Contributions
Abstract: PB1820
Type: Publication Only
Background
The efficacy of branded imatinib (Gleevec) in the first-line treatment of chronic myeloid leukemia (CML) has been demonstrated in several clinical studies. However, there are few consistent data in the literature on the efficacy and adverse effects of generic formulations of imatinib. In Brazil, CML patients have been treated in the national public health system with generic imatinib since June 2013.
Aims
The present study aims to evaluate the efficacy and safety of generic imatinib in the treatment of CML in comparison with the reference drug (Gleevec) in the first three months of imatinib treatment.
Methods
This is a multicenter, observational, ambispective, cohort-type study. The study was initiated in January 2015 with the intended participation of 17 Brazilian centers. In the prospective group, were selected chronic phase CML patients who started their first-line treatment with generic imatinib between January 2015 and October 2016, whereas retrospective group was treated with Gleevec between January 2010 and December 2011. All patients started imatinib less than six months from diagnosis. Study data were collected and managed using REDCap electronic data capture tools. Demographic data were collected at diagnosis: age, gender, Sokal, Hasford, EUTOS score, comorbidities, cytogenetics, BCR-ABL transcript type. The definition of the responses followed the European Leukemia Net 2013 criteria. Adverse events were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.3, 2010. Statistical analysis: SPSS version 21.0 was used applying the chi-square and t-test, when adequate. All analysis considered p-value < 0.05 as significant.
Results
Ten centers have registered 177 patients in the retrospective group and 68 patients in the prospective group so far. For this preliminary analysis, response data from 132 patients were available (47 from prospective and 85 from the retrospective groups). The median age of patients was 54 years in the prospective group and 46 years in the retrospective group (P=0.12). Sokal score in prospective and retrospective groups, respectively: low risk 42%/52%; intermediate risk 42%/31% and high risk 45%/67% (P=0.48). There was no difference between the groups concerning gender, Hasford, EUTOS scores, ECOG, blood cell counts at diagnosis and before starting imatinib and BCR-ABL transcripts. Regarding responses, there was no difference in the hematological, complete cytogenetic responses and rate of BCR-ABL transcripts >10% at three months. However, there was a higher rate of failure at three months according to the ELN 2013 criteria in the prospective group (14.9% versus 4.7% Gleevec group, P=0.04). There was no significant difference in grade 3 and 4 hematological and non-hematological toxicity, but there was one early death in the prospective group (acute peripheral arterial occlusion and renal failure). Four patients discontinued imatinib: one from Gleevec group (resistance) and three from the generic group due to intolerance (1) and resistance (2).
Conclusion
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Treatment, Generic drugs, Chronic myeloid leukemia
Abstract: PB1820
Type: Publication Only
Background
The efficacy of branded imatinib (Gleevec) in the first-line treatment of chronic myeloid leukemia (CML) has been demonstrated in several clinical studies. However, there are few consistent data in the literature on the efficacy and adverse effects of generic formulations of imatinib. In Brazil, CML patients have been treated in the national public health system with generic imatinib since June 2013.
Aims
The present study aims to evaluate the efficacy and safety of generic imatinib in the treatment of CML in comparison with the reference drug (Gleevec) in the first three months of imatinib treatment.
Methods
This is a multicenter, observational, ambispective, cohort-type study. The study was initiated in January 2015 with the intended participation of 17 Brazilian centers. In the prospective group, were selected chronic phase CML patients who started their first-line treatment with generic imatinib between January 2015 and October 2016, whereas retrospective group was treated with Gleevec between January 2010 and December 2011. All patients started imatinib less than six months from diagnosis. Study data were collected and managed using REDCap electronic data capture tools. Demographic data were collected at diagnosis: age, gender, Sokal, Hasford, EUTOS score, comorbidities, cytogenetics, BCR-ABL transcript type. The definition of the responses followed the European Leukemia Net 2013 criteria. Adverse events were assessed based on the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.3, 2010. Statistical analysis: SPSS version 21.0 was used applying the chi-square and t-test, when adequate. All analysis considered p-value < 0.05 as significant.
Results
Ten centers have registered 177 patients in the retrospective group and 68 patients in the prospective group so far. For this preliminary analysis, response data from 132 patients were available (47 from prospective and 85 from the retrospective groups). The median age of patients was 54 years in the prospective group and 46 years in the retrospective group (P=0.12). Sokal score in prospective and retrospective groups, respectively: low risk 42%/52%; intermediate risk 42%/31% and high risk 45%/67% (P=0.48). There was no difference between the groups concerning gender, Hasford, EUTOS scores, ECOG, blood cell counts at diagnosis and before starting imatinib and BCR-ABL transcripts. Regarding responses, there was no difference in the hematological, complete cytogenetic responses and rate of BCR-ABL transcripts >10% at three months. However, there was a higher rate of failure at three months according to the ELN 2013 criteria in the prospective group (14.9% versus 4.7% Gleevec group, P=0.04). There was no significant difference in grade 3 and 4 hematological and non-hematological toxicity, but there was one early death in the prospective group (acute peripheral arterial occlusion and renal failure). Four patients discontinued imatinib: one from Gleevec group (resistance) and three from the generic group due to intolerance (1) and resistance (2).
Conclusion
Session topic: 8. Chronic myeloid leukemia - Clinical
Keyword(s): Treatment, Generic drugs, Chronic myeloid leukemia