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Halving Time of BCR-ABL1 in Chronic Myeloid Leukemia: Is It Better Than Day-90 Value-A Multicenter Study From South
Shashidhar V Karpurmath1, Arun Seshachalam2, Kalaiselvi Selvaraj3
1Department of Medical Oncology, Vydehi Institute of Medical Sciences and Research Centre, Bengaluru, India.
Insights
The rate of decline in BCR-ABL1 levels, measured as halving time, is a more accurate predictor of molecular response in chronic myeloid leukemia (CML) patients than single 90-day values. This finding supports halving time as a promising prognostic tool for CML outcomes.
Area of Science:
- Hematology
- Oncology
- Molecular Diagnostics
Background:
- The 90-day BCR-ABL1 level is a standard milestone for predicting molecular response in chronic myeloid leukemia (CML).
- The rate of BCR-ABL1 decline is a potentially better, yet less accepted, predictor.
- Evidence for the rate of decline's accuracy in the Indian context is limited.
Purpose of the Study:
- To evaluate the accuracy of BCR-ABL1 decline rate in predicting molecular response in CML patients.
- To compare the predictive accuracy of BCR-ABL1 halving time versus single 90-day BCR-ABL1 values.
- To assess the utility of BCR-ABL1 decline rate in the Indian population.
Main Methods:
- Retrospective cohort study of CML patients diagnosed between 2013-2018.
- Serial BCR-ABL1 levels measured at 0, 45, 90 days, 6 months, and 1 year.
- Halving time calculated via log reduction and compared with 90-day BCR-ABL1 values using ROC curve analysis.
Main Results:
- The rate of BCR-ABL1 decline demonstrated higher predictive accuracy (AUC 0.83) than 90-day values (AUC 0.80).
- A halving time < 20 days identified 95% of patients achieving major molecular response at 12 months.
- This contrasts with 80% identification rate using the single 90-day BCR-ABL1 response.
Conclusions:
- BCR-ABL1 halving time shows significant promise as a predictor of treatment outcomes in CML.
- This metric offers a more accurate assessment of molecular response compared to static 90-day levels.
- Further validation in diverse populations is warranted.
Background:
The 90-day BCR-ABL1 (breakpoint cluster region-Abelson 1) level has been one of the accepted milestones for predicting the molecular response in patients with chronic myeloid leukemia (CML). The rate of decline in BCR-ABL1 has been considered a better predictor of the response but has not been uniformly accepted. A paucity of evidence is available to predict the accuracy of the rate of decline in the Indian context. Therefore, we tested the accuracy of the rate of decline of BCR-ABL1 in predicting the molecular response compared with the single 90-day values in a retrospective cohort study of selected cancer centers in south India.
Methods And Materials:
Patients with chronic-phase CML diagnosed from January 2013 to December 2018, the serial BCR-ABL1 levels were estimated at 0, 45, and 90 days, 6 months, and 1 year. Data on patient demographics, risk stratification assessed using the Sokal and EUTOS (European Treatment and Outcome Study) scores were extracted using a mobile-based data capture tool from the medical records of the enrolled patients. The halving time, determined by log reduction, was compared with the 90-day BCR-ABL1 values using the receiver operating characteristic curve for the major and complete molecular response at 6 months and 1 year as standards. Accuracy was determined from the area under the curve. The cutoff for the halving time was chosen to balance the sensitivity and specificity.
Results:
The rate of decline had more predictive accuracy compared with the 90-day BCR-ABL1 values (area under the curve for rate of decline, 0.83; 90-day, 0.80). A halving time of < 20 days identified 95% of the patients who had achieved major molecular response at 12 months compared with 80% using the single 90-day BCR-ABL1 response.
Conclusions:
The halving time of BCR-ABL1 appears promising as a predictor of the outcomes for patients with CML.
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