Erna Islamagic1, Azra Hasic1, Sabira Kurtovic2, Emina Suljovic Hadzimesic2, Lejla Mehinovic1, Mirza Kozaric3, Amina Kurtovic-Kozaric4. 1. Faculty of Science, University of Sarajevo, Sarajevo, Bosnia and Herzegovina. 2. Hematology Clinic, Clinical Center of the University of Sarajevo, Sarajevo, Bosnia and Herzegovina. 3. Clinic of Obstetrics and Gynecology, Clinical Center of the University of Sarajevo, Sarajevo, Bosnia and Herzegovina. 4. Department of Pathology, Cytology and Human Genetics, Clinical Center of the University of Sarajevo, Sarajevo, Bosnia and Herzegovina. Electronic address: amina.kozaric@kcus.ba.
Abstract
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 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. PATIENTS AND METHODS: 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. RESULTS: 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. 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 with branded imatinib.
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 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. PATIENTS AND METHODS: 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. RESULTS: 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. 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 with branded imatinib.
Authors: A Hochhaus; M Baccarani; R T Silver; C Schiffer; J F Apperley; F Cervantes; R E Clark; J E Cortes; M W Deininger; F Guilhot; H Hjorth-Hansen; T P Hughes; J J W M Janssen; H M Kantarjian; D W Kim; R A Larson; J H Lipton; F X Mahon; J Mayer; F Nicolini; D Niederwieser; F Pane; J P Radich; D Rea; J Richter; G Rosti; P Rousselot; G Saglio; S Saußele; S Soverini; J L Steegmann; A Turkina; A Zaritskey; R Hehlmann Journal: Leukemia Date: 2020-03-03 Impact factor: 11.528