EFFICACY OF GENERIC IMATINIB IN NEWLY DIAGNOSED CP-CML PATIENTS IN ESTONIAN POPULATION
(Abstract release date: 05/19/16)
EHA Library. Laane E. 06/09/16; 134734; PB1834
Dr. Edward Laane
Contributions
Contributions
Abstract
Abstract: PB1834
Type: Publication Only
Background
Tyrosin kinase inhibiitor (TKI) imatinib is the gold standard 1st line therapy of chronic phase chronic myeloid leukemia (CP-CML). Imatinib was implemented in Estonia for the 1st line therapy of CML in July 1, 2006. However in 2012 generic version of imatinib was approved in European Union and since January 1, 2014 only generic imatinib has been available in Estonia.
Aims
The aim of the study was to evaluate the clinical efficacy of generic imatinib in the treatment of CP-CML in Estonia and to compare results with historical group of patients treated brand name imatinib.
Methods
25 patients in CP-CML have been diagnosed during 2014-2015 and have started 1st line treatment with generic imatinib. Optimal response was assessed at 3, 6 and 12 months after the start of treatment according to European LeukemiaNet 2013 guidelines: BCR/ABL ≤10%, <1% and ≤0,1% at 3, 6, 12 months respectively.For comparison historical group of 72 patients in CP-CML who received brand name imatinib for 1st line treatment during 2006-2013 were used. In this group pre-treatment with hydroxyurea for maximum 3 months but not interferon-alfa was allowed, OR was assessed at 6, 12 and 18 months after the start of imatinib and defined according to European LeukemiaNet 2010 recommendations.
Results
OR with generic imatinib was achieved in 16/21 (76.2%) evaluable patients at 3 months, 11/14 (78.6%) patients at 6 months and 7/11 (63.6%) at 12 months. At 18 months there were only 3 evaluable patients who all obtained OR. None of the patients not having OR at 3 months and continuing with imatinib, obtained OR later. One patient without OR at 3 and 6 months, progressed to lymphoid blastic crisis in 9 months after diagnosis. Two patients had failure to generic imatinib - one patient having BCR/ABL level at 6 months over 10% and one patient over 1% at 12 months; both patients were switched to the 2nd generation TKIs. Three patients having OR at 3 and 6 months lost it by 12th month, but 2 of them had treatment interruption periods due to poor tolerability. No new safety signal emerged. The most common adverse effects to generic imatinib occurring more than 10% of patients were nausea/vomiting, diarrhea/constipation, muscle pain in legs, periorbital oedema and allergic skin reactions. Due to adverse events 6 patients were switched to different generic imatinib and one patient not tolerating two different generic imatinibs was switched to the 2nd generation TKI.In the historical group OR was achieved in 33/45 (73%) evaluable patients at 6 months and 33/50 (66%) patients at 12 months. At 18 months OR was obtained in 22/51 (43%) evaluable patients. None of 11 patients not in OR at 6m obtained OR at 12m or 18 months.
Conclusion
Generic imatinib appears to have the same efficacy as brand name imatinib. Despite differences in group size and OR definition by European LeukemiaNet 2010 vs 2013 recommendations the treatment results with generic and brand name imatinib were quite comparable with 78.6-66% of OR rate at 6 months and 63.6-66% at 12 months. To improve treatment results, for patients not achieving early OR at 3 months or 6 months should be offered treatment with 2nd generation TKI.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs
Type: Publication Only
Background
Tyrosin kinase inhibiitor (TKI) imatinib is the gold standard 1st line therapy of chronic phase chronic myeloid leukemia (CP-CML). Imatinib was implemented in Estonia for the 1st line therapy of CML in July 1, 2006. However in 2012 generic version of imatinib was approved in European Union and since January 1, 2014 only generic imatinib has been available in Estonia.
Aims
The aim of the study was to evaluate the clinical efficacy of generic imatinib in the treatment of CP-CML in Estonia and to compare results with historical group of patients treated brand name imatinib.
