Outcome of Frontline Treatment With “Generic” Imatinib in Adult Patients With Chronic Myeloid Leukemia in Algerian Population: A Multicenter Study.

Abstract

IntroductionIn a developing country like Algeria, such expensive therapy is not available. Alternative approaches are needed to help these adult. In Algeria ‘imatib’ (CIPLA-India) was introduced in 2006; but no study has been published yet in the North Africa region regarding response and outcome of this copy in CML patients. The goal of this multicenter study is to characterize newly adult CML in the western region of Algeria and to assess the effectiveness and safety of imatib (IM, copy) as frontline therapy for patients with CML.Patients and MethodsThe study was carried out in 7 hematology centers in the western Algeria. Patients, who were diagnosed to be suffering from CML between January 1st, 2007 and December 31st, 2014 were selected for data analysis. All patients received a copy preparation, consisting of the alpha crystal form of imatinib, (IM, copy) at an oral dose of 400 mg daily and monitored for tolerance and side effects while on therapy.ResultsBetween January 2007 and December 2014, 355 patients with CML were treated with imatib (Copy). The median follow- up of the study was 46 months (range: 13–107 months). Complete hematological response (CHR) was seen in 83% of patients within 3 months. According to the Sokal score, 72% patients with low, 78% with intermediate and 69% with high risk disease achieved a CHR in 3 months (p=0.26) and according to the EUTOS score, 81% of patients with low and 70% with high risk disease achieved a CHR in 3 months (p=0.08). The major molecular response (MMR) at six months (M6), M9, M12, M18 and M24 was 21%, 38%, 35%, 51% and 67% respectively and 34% of patients achieved a complete molecular response (CMR). The projected 5-year overall survival (OS) rate was 83%. Side effects of imatib (copy) in this study were similar to those reported previously for the entire imatinib mesylate treatment study and only 8% of patients were intolerant to imatib (copy) and treated with a second generation of BCR-ABL inhibitor.ConclusionThis study reflects real world experience treating patients with CML in a developing country and thus sheds light on differences in this population compared to Western countries. In conclusion, imatib (copy) is effective and safe in treating patients with CML in chronic phase and proves to have a durable outcome. To our knowledge this is the first study reporting the response to imatib (copy) in an Algerian population.

Early molecular response in East African Philadelphia chromosome-positive chronic myeloid leukaemia patients treated with Imatinib and barriers to access treatment

“…The finding of higher WBC in Sub-Saharan Africa has been described earlier [ 24 – 26 ] and is likely to be a sign of late presentation of the patients to the hospital. Following this logic, the late presentation contributes as well to the fact of splenomegaly in all patients in this study and in the majority of patients in other published African CML data [ 24 , 26 , 27 , 28 ].…”

Use of generic imatinib as first-line treatment in patients with chronic myeloid leukemia (CML): the GIMS (Glivec to Imatinib Switch) study

“…Moreover, achieving major MR at 6 months had a prognostic relevance for branded imatinib [ 26 ]. In another Algerian retrospective study on 355 patients treated with CIPLA imatinib, 83% of patients achieved a CCyR after 3 months, 35% a major MR at one year, and 67% after two years [ 27 ]. On the contrary, 52% of patients had to switch to second generation TKI inhibitors due to treatment failure or AEs in a series of 27 patients treated in Bosnia with three different formulation of generic imatinib upfront [ 28 ].…”

Efficacy and safety of generic imatinib after switching from original imatinib in patients treated for chronic myeloid leukemia in the United States

“…They also concluded that the drug was safe, with just 8% of patients switching to second-generation TKI because of intolerance. 35 Razmkhah et al 36 reported on 30 patients treated with generic imatinib (CIPLA Imatib, India) as first line therapy for CML chronic phase, and had CHR and CMR in 90% and 46.7%, respectively. Awidi et al conducted an observational, multicentric prospective study on 91 patients receiving generic imatinib (Cemivil, Hikma Pharmaceuticals) either in upfront setting or after switch from original imatinib.…”

“…At a median follow‐up of 46 months, 83% of patients achieved CHR at 3 months, 35% achieved MMR at one year and 67% at 2 years; of them, 34% of patients were in CMR. They also concluded that the drug was safe, with just 8% of patients switching to second‐generation TKI because of intolerance . Razmkhah et al reported on 30 patients treated with generic imatinib (CIPLA Imatib, India) as first line therapy for CML chronic phase, and had CHR and CMR in 90% and 46.7%, respectively.…”