Contributions
Abstract: PB1947
Type: Publication Only
Background
Nilotinib, a second-generation tyrosine kinase inhibitor, has shown faster and deeper molecular responses when used as initial therapy in chronic phase chronic myeloid leukemia (CML). Data on efficacy and safety of Nilotinib in Asian population, particularly from Pakistan is scarce.
Aims
We aimed to determine the molecular response to Nilotinib and its safety profile in our population of chronic phase CML patients.
Methods
This single arm, non-randomized clinical trial was conducted among 138 newly diagnosed CML patients presented in chronic phase. All patients received Nilotinib 600 mg per day. The haematological and molecular response was assessed at 3 and 6 months respectively and thereafter at 6 monthly intervals. Moreover, event free survival (EFS), transformation free survival (TFS), overall survival (OS) and adverse events were also observed at long term analysis.
Results
The cumulative incidence of major molecular response (MMR) was 86% and deep molecular response (DMR i.e. MR 4.0 and MR 4.5) was 39%. Early MMR and DMR at 6 months of therapy were achieved by 71% and 32% patients respectively. Two- year EFS, TFS and OS rates for the whole group were 93%, 95%, and 97%, respectively. At median follow up of 29 months, 75% and 45% of patients were able to sustain MMR and DMR respectively. 50% patients had a high Sokal score at diagnosis. Adverse events were mainly weight gain in 29% and myelosuppression in 15% of patients.
Conclusion
Our results show high efficacy and safety of Nilotinib in both high and low Sokal risk CML patients.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Drug resistance, Molecular response, Tyrosine kinase inhibitor
Abstract: PB1947
Type: Publication Only
Background
Nilotinib, a second-generation tyrosine kinase inhibitor, has shown faster and deeper molecular responses when used as initial therapy in chronic phase chronic myeloid leukemia (CML). Data on efficacy and safety of Nilotinib in Asian population, particularly from Pakistan is scarce.
Aims
We aimed to determine the molecular response to Nilotinib and its safety profile in our population of chronic phase CML patients.
Methods
This single arm, non-randomized clinical trial was conducted among 138 newly diagnosed CML patients presented in chronic phase. All patients received Nilotinib 600 mg per day. The haematological and molecular response was assessed at 3 and 6 months respectively and thereafter at 6 monthly intervals. Moreover, event free survival (EFS), transformation free survival (TFS), overall survival (OS) and adverse events were also observed at long term analysis.
Results
The cumulative incidence of major molecular response (MMR) was 86% and deep molecular response (DMR i.e. MR 4.0 and MR 4.5) was 39%. Early MMR and DMR at 6 months of therapy were achieved by 71% and 32% patients respectively. Two- year EFS, TFS and OS rates for the whole group were 93%, 95%, and 97%, respectively. At median follow up of 29 months, 75% and 45% of patients were able to sustain MMR and DMR respectively. 50% patients had a high Sokal score at diagnosis. Adverse events were mainly weight gain in 29% and myelosuppression in 15% of patients.
Conclusion
Our results show high efficacy and safety of Nilotinib in both high and low Sokal risk CML patients.
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Chronic myeloid leukemia, Drug resistance, Molecular response, Tyrosine kinase inhibitor