PREDICTORS FOR 12-MONTH MAJOR MOLECULAR RESPONSE IN CP CML PATIENTS WHO FAILED 3-MONTH EARLY MOLECULAR RESPONSE WITH IMATINIB THERAPY
(Abstract release date: 05/19/16)
EHA Library. Lee S. 06/09/16; 134723; PB1823
Dr. Sung-Eun Lee
Contributions
Contributions
Abstract
Abstract: PB1823
Type: Publication Only
Background
Recent studies have demonstrated that measurements of BCR-ABL1 transcript levels at 3 months were able to identify high-risk patients treated with imatinib (IM). However, the value of early molecular response (EMR) has not been fully defined. Until now, whether no achievement of BCR-ABL1 transcripts ≤10% after 3 months of treatment is sufficient to define failure necessitating a change of treatment remains obscure.
Aims
The aim of this study was to identify predictive factors for an achievement of 12-month major molecular response (MMR) in the patients who failed 3-month EMR, as additional information to guide clinical decisions on selecting high-risk patients.
Methods
Among 413 newly diagnosed CP CML patients who received IM with no prior treatment and had available molecular data at 3 months, 120 (29.1%) patients failed to achieve 3-month EMR. Finally, to identify predictive factors for an achievement of 12-month MMR, 94 patients with available decision for 12-month MMR were included in this study. All qRT-PCR were tested with at least 4.5-log sensitivity in a single laboratory (Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
Ninety-four newly diagnosed CP CML patients (including 69 men and 25 women) were analyzed. With a median age of 36 years (range, 14-73 years), the distribution of low, intermediate, and high Sokal risk scores were 30%, 42% and 25%, respectively, with 4% unknown risk. 16 (17%) patients of the patients who did not achieve a 3-month EMR had MMR at 12 months, while 78 (83%) patients failed to achieve MMR at 12 months. Univariate analyses revealed that female sex, transcript type of b3a2, >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months, and smaller spleen size were potential predictive factors for an achievement of 12-month MMR. After adjusting for factors affecting achievement of 12-month MMR on univariate analyses, multivariate analyses showed that transcript type of b3a2, compared to b2a2 (RR of 0.09, P = 0.022) and >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months (RR of 5.75, P = 0.031) were independent factors for the achievement of 12-month MMR. The patients with larger spleen size showed a trend for no 12-month MMR (RR of 0.82, P = 0.057).
Conclusion
This study analyzed various predictive factors for an achievement of 12-month MMR in the patients group who failed 3-month EMR. It provides additional information on selecting high-risk patients necessitating a change of treatment. Base on our findings, the patients with transcript type of b2a2, larger spleen size, and ≤0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months need a clinical decision of changing therapy according to the results of qRT-PCR at 3 months. Further clinical investigations in a larger patient population with longer follow-up are needed.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response, Prediction
Type: Publication Only
Background
Recent studies have demonstrated that measurements of BCR-ABL1 transcript levels at 3 months were able to identify high-risk patients treated with imatinib (IM). However, the value of early molecular response (EMR) has not been fully defined. Until now, whether no achievement of BCR-ABL1 transcripts ≤10% after 3 months of treatment is sufficient to define failure necessitating a change of treatment remains obscure.
Aims
The aim of this study was to identify predictive factors for an achievement of 12-month major molecular response (MMR) in the patients who failed 3-month EMR, as additional information to guide clinical decisions on selecting high-risk patients.
Methods
Among 413 newly diagnosed CP CML patients who received IM with no prior treatment and had available molecular data at 3 months, 120 (29.1%) patients failed to achieve 3-month EMR. Finally, to identify predictive factors for an achievement of 12-month MMR, 94 patients with available decision for 12-month MMR were included in this study. All qRT-PCR were tested with at least 4.5-log sensitivity in a single laboratory (Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
Ninety-four newly diagnosed CP CML patients (including 69 men and 25 women) were analyzed. With a median age of 36 years (range, 14-73 years), the distribution of low, intermediate, and high Sokal risk scores were 30%, 42% and 25%, respectively, with 4% unknown risk. 16 (17%) patients of the patients who did not achieve a 3-month EMR had MMR at 12 months, while 78 (83%) patients failed to achieve MMR at 12 months. Univariate analyses revealed that female sex, transcript type of b3a2, >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months, and smaller spleen size were potential predictive factors for an achievement of 12-month MMR. After adjusting for factors affecting achievement of 12-month MMR on univariate analyses, multivariate analyses showed that transcript type of b3a2, compared to b2a2 (RR of 0.09, P = 0.022) and >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months (RR of 5.75, P = 0.031) were independent factors for the achievement of 12-month MMR. The patients with larger spleen size showed a trend for no 12-month MMR (RR of 0.82, P = 0.057).
