The Three Year Follow-up of CML Patients Treated with First-line Generic and First-line Branded Imatinib in Bosnia and Herzegovina.

Abstract

Imatinib mesylate, a selective BCR-ABL tyrosine kinase inhibitor, has been well established as the standard of care for chronic myeloid leukaemia patients. In this study, we compared clinical outcomes of patients who received first-line Glivec (Group 1) with patients who received first-line generic imatinib (Group 2) in Bosnia and Herzegovina with three years follow-up of therapy. At 24 months of therapy, the achievement of complete cytogenetic response and major molecular response were comparable between the studied groups (CCyR was 69% vs. 70%, respectively; MMR was 54% vs. 48%, respectively). After comparing the reasons for the switch to nilotinib, we found that treatment failure was higher in patients treated with generic imatinib (30% vs. 8%, respectively) and side effects were similar in both patient groups (22% vs. 19%, respectively). In general, patients on first-line generic imatinib had higher rates of treatment failure compared to patients treated with first-line branded imatinib. Keywords: Generic imatinib, Glivec, Clinical outcomes, CML ÖZET Bosna Hersek'te İlk-basamak Jenerik ve İlk-basamak Preparat Imatinib ile Tedavi Edilmiş CML Hastalarının Üç Yıllık TakbiSelektif BCR-ABL tirozin kinaz inhibitörü olan İmatinib Mesilat, Kronik miyeloid lösemi hastalarının tedavisinde iyi bir standart olarak saptanmıştır. Bu çalışmada, Bosna Hersek'teki İlk-basamak Glivec (Grup 1) alan hastalarla ilk-basamak jenerik imatinib (Grup 2) alan hastaların klinik sonuçlarını üç yıllık tedavi takibi ile karşılaştırdık. 24 aylık tedavide, tam sitogenetik cevap ve majör moleküler cevabın başarısı, incelenen gruplar arasında karşılaştırılabilir düzeydeydi (sırasıyla, CCyR %69'a karşı %70; MMR, sırasıyla %54'e karşı %48 idi).Nilotinib'e geçiş nedenlerini karşılaştırdıktan sonra, jenerik imatinib ile tedavi edilen hastalarda tedavi başarısızlığının daha yüksek olmakla beraber (sırasıyla %30 ve %8), yan etkiler her iki hasta grubunda benzerdi (sırasıyla, %22'ye karşı %19). Genel olarak, ilk-basamak jenerik imatinib verilen hastalarda başarısızlık oranlarını, ilk-basamak preparat imatinib ile tedavi edilen hastalara kıyasla daha yüksek saptadık.

Clinical Outcomes of CML Patients After Delayed Start of Nilotinib Treatment

“…Results from previous studies in Bosnia showed that there was no significant difference in the overall survival and achievement of CCyR between front-line branded imatinib and front-line generic imatinib. [20][21][22] Delayed targeted treatment significantly affected all CML patient outcomes, including survival and cytogenetic and molecular response. However, recent study that analyzed effects of delayed therapy in GIST patients showed that patients who received immediate imatinib therapy for < 1 year did not show better clinical outcomes compared to patients who received the same duration of therapy but had to wait > 6 months for the start of therapy.…”

A Review of Molecular and Genetic Diagnostics of Myeloid Malignancies with Emphasis on Diagnostics in Bosnia and Herzegovina

“…These patients had worse responses to the therapy, progression or transformation of the disease, and lower survival rate (112). It was shown that generic versions of imatinib in Bosnia and Herzegovina (Anzovip, Meaxin, Plivatinib) are cost-effective, and response to the therapy was similar to the response to Glivec (115)(116)(117). In 2011, nilotinib (Tasigna, Novartis, second-generation TKI) became available as front-or second-line therapy, and it was designed to overcome specific BCR-ABL1 mutations in imatinib-resistant patients (85,87,(118)(119)(120)(121).…”