ASSESSMENT OF THE MOLECULAR DISEASE LEVEL IN PATIENTS WITH BCR-ABL1 POSITIVE CML IN DENMARK AND ICELAND
(Abstract release date: 05/19/16)
EHA Library. Pallisgaard N. 06/09/16; 134731; PB1831
Dr. Niels Pallisgaard
Contributions
Contributions
Abstract
Abstract: PB1831
Type: Publication Only
Background
Since the introduction of TKI treatment in CML in the beginning of this century, the expected survival of CML patients has increased substantially and is now close to the survival of the background population. Thus, the prevalence of CML has increased dramatically, and the number of patients in therapy, needing molecular monitoring increases accordingly. Whereas a large number of studies analyze the outcome of CML in cohorts, no population-based studies to our knowledge have focused on the distribution among the various TKIs and the molecular response.
Aims
The aim of this multicenter study was to measure the cross sectional molecular BCR-ABL1 response in CML patients in a demographic area and to analyze the molecular response across the different treatments available along with the distribution of treatment duration.
Methods
All hematological centers in Denmark and Iceland were invited to participate. One blood sample was taken in two Paxgene tubes per CML patient after informed consent as part of a routine visit and shipped to central BCR-ABL1 analysis in the EUTOS MR4.5 certified laboratory in Vejle along with information on date of birth, gender, current treatment, dose, start date and line of treatment.
Results
Eight out of ten hematological centers I Denmark participated in the study as well as the Icelandic center. Five of the centers included more than 95% of their CML patients and in total 360 samples were included. One blood sample was lost during preparation, and of the remaining 359 samples 354 samples fulfilled the EUTOS quality criteria for Molecular Response (MR) scoring (>24,000 GUSB copies per qPCR well). In the MR scoring system the patients were found to be 6.5% >MR2.0, 7.3 % in MR2.0, 19% in MR3.0 (=MMR), 17% in MR4.0 (of which 55/59 were BCR-ABL1 positive) and 50% in MR4.5 (of which 26/176 were BCR-ABL1 positive). Thus 150 pt (42 %) were BCR-ABL1 negative and in MR4.5, indicating that the potential for TKI interruption was high in this population, predominantly treated with imatinib. The average and median age of the patient group at sampling time was 58.7 years and 61.0 years, respectively with a gender distribution of 57% males and 42% females.Of the 360 patients,214 pt (59%) were in 1st line treatment, average duration 10.4 years (197/Imatinib, 4/Dasatinib, 12/Nilotinib and 1/NA);97 pt (27%) were in 2nd line treatment, average duration 3.3 years (16/Imatinib, 47/Dasatinib, 28/Nilotinib, 5/TKI and/or interferon combinations and 1/Pause (BCR-ABL1 negative);33 pt (9%) were in 3rd line treatment, average duration 2.6 years (3/Imatinib, 8/Dasatinib, 18/Nilotinib, 3/Bosutinib and 1/Pause (BCR-ABL1 negative);10 pt (3%) were >3rd line treatment, average duration 1.1 year (1/Imatinib, 5/Dasatinib, 3/Bosutinib, 1/Ponatinib);3 pt were transplanted;1 BCR-ABL1 positive pt had been in treatment free remission for 12 years; and2 pt lacked information on treatment line.
Conclusion
This study describes in the Danish and Icelandic CML patient population the present distribution of treatment, treatment line and duration combined with molecular response.
Session topic: E-poster
Keyword(s): BCR-ABL, MRD, Population, Quantitative RT-PCR
Type: Publication Only
Background
Since the introduction of TKI treatment in CML in the beginning of this century, the expected survival of CML patients has increased substantially and is now close to the survival of the background population. Thus, the prevalence of CML has increased dramatically, and the number of patients in therapy, needing molecular monitoring increases accordingly. Whereas a large number of studies analyze the outcome of CML in cohorts, no population-based studies to our knowledge have focused on the distribution among the various TKIs and the molecular response.
Aims
The aim of this multicenter study was to measure the cross sectional molecular BCR-ABL1 response in CML patients in a demographic area and to analyze the molecular response across the different treatments available along with the distribution of treatment duration.
