Efikasnost generičkog imatiniba u lečenju bolesnika sa hroničnom mijeloidnom leukemijom – rezultati jednog centra

  • Ivana Urošević Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Ivanka Perčić Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Marina Dragičević Jojkić Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Marina Dokić Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Amir El Farra Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Aleksandar Savić Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Ivana Milošević Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Nada Vlaisavljević Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Borivoj Sekulić Clinical Center Vojvodina, Clinic of Hemathology, Novi Sad, Serbia
  • Bela Balint Serbian Academy of Sciences and Arts, Department of Medical Sciences, Belgrade, Serbia
Ključne reči: leukemija, mijeloidna, hronična, imatinib mesilat, lekovi, generički, preživljavanje

Sažetak


Uvod/Cilj. Ciljna terapija je značajno izmenila uspeh lečenja bolesnika sa hroničnom mijeloidnom leukemijom (CML). Cilj rada je bio da se proceni efikasnost lečenja obolelih od CML generičkim imatinibom u našem centru. Metode. Istraživanje je bilo retrospektivno. Obuhvatilo je 101 obolelog od CML u hroničnj fazi. Bolesnici su bili podeljeni u dve grupe. Prvu grupu je činilo 55 bolesnika koji su inicijalno lečeni originalnim imatinibom i koji su kasnije tokom lečenja prevedeni na terapiju gneričkim imatinibom. Drugu grupu činilo je 46 novodijagnostikovanih bolesnika koji su od početka lečeni generičkim imatinibom. Rezultati. Bolesnici su originalnim imatinibom bili lečeni u proseku 42 meseca (od 6 do 132 meseca) nakon čega su prevedeni na generički imatinib. Lečenje generičkim imatinibom je u proseku trajalo 25 meseci (od 3 do 66 meseci). Četvrtina bolesnika prve grupe izgubila je citogenetski odgovor nakon prevođenja na generički imatinib. Nije bilo znakova za transformaciju u akutnu leukemiju. Bolesnici lečeni originalnim imatinibom imali su statistički značajno duže preživljavanje bez događaja koje podrazumeva smrtni ishod (event-free survival – EFS) i preživljavanje bez neuspeha terapije (failure-free survival – FFS) (log-rank p = 0,01 i p = 0,03, redom). Na ovakve rezultate mogla je da utiče učestala promena dozne formulacije i proizvođača generičkog imatiniba. Zaključak. Naše istraživanje ukazalo je na značajno duže EFS i FFS kod bolesnika koji su lečenje započeli originalnim imatinibom u odnosu na bolesnike koji su sve vreme lečeni generičkim imatinibom. Navedeni rezultati pružaju korisnu informaciju, ali se moraju tumačiti u kontekstu studije po tipu unakrsnog izajna. 

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2021/06/14
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