The Efficacy of Generic Imatinib as First- and Second-line Therapy: 3-Year Follow-up of Patients With Chronic Myeloid Leukemia

• Published in: Clinical lymphoma, myeloma and leukemia Vol. 17; no. 4; pp. 238 - 240
• Main Authors: Islamagic, Erna, Hasic, Azra, Kurtovic, Sabira, Suljovic Hadzimesic, Emina, Mehinovic, Lejla, Kozaric, Mirza, Kurtovic-Kozaric, Amina
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01-04-2017
• Subjects: Adult; Antineoplastic Agents - therapeutic use; Bosnia and Herzegovina; Clinical outcomes; CML; Drugs, Generic - therapeutic use; Female; Follow-Up Studies; Glivec; Humans; Imatinib Mesylate - therapeutic use; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy; Male; Middle Aged; Molecular response; Retrospective Studies; CML; Glivec; Bosnia and Herzegovina; Molecular response; Clinical outcomes
• ISSN: 2152-2650; 2152-2669
• DOI: 10.1016/j.clml.2017.02.001

We examined the long-term clinical outcomes of patients with chronic myeloid leukemia (n = 41) receiving generic imatinib as first-line (n = 27) and second-line therapy (n = 14) in Bosnia and Herzegovina. Overall survival rates for first-line and second-line generic imatinib were 85% and 100%, respectively. For first-line generic imatinib, complete cytogenetic response was 81%. Generic imatinib as second-line therapy does not have deleterious effects on patient outcomes.
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 patients with chronic myeloid leukemia (CML). The aim of this study was to evaluate the long-term clinical outcomes of patients with CML receiving first-line and second-line generic imatinib in Bosnia and Herzegovina.
This was a multicenter retrospective cohort study of patients (n = 41) treated with generic imatinib in Bosnia between September 1, 2013 and August 5, 2016. Patients were categorized into 2 study groups: Group 1 (n = 27) included newly diagnosed patients with CML 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.
The 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, the overall survival for patients in Group 1 was 85%, and the achievement of complete cytogenetic response was 81%. At 24 months, the major molecular response rate was 48%. Overall, 52% of patients switched from first-line generic imatinib to nilotinib owing to treatment failure and side-effects. In Group 2, 93% of patients sustained cytogenetic and molecular response at 3 years after the switch from branded to generic imatinib.
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 with branded imatinib.