VERY EARLY MOLECULAR RESPONSE AT 1 MONTH CAN PREDICT 12-MONTH MAJOR MOLECULAR RESPONSE IN CHRONIC PHASE CHRONIC MYELOID LEUKEMIA TREATED WITH TKIS
(Abstract release date: 05/19/16)
EHA Library. Song H. 06/09/16; 132652; E1103
Ms. Hye-Young Song
Contributions
Contributions
Abstract
Abstract: E1103
Type: Eposter Presentation
Background
Imatinib (IM) has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML). Recent studies have demonstrated that BCR-ABL1 transcript levels at 3 and 6-month of front-line therapy is a useful predictor of long-term outcomes. Neelakantan et al(Blood 2013; 121:2739-42). found that the prognostic value of the 3-month early molecular response (EMR) could be improved by combining the 3- and 6-month results, but suggested that the 3-month EMR had superior prognostic value than the 6-month EMR so early interventions could be determined based on the 3-month result. However, prognostic value of very early molecular response (VEMR) have not been fully defined.
Aims
In this study, predictive value of BCR-ABL1IS at 1 month after front-line therapy for an achieving MMR at 12 months was evaluated. In addition, the difference of prognostic role of VEMR in IM group and 2G TKI group were compared.
Methods
With a data cut-off date of 20 Feb 2016, among 223 newly diagnosed CP CML patients who received IM (N=127) and 2G TKI (N=96) treatment and had molecular data at 1 month, 98 patients in IM group and 65 patients in 2G TKI group with at least 1 year of follow-up and available RQ-PCR at 12 months were included. Based on receiver operating characteristic (ROC) curve analysis, the predictive cutoffs of BCL-ABL1 transcripts at 1 month for achieving MMR at 12 months in IM group and 2G TKI group were evaluated. All RQ-PCR were tested with at least 4.5-log sensitivity in the central laboratory (Catholic Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
A total of 163 patients (101 men and 62 women) were analyzed. With a median age of 44 years (range, 18-81 years), the distribution of low, intermediate, and high Sokal risk scores were 41%, 39%, 20%. 36 (37%) of 98 patients in IM group and 46 (71%) of 65 patients in 2G TKI group achieved MMR at 12 months of front-line treatment. The predictive cutoffs of BCR-ABL1IS level at 1 month for achieving MMR at 12 months were 42.57% (sensitivity 66.67%, specificity 56.45%, AUC 0.585(0.481-0.684), P = 0.1617)and 38.41% (sensitivity 84.78%, specificity 89.47%, AUC 0.846(0.734-0.923), P = 0.0001)in IM group and 2G TKI group, respectively based on ROC curve analysis. In IM group, 24(47%) of 51 patients with ≤ 42% and 12(25%) of 47 patients with > 42% achieved 12-month MMR respectively (P=0.027). In 2G TKI group, 39(95%) of 41 patients with ≤ 38% and 7(30%) of 24 patients with > 38% achieved 12-month MMR respectively (P<0.001).
Conclusion
Our results demonstrated that VEMR is a predictor for an achieving 12-month MMR in both IM-group and 2G TKI group. Specially, 38.4% cutoff in 2G TKI group showed higher sensitivity and specificity, compared with those of IM group.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response
Type: Eposter Presentation
Background
Imatinib (IM) has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML). Recent studies have demonstrated that BCR-ABL1 transcript levels at 3 and 6-month of front-line therapy is a useful predictor of long-term outcomes. Neelakantan et al(Blood 2013; 121:2739-42). found that the prognostic value of the 3-month early molecular response (EMR) could be improved by combining the 3- and 6-month results, but suggested that the 3-month EMR had superior prognostic value than the 6-month EMR so early interventions could be determined based on the 3-month result. However, prognostic value of very early molecular response (VEMR) have not been fully defined.
