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ELEVEN-YEAR RESULTS OF THE THERAPY OF CML TYROSINE KINASE INHIBITOR IN A LARGE INDUSTRIAL CENTER OF SIBERIA
Author(s): ,
Anna Lyamkina
Affiliations:
Therapy, hematology and transfusiology,Novosibirsk State Medical University,Novosibirsk,Russian Federation
Tatiana Pospelova
Affiliations:
Therapy, hematology and transfusiology,Novosibirsk State Medical University,Novosibirsk,Russian Federation
(Abstract release date: 05/19/16) EHA Library. Lyamkina A. 06/09/16; 134740; PB1840
Dr. Anna Lyamkina
Dr. Anna Lyamkina
Contributions
Abstract
Abstract: PB1840

Type: Publication Only

Background
Modern method of therapy inhibitors tyrosine kinase (ITK) of chronic myeloid leukemia (CML) allows patients have long-term remission and life expectancy comparable to the general population. The effectiveness of treatment depends on the sensitivity of the malignant clone to a medicine, and from of patient compliance of treatment.

Aims
To evaluate eleven-year results of therapy of chronic myelogenous leukemia treatment with tyrosine kinase inhibitors.

Methods
For the period of January 2004 and up until now the 103 CML patients have been observed at the municipal hematology center of Novosibirsk – capital of Siberia: 39 men (37.9%) and 64 women (62.1%), with age ranging from 16 to 78 years, and the mean value being 43.4±14.15 years, 71.8% patients was included in the analysis  (74 patients): 71 people in the chronic phase, 3 - in the acceleration phase. All patients in the chronic phase started taking the TKI in the first 6 months after diagnosis of CML. Patients in accelerated phase and blast crisis were diagnosed before 2003, these patients were significantly pre-treated with various cytotoxic medications and interferons. All patients are receiving treatment by various tyrosine kinase inhibitors (imatinib at a dose of 400-800 mg per day, nilotinib at 800 mg per day, dasatinib 80-100 mg per day). In Russia, imatinib therapy  became available only in 2004, as part of the charity program GIPAP (on treatment 10% of patients). All the patients treatment became available in 2005. Today in Russia are using generic medications Philachromin® and Genfatinib®, instead of using original medication Glivec®, their effectiveness requires further observation. New patients - 10 people (9.7%), they are treated by the TKI less than 6 months and have not got the analysis. Also excluded from the analysis of 19 people (18.4%) with low compliance to therapy, they have not received an adequate response to treatment. 22 patients have died: 9 patients in chronic phase, for reasons not related to hematological malignancies, 13 patients with low compliance due to the progression of CML.

Results
Administration of a TKI as a first and second line was followed by a complete clinical and hematological response in 98.5% patients, complete cytogenetic response (CCyR) – in 83,1%, major molecular response (MMO) – in 63,1%. In 3 patients AP - clinical and hematological response. Survival was analyzed in patients administered TKI, as compared to patients not administered TKI (data based on the retrospective review of medical records of CML patients observed at Novosibirsk municipal hematology center for the period of 1999 – 2004). A statistical method of calculating the cumulative fraction of survivals (Kaplan-Meier) was used to evaluate survival, with p<0,05 established as the reliability criterion. No medial survival was established in the group administered TKI, the 11-year survival - 84.8%, the estimated 15-year survival was 71,2%. Overall event-free survival rate was 57.8%,  in the chronic phase - 69.7%. In the group treated with other cytotoxic agents median survival was 4.1 years, the estimated 15-year survival rate - 3%, p <0,000001.  

Conclusion
TKI (оriginal medicine and branded generics) are considered an effective and safe method of treatment for CML in CP, if the patient in compliance with all recommendations of the doctor, associated with a high MMO rate in the chronic phase, which leads to a significant increase in the overall and event-free survival.

Session topic: E-poster

Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor
Abstract: PB1840

Type: Publication Only

Background
Modern method of therapy inhibitors tyrosine kinase (ITK) of chronic myeloid leukemia (CML) allows patients have long-term remission and life expectancy comparable to the general population. The effectiveness of treatment depends on the sensitivity of the malignant clone to a medicine, and from of patient compliance of treatment.

Aims
To evaluate eleven-year results of therapy of chronic myelogenous leukemia treatment with tyrosine kinase inhibitors.

Methods
For the period of January 2004 and up until now the 103 CML patients have been observed at the municipal hematology center of Novosibirsk – capital of Siberia: 39 men (37.9%) and 64 women (62.1%), with age ranging from 16 to 78 years, and the mean value being 43.4±14.15 years, 71.8% patients was included in the analysis  (74 patients): 71 people in the chronic phase, 3 - in the acceleration phase. All patients in the chronic phase started taking the TKI in the first 6 months after diagnosis of CML. Patients in accelerated phase and blast crisis were diagnosed before 2003, these patients were significantly pre-treated with various cytotoxic medications and interferons. All patients are receiving treatment by various tyrosine kinase inhibitors (imatinib at a dose of 400-800 mg per day, nilotinib at 800 mg per day, dasatinib 80-100 mg per day). In Russia, imatinib therapy  became available only in 2004, as part of the charity program GIPAP (on treatment 10% of patients). All the patients treatment became available in 2005. Today in Russia are using generic medications Philachromin® and Genfatinib®, instead of using original medication Glivec®, their effectiveness requires further observation. New patients - 10 people (9.7%), they are treated by the TKI less than 6 months and have not got the analysis. Also excluded from the analysis of 19 people (18.4%) with low compliance to therapy, they have not received an adequate response to treatment. 22 patients have died: 9 patients in chronic phase, for reasons not related to hematological malignancies, 13 patients with low compliance due to the progression of CML.

Results
Administration of a TKI as a first and second line was followed by a complete clinical and hematological response in 98.5% patients, complete cytogenetic response (CCyR) – in 83,1%, major molecular response (MMO) – in 63,1%. In 3 patients AP - clinical and hematological response. Survival was analyzed in patients administered TKI, as compared to patients not administered TKI (data based on the retrospective review of medical records of CML patients observed at Novosibirsk municipal hematology center for the period of 1999 – 2004). A statistical method of calculating the cumulative fraction of survivals (Kaplan-Meier) was used to evaluate survival, with p<0,05 established as the reliability criterion. No medial survival was established in the group administered TKI, the 11-year survival - 84.8%, the estimated 15-year survival was 71,2%. Overall event-free survival rate was 57.8%,  in the chronic phase - 69.7%. In the group treated with other cytotoxic agents median survival was 4.1 years, the estimated 15-year survival rate - 3%, p <0,000001.  

Conclusion
TKI (оriginal medicine and branded generics) are considered an effective and safe method of treatment for CML in CP, if the patient in compliance with all recommendations of the doctor, associated with a high MMO rate in the chronic phase, which leads to a significant increase in the overall and event-free survival.

Session topic: E-poster

Keyword(s): Chronic myeloid leukemia, Tyrosine kinase inhibitor

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