EVALUATION OF CLINICAL EFFICACY AND SAFETY OF GENERIC IMATINIB IN THE TREATMENT OF CHRONIC MYELOID LEUKEMIA
(Abstract release date: 05/19/16)
EHA Library. Irena C. 06/09/16; 134717; PB1817
Dr. Cojbasic Irena
Contributions
Contributions
Abstract
Abstract: PB1817
Type: Publication Only
Background
Application of generic imatinib (GI) should allow to lower price of cancer drug making it available to a larger number of patients, that way improving health care of the population. Serbia was one of the first countries in Europe to adopt generic imatinib which has been used since 2012. Thereafter, all patients with CML have been switched from the original imatinib (OI) to GI, while newly diagnosed CML patients have been frontline treated with GI.
Aims
The aim of this study was to evaluate the clinical efficacy and safety of GI in the treatment of patients with CML both as frontline therapy and continued therapy after switching from the OI.
Methods
Our study included 70 adult patients with chronic phase CML that were treated with OI and/or GI in the period from August 2006 until February 2016. Patients were divided into two study groups: the first one had 34 patients switched from the OI to GI, second had 36 newly diagnosed patients who were treated with GI as frontline therapy. All patients underwent hematological, cytogenetic and molecular monitoring and had been treated in accordance with the applicable national guidelines and ELN recommendations.
Results
The median follow-up was 74.7 months (range 46-115) for the patients who started treatment with OI and 20.3 months (range 6-43) for those receiving frontline GI. In the both analysed groups a slight predominance of female subjects was found. In the first group, at the time of the switch from OI to GI, all patients achieved complete cytogenetic response (CCgR) while major molecular response (MMoR) achieved 25/34 (73.5%) of analysed patients. During 41 months of follow-up, 6 patients lost CCgR, but after switching to the 2nd line therapy nilotinib, all have achieved secondary CCgR. The overall rate of MMoR for the group of patients that switched from OI to GI was 22/28 (78.6%). Among newly diagnosed patients receiving frontline GI, the overall rate of CCgR was 29/36 (80.6%), while overall rate of MMoR was 17/36 (47.2%). During the study follow-up, 10 patients were switched to 2nd line therapy nilotinib due to cytogenetic refractoriness or relapse and 7 of them achieved secondary CCgR. When the two study groups were compared regarding the most common non-hematologic adverse events (AEs) of any grade, in the group that started with OI therapy, there were peripheral edema (n=8), skin reactions (n=4) and myalgia (n=3), while in group with frontline GI there were nausea (n = 10), peripheral edema (n=6) and fatigue (n=4). In both groups most common hematological AEs were neutropenia (n=5 vs. n=4) and thrombocytopenia (n=2 vs. n=3). There were no dose reductions due to toxicities in both groups.
Conclusion
The results of our study have shown that generic imatinib is not inferior in efficacy and safety compared to the original imatinib. Despite these encouraging results, the need remains for the large prospective randomized studies that would allow for the definitive confirmation of the generic imatinib efficiency in the treatment of patients with CP-CML.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Type: Publication Only
Background
Application of generic imatinib (GI) should allow to lower price of cancer drug making it available to a larger number of patients, that way improving health care of the population. Serbia was one of the first countries in Europe to adopt generic imatinib which has been used since 2012. Thereafter, all patients with CML have been switched from the original imatinib (OI) to GI, while newly diagnosed CML patients have been frontline treated with GI.
Aims
The aim of this study was to evaluate the clinical efficacy and safety of GI in the treatment of patients with CML both as frontline therapy and continued therapy after switching from the OI.
Methods
Our study included 70 adult patients with chronic phase CML that were treated with OI and/or GI in the period from August 2006 until February 2016. Patients were divided into two study groups: the first one had 34 patients switched from the OI to GI, second had 36 newly diagnosed patients who were treated with GI as frontline therapy. All patients underwent hematological, cytogenetic and molecular monitoring and had been treated in accordance with the applicable national guidelines and ELN recommendations.
Results
The median follow-up was 74.7 months (range 46-115) for the patients who started treatment with OI and 20.3 months (range 6-43) for those receiving frontline GI. In the both analysed groups a slight predominance of female subjects was found. In the first group, at the time of the switch from OI to GI, all patients achieved complete cytogenetic response (CCgR) while major molecular response (MMoR) achieved 25/34 (73.5%) of analysed patients. During 41 months of follow-up, 6 patients lost CCgR, but after switching to the 2nd line therapy nilotinib, all have achieved secondary CCgR. The overall rate of MMoR for the group of patients that switched from OI to GI was 22/28 (78.6%). Among newly diagnosed patients receiving frontline GI, the overall rate of CCgR was 29/36 (80.6%), while overall rate of MMoR was 17/36 (47.2%). During the study follow-up, 10 patients were switched to 2nd line therapy nilotinib due to cytogenetic refractoriness or relapse and 7 of them achieved secondary CCgR. When the two study groups were compared regarding the most common non-hematologic adverse events (AEs) of any grade, in the group that started with OI therapy, there were peripheral edema (n=8), skin reactions (n=4) and myalgia (n=3), while in group with frontline GI there were nausea (n = 10), peripheral edema (n=6) and fatigue (n=4). In both groups most common hematological AEs were neutropenia (n=5 vs. n=4) and thrombocytopenia (n=2 vs. n=3). There were no dose reductions due to toxicities in both groups.