Aims
In this study, predictive value of BCR-ABL1IS at 1 month after front-line therapy for an achieving MMR at 12 months was evaluated. In addition, the difference of prognostic role of VEMR in IM group and 2G TKI group were compared.
Methods
With a data cut-off date of 20 Feb 2016, among 223 newly diagnosed CP CML patients who received IM (N=127) and 2G TKI (N=96) treatment and had molecular data at 1 month, 98 patients in IM group and 65 patients in 2G TKI group with at least 1 year of follow-up and available RQ-PCR at 12 months were included. Based on receiver operating characteristic (ROC) curve analysis, the predictive cutoffs of BCL-ABL1 transcripts at 1 month for achieving MMR at 12 months in IM group and 2G TKI group were evaluated. All RQ-PCR were tested with at least 4.5-log sensitivity in the central laboratory (Catholic Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
A total of 163 patients (101 men and 62 women) were analyzed. With a median age of 44 years (range, 18-81 years), the distribution of low, intermediate, and high Sokal risk scores were 41%, 39%, 20%. 36 (37%) of 98 patients in IM group and 46 (71%) of 65 patients in 2G TKI group achieved MMR at 12 months of front-line treatment. The predictive cutoffs of BCR-ABL1IS level at 1 month for achieving MMR at 12 months were 42.57% (sensitivity 66.67%, specificity 56.45%, AUC 0.585(0.481-0.684), P = 0.1617)and 38.41% (sensitivity 84.78%, specificity 89.47%, AUC 0.846(0.734-0.923), P = 0.0001)in IM group and 2G TKI group, respectively based on ROC curve analysis. In IM group, 24(47%) of 51 patients with ≤ 42% and 12(25%) of 47 patients with > 42% achieved 12-month MMR respectively (P=0.027). In 2G TKI group, 39(95%) of 41 patients with ≤ 38% and 7(30%) of 24 patients with > 38% achieved 12-month MMR respectively (P<0.001).
Conclusion
Our results demonstrated that VEMR is a predictor for an achieving 12-month MMR in both IM-group and 2G TKI group. Specially, 38.4% cutoff in 2G TKI group showed higher sensitivity and specificity, compared with those of IM group.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response
Abstract: E1103
Type: Eposter Presentation
Background
Imatinib (IM) has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML). Recent studies have demonstrated that BCR-ABL1 transcript levels at 3 and 6-month of front-line therapy is a useful predictor of long-term outcomes. Neelakantan et al(Blood 2013; 121:2739-42). found that the prognostic value of the 3-month early molecular response (EMR) could be improved by combining the 3- and 6-month results, but suggested that the 3-month EMR had superior prognostic value than the 6-month EMR so early interventions could be determined based on the 3-month result. However, prognostic value of very early molecular response (VEMR) have not been fully defined.
Aims
In this study, predictive value of BCR-ABL1IS at 1 month after front-line therapy for an achieving MMR at 12 months was evaluated. In addition, the difference of prognostic role of VEMR in IM group and 2G TKI group were compared.
Methods
With a data cut-off date of 20 Feb 2016, among 223 newly diagnosed CP CML patients who received IM (N=127) and 2G TKI (N=96) treatment and had molecular data at 1 month, 98 patients in IM group and 65 patients in 2G TKI group with at least 1 year of follow-up and available RQ-PCR at 12 months were included. Based on receiver operating characteristic (ROC) curve analysis, the predictive cutoffs of BCL-ABL1 transcripts at 1 month for achieving MMR at 12 months in IM group and 2G TKI group were evaluated. All RQ-PCR were tested with at least 4.5-log sensitivity in the central laboratory (Catholic Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
A total of 163 patients (101 men and 62 women) were analyzed. With a median age of 44 years (range, 18-81 years), the distribution of low, intermediate, and high Sokal risk scores were 41%, 39%, 20%. 36 (37%) of 98 patients in IM group and 46 (71%) of 65 patients in 2G TKI group achieved MMR at 12 months of front-line treatment. The predictive cutoffs of BCR-ABL1IS level at 1 month for achieving MMR at 12 months were 42.57% (sensitivity 66.67%, specificity 56.45%, AUC 0.585(0.481-0.684), P = 0.1617)and 38.41% (sensitivity 84.78%, specificity 89.47%, AUC 0.846(0.734-0.923), P = 0.0001)in IM group and 2G TKI group, respectively based on ROC curve analysis. In IM group, 24(47%) of 51 patients with ≤ 42% and 12(25%) of 47 patients with > 42% achieved 12-month MMR respectively (P=0.027). In 2G TKI group, 39(95%) of 41 patients with ≤ 38% and 7(30%) of 24 patients with > 38% achieved 12-month MMR respectively (P<0.001).
