RESULTS OF OBSERVATION WITHOUT TREATMENT IN CHRONIC MYELOID LEUKEMIA PATIENTS WITH DEEP MOLECULAR RESPONSE WHO STOPPED THERAPY DUE TO PREGNANCY, ADVERSE EVENTS OR BY OWN CONSIDERATION
(Abstract release date: 05/19/16)
EHA Library. Chelysheva E. 06/09/16; 132663; E1114
Dr. Ekaterina Chelysheva
Contributions
Contributions
Abstract
Abstract: E1114
Type: Eposter Presentation
Background
A possibility of observation without treatment in chronic myeloid leukemia (CML) patients is important as the long-term survival on tyrosine kinase inhibitors (TKI) therapy is excellent and a significant proportion of patients (pts) may achieve a deep molecular response (DMR).
Aims
To evaluate the results of observation without TKI treatment in CML patients with DMR who stopped therapy for different reasons.
Methods
Sixty-one CML pts with DMR were observed after TKI cessation. Fifty-nine pts had chronic phase, 2 pts had accelerated phase of CML at initial diagnosis. Sokal risk groups ratio low/intermediate/high was 65%/20%/15%. Male/female ratio was 15/46. Median (Me) age at TKI cessation was 37 years (range 22-76).The reasons for TKI discontinuation were: 1) adverse events (AE) of TKI (n=28), 2) self-made decisions of pts or TKI absence (n=15), 3) pregnancy (n=18). Imatinib and second generation TKI (TKI2) were used in 40(66%) and 21(34%) of pts respectively. Twenty-three (38%) pts were pretreated with interferon prior to TKI. Me treatment duration before TKI discontinuation was 72 months (range 6-159 months).BCR-ABL transcript level was assessed by quantitative Real-time polymerase chain reaction according to international scale (IS). DMR was considered for at least molecular response 4 log (МR4) or BCR-ABL<0,01%. TKI were resumed after loss of major molecular response (MMR) or BCR-ABL>0,1%. For pregnant pts therapy was resumed at BCR-ABL level>1% if it happened during pregnancy and at BCR-ABL level>0,1% if it happened after delivery. МR4 duration >2 years was in 45 (74%) of pts. We evaluated survival probability without MMR loss, terms of MMR loss and BCR-ABL level at MMR loss.
Results
Ме follow-up after TKI discontinuation was 31 month (range 4-99 months). MMR was lost in 28 (46%) pts, TKI were restarted in all of them. Ме time of MMR loss was 5 months (range 1-22 months). MMR loss happened within 6 and 12 months after TKI cessation in 20(33%) and in 5(8%) of pts respectively. In 3(5%) pts MMR loss was at 13,21 and 22 months. No hematologic relapses were observed. At the time of MMR loss BCR-ABL level ranged from 0,11% to 13%. In 6 pts TKI were restarted without MMR loss by physician’s decision at BCR-ABL level 0-0,082%. Two pts with DMR died due to concomitant diseases. Twenty-five (41%) pts continued to be treatment free under monitoring for Me 20 months (range 4-93 months), including 4 women without MMR loss after delivery.The probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 57% and 49% respectively. For pregnancy group the probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 32% and 37% respectively. No significant difference with pts in whom TKI were stopped for other reasons was found (p=0,46, figure 1). No MMR loss was observed after 24 months of TKI discontinuation neither in patients who stopped TKI due to pregnancy nor in those who stopped treatment for other reasons
Conclusion
Approximately half of CML patients with DMR had a possibility to keep MMR within one year after TKI cessation. MMR loss mostly occurred within first 6 months after TKI discontinuation. No MMR loss was marked after 24 months of treatment free observation. Pregnancy in CML patients with DMR did not influence on the ability to maintain MMR after TKI cessation. A safe treatment free observation in CML patients who stop TKI may be warranted only with accompanying regular BCR-ABL level monitoring.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular relapse, Molecular response, Pregnancy
Type: Eposter Presentation
Background
A possibility of observation without treatment in chronic myeloid leukemia (CML) patients is important as the long-term survival on tyrosine kinase inhibitors (TKI) therapy is excellent and a significant proportion of patients (pts) may achieve a deep molecular response (DMR).
Aims
To evaluate the results of observation without TKI treatment in CML patients with DMR who stopped therapy for different reasons.
