Deeper molecular responses is associated with a reduction in disease progression and improvements in survival1
Getting CML under control
Results from CML Study IV showed that deeper molecular responses are associated with improved outcomes in patients with newly diagnosed CML-CP
Achievement of Early response is directly associated with improved overall survival2
8-year probability of OS for patients according to their risk group defined by transcript level at 3 months3
- EMR of BCR::ABL1IS 10% at 3 or 6 months is an established response target in CML treatment guidelines2
- 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 OS2
- In a single-institution study of adult patients with CML-CP receiving 1L imatinib, high-risk patients/those without EMR (BCR::ABL1IS9.84% at 3 months) had significantly lower 8-year probability of OS and PFS among other target responses3
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 December2010, 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.
CCyR, complete cytogenetic response; CML-CP, chronic myeloid leukemia in chronic phase; IFN, interferon; IS, International Scale; MMR, major molecular response (BCR::ABL1IS ≤ 0.1%); MR4, ≤ 0.01% BCR::ABL1IS; MR4·5, BCR::ABL1IS ≤0.0032%; OS, overall survival; 1L, 1st line; ABL1, Abelson protein tyrosine kinase 1; BCR, breakpoint cluster region; DMR, deep molecular response; EMR, early molecular response; IS, International Scale; OS, overall survival; PFS, progression-free survival; EFS, Event free survival; RQ-PCR, real-time quantitative polymerase chain reaction
References
Hehlmann R, Müller MC, Lauseker M, Hanfstein B, Fabarius A, Schreiber A, Proetel U, Pletsch N, Pfirrmann M, Haferlach C, Schnittger S. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-study IV. Journal of clinical oncology. 2014 Feb 10;32(5):415-23.
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.
Approved by Egyptian Drug Authority: HF0424OA5944/042026. Invalidation date: 20/04/2028
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HF0424OA5944/042026 20/04/2028 |