Methods
25 patients in CP-CML have been diagnosed during 2014-2015 and have started 1st line treatment with generic imatinib. Optimal response was assessed at 3, 6 and 12 months after the start of treatment according to European LeukemiaNet 2013 guidelines: BCR/ABL ≤10%, <1% and ≤0,1% at 3, 6, 12 months respectively.For comparison historical group of 72 patients in CP-CML who received brand name imatinib for 1st line treatment during 2006-2013 were used. In this group pre-treatment with hydroxyurea for maximum 3 months but not interferon-alfa was allowed, OR was assessed at 6, 12 and 18 months after the start of imatinib and defined according to European LeukemiaNet 2010 recommendations.
Results
OR with generic imatinib was achieved in 16/21 (76.2%) evaluable patients at 3 months, 11/14 (78.6%) patients at 6 months and 7/11 (63.6%) at 12 months. At 18 months there were only 3 evaluable patients who all obtained OR. None of the patients not having OR at 3 months and continuing with imatinib, obtained OR later. One patient without OR at 3 and 6 months, progressed to lymphoid blastic crisis in 9 months after diagnosis. Two patients had failure to generic imatinib - one patient having BCR/ABL level at 6 months over 10% and one patient over 1% at 12 months; both patients were switched to the 2nd generation TKIs. Three patients having OR at 3 and 6 months lost it by 12th month, but 2 of them had treatment interruption periods due to poor tolerability. No new safety signal emerged. The most common adverse effects to generic imatinib occurring more than 10% of patients were nausea/vomiting, diarrhea/constipation, muscle pain in legs, periorbital oedema and allergic skin reactions. Due to adverse events 6 patients were switched to different generic imatinib and one patient not tolerating two different generic imatinibs was switched to the 2nd generation TKI.In the historical group OR was achieved in 33/45 (73%) evaluable patients at 6 months and 33/50 (66%) patients at 12 months. At 18 months OR was obtained in 22/51 (43%) evaluable patients. None of 11 patients not in OR at 6m obtained OR at 12m or 18 months.
Conclusion
Generic imatinib appears to have the same efficacy as brand name imatinib. Despite differences in group size and OR definition by European LeukemiaNet 2010 vs 2013 recommendations the treatment results with generic and brand name imatinib were quite comparable with 78.6-66% of OR rate at 6 months and 63.6-66% at 12 months. To improve treatment results, for patients not achieving early OR at 3 months or 6 months should be offered treatment with 2nd generation TKI.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs
Abstract: PB1834
Type: Publication Only
Background
Tyrosin kinase inhibiitor (TKI) imatinib is the gold standard 1st line therapy of chronic phase chronic myeloid leukemia (CP-CML). Imatinib was implemented in Estonia for the 1st line therapy of CML in July 1, 2006. However in 2012 generic version of imatinib was approved in European Union and since January 1, 2014 only generic imatinib has been available in Estonia.
Aims
The aim of the study was to evaluate the clinical efficacy of generic imatinib in the treatment of CP-CML in Estonia and to compare results with historical group of patients treated brand name imatinib.
Methods
25 patients in CP-CML have been diagnosed during 2014-2015 and have started 1st line treatment with generic imatinib. Optimal response was assessed at 3, 6 and 12 months after the start of treatment according to European LeukemiaNet 2013 guidelines: BCR/ABL ≤10%, <1% and ≤0,1% at 3, 6, 12 months respectively.For comparison historical group of 72 patients in CP-CML who received brand name imatinib for 1st line treatment during 2006-2013 were used. In this group pre-treatment with hydroxyurea for maximum 3 months but not interferon-alfa was allowed, OR was assessed at 6, 12 and 18 months after the start of imatinib and defined according to European LeukemiaNet 2010 recommendations.