Methods
Sixty-one CML pts with DMR were observed after TKI cessation. Fifty-nine pts had chronic phase, 2 pts had accelerated phase of CML at initial diagnosis. Sokal risk groups ratio low/intermediate/high was 65%/20%/15%. Male/female ratio was 15/46. Median (Me) age at TKI cessation was 37 years (range 22-76).The reasons for TKI discontinuation were: 1) adverse events (AE) of TKI (n=28), 2) self-made decisions of pts or TKI absence (n=15), 3) pregnancy (n=18). Imatinib and second generation TKI (TKI2) were used in 40(66%) and 21(34%) of pts respectively. Twenty-three (38%) pts were pretreated with interferon prior to TKI. Me treatment duration before TKI discontinuation was 72 months (range 6-159 months).BCR-ABL transcript level was assessed by quantitative Real-time polymerase chain reaction according to international scale (IS). DMR was considered for at least molecular response 4 log (МR4) or BCR-ABL<0,01%. TKI were resumed after loss of major molecular response (MMR) or BCR-ABL>0,1%. For pregnant pts therapy was resumed at BCR-ABL level>1% if it happened during pregnancy and at BCR-ABL level>0,1% if it happened after delivery. МR4 duration >2 years was in 45 (74%) of pts. We evaluated survival probability without MMR loss, terms of MMR loss and BCR-ABL level at MMR loss.
Results
Ме follow-up after TKI discontinuation was 31 month (range 4-99 months). MMR was lost in 28 (46%) pts, TKI were restarted in all of them. Ме time of MMR loss was 5 months (range 1-22 months). MMR loss happened within 6 and 12 months after TKI cessation in 20(33%) and in 5(8%) of pts respectively. In 3(5%) pts MMR loss was at 13,21 and 22 months. No hematologic relapses were observed. At the time of MMR loss BCR-ABL level ranged from 0,11% to 13%. In 6 pts TKI were restarted without MMR loss by physician’s decision at BCR-ABL level 0-0,082%. Two pts with DMR died due to concomitant diseases. Twenty-five (41%) pts continued to be treatment free under monitoring for Me 20 months (range 4-93 months), including 4 women without MMR loss after delivery.The probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 57% and 49% respectively. For pregnancy group the probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 32% and 37% respectively. No significant difference with pts in whom TKI were stopped for other reasons was found (p=0,46, figure 1). No MMR loss was observed after 24 months of TKI discontinuation neither in patients who stopped TKI due to pregnancy nor in those who stopped treatment for other reasons
Conclusion
Approximately half of CML patients with DMR had a possibility to keep MMR within one year after TKI cessation. MMR loss mostly occurred within first 6 months after TKI discontinuation. No MMR loss was marked after 24 months of treatment free observation. Pregnancy in CML patients with DMR did not influence on the ability to maintain MMR after TKI cessation. A safe treatment free observation in CML patients who stop TKI may be warranted only with accompanying regular BCR-ABL level monitoring.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular relapse, Molecular response, Pregnancy
Abstract: E1114
Type: Eposter Presentation
Background
A possibility of observation without treatment in chronic myeloid leukemia (CML) patients is important as the long-term survival on tyrosine kinase inhibitors (TKI) therapy is excellent and a significant proportion of patients (pts) may achieve a deep molecular response (DMR).
Aims
To evaluate the results of observation without TKI treatment in CML patients with DMR who stopped therapy for different reasons.
Methods
Sixty-one CML pts with DMR were observed after TKI cessation. Fifty-nine pts had chronic phase, 2 pts had accelerated phase of CML at initial diagnosis. Sokal risk groups ratio low/intermediate/high was 65%/20%/15%. Male/female ratio was 15/46. Median (Me) age at TKI cessation was 37 years (range 22-76).The reasons for TKI discontinuation were: 1) adverse events (AE) of TKI (n=28), 2) self-made decisions of pts or TKI absence (n=15), 3) pregnancy (n=18). Imatinib and second generation TKI (TKI2) were used in 40(66%) and 21(34%) of pts respectively. Twenty-three (38%) pts were pretreated with interferon prior to TKI. Me treatment duration before TKI discontinuation was 72 months (range 6-159 months).BCR-ABL transcript level was assessed by quantitative Real-time polymerase chain reaction according to international scale (IS). DMR was considered for at least molecular response 4 log (МR4) or BCR-ABL<0,01%. TKI were resumed after loss of major molecular response (MMR) or BCR-ABL>0,1%. For pregnant pts therapy was resumed at BCR-ABL level>1% if it happened during pregnancy and at BCR-ABL level>0,1% if it happened after delivery. МR4 duration >2 years was in 45 (74%) of pts. We evaluated survival probability without MMR loss, terms of MMR loss and BCR-ABL level at MMR loss.
