Contributions
Abstract: PB1910
Type: Publication Only
Background
The superior efficacy of nilotinib over imatinib as frontline therapy for CML-CP was first demonstrated in the international phase 3 study Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd).
Aims
Because the efficacy and safety of TKIs may vary depending on ethnic background or genetic factors, focused investigations within well-defined patient populations are crucial in order to better understand the relative benefits and risks of each treatment option for individual patients. We did conduct this study in Albanian patients with newly diagnosed chronic myeloid leukemia in chronic phase
Methods
Adult patients of Albanian ethnicity with Ph+ CML-CP within 6 months of diagnosis and with an Eastern Cooperative Oncology Group performance status ≤2 were eligible. Patients were randomized 1:1 to nilotinib 300 mg twice daily or imatinib 400 mg once daily.The study was conducted according to the ethical principles of the Declaration of Helsinki
Results
Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP).
A total of 121 patients were randomized (nilotinib, n = 61; imatinib, n = 60) from May of 2011 to August 2014 at Hematology clinic ,University Hospital Center “Mother Teresa “. In this study, we present the results of a 48 months follow-up data of a study that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in Albanian population. This study met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 ≤0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (50.2 % vs 26.3; P < .0001), and MMR rates remained higher with nilotinib vs imatinib throughout the follow-up period. . Estimated 60 months rates of freedom from progression to AP/BC on study were significantly higher on nilotinib (95.1% [P = .0497] compared with imatinib (91.2%).
Conclusion
For the first time we are presenting a geographical distribution of CML patients in Albania .
In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Albanian patients with newly diagnosed Ph+ CML-CP. These results suggest that treatment with frontline nilotinib may allow more patients with Ph+ CML-CP to achieve early, deep molecular responses and attain improved long-term outcomes. Estimated rates of 5-year OR on study were 96.7%, and 93.3% for nilotinib 300 mg twice daily and imatinib 400 mg once daily . The safety profiles of both drugs were similar to those from previous studies.
e international phase 3 study Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd). Because the efficacy and safety of TKIs may vary depending on ethnic background or genetic factors, focused investigations within well-defined patient populations are crucial in order to better understand the relative benefits and risks of each treatment option for individual patients. We did conduct this study in Albanian patients with newly diagnosed chronic myeloid leukemia in chronic phase
Session topic: 7. Chronic myeloid leukemia – Biology & Translational Research
Keyword(s): Chronic myeloid leukemia, imatinib, myeloid leukemia
Abstract: PB1910
Type: Publication Only
Background
The superior efficacy of nilotinib over imatinib as frontline therapy for CML-CP was first demonstrated in the international phase 3 study Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd).
Aims
Because the efficacy and safety of TKIs may vary depending on ethnic background or genetic factors, focused investigations within well-defined patient populations are crucial in order to better understand the relative benefits and risks of each treatment option for individual patients. We did conduct this study in Albanian patients with newly diagnosed chronic myeloid leukemia in chronic phase
Methods
Adult patients of Albanian ethnicity with Ph+ CML-CP within 6 months of diagnosis and with an Eastern Cooperative Oncology Group performance status ≤2 were eligible. Patients were randomized 1:1 to nilotinib 300 mg twice daily or imatinib 400 mg once daily.The study was conducted according to the ethical principles of the Declaration of Helsinki
Results
Treatment with a tyrosine kinase inhibitor (TKI) targeting BCR-ABL1 is currently the standard of care for patients with chronic myeloid leukemia (CML) in chronic phase (CML-CP).
A total of 121 patients were randomized (nilotinib, n = 61; imatinib, n = 60) from May of 2011 to August 2014 at Hematology clinic ,University Hospital Center “Mother Teresa “. In this study, we present the results of a 48 months follow-up data of a study that was conducted to investigate nilotinib 300 mg twice daily vs imatinib 400 mg once daily in Albanian population. This study met its primary end point with a statistically significant higher rate of major molecular response (MMR; BCR-ABL1 ≤0.1% on the International Scale) at 12 months in the nilotinib arm vs the imatinib arm (50.2 % vs 26.3; P < .0001), and MMR rates remained higher with nilotinib vs imatinib throughout the follow-up period. . Estimated 60 months rates of freedom from progression to AP/BC on study were significantly higher on nilotinib (95.1% [P = .0497] compared with imatinib (91.2%).
Conclusion
For the first time we are presenting a geographical distribution of CML patients in Albania .
In conclusion, rates of MMR at 12 months were superior with nilotinib vs imatinib in Albanian patients with newly diagnosed Ph+ CML-CP. These results suggest that treatment with frontline nilotinib may allow more patients with Ph+ CML-CP to achieve early, deep molecular responses and attain improved long-term outcomes. Estimated rates of 5-year OR on study were 96.7%, and 93.3% for nilotinib 300 mg twice daily and imatinib 400 mg once daily . The safety profiles of both drugs were similar to those from previous studies.
e international phase 3 study Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd). Because the efficacy and safety of TKIs may vary depending on ethnic background or genetic factors, focused investigations within well-defined patient populations are crucial in order to better understand the relative benefits and risks of each treatment option for individual patients. We did conduct this study in Albanian patients with newly diagnosed chronic myeloid leukemia in chronic phase
Session topic: 7. Chronic myeloid leukemia – Biology & Translational Research
Keyword(s): Chronic myeloid leukemia, imatinib, myeloid leukemia