Methods
All hematological centers in Denmark and Iceland were invited to participate. One blood sample was taken in two Paxgene tubes per CML patient after informed consent as part of a routine visit and shipped to central BCR-ABL1 analysis in the EUTOS MR4.5 certified laboratory in Vejle along with information on date of birth, gender, current treatment, dose, start date and line of treatment.
Results
Eight out of ten hematological centers I Denmark participated in the study as well as the Icelandic center. Five of the centers included more than 95% of their CML patients and in total 360 samples were included. One blood sample was lost during preparation, and of the remaining 359 samples 354 samples fulfilled the EUTOS quality criteria for Molecular Response (MR) scoring (>24,000 GUSB copies per qPCR well). In the MR scoring system the patients were found to be 6.5% >MR2.0, 7.3 % in MR2.0, 19% in MR3.0 (=MMR), 17% in MR4.0 (of which 55/59 were BCR-ABL1 positive) and 50% in MR4.5 (of which 26/176 were BCR-ABL1 positive). Thus 150 pt (42 %) were BCR-ABL1 negative and in MR4.5, indicating that the potential for TKI interruption was high in this population, predominantly treated with imatinib. The average and median age of the patient group at sampling time was 58.7 years and 61.0 years, respectively with a gender distribution of 57% males and 42% females.Of the 360 patients,214 pt (59%) were in 1st line treatment, average duration 10.4 years (197/Imatinib, 4/Dasatinib, 12/Nilotinib and 1/NA);97 pt (27%) were in 2nd line treatment, average duration 3.3 years (16/Imatinib, 47/Dasatinib, 28/Nilotinib, 5/TKI and/or interferon combinations and 1/Pause (BCR-ABL1 negative);33 pt (9%) were in 3rd line treatment, average duration 2.6 years (3/Imatinib, 8/Dasatinib, 18/Nilotinib, 3/Bosutinib and 1/Pause (BCR-ABL1 negative);10 pt (3%) were >3rd line treatment, average duration 1.1 year (1/Imatinib, 5/Dasatinib, 3/Bosutinib, 1/Ponatinib);3 pt were transplanted;1 BCR-ABL1 positive pt had been in treatment free remission for 12 years; and2 pt lacked information on treatment line.
Conclusion
This study describes in the Danish and Icelandic CML patient population the present distribution of treatment, treatment line and duration combined with molecular response.
Session topic: E-poster
Keyword(s): BCR-ABL, MRD, Population, Quantitative RT-PCR
Abstract: PB1831
Type: Publication Only
Background
Since the introduction of TKI treatment in CML in the beginning of this century, the expected survival of CML patients has increased substantially and is now close to the survival of the background population. Thus, the prevalence of CML has increased dramatically, and the number of patients in therapy, needing molecular monitoring increases accordingly. Whereas a large number of studies analyze the outcome of CML in cohorts, no population-based studies to our knowledge have focused on the distribution among the various TKIs and the molecular response.
Aims
The aim of this multicenter study was to measure the cross sectional molecular BCR-ABL1 response in CML patients in a demographic area and to analyze the molecular response across the different treatments available along with the distribution of treatment duration.
Methods
All hematological centers in Denmark and Iceland were invited to participate. One blood sample was taken in two Paxgene tubes per CML patient after informed consent as part of a routine visit and shipped to central BCR-ABL1 analysis in the EUTOS MR4.5 certified laboratory in Vejle along with information on date of birth, gender, current treatment, dose, start date and line of treatment.
Results
Eight out of ten hematological centers I Denmark participated in the study as well as the Icelandic center. Five of the centers included more than 95% of their CML patients and in total 360 samples were included. One blood sample was lost during preparation, and of the remaining 359 samples 354 samples fulfilled the EUTOS quality criteria for Molecular Response (MR) scoring (>24,000 GUSB copies per qPCR well). In the MR scoring system the patients were found to be 6.5% >MR2.0, 7.3 % in MR2.0, 19% in MR3.0 (=MMR), 17% in MR4.0 (of which 55/59 were BCR-ABL1 positive) and 50% in MR4.5 (of which 26/176 were BCR-ABL1 positive). Thus 150 pt (42 %) were BCR-ABL1 negative and in MR4.5, indicating that the potential for TKI interruption was high in this population, predominantly treated with imatinib. The average and median age of the patient group at sampling time was 58.7 years and 61.0 years, respectively with a gender distribution of 57% males and 42% females.Of the 360 patients,214 pt (59%) were in 1st line treatment, average duration 10.4 years (197/Imatinib, 4/Dasatinib, 12/Nilotinib and 1/NA);97 pt (27%) were in 2nd line treatment, average duration 3.3 years (16/Imatinib, 47/Dasatinib, 28/Nilotinib, 5/TKI and/or interferon combinations and 1/Pause (BCR-ABL1 negative);33 pt (9%) were in 3rd line treatment, average duration 2.6 years (3/Imatinib, 8/Dasatinib, 18/Nilotinib, 3/Bosutinib and 1/Pause (BCR-ABL1 negative);10 pt (3%) were >3rd line treatment, average duration 1.1 year (1/Imatinib, 5/Dasatinib, 3/Bosutinib, 1/Ponatinib);3 pt were transplanted;1 BCR-ABL1 positive pt had been in treatment free remission for 12 years; and2 pt lacked information on treatment line.