Conclusion
The results of our study have shown that generic imatinib is not inferior in efficacy and safety compared to the original imatinib. Despite these encouraging results, the need remains for the large prospective randomized studies that would allow for the definitive confirmation of the generic imatinib efficiency in the treatment of patients with CP-CML.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Abstract: PB1817
Type: Publication Only
Background
Application of generic imatinib (GI) should allow to lower price of cancer drug making it available to a larger number of patients, that way improving health care of the population. Serbia was one of the first countries in Europe to adopt generic imatinib which has been used since 2012. Thereafter, all patients with CML have been switched from the original imatinib (OI) to GI, while newly diagnosed CML patients have been frontline treated with GI.
Aims
The aim of this study was to evaluate the clinical efficacy and safety of GI in the treatment of patients with CML both as frontline therapy and continued therapy after switching from the OI.
Methods
Our study included 70 adult patients with chronic phase CML that were treated with OI and/or GI in the period from August 2006 until February 2016. Patients were divided into two study groups: the first one had 34 patients switched from the OI to GI, second had 36 newly diagnosed patients who were treated with GI as frontline therapy. All patients underwent hematological, cytogenetic and molecular monitoring and had been treated in accordance with the applicable national guidelines and ELN recommendations.
Results
The median follow-up was 74.7 months (range 46-115) for the patients who started treatment with OI and 20.3 months (range 6-43) for those receiving frontline GI. In the both analysed groups a slight predominance of female subjects was found. In the first group, at the time of the switch from OI to GI, all patients achieved complete cytogenetic response (CCgR) while major molecular response (MMoR) achieved 25/34 (73.5%) of analysed patients. During 41 months of follow-up, 6 patients lost CCgR, but after switching to the 2nd line therapy nilotinib, all have achieved secondary CCgR. The overall rate of MMoR for the group of patients that switched from OI to GI was 22/28 (78.6%). Among newly diagnosed patients receiving frontline GI, the overall rate of CCgR was 29/36 (80.6%), while overall rate of MMoR was 17/36 (47.2%). During the study follow-up, 10 patients were switched to 2nd line therapy nilotinib due to cytogenetic refractoriness or relapse and 7 of them achieved secondary CCgR. When the two study groups were compared regarding the most common non-hematologic adverse events (AEs) of any grade, in the group that started with OI therapy, there were peripheral edema (n=8), skin reactions (n=4) and myalgia (n=3), while in group with frontline GI there were nausea (n = 10), peripheral edema (n=6) and fatigue (n=4). In both groups most common hematological AEs were neutropenia (n=5 vs. n=4) and thrombocytopenia (n=2 vs. n=3). There were no dose reductions due to toxicities in both groups.
Conclusion
The results of our study have shown that generic imatinib is not inferior in efficacy and safety compared to the original imatinib. Despite these encouraging results, the need remains for the large prospective randomized studies that would allow for the definitive confirmation of the generic imatinib efficiency in the treatment of patients with CP-CML.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
Type: Publication Only
Background
Application of generic imatinib (GI) should allow to lower price of cancer drug making it available to a larger number of patients, that way improving health care of the population. Serbia was one of the first countries in Europe to adopt generic imatinib which has been used since 2012. Thereafter, all patients with CML have been switched from the original imatinib (OI) to GI, while newly diagnosed CML patients have been frontline treated with GI.
Aims
The aim of this study was to evaluate the clinical efficacy and safety of GI in the treatment of patients with CML both as frontline therapy and continued therapy after switching from the OI.
Methods
Our study included 70 adult patients with chronic phase CML that were treated with OI and/or GI in the period from August 2006 until February 2016. Patients were divided into two study groups: the first one had 34 patients switched from the OI to GI, second had 36 newly diagnosed patients who were treated with GI as frontline therapy. All patients underwent hematological, cytogenetic and molecular monitoring and had been treated in accordance with the applicable national guidelines and ELN recommendations.
Results
The median follow-up was 74.7 months (range 46-115) for the patients who started treatment with OI and 20.3 months (range 6-43) for those receiving frontline GI. In the both analysed groups a slight predominance of female subjects was found. In the first group, at the time of the switch from OI to GI, all patients achieved complete cytogenetic response (CCgR) while major molecular response (MMoR) achieved 25/34 (73.5%) of analysed patients. During 41 months of follow-up, 6 patients lost CCgR, but after switching to the 2nd line therapy nilotinib, all have achieved secondary CCgR. The overall rate of MMoR for the group of patients that switched from OI to GI was 22/28 (78.6%). Among newly diagnosed patients receiving frontline GI, the overall rate of CCgR was 29/36 (80.6%), while overall rate of MMoR was 17/36 (47.2%). During the study follow-up, 10 patients were switched to 2nd line therapy nilotinib due to cytogenetic refractoriness or relapse and 7 of them achieved secondary CCgR. When the two study groups were compared regarding the most common non-hematologic adverse events (AEs) of any grade, in the group that started with OI therapy, there were peripheral edema (n=8), skin reactions (n=4) and myalgia (n=3), while in group with frontline GI there were nausea (n = 10), peripheral edema (n=6) and fatigue (n=4). In both groups most common hematological AEs were neutropenia (n=5 vs. n=4) and thrombocytopenia (n=2 vs. n=3). There were no dose reductions due to toxicities in both groups.
Conclusion
The results of our study have shown that generic imatinib is not inferior in efficacy and safety compared to the original imatinib. Despite these encouraging results, the need remains for the large prospective randomized studies that would allow for the definitive confirmation of the generic imatinib efficiency in the treatment of patients with CP-CML.
Session topic: E-poster
Keyword(s): Chronic myeloid leukemia, Generic drugs, Imatinib
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