Conclusion
Our results demonstrated that VEMR is a predictor for an achieving 12-month MMR in both IM-group and 2G TKI group. Specially, 38.4% cutoff in 2G TKI group showed higher sensitivity and specificity, compared with those of IM group.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response
Type: Eposter Presentation
Background
Imatinib (IM) has been the standard of care for chronic phase (CP) chronic myeloid leukemia (CML). Recent studies have demonstrated that BCR-ABL1 transcript levels at 3 and 6-month of front-line therapy is a useful predictor of long-term outcomes. Neelakantan et al(Blood 2013; 121:2739-42). found that the prognostic value of the 3-month early molecular response (EMR) could be improved by combining the 3- and 6-month results, but suggested that the 3-month EMR had superior prognostic value than the 6-month EMR so early interventions could be determined based on the 3-month result. However, prognostic value of very early molecular response (VEMR) have not been fully defined.
Aims
In this study, predictive value of BCR-ABL1IS at 1 month after front-line therapy for an achieving MMR at 12 months was evaluated. In addition, the difference of prognostic role of VEMR in IM group and 2G TKI group were compared.
Methods
With a data cut-off date of 20 Feb 2016, among 223 newly diagnosed CP CML patients who received IM (N=127) and 2G TKI (N=96) treatment and had molecular data at 1 month, 98 patients in IM group and 65 patients in 2G TKI group with at least 1 year of follow-up and available RQ-PCR at 12 months were included. Based on receiver operating characteristic (ROC) curve analysis, the predictive cutoffs of BCL-ABL1 transcripts at 1 month for achieving MMR at 12 months in IM group and 2G TKI group were evaluated. All RQ-PCR were tested with at least 4.5-log sensitivity in the central laboratory (Catholic Leukemia Research Institute, The Catholic University of Korea, Seoul, Korea).
Results
A total of 163 patients (101 men and 62 women) were analyzed. With a median age of 44 years (range, 18-81 years), the distribution of low, intermediate, and high Sokal risk scores were 41%, 39%, 20%. 36 (37%) of 98 patients in IM group and 46 (71%) of 65 patients in 2G TKI group achieved MMR at 12 months of front-line treatment. The predictive cutoffs of BCR-ABL1IS level at 1 month for achieving MMR at 12 months were 42.57% (sensitivity 66.67%, specificity 56.45%, AUC 0.585(0.481-0.684), P = 0.1617)and 38.41% (sensitivity 84.78%, specificity 89.47%, AUC 0.846(0.734-0.923), P = 0.0001)in IM group and 2G TKI group, respectively based on ROC curve analysis. In IM group, 24(47%) of 51 patients with ≤ 42% and 12(25%) of 47 patients with > 42% achieved 12-month MMR respectively (P=0.027). In 2G TKI group, 39(95%) of 41 patients with ≤ 38% and 7(30%) of 24 patients with > 38% achieved 12-month MMR respectively (P<0.001).
Conclusion
Our results demonstrated that VEMR is a predictor for an achieving 12-month MMR in both IM-group and 2G TKI group. Specially, 38.4% cutoff in 2G TKI group showed higher sensitivity and specificity, compared with those of IM group.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular response
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