Comparison of effectiveness and safety of Iranian-made vs. Indian-made imatinib in treatment of chronic myeloid leukemia

Authors
Kamran Moshfeghi 1
Neda Nazemzadeh 2
Valiollah Mehrzad 3
Alireza Hajiannejad 4
Farah Esmaili 5
1 Department of Hematology and Oncology, Arak University of Medical Sciences, Iran
2 Department of Internal Medicine, Arak University of Medical Sciences, Iran
3 Department of Hematology and Oncology, Isfahan University of Medical Sciences, Iran
4 Department of Cardiac Medicine, Isfahan University of Medical Sciences, Iran
5 Department of Internal Medicine, Isfahan University of Medical Sciences, Iran
Abstract
Background: Currently, imatinib is the drug of choice for initiation of medical treatment of chronic myeloid leukemia (CML) in the chronic phase. The current study was carried out to compare effectiveness and safety of Iranian vs. Indian imatinib.
Materials and Methods: The clinical study was performed on newly diagnosed CML patients in Seyyed-oShohada Hospital (Isfahan) and Khansari Hospital (Arak) from January to June 2011. The control group consisted of CML patients who received Indian imatinib previously. The drug was initiated with the dose of 400 mg daily. The patients were followed for six months, and the treatment outcomes (WBC <10 4 ) and molecular response. Finally, the two groups were compared in these respects.
Result: We evaluated 43 patients in each group. The hematological and molecular responses for the Iranian Imatinib were respectively 86.0% and 46.5%, while the rates were respectively 86.0 and 44.2% for the Indian imatinib. The two groups were similar with regard to the treatment outcome. The two groups were not significantly different with regard to the drug adverse effects.
Conclusion: According to the findings, the Iranian imatinib is not different from the Indian drug in the hematological and molecular responses in treatment of the chronic phase of CML patients. Furthermore, the adverse effects of the two kinds were not significantly different. Compared with the results of other studies, the effectiveness of Iranian imatinib is equivalent to the Indian drug can be employed for treatment of CML patients in the chronic phase.

Keywords

1. Cervantes F, Mauro M. Practical management of patients with chronic myeloid leukemia. Cancer 2011;117:4343-54.  Back to cited text no. 1
    
2. Fullmer A, Kantarjian H, Cortes J, Jabbour E. New developments in the treatment of chronic myeloid leukemia and Philadelphia-positive acute lymphoblastic leukemia. Leuk Lymphoma 2011;52:81-91.  Back to cited text no. 2
    
3. Deininger M, Buchdunger E, Druker BJ. The development of imatinib as a therapeutic agent for chronic myeloid leukemia. Blood 2005;105:2640-53.  Back to cited text no. 3
    
4. Marin D. Current status of imatinib as frontline therapy for chronic myeloid leukemia. Semin Hematol 2010;47:312-8.  Back to cited text no. 4
    
5. O'Brien SG, Guilhot F, Larson RA, Gathmann I, Baccarani M, Cervantes F, et al. Imatinib compared with interferon and low-dose cytarabine for newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2003;348:994-1004.  Back to cited text no. 5
    
6. Kantarjian HM, Cortes JE, O'Brien S, Giles F, Garcia-Manero G, Faderl S, et al. Imatinib mesylate therapy in newly diagnosed patients with Philadelphia chromosome-positive chronic myelogenous leukemia: High incidence of early complete and major cytogenetic responses. Blood 2003;101:97-100.  Back to cited text no. 6
    
7. Hughes TP, Kaeda J, Branford S, Rudzki Z, Hochhaus A, Hensley ML, et al. Frequency of major molecular responses to imatinib or interferon alfa plus cytarabine in newly diagnosed chronic myeloid leukemia. N Engl J Med 2003;349:1423-32.  Back to cited text no. 7
    
8. de Lavallade LH, Apperley JF, Khorashad JS, Milojkovic D, Reid AG, Bua M, et al. Imatinib for newly diagnosed patients with chronic myeloid leukemia: Incidence of sustained responses in an intention-to-treat analysis. J Clin Oncol 2008;26:3358-63.  Back to cited text no. 8
    
9. Razmkhah F, Razavi M. Hematologic and molecular responses to generic imatinib in patients with chronic myeloid leukemia. Lab Med 2010;41:547-50.  Back to cited text no. 9
    
10. Deininger MW, O'Brien SG, Ford JM, Druker BJ. Practical management of patients with chronic myeloid leukemia receiving imatinib. J Clin Oncol 2003;21:1637-47.  Back to cited text no. 10
    
11. Hahn EA, Glendenning GA, Sorensen MV, Hudgens SA, Druker BJ, Guilhot F, et al. Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: Results from the IRIS Study. J Clin Oncol 2003;21:2138-46.  Back to cited text no. 11
    
Advanced Biomedical Research
Volume 2013, March
March 2013
Pages 1-6