Contributions
Abstract: PB1960
Type: Publication Only
Background
Imatinib, is the first tyrosine kinase inhibitor of the BCR-ABL protein. Imatinib was introduced for the treatment of with Chronic Myeloid Leukaemia (CML) in 2001.The discovery of the wonder drug, has changed the treatment paradigm of CML, now moving towards for the "treatment free remission". Appearance of kinase domain mutations and non-adherence are the main current challenges.
Imatinib has proven its safety and efficacy in long term 10 year follow up data of IRIS study with overall survival of 83.3% without any cumulative or late toxic effects.
The paucity of such studies analyzing the expanding Asian patient population, is a significant drawback in clinical practice, especially in explaining some side effects in them such as skin manifestations.
Aims
To look at the demographics in CML patients across the country in Sri Lanka and analysis of the response rates to Imatinib as the first line treatment in CML.
To identify the variation of the side effect profile in the Sri Lankan population
Methods
A total of 86 patients were treated with Imatinib as the first line TKI,who had completed minimum of 2 years of treatment were included.
The data set was analyzed for basic demographics, Haematological and cytogenetic response.
The side effect profile was analyzed, in relation to the time from starting treatment and the severity and graded the severity of cytopenias according to the WHO grading.
Results
Of the 86 patients, consist of 48 (56%) males and 38(44%) females, within the age of 15- 72 years at diagnosis, representing whole country.
38% of the patients were in high sokal risk category and 62% low or IM risk group.
Analysis of the response to therapy according to the ENL response criteria 2016, revealed 89% hematological and 56% complete cytogenetic response achieved within optimal time frame.
A detailed analysis of 36 patient’s revealed 51% achieved a Major molecular response (MMR) by the completion of one year treatment.
In terms of side effect profile, commonest during the first 6 months were of grade1 and 2, specifically gastrointestinal effects (86%), Skin hypopigmentation (69%), Muscular skeletal (63%), derangement of the liver enzymes(58%),fluid retention (32%) and other skin manifestations accounted in 20%.
Of the haematological toxicities, neutropenia (57%) and thrombocytopenia (52%) were the commonest, and mostly grade 1 and 2 while, Grade 3 and 4 cytopenias were in 9 patients (10%).
Most of the off target effects were settled after 6 months of the treatment. Most importantly, skin manifestations were the commonest which was persisted beyond 6 months of treatment. Interestingly, it was persisted in all the patients while on the treatment and was reversible on withdrawal. Skin hyperpigmentation was observed in 4 (7%).
Conclusion
Imatinib has induced optimal response in majority of patients. Therefore, Imatinib has shone it’s efficacy in real life conditions, in our population.
Reversible skin hypopigmentation is significantly higher than reported.
There is higher events of transient liver derangement and cytopenias, could be explained by the smaller body built of the population.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, imatinib
Abstract: PB1960
Type: Publication Only
Background
Imatinib, is the first tyrosine kinase inhibitor of the BCR-ABL protein. Imatinib was introduced for the treatment of with Chronic Myeloid Leukaemia (CML) in 2001.The discovery of the wonder drug, has changed the treatment paradigm of CML, now moving towards for the "treatment free remission". Appearance of kinase domain mutations and non-adherence are the main current challenges.
Imatinib has proven its safety and efficacy in long term 10 year follow up data of IRIS study with overall survival of 83.3% without any cumulative or late toxic effects.
The paucity of such studies analyzing the expanding Asian patient population, is a significant drawback in clinical practice, especially in explaining some side effects in them such as skin manifestations.
Aims
To look at the demographics in CML patients across the country in Sri Lanka and analysis of the response rates to Imatinib as the first line treatment in CML.
To identify the variation of the side effect profile in the Sri Lankan population
Methods
A total of 86 patients were treated with Imatinib as the first line TKI,who had completed minimum of 2 years of treatment were included.
The data set was analyzed for basic demographics, Haematological and cytogenetic response.
The side effect profile was analyzed, in relation to the time from starting treatment and the severity and graded the severity of cytopenias according to the WHO grading.
Results
Of the 86 patients, consist of 48 (56%) males and 38(44%) females, within the age of 15- 72 years at diagnosis, representing whole country.
38% of the patients were in high sokal risk category and 62% low or IM risk group.
Analysis of the response to therapy according to the ENL response criteria 2016, revealed 89% hematological and 56% complete cytogenetic response achieved within optimal time frame.
A detailed analysis of 36 patient’s revealed 51% achieved a Major molecular response (MMR) by the completion of one year treatment.
In terms of side effect profile, commonest during the first 6 months were of grade1 and 2, specifically gastrointestinal effects (86%), Skin hypopigmentation (69%), Muscular skeletal (63%), derangement of the liver enzymes(58%),fluid retention (32%) and other skin manifestations accounted in 20%.
Of the haematological toxicities, neutropenia (57%) and thrombocytopenia (52%) were the commonest, and mostly grade 1 and 2 while, Grade 3 and 4 cytopenias were in 9 patients (10%).
Most of the off target effects were settled after 6 months of the treatment. Most importantly, skin manifestations were the commonest which was persisted beyond 6 months of treatment. Interestingly, it was persisted in all the patients while on the treatment and was reversible on withdrawal. Skin hyperpigmentation was observed in 4 (7%).
Conclusion
Imatinib has induced optimal response in majority of patients. Therefore, Imatinib has shone it’s efficacy in real life conditions, in our population.
Reversible skin hypopigmentation is significantly higher than reported.
There is higher events of transient liver derangement and cytopenias, could be explained by the smaller body built of the population.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, imatinib