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A Method for Screening and Validation of Resistant Mutations Against Kinase Inhibitors
Published on: December 7, 2014
A population-based study of chronic myeloid leukemia patients treated with imatinib in first line
Fausto Castagnetti1,2, Francesco Di Raimondo3, Antonio De Vivo1,2
1Department of Oncology and Hematology, "S.Orsola-Malpighi" University Hospital, University of Bologna, Bologna, Italy.
Abstract:
Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion-exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion-exclusion criteria do not exist, and the treatment outcome does not only depend on the choice of first-line TKI but also on second- and third-line TKIs. To investigate in a real-life setting the response and the outcome on first-line imatinib, with switch to second generation TKIs in case of unsatisfying response or intolerance, we analyzed all newly diagnosed patients (N = 236), living in two Italian regions, registered in a prospective study according to population-based criteria and treated front-line with imatinib. A switch from imatinib to second-generation TKIs was reported in 14% of patients for side effects and in 24% for failure or suboptimal response, with an improvement of molecular response in 57% of them. The 5-year overall survival (OS) and leukemia-related survival (LRS) were 85% and 93%, respectively; the 4-year rates of MR3.0 and MR4.0 were 75% and 48%, respectively. Cardiovascular complications were reported in 4% of patients treated with imatinib alone and in 6% of patients receiving nilotinib as second-line. Older age (≥70 years) affected OS, but not LRS. These data provide an unbiased reference on the CML management and on the results of TKI treatment in real-life, according to ELN recommendations, using imatinib as first-line treatment and second-generation TKIs as second-line therapy. Am. J. Hematol. 92:82-87, 2017. © 2016 Wiley Periodicals, Inc.
Insights
This study shows that imatinib as a first-line treatment for chronic myeloid leukemia (CML) followed by second-generation tyrosine kinase inhibitors (TKIs) offers good survival rates and molecular response in real-world clinical practice. Older patients still experience positive outcomes.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Clinical trials for chronic myeloid leukemia (CML) use strict inclusion-exclusion criteria, not reflecting real-life patient populations.
- Treatment outcomes in CML depend on first-line, second-line, and third-line tyrosine kinase inhibitor (TKI) therapies in clinical practice.
- Real-world data is crucial for understanding the effectiveness of CML management strategies.
Purpose of the Study:
- To evaluate the real-life response and outcomes of first-line imatinib treatment in newly diagnosed CML patients.
- To assess the impact of switching to second-generation TKIs for unsatisfactory response or intolerance.
- To analyze overall survival (OS), leukemia-related survival (LRS), and molecular response rates.
Main Methods:
- Prospective study of 236 newly diagnosed CML patients in two Italian regions, treated front-line with imatinib.
- Analysis of patient data based on population-based criteria, including switches to second-generation TKIs.
- Evaluation of molecular response (MR3.0, MR4.0), survival rates (OS, LRS), and cardiovascular complications.
Main Results:
- A switch to second-generation TKIs occurred in 14% of patients due to side effects and 24% due to suboptimal response, improving molecular response in 57%.
- Five-year OS and LRS were 85% and 93%, respectively; four-year MR3.0 and MR4.0 rates were 75% and 48%.
- Cardiovascular complications were reported in 4% with imatinib alone and 6% with nilotinib as second-line; older age (≥70) impacted OS but not LRS.
Conclusions:
- First-line imatinib followed by second-generation TKIs provides effective CML management in a real-life setting.
- The study establishes an unbiased reference for TKI treatment outcomes in CML according to ELN recommendations.
- Real-world data confirms the efficacy and safety of sequential TKI therapy in diverse CML patient populations.
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