Conclusion
This study analyzed various predictive factors for an achievement of 12-month MMR in the patients group who failed 3-month EMR. It provides additional information on selecting high-risk patients necessitating a change of treatment. Base on our findings, the patients with transcript type of b2a2, larger spleen size, and ≤0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months need a clinical decision of changing therapy according to the results of qRT-PCR at 3 months. Further clinical investigations in a larger patient population with longer follow-up are needed.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response, Prediction
Abstract: PB1823
Type: Publication Only
Background
Recent studies have demonstrated that measurements of BCR-ABL1 transcript levels at 3 months were able to identify high-risk patients treated with imatinib (IM). However, the value of early molecular response (EMR) has not been fully defined. Until now, whether no achievement of BCR-ABL1 transcripts ≤10% after 3 months of treatment is sufficient to define failure necessitating a change of treatment remains obscure.
Aims
The aim of this study was to identify predictive factors for an achievement of 12-month major molecular response (MMR) in the patients who failed 3-month EMR, as additional information to guide clinical decisions on selecting high-risk patients.
Methods
Among 413 newly diagnosed CP CML patients who received IM with no prior treatment and had available molecular data at 3 months, 120 (29.1%) patients failed to achieve 3-month EMR. Finally, to identify predictive factors for an achievement of 12-month MMR, 94 patients with available decision for 12-month MMR were included in this study. All qRT-PCR were tested with at least 4.5-log sensitivity in a single laboratory (Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
Ninety-four newly diagnosed CP CML patients (including 69 men and 25 women) were analyzed. With a median age of 36 years (range, 14-73 years), the distribution of low, intermediate, and high Sokal risk scores were 30%, 42% and 25%, respectively, with 4% unknown risk. 16 (17%) patients of the patients who did not achieve a 3-month EMR had MMR at 12 months, while 78 (83%) patients failed to achieve MMR at 12 months. Univariate analyses revealed that female sex, transcript type of b3a2, >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months, and smaller spleen size were potential predictive factors for an achievement of 12-month MMR. After adjusting for factors affecting achievement of 12-month MMR on univariate analyses, multivariate analyses showed that transcript type of b3a2, compared to b2a2 (RR of 0.09, P = 0.022) and >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months (RR of 5.75, P = 0.031) were independent factors for the achievement of 12-month MMR. The patients with larger spleen size showed a trend for no 12-month MMR (RR of 0.82, P = 0.057).
Conclusion
This study analyzed various predictive factors for an achievement of 12-month MMR in the patients group who failed 3-month EMR. It provides additional information on selecting high-risk patients necessitating a change of treatment. Base on our findings, the patients with transcript type of b2a2, larger spleen size, and ≤0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months need a clinical decision of changing therapy according to the results of qRT-PCR at 3 months. Further clinical investigations in a larger patient population with longer follow-up are needed.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response, Prediction
Type: Publication Only
Background
Recent studies have demonstrated that measurements of BCR-ABL1 transcript levels at 3 months were able to identify high-risk patients treated with imatinib (IM). However, the value of early molecular response (EMR) has not been fully defined. Until now, whether no achievement of BCR-ABL1 transcripts ≤10% after 3 months of treatment is sufficient to define failure necessitating a change of treatment remains obscure.
Aims
The aim of this study was to identify predictive factors for an achievement of 12-month major molecular response (MMR) in the patients who failed 3-month EMR, as additional information to guide clinical decisions on selecting high-risk patients.
Methods
Among 413 newly diagnosed CP CML patients who received IM with no prior treatment and had available molecular data at 3 months, 120 (29.1%) patients failed to achieve 3-month EMR. Finally, to identify predictive factors for an achievement of 12-month MMR, 94 patients with available decision for 12-month MMR were included in this study. All qRT-PCR were tested with at least 4.5-log sensitivity in a single laboratory (Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
Ninety-four newly diagnosed CP CML patients (including 69 men and 25 women) were analyzed. With a median age of 36 years (range, 14-73 years), the distribution of low, intermediate, and high Sokal risk scores were 30%, 42% and 25%, respectively, with 4% unknown risk. 16 (17%) patients of the patients who did not achieve a 3-month EMR had MMR at 12 months, while 78 (83%) patients failed to achieve MMR at 12 months. Univariate analyses revealed that female sex, transcript type of b3a2, >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months, and smaller spleen size were potential predictive factors for an achievement of 12-month MMR. After adjusting for factors affecting achievement of 12-month MMR on univariate analyses, multivariate analyses showed that transcript type of b3a2, compared to b2a2 (RR of 0.09, P = 0.022) and >0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months (RR of 5.75, P = 0.031) were independent factors for the achievement of 12-month MMR. The patients with larger spleen size showed a trend for no 12-month MMR (RR of 0.82, P = 0.057).
Conclusion
This study analyzed various predictive factors for an achievement of 12-month MMR in the patients group who failed 3-month EMR. It provides additional information on selecting high-risk patients necessitating a change of treatment. Base on our findings, the patients with transcript type of b2a2, larger spleen size, and ≤0.65 of log reduction of BCR-ABL1 from individual baselines to 3 months need a clinical decision of changing therapy according to the results of qRT-PCR at 3 months. Further clinical investigations in a larger patient population with longer follow-up are needed.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response, Prediction
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