Conclusion
This study describes in the Danish and Icelandic CML patient population the present distribution of treatment, treatment line and duration combined with molecular response.
Session topic: E-poster
Keyword(s): BCR-ABL, MRD, Population, Quantitative RT-PCR
Type: Publication Only
Background
Since the introduction of TKI treatment in CML in the beginning of this century, the expected survival of CML patients has increased substantially and is now close to the survival of the background population. Thus, the prevalence of CML has increased dramatically, and the number of patients in therapy, needing molecular monitoring increases accordingly. Whereas a large number of studies analyze the outcome of CML in cohorts, no population-based studies to our knowledge have focused on the distribution among the various TKIs and the molecular response.
Aims
The aim of this multicenter study was to measure the cross sectional molecular BCR-ABL1 response in CML patients in a demographic area and to analyze the molecular response across the different treatments available along with the distribution of treatment duration.
Methods
All hematological centers in Denmark and Iceland were invited to participate. One blood sample was taken in two Paxgene tubes per CML patient after informed consent as part of a routine visit and shipped to central BCR-ABL1 analysis in the EUTOS MR4.5 certified laboratory in Vejle along with information on date of birth, gender, current treatment, dose, start date and line of treatment.
Results
Eight out of ten hematological centers I Denmark participated in the study as well as the Icelandic center. Five of the centers included more than 95% of their CML patients and in total 360 samples were included. One blood sample was lost during preparation, and of the remaining 359 samples 354 samples fulfilled the EUTOS quality criteria for Molecular Response (MR) scoring (>24,000 GUSB copies per qPCR well). In the MR scoring system the patients were found to be 6.5% >MR2.0, 7.3 % in MR2.0, 19% in MR3.0 (=MMR), 17% in MR4.0 (of which 55/59 were BCR-ABL1 positive) and 50% in MR4.5 (of which 26/176 were BCR-ABL1 positive). Thus 150 pt (42 %) were BCR-ABL1 negative and in MR4.5, indicating that the potential for TKI interruption was high in this population, predominantly treated with imatinib. The average and median age of the patient group at sampling time was 58.7 years and 61.0 years, respectively with a gender distribution of 57% males and 42% females.Of the 360 patients,214 pt (59%) were in 1st line treatment, average duration 10.4 years (197/Imatinib, 4/Dasatinib, 12/Nilotinib and 1/NA);97 pt (27%) were in 2nd line treatment, average duration 3.3 years (16/Imatinib, 47/Dasatinib, 28/Nilotinib, 5/TKI and/or interferon combinations and 1/Pause (BCR-ABL1 negative);33 pt (9%) were in 3rd line treatment, average duration 2.6 years (3/Imatinib, 8/Dasatinib, 18/Nilotinib, 3/Bosutinib and 1/Pause (BCR-ABL1 negative);10 pt (3%) were >3rd line treatment, average duration 1.1 year (1/Imatinib, 5/Dasatinib, 3/Bosutinib, 1/Ponatinib);3 pt were transplanted;1 BCR-ABL1 positive pt had been in treatment free remission for 12 years; and2 pt lacked information on treatment line.
Conclusion
This study describes in the Danish and Icelandic CML patient population the present distribution of treatment, treatment line and duration combined with molecular response.
Session topic: E-poster
Keyword(s): BCR-ABL, MRD, Population, Quantitative RT-PCR
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