Results
Ме follow-up after TKI discontinuation was 31 month (range 4-99 months). MMR was lost in 28 (46%) pts, TKI were restarted in all of them. Ме time of MMR loss was 5 months (range 1-22 months). MMR loss happened within 6 and 12 months after TKI cessation in 20(33%) and in 5(8%) of pts respectively. In 3(5%) pts MMR loss was at 13,21 and 22 months. No hematologic relapses were observed. At the time of MMR loss BCR-ABL level ranged from 0,11% to 13%. In 6 pts TKI were restarted without MMR loss by physician’s decision at BCR-ABL level 0-0,082%. Two pts with DMR died due to concomitant diseases. Twenty-five (41%) pts continued to be treatment free under monitoring for Me 20 months (range 4-93 months), including 4 women without MMR loss after delivery.The probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 57% and 49% respectively. For pregnancy group the probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 32% and 37% respectively. No significant difference with pts in whom TKI were stopped for other reasons was found (p=0,46, figure 1). No MMR loss was observed after 24 months of TKI discontinuation neither in patients who stopped TKI due to pregnancy nor in those who stopped treatment for other reasons
Conclusion
Approximately half of CML patients with DMR had a possibility to keep MMR within one year after TKI cessation. MMR loss mostly occurred within first 6 months after TKI discontinuation. No MMR loss was marked after 24 months of treatment free observation. Pregnancy in CML patients with DMR did not influence on the ability to maintain MMR after TKI cessation. A safe treatment free observation in CML patients who stop TKI may be warranted only with accompanying regular BCR-ABL level monitoring.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular relapse, Molecular response, Pregnancy
Type: Eposter Presentation
Background
A possibility of observation without treatment in chronic myeloid leukemia (CML) patients is important as the long-term survival on tyrosine kinase inhibitors (TKI) therapy is excellent and a significant proportion of patients (pts) may achieve a deep molecular response (DMR).
Aims
To evaluate the results of observation without TKI treatment in CML patients with DMR who stopped therapy for different reasons.
Methods
Sixty-one CML pts with DMR were observed after TKI cessation. Fifty-nine pts had chronic phase, 2 pts had accelerated phase of CML at initial diagnosis. Sokal risk groups ratio low/intermediate/high was 65%/20%/15%. Male/female ratio was 15/46. Median (Me) age at TKI cessation was 37 years (range 22-76).The reasons for TKI discontinuation were: 1) adverse events (AE) of TKI (n=28), 2) self-made decisions of pts or TKI absence (n=15), 3) pregnancy (n=18). Imatinib and second generation TKI (TKI2) were used in 40(66%) and 21(34%) of pts respectively. Twenty-three (38%) pts were pretreated with interferon prior to TKI. Me treatment duration before TKI discontinuation was 72 months (range 6-159 months).BCR-ABL transcript level was assessed by quantitative Real-time polymerase chain reaction according to international scale (IS). DMR was considered for at least molecular response 4 log (МR4) or BCR-ABL<0,01%. TKI were resumed after loss of major molecular response (MMR) or BCR-ABL>0,1%. For pregnant pts therapy was resumed at BCR-ABL level>1% if it happened during pregnancy and at BCR-ABL level>0,1% if it happened after delivery. МR4 duration >2 years was in 45 (74%) of pts. We evaluated survival probability without MMR loss, terms of MMR loss and BCR-ABL level at MMR loss.
Results
Ме follow-up after TKI discontinuation was 31 month (range 4-99 months). MMR was lost in 28 (46%) pts, TKI were restarted in all of them. Ме time of MMR loss was 5 months (range 1-22 months). MMR loss happened within 6 and 12 months after TKI cessation in 20(33%) and in 5(8%) of pts respectively. In 3(5%) pts MMR loss was at 13,21 and 22 months. No hematologic relapses were observed. At the time of MMR loss BCR-ABL level ranged from 0,11% to 13%. In 6 pts TKI were restarted without MMR loss by physician’s decision at BCR-ABL level 0-0,082%. Two pts with DMR died due to concomitant diseases. Twenty-five (41%) pts continued to be treatment free under monitoring for Me 20 months (range 4-93 months), including 4 women without MMR loss after delivery.The probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 57% and 49% respectively. For pregnancy group the probability of survival without MMR loss after TKI cessation at 6, 12 and 24 months was 67%, 32% and 37% respectively. No significant difference with pts in whom TKI were stopped for other reasons was found (p=0,46, figure 1). No MMR loss was observed after 24 months of TKI discontinuation neither in patients who stopped TKI due to pregnancy nor in those who stopped treatment for other reasons
Conclusion
Approximately half of CML patients with DMR had a possibility to keep MMR within one year after TKI cessation. MMR loss mostly occurred within first 6 months after TKI discontinuation. No MMR loss was marked after 24 months of treatment free observation. Pregnancy in CML patients with DMR did not influence on the ability to maintain MMR after TKI cessation. A safe treatment free observation in CML patients who stop TKI may be warranted only with accompanying regular BCR-ABL level monitoring.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Molecular relapse, Molecular response, Pregnancy
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