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Bosutinib for pretreated patients with chronic phase chronic myeloid leukemia : primary results of the phase 4 BYOND study

Hochhaus, Andreas (author)
Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany
Gambacorti-Passerini, Carlo (author)
Univ Milano Bicocca, Monza, Italy
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
Brümmendorf, Tim H. (author)
Univ Klinikum RWTH Aachen, Aachen, Germany
Smith, B. Douglas (author)
Johns Hopkins Sidney Kimmel Comprehens Canc Ctr, Baltimore, MD USA
Ernst, Thomas (author)
Univ Klinikum Jena, Klin Innere Med 2, Jena, Germany
Giraldo-Castellano, Pilar (author)
Miguel Servet Univ Hosp, CIBER Enfermedades Raras, Zaragoza, Spain
Olsson-Strömberg, Ulla (author)
Uppsala universitet,Hematologi
Saussele, Susanne (author)
Heidelberg Univ, Univ Med Mannheim, Mannheim, Germany
Bardy-Bouxin, Nathalie (author)
Pfizer Int Operat Oncol, Paris, France
Viqueira, Andrea (author)
Pfizer SLU, Madrid, Spain
Leip, Eric (author)
Pfizer Inc, Cambridge, MA USA
Russell-Smith, T. Alexander (author)
Pfizer Inc, New York, NY USA
Leone, Jocelyn (author)
Pfizer Inc, Cambridge, MA USA
Rosti, Gianantonio (author)
Univ Bologna, Univ Hosp, Bologna, Italy
Watts, Justin (author)
Univ Miami, Sylvester Comprehens Canc Ctr, Miami, FL USA
Giles, Francis J. (author)
Dev Therapeut Consortium, Chicago, IL USA
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 (creator_code:org_t)
2020-06-22
2020
English.
In: Leukemia. - : Springer Science and Business Media LLC. - 0887-6924 .- 1476-5551. ; 34:8, s. 2125-2137
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https://uu.diva-port... (primary) (Raw object)
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  • Journal article (peer-reviewed)
Abstract Subject headings
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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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