EHA Library - The official digital education library of European Hematology Association (EHA)

Serbia was the first country in Europe introduced generic imatinib (ANZOVIP®, Actavis). Lot of concerns and many issues were arisen by general and medical public, especially by patients knowing reports about treatment failures. All patients in Serbia were switched to the same drug together with newly diagnosed patients. To realize real efficiency of the drug, we made evaluation of newly diagnosed patients only.

As the largest institution, Clinic of Hematology CCS, we analyzed cohort of 49 patients with CML in chronic phase, frontline treated by generic imatinib from August 2012 to March 2014. All patients were treated according to ELN 2009 based National guidelines with regular cytogenetic follow up and molecular monitoring after 12 months (after CCgR). In all patients the follow up of treatment was at least 6 month.

Our 49 patients, had median age of 47yrs ranging from 24 to 74yrs. There were 31 male and 18 female patients. In all patients CHR was achieved within 3 months of treatment. In 17 pts after their approval, we have performed early cytogenetic evaluation at 3 mths: 3/17 pts was without mitoses, 10/17 pts (58%) had Ph<35%, and 4 were non responders (Ph from 50-100%). According to our National guidelines evaluation at 6 and 12 months were performed. At 6 months, 23/49 pts achieved CCgR (46.9%), 38/49 (77.5%) was in majorCgR (ELN 2009 optimal), and 9/49 pts had insufficient response (no major CgR). At 12 mths similar evaluation revealed 26/49 pts achieving CCgR (53%), and ELN 2009 suboptimal response was noted in 7/49 pts (14.3%). Unfortunately we have also noted that some patients lost their previously achieved response after one year of treatment. Also 3 patients developed sudden blast phase. Taken together failure >12 mths was in 5+3 pts (16%). Besides 7 pts (14.3%) never achieved optimal response by 400mg imatinib up to one year of treatment. Seven patients (14.3%) were treated by imatinib escalation (800mg), and 4 achieved CCgR. 9 pts were treated with second line nilotinib (failure by ELN 2009) and 5 of them achieved secondary CCgR. From other four patients without optimal response to nilotinib, 3 of them were sent to BMT. Molecular evaluation was performed at M12 and M18 from start of the treatment. Due to technical reasons it was performed in more than half of the patients, 30 of 49 (61%), and optimal molecular response at M12 of M18 was achieved in 25 of 30 analyzed patients (at least MR3) but in 5 patients MR3 was not achieved even they are in continuous CCgR up to at M18.