Results
OR with generic imatinib was achieved in 16/21 (76.2%) evaluable patients at 3 months, 11/14 (78.6%) patients at 6 months and 7/11 (63.6%) at 12 months. At 18 months there were only 3 evaluable patients who all obtained OR. None of the patients not having OR at 3 months and continuing with imatinib, obtained OR later. One patient without OR at 3 and 6 months, progressed to lymphoid blastic crisis in 9 months after diagnosis. Two patients had failure to generic imatinib - one patient having BCR/ABL level at 6 months over 10% and one patient over 1% at 12 months; both patients were switched to the 2nd generation TKIs. Three patients having OR at 3 and 6 months lost it by 12th month, but 2 of them had treatment interruption periods due to poor tolerability. No new safety signal emerged. The most common adverse effects to generic imatinib occurring more than 10% of patients were nausea/vomiting, diarrhea/constipation, muscle pain in legs, periorbital oedema and allergic skin reactions. Due to adverse events 6 patients were switched to different generic imatinib and one patient not tolerating two different generic imatinibs was switched to the 2nd generation TKI.In the historical group OR was achieved in 33/45 (73%) evaluable patients at 6 months and 33/50 (66%) patients at 12 months. At 18 months OR was obtained in 22/51 (43%) evaluable patients. None of 11 patients not in OR at 6m obtained OR at 12m or 18 months.
Conclusion
Generic imatinib appears to have the same efficacy as brand name imatinib. Despite differences in group size and OR definition by European LeukemiaNet 2010 vs 2013 recommendations the treatment results with generic and brand name imatinib were quite comparable with 78.6-66% of OR rate at 6 months and 63.6-66% at 12 months. To improve treatment results, for patients not achieving early OR at 3 months or 6 months should be offered treatment with 2nd generation TKI.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs
Type: Publication Only
Background
Tyrosin kinase inhibiitor (TKI) imatinib is the gold standard 1st line therapy of chronic phase chronic myeloid leukemia (CP-CML). Imatinib was implemented in Estonia for the 1st line therapy of CML in July 1, 2006. However in 2012 generic version of imatinib was approved in European Union and since January 1, 2014 only generic imatinib has been available in Estonia.
Aims
The aim of the study was to evaluate the clinical efficacy of generic imatinib in the treatment of CP-CML in Estonia and to compare results with historical group of patients treated brand name imatinib.
Methods
25 patients in CP-CML have been diagnosed during 2014-2015 and have started 1st line treatment with generic imatinib. Optimal response was assessed at 3, 6 and 12 months after the start of treatment according to European LeukemiaNet 2013 guidelines: BCR/ABL ≤10%, <1% and ≤0,1% at 3, 6, 12 months respectively.For comparison historical group of 72 patients in CP-CML who received brand name imatinib for 1st line treatment during 2006-2013 were used. In this group pre-treatment with hydroxyurea for maximum 3 months but not interferon-alfa was allowed, OR was assessed at 6, 12 and 18 months after the start of imatinib and defined according to European LeukemiaNet 2010 recommendations.
Results
OR with generic imatinib was achieved in 16/21 (76.2%) evaluable patients at 3 months, 11/14 (78.6%) patients at 6 months and 7/11 (63.6%) at 12 months. At 18 months there were only 3 evaluable patients who all obtained OR. None of the patients not having OR at 3 months and continuing with imatinib, obtained OR later. One patient without OR at 3 and 6 months, progressed to lymphoid blastic crisis in 9 months after diagnosis. Two patients had failure to generic imatinib - one patient having BCR/ABL level at 6 months over 10% and one patient over 1% at 12 months; both patients were switched to the 2nd generation TKIs. Three patients having OR at 3 and 6 months lost it by 12th month, but 2 of them had treatment interruption periods due to poor tolerability. No new safety signal emerged. The most common adverse effects to generic imatinib occurring more than 10% of patients were nausea/vomiting, diarrhea/constipation, muscle pain in legs, periorbital oedema and allergic skin reactions. Due to adverse events 6 patients were switched to different generic imatinib and one patient not tolerating two different generic imatinibs was switched to the 2nd generation TKI.In the historical group OR was achieved in 33/45 (73%) evaluable patients at 6 months and 33/50 (66%) patients at 12 months. At 18 months OR was obtained in 22/51 (43%) evaluable patients. None of 11 patients not in OR at 6m obtained OR at 12m or 18 months.
Conclusion
Generic imatinib appears to have the same efficacy as brand name imatinib. Despite differences in group size and OR definition by European LeukemiaNet 2010 vs 2013 recommendations the treatment results with generic and brand name imatinib were quite comparable with 78.6-66% of OR rate at 6 months and 63.6-66% at 12 months. To improve treatment results, for patients not achieving early OR at 3 months or 6 months should be offered treatment with 2nd generation TKI.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs
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