration 23.7 months), 56.4% of Ph+ CP CML patients remained on bosutinib. Primary endpoint of cumulative confirmed major cytogenetic response (MCyR) rate by 1 year was 75.8% in Ph+ CP CML patients after one or two prior TKIs and 62.2% after three prior TKIs. Cumulative complete cytogenetic response (CCyR) and major molecular response (MMR) rates by 1 year were 80.6% and 70.5%, respectively, in Ph+ CP CML patients overall. No patient progressed to AP/BP on treatment. Across all patients, the most common treatment-emergent adverse events were diarrhea (87.7%), nausea (39.9%), and vomiting (32.5%). The majority of patients had confirmed MCyR by 1 year and MMR by 1 year, further supporting bosutinib use for Ph+ CP CML patients resistant/intolerant to prior TKIs.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
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Hochhaus, Andrea ...
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Gambacorti-Passe ...
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Abboud, Camille
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Gjertsen, Bjørn ...
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Brümmendorf, Tim ...
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Smith, B. Dougla ...
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Ernst, Thomas
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Giraldo-Castella ...
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Olsson-Strömberg ...
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Saussele, Susann ...
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Bardy-Bouxin, Na ...
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Viqueira, Andrea
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Leip, Eric
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Russell-Smith, T ...
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Leone, Jocelyn
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Rosti, Giananton ...
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Watts, Justin
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Giles, Francis J ...
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MEDICAL AND HEAL ...
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Leukemia
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Uppsala University