Relationship between molecular response and quality of life with bosutinib or imatinib for chronic myeloid leukemia
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ORIGINAL ARTICLE
Relationship between molecular response and quality of life with bosutinib or imatinib for chronic myeloid leukemia Tim H. Brümmendorf 1 & Carlo Gambacorti-Passerini 2 & Andrew G. Bushmakin 3 & Joseph C. Cappelleri 3 & Andrea Viqueira 4 & Arlene Reisman 5 & Susanne Isfort 1 & Carla Mamolo 3 Received: 31 January 2020 / Accepted: 30 March 2020 # The Author(s) 2020
Abstract Patients with newly diagnosed chronic phase chronic myeloid leukemia (CP CML) can be effectively treated with tyrosine kinase inhibitors (TKIs) and achieve a lifespan similar to the general population. The success of TKIs, however, requires long-term and sometimes lifelong treatment; thus, patient-assessed health-related quality of life (HRQoL) has become an increasingly important parameter for treatment selection. Bosutinib is a TKI approved for CP CML in newly diagnosed adults and in those resistant or intolerant to prior therapy. In the Bosutinib Trial in First-Line Chronic Myelogenous Leukemia Treatment (BFORE), bosutinib demonstrated a significantly higher major molecular response rate compared with imatinib, with maintenance of HRQoL (measured by the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) questionnaire), after 12 months of firstline treatment. We examined relationships between molecular response (MR) and HRQoL. MR values were represented by a logreduction scale (MRLR; a continuous variable). A repeated-measures longitudinal model was used to estimate the relationships between MRLR as a predictor and each FACT-Leu domain as an outcome. Effect sizes were calculated to determine strength of effects and allow comparisons across domains. The majority of FACT-Leu domains (with the exception of social well-being and physical well-being) demonstrated a significant relationship with MRLR (p < 0.05). Our results showed variable impact of clinical improvement on different dimensions of HRQoL. For patients who achieved MR5, emotional well-being and leukemia-specific domains showed the greatest improvement, with medium differences in effect sizes, whereas social wellbeing and physical well-being had the weakest relationship with MR. Keywords Chronic myeloid leukemia . Health-related quality of life . Molecular response . Bosutinib . Imatinib
Introduction Tyrosine kinase inhibitors (TKIs) that block the activity of the BCR-ABL1 gene fusion product, the hallmark of chronic myeloid leukemia (CML), have substantially improved efficacy and tolerability of treatment and extended patient life expectancy to nearly that of the general population [1]. In clinical * Tim H. Brümmendorf [email protected] 1
Universitätsklinikum RWTH Aachen, Pauwelsstrasse 30, 52074 Aachen, Germany
2
University of Milano-Bicocca, Monza, Italy
3
Pfizer Inc, Groton, CT, USA
4
Pfizer SLU, Madrid, Spain
5
Pfizer Inc, New York, NY, USA
trials that compared second-generation TKIs (bosutinib, dasatinib, or nilotinib) with the first-generation TKI imatinib in newly diagnosed patients with chronic phase (CP) CML, the second-generation TK
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