The efficacy of generic imatinib as first- and second-line therapy: three year follow-up of chronic myeloid leukemia patients

• Published in: Clinical lymphoma, myeloma and leukemia
• Main Authors: Islamagic, Erna, Ms, Hasic, Azra, MD, Kurtovic, Sabira, MD, Hadzimesic, Emina Suljovic, MD, Mehinovic, Lejla, Ms, Kozaric, Mirza, MD, Kurtovic-Kozaric, Amina, PhD
• Format: Journal Article
• Language: English
• Published: 2017
• Subjects: Hematology, Oncology and Palliative Medicine; clinical outcomes; CML; generic imatinib; Glivec
• ISSN: 2152-2650
• DOI: 10.1016/j.clml.2017.02.001

Introduction Generics of imatinib mesylate, the first tyrosine kinase inhibitor targeting the BCR-ABL1 fusion protein, have recently been approved in many countries as the alternative, low cost forms, for the treatment of chronic myeloid leukemia (CML) patients. The aim of this study was to evaluate the long-term clinical outcomes of CML patients receiving first-line and second-line generic imatinib in Bosnia and Herzegovina. Patients and Methods This was a multicenter retrospective cohort study of patients (n = 41) treated with generic imatinib in Bosnia between 09/01/2013 and 08/05/2016. Patients were categorized into two study groups: Group 1 (n=27) included newly diagnosed CML patients receiving front-line generic imatinib, and Group 2 (n=14) consisted of patients who started with front-line Glivec and were mandated to switch to the second-line generic imatinib. Results Median follow-up for Group 1 (first-line generic imatinib) and Group 2 (second-line generic imatinib), was 16 and 36 months, respectively. At 36 months, overall survival for patients in Group 1 was 85% and the achievement of CCyR was 81%. At 24 months, MMR rate was 48%. Overall, 52% of patients switched from first-line generic imatinib to nilotinib due to treatment failure and side effects. In Group 2, 93% of patients sustained cytogenetic and molecular response at three years after the switch from branded to generic imatinib. Conclusion Our results lead us to conclude that generic imatinib as second-line therapy does not have deleterious effects on patient outcomes. However, first-line generic imatinib showed suboptimal efficacy compared to branded imatinib.