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

DOSE REDUCTION OF ITKS IN THE TREATMENT OF CHRONIC MYELOID LEUKEMIA. RETROSPECTIVE STUDY OF A SINGLE CENTER EXPERIENCE: SAFETY, EFFICIENCY AND ECONOMIC IMPACT.
Author(s): ,
Fernando Marco De Lucas
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Leyre Martinez
Affiliations:
Facultad de Medicina,UPV,Bilbao,Spain
,
Leire Otaolea
Affiliations:
Servicio de Genética. HU Basurto,Osakidetza,Bilbao,Spain
,
Jasone Uriarte
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Zuriñe Díez Gallarreta
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Cristina Barrenetxea
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Juan Ignacio Rodríguez Gutíérrez
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Olga Arce Fernández
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Angela Blanco
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Leticia Vidal Lartitegui
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Daniela Caballero
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Sara Amandi
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
José Antonio Márquez
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Susana Herráez
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
,
Irene Leal
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
Arantza Mendizabal
Affiliations:
Servicio de Hematologia del Hospital Universitario Basurto,Osakidetza. Biocruces,Bilbao,Spain
EHA Library. Marco De Lucas F. 06/09/21; 324204; PB1526
Prof. Dr. Fernando Marco De Lucas
Prof. Dr. Fernando Marco De Lucas
Contributions
Abstract

Abstract: PB1526

Type: Publication Only

Session title: Chronic myeloid leukemia - Clinical

Background
Discontinuation of TKIs has been gaining ground in recent years in the usual practice of CML treatment. Long-term dose reduction is another strategy shown in different publications that may in some cases contribute to improving the quality of life of patients without putting disease control at risk.

Aims
Evaluate in retrospect the clinical and analytical evolution of the cases of our service in which the doses of ITKs have been reduced in the treatment of patients with CML and make an estimate of the economic savings obtained by dose reduction.

Methods
We have reviewed the clinical and analytical course of patients with CML in follow-up in H.U. Basurto between June 2013 and April 2020. Among them we have selected 20 patients in which the dose of ITK was reduced below the standard dose and we have analyzed the evolution of its clinical course and various analytical data, including BCR-ABL/ABL (IS), blood count, glucose, cholesterol, AST, ALT and triglycerides, both before and after dose reduction of ITK. Economic savings were calculated by multiplying the monthly price of each drug by the number of months of reduction and the fraction of reduced dose.

Results
A total of 20 patients with dose reduction were identified, with a median age of 60 years (40-89). ITK distribution was 16 imatinib, 14 nilotinib, 5 dasatinib and 1 bosutinib. Twenty-six patients were under first-line treatment, 9 second-line treatment and 1 on third-line.
A total of 36 dose reduction episodes were collected in the study. The average treatment time with ITK prior to reduction was 24.6 months (0-135 months). The reason for the reduction was toxicity in most cases, although in 4 cases with nilotinib it was to prevent cardiovascular toxicity and in 1 case it was by the patient's own decision. Pre- and post-reduction molecular response levels are listed in Table 1. No cases of  blast crisis or accelerated phase was observed after the reduction. Of 26 reductions the molecular response worsened in 4 cases and only one loss of MMR was observed, which was subsequently rescued without increasing the dose. The improvement in toxicity symptomatology was greater than 80% with all drugs. A significant increase in Hb and cholesterol levels was observed following dose reduction of imatinib. The estimated overall economic savings from dose reduction of ITKs were 568,367 (nilotinib 428.729 €, dasatinib: 136.153 €, bosutinib: 2.286 €, imatinib: 1.198 €).

Conclusion
Our series shows that dose reduction of ITKs in selected cases may reduce toxicity and improve the quality of life of patients with CML with little effect on treatment efficacy and a big impact on pharmaceutical cost.

Keyword(s): Chronic myeloid leukemia, Cost analysis, Toxicity

Abstract: PB1526

Type: Publication Only

Session title: Chronic myeloid leukemia - Clinical

Background
Discontinuation of TKIs has been gaining ground in recent years in the usual practice of CML treatment. Long-term dose reduction is another strategy shown in different publications that may in some cases contribute to improving the quality of life of patients without putting disease control at risk.

Aims
Evaluate in retrospect the clinical and analytical evolution of the cases of our service in which the doses of ITKs have been reduced in the treatment of patients with CML and make an estimate of the economic savings obtained by dose reduction.

Methods
We have reviewed the clinical and analytical course of patients with CML in follow-up in H.U. Basurto between June 2013 and April 2020. Among them we have selected 20 patients in which the dose of ITK was reduced below the standard dose and we have analyzed the evolution of its clinical course and various analytical data, including BCR-ABL/ABL (IS), blood count, glucose, cholesterol, AST, ALT and triglycerides, both before and after dose reduction of ITK. Economic savings were calculated by multiplying the monthly price of each drug by the number of months of reduction and the fraction of reduced dose.

Results
A total of 20 patients with dose reduction were identified, with a median age of 60 years (40-89). ITK distribution was 16 imatinib, 14 nilotinib, 5 dasatinib and 1 bosutinib. Twenty-six patients were under first-line treatment, 9 second-line treatment and 1 on third-line.
A total of 36 dose reduction episodes were collected in the study. The average treatment time with ITK prior to reduction was 24.6 months (0-135 months). The reason for the reduction was toxicity in most cases, although in 4 cases with nilotinib it was to prevent cardiovascular toxicity and in 1 case it was by the patient's own decision. Pre- and post-reduction molecular response levels are listed in Table 1. No cases of  blast crisis or accelerated phase was observed after the reduction. Of 26 reductions the molecular response worsened in 4 cases and only one loss of MMR was observed, which was subsequently rescued without increasing the dose. The improvement in toxicity symptomatology was greater than 80% with all drugs. A significant increase in Hb and cholesterol levels was observed following dose reduction of imatinib. The estimated overall economic savings from dose reduction of ITKs were 568,367 (nilotinib 428.729 €, dasatinib: 136.153 €, bosutinib: 2.286 €, imatinib: 1.198 €).

Conclusion
Our series shows that dose reduction of ITKs in selected cases may reduce toxicity and improve the quality of life of patients with CML with little effect on treatment efficacy and a big impact on pharmaceutical cost.

Keyword(s): Chronic myeloid leukemia, Cost analysis, Toxicity

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