Achievement of Early response is directly associated with improved overall survival1
8-year probability of OS for patients according to their risk group defined by transcript level at 3 months2
Objective:
In this study, we identified molecular milestones at 3, 6, and 12 months after starting first line tyrosine kinase inhibitor that strongly predict for OS and other outcomes.
Methods:
Between June 2000 and December 2010, 282 consecutive adult patients with CML-CP seen at our institution received first-line therapy, Patients gave written informed consent for their data to be used in this analysis.
The median follow-up was 69 months (range, 17 to 131 months), In addition, patients underwent transplantation after second-line therapy failed.
BCR-ABL1 transcripts were measured in the blood at 6- to 12-week intervals by using RQ-PCR, Probabilities of OS, PFS, and event-free survival (EFS) were calculated by using the Kaplan-Meier method.
• EMR of BCR::ABL1IS 10% at 3 or 6 months is an established response target in CML treatment guidelines1
• Early molecular response (EMR; 10% BCR::ABL1IS at 3 and 6 months) after first-line TKI therapy has emerged as an effective prognosticator of favorable long-term PFS and OS1
• In a single-institution study of adult patients with CML-CP receiving 1L imatinib, high-risk patients/those without EMR (BCR::ABL1IS 9.84% at 3 months) had significantly lower 8-year probability of OS and PFS among other target responses2
Achievement of Early response is directly associated with improved
progression-free survival1
Progression-free Survival of the BCR-ABLIS >10% group was inferior as compared with the neighboring >1–10% group , (P=0.037), and as compared with the 1% group (P=0.002)3
Objective & Methods:
The aim of the present study was to clarify the relation between early kinetics of molecular and cytogenetic response and the risk for disease progression and death in patients after receiving first line TKI, Analyzing patients of the German randomized CML Study IV, we report here molecular and cytogenetic milestones to be achieved at 3 and 6 months of treatment to ensure the most favorable outcome and effective TKI treatment.
1L, 1st line; ABL1, Abelson protein tyrosine kinase 1; BCR, breakpoint cluster region; CML-CP, chronic myeloid leukemia in chronic phase;DMR, deep molecular response; EFS, event-free survival; EMR, early molecular response; IS, International Scale;OS, overall survival; PFS, progression-free survival; RQ-PCR, real-time quantitative polymerase chain reaction.
References
National Comprehensive Cancer Network® (NCCN®), NCCN Guidelines Version 1.2026 Chronic Myeloid Leukemia. Available at: https://www.nccn.org/professionals/physician_gls/pdf/cml.pdf . Last accessed 10/9/2025
Marin D, Ibrahim AR, Lucas C, Gerrard G, Wang L, Szydlo RM, Clark RE, Apperley JF, Milojkovic D, Bua M, Pavlu J. Assessment of BCR-ABL1 transcript levels at 3 months is the only requirement for predicting outcome for patients with chronic myeloid leukemia treated with tyrosine kinase inhibitors. Journal of Clinical Oncology. 2012 Jan 1;30(3):232.
Hanfstein B, Müller MC, Hehlmann R, Erben P, Lauseker M, Fabarius A, Schnittger S, Haferlach C, Göhring G, Proetel U, Kolb HJ. Early molecular and cytogenetic response is predictive for long-term progression-free and overall survival in chronic myeloid leukemia (CML). Leukemia. 2012 Sep;26(9):2096-102.
Approved by Egyptian Drug Authority: HF0424OA5944/042026. Invalidation date: 20/04/2028
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HF0424OA5944/042026 20/04/2028 |