TY - JOUR
T1 - A retrospective observational research study to describe the real-world use of bosutinib in patients with chronic myeloid leukemia in the United Kingdom and the Netherlands
AU - Claudiani, Simone
AU - Janssen, Jeroen J. W. M.
AU - Byrne, Jenny
AU - Smith, Graeme
AU - Blijlevens, Nicole
AU - Raghavan, Manoj
AU - Smith, Matthew
AU - Clark, Richard E.
AU - Mclain-Smith, Susan
AU - Carter, Angela M.
AU - Milojkovic, Dragana
AU - Apperley, Jane F.
N1 - Funding Information: The authors would like to thank all the participating patients and their families, study research nurses, study coordinators, and operations staff. The authors would also like to thank Dr. Andres Virchis and Dr. Hugues De Lavallade for their contributions to this study. Pfizer was involved in study design, interpretation of data, and review and approval of this manuscript. pH Ltd, doing business as OPEN Health, was commissioned by Pfizer Ltd, UK, to provide support for study design, implementation, data analysis and interpretation, and development of this manuscript. J.F.A. is a NIHR Senior Investigator and together with D.M. and S.C. would like to acknowledge the support provided by the Imperial College NIHR-BRC. S.C., D.M., and J.F.A. acknowledge the support of the NIHR Imperial Biomedical Research Center. Medical writing support was provided by Emily Balevich, PhD, of Engage Scientific Solutions and was funded by Pfizer. Funding Information: S.C. reports personal fees from Pfizer. J.J.W.M.J. reports research funding from Novartis and Bristol Myers Squibb; speaker fees from Incyte and Pfizer; advisory board honoraria from AbbVie, Incyte, Novartis, and Pfizer; and is the President of the Apps for Care and Science Foundation that develops the HematologyApp and that has received funding from Abbvie, Amgen, Astellas, Celgene/Bristol Myers Squibb, Daiichi‐Sankyo, Incyte, Janssen, Jazz, Novartis, Sanofi Genzyme, Takeda, Roche, and Servier. J.B. reports Pfizer advisory board and speaker fees and personal fees from Pfizer during the conduct of the study. G.S. reports advisory board attendance and honoraria from Ariad/Incyte, Bristol Myers Squibb, Novartis, and Pfizer. N.B. reports grants from Bristol Myers Squibb, Incyte, Novartis, Pfizer, and ZonMw. M.R. reports speaker fees from Incyte, Novartis, and Pfizer. M.S. reports grants from Pfizer Ltd, UK, during the conduct of the study (site fees for data collection) and personal fees from ARIAD (speaker fees). R.E.C. reports research funding from Bristol Myers Squibb, Novartis, and Pfizer, and honoraria from AbbVie, Bristol Myers Squibb, Jazz Pharmaceuticals, Novartis, and Pfizer. S.M‐S. and A.M.C. are employees of PH Associates Ltd, doing business as OPEN Health, who were commissioned by Pfizer to provide support for study design, implementation, data analysis and interpretation, and development of this manuscript. D.M. reports honoraria and speakers bureau fees from Novartis, Pfizer, Bristol Myers Squibb and Incyte. J.F.A. reports advisory board membership for Ariad/Incyte, Novartis, and Pfizer; speaker at satellite symposia for Ariad/Incyte, Bristol Myers Squibb, Novartis, and Pfizer; and research funding from Ariad/Incyte and Pfizer. Publisher Copyright: © 2022 The Authors. European Journal of Haematology published by John Wiley & Sons Ltd.
PY - 2022/7/1
Y1 - 2022/7/1
N2 - Objectives: To describe the real-world effectiveness and safety of bosutinib in patients with chronic myeloid leukemia (CML). Methods: This was a multi-center, retrospective, non-interventional chart review study conducted in 10 hospitals in the United Kingdom and the Netherlands. Results: Eighty-seven patients were included. Bosutinib was the third-line tyrosine kinase inhibitor (TKI) in 33 (38%) and fourth-line in 44 (51%) patients. Median treatment duration was 15.6 months. Among 84 patients in chronic phase (CP) at baseline, 26 (31%) switched to bosutinib due to resistance and 57 (68%) due to intolerance to prior TKIs. Cumulative complete cytogenetic and major molecular response rates in CP patients were 67% and 55%, respectively. After a median follow-up of 21.5 months, nine (11%) patients in CP died; estimated overall survival rates at 1 and 2 years postbosutinib initiation were 95% and 91%, respectively. Overall, 33/87 (38%) patients discontinued bosutinib due to either lack of efficacy/disease progression (17%), adverse events (14%), death (2%), or other reasons (5%). Eighty-two (94%) patients experienced ≥1 adverse event possibly related to bosutinib, most commonly diarrhea (52%). Conclusions: Bosutinib used in routine clinical practice in heavily pretreated patients with CML is an effective treatment for patients in CP and is generally tolerable.
AB - Objectives: To describe the real-world effectiveness and safety of bosutinib in patients with chronic myeloid leukemia (CML). Methods: This was a multi-center, retrospective, non-interventional chart review study conducted in 10 hospitals in the United Kingdom and the Netherlands. Results: Eighty-seven patients were included. Bosutinib was the third-line tyrosine kinase inhibitor (TKI) in 33 (38%) and fourth-line in 44 (51%) patients. Median treatment duration was 15.6 months. Among 84 patients in chronic phase (CP) at baseline, 26 (31%) switched to bosutinib due to resistance and 57 (68%) due to intolerance to prior TKIs. Cumulative complete cytogenetic and major molecular response rates in CP patients were 67% and 55%, respectively. After a median follow-up of 21.5 months, nine (11%) patients in CP died; estimated overall survival rates at 1 and 2 years postbosutinib initiation were 95% and 91%, respectively. Overall, 33/87 (38%) patients discontinued bosutinib due to either lack of efficacy/disease progression (17%), adverse events (14%), death (2%), or other reasons (5%). Eighty-two (94%) patients experienced ≥1 adverse event possibly related to bosutinib, most commonly diarrhea (52%). Conclusions: Bosutinib used in routine clinical practice in heavily pretreated patients with CML is an effective treatment for patients in CP and is generally tolerable.
KW - bosutinib
KW - chronic myeloid leukemia
KW - retrospective studies
KW - tyrosine kinase inhibitor
UR - http://www.scopus.com/inward/record.url?scp=85131573313&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/ejh.13775
DO - https://doi.org/10.1111/ejh.13775
M3 - Article
C2 - 35403752
SN - 0902-4441
VL - 109
SP - 90
EP - 99
JO - European journal of haematology
JF - European journal of haematology
IS - 1
ER -