Irena Ćojbašić1, Lana Mačukanović-Golubović2, Miodrag Vučić2, Žarko Ćojbašić3. 1. Clinic of Hematology and Clinical Immunology, Clinical Centre Niš, Niš, Serbia; Faculty of Medicine, University of Niš, Niš, Serbia. Electronic address: icojbasic@gmail.com. 2. Clinic of Hematology and Clinical Immunology, Clinical Centre Niš, Niš, Serbia; Faculty of Medicine, University of Niš, Niš, Serbia. 3. Mechanical Engineering Faculty, University of Niš, Niš, Serbia.
Abstract
BACKGROUND: Similar to the application of other generic drugs, the use of generic imatinib in the treatment of chronic myeloid leukemia (CML) leads to significant cost savings, but it also raises issues related to efficacy, safety, and quality. This study assessed the long-term outcome of CML patients after administration of generic imatinib. PATIENTS AND METHODS: The cohort of 83 patients was divided into 2 groups depending on whether generic imatinib was applied in the front-line setting or after switching from original imatinib. The groups were compared regarding rates of optimal treatment response, adverse events, and survival. RESULTS: In the first group, at the time of switching, rates of complete cytogenetic response experienced, and major molecular response were 95% and 87.5% of patients in the front-line generic imatinib group and the group that switched from original to generic imatinib, respectively. After 24 months of treatment with generic imatinib, the rates of sustained, lost, and experienced major molecular response were 72.5%, 15%, and 12.5%, respectively. In the group treated with front-line generic imatinib at 6 months, 67.4% experienced complete cytogenetic response, while for major molecular response at 12 and 24 months, it was 58.1% and 69.8%, respectively. Estimated 5-year overall survival in the group treated with front-line generic imatinib was 86.1%, while 10-year overall survival in the group treated with second-line generic imatinib was 93.8%. CONCLUSION: Results of this study with long-term follow-up are further evidence that generic imatinib is at least noninferior to original imatinib regarding efficacy and survival, both when provided initially and as a subsequent replacement for original imatinib.
BACKGROUND: Similar to the application of other generic drugs, the use of generic imatinib in the treatment of chronic myeloid leukemia (CML) leads to significant cost savings, but it also raises issues related to efficacy, safety, and quality. This study assessed the long-term outcome of CMLpatients after administration of generic imatinib. PATIENTS AND METHODS: The cohort of 83 patients was divided into 2 groups depending on whether generic imatinib was applied in the front-line setting or after switching from original imatinib. The groups were compared regarding rates of optimal treatment response, adverse events, and survival. RESULTS: In the first group, at the time of switching, rates of complete cytogenetic response experienced, and major molecular response were 95% and 87.5% of patients in the front-line generic imatinib group and the group that switched from original to generic imatinib, respectively. After 24 months of treatment with generic imatinib, the rates of sustained, lost, and experienced major molecular response were 72.5%, 15%, and 12.5%, respectively. In the group treated with front-line generic imatinib at 6 months, 67.4% experienced complete cytogenetic response, while for major molecular response at 12 and 24 months, it was 58.1% and 69.8%, respectively. Estimated 5-year overall survival in the group treated with front-line generic imatinib was 86.1%, while 10-year overall survival in the group treated with second-line generic imatinib was 93.8%. CONCLUSION: Results of this study with long-term follow-up are further evidence that generic imatinib is at least noninferior to original imatinib regarding efficacy and survival, both when provided initially and as a subsequent replacement for original imatinib.