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

EFFECTIVENESS IN REAL LIFE OF TKI TREATMENT ON CML. RESULTS FROM THE ANDALUSIAN REGISTRY OF CHRONIC MYELOID LEUKEMIA (RALMC) 2002-2016.
Author(s): ,
Jose Manuel Puerta-Puerta
Affiliations:
Hematology,UGC intercentros Hospital Universitario Virgen de las Nieves-Nuevo San Cecilio,Granada,Spain
,
Antonio Jiménez-Velasco
Affiliations:
Hematology,Hospital Regional Universitario Carlos Haya,Málaga,Spain
,
María Isabel Mata-Vázquez
Affiliations:
Hematology,Hospital Costa del Sol,Marbella,Spain
,
María José Ramírez-Sánchez
Affiliations:
Hospital de Jerez,Jerez de la Frontera,Spain
,
María Ángeles Portero-Frías
Affiliations:
Hematology,Hospital Universitario Virgen Macarena,Sevilla,Spain
,
María José García-Pérez
Affiliations:
Hematology,Hospital Torrecárdenas,Almería,Spain
,
Concepción Ruiz-Nuño
Affiliations:
Hematology,Hospital Regional Universitario Carlos Haya,Málaga,Spain
,
María Soledad Durán
Affiliations:
Complejo Hospitalario de Jaén,Jaén,Spain
,
Antonio Paz-Coll
Affiliations:
Hematology,Hospital de Puerto Real,Puerto Real,Spain
,
Ana Rosell-Mas
Affiliations:
Hematology,Hospital Universitario Virgen de la Victoria,Málaga,Spain
,
María del Carmen Fernández-Valle
Affiliations:
Hopital Puerta del Mar,Cádiz,Spain
,
Isabel Simón-Pilo
Affiliations:
Hospital Virgen de Valme,Sevilla,Spain
,
Carmen Ferrer-Chaves
Affiliations:
Hematology,Hospital San Juan de la Cruz,Úbeda,Spain
,
Inmaculada Ballesteros
Affiliations:
Hospital de la Axarquía,Vélez Málaga,Spain
,
Youssef Moatassim
Affiliations:
Hematology,Hospital Santa Ana,Motril,Spain
,
María Carmen Avellaneda
Affiliations:
Hospital San Agustín,Linares,Spain
,
Jesús Oliveros
Affiliations:
Hematology,Hospital La Inmaculada,Huércal Overa,Spain
Pilar López-Garrido
Affiliations:
Grupo Andaluz de LMC,Granada,Spain
(Abstract release date: 05/17/18) EHA Library. Manuel Puerta-Puerta J. 06/14/18; 215982; PB1949
Jose Manuel Puerta-Puerta
Jose Manuel Puerta-Puerta
Contributions
Abstract

Abstract: PB1949

Type: Publication Only

Background
Normally, information regarding efficacy of treatments is obtained through clinical trials which are characterized by their strict inclusion and exclusion criteria.

In real life, results depend on the relationship between the physician and the patient and on the selection of first and subsequent lines of treatment for patients who show intolerance or resistance to TKI treatment.

Aims
TKI treatment description results among TKI patients with CML from the RALMC in real life: Overall survival rates (OS) as it relates with leukemia (LRS), progression and event free survival (PFS and EFS). Rates of discontinuation due to inefficacy and intolerance.

To compare effectiveness and security among imatinib and 2GTKI (nilotinib and dasatinib).

Methods
Retrospective descriptive analysis of patients from the RALMC with clinical and therapeutic follow-up since January 2002 to December 2016.

Analysis of survival rates through Kaplan-Meier method, distinguishing among OS: time span since diagnosis until death due to any cause; LRS: time span since diagnosis until dead due to a cause connected to CML; PFS: time span since diagnosis until progression to AP or BC or death and EFS: time span since diagnosis until death due to any cause, progression of illness or change of treatment on first line due to inefficacy or intolerance.

Results
505 patients, 279 males (55.2%), 104 (20.6%) of whom were over 70 years. 427 (84.6%) began on Imatinib, 46 (9.1%) on Nilotinib, and 32 (6.3%) on Dasatinib.

131 patients (30.7%) with imatinib in first-line changed treatment: 46 (10.8%) due to intolerance and 85 (19.9%) due to inefficacy. 11 patients with 2GTKI (14.1%) changed treatmente too: 6 (7.7%) due to intolerance and 5 (6.4%) due to inefficacy.

21 patients (4.2%) progressed to advanced phases: 14 (2.8%) to BC and 7 (1.4%) to AP.

63 patients (12.5%) died during the follow-up. 15 (23.8%) due to causes related to CML and 48 (76.2%) due to causes not directly related to CML.  49 patients over 70 (47.1%) died during the follow-up: 41 (83.7%) due to causes not related to CML.

Global series

OS

LRS

PFS

EFS

5 years

92.9%

98.3%

91.2%

69.7%

10 years

85.4%

97.2%

82.9%

57.6%

OS, PFS and EFS are higher among patients treated with 2GTKI vs Imatinib to 5 years (98.6% vs 81.6%; 97.2% vs 80.5%; 84.7% vs 59.8%, p=0.002) 

Conclusion
Patients from RALMC present high OS rates and death causes are not related directly with the illness, independently of time of diagnosis.

Patients treated on first line with 2GTKI present better OS, PFS and EFS rates than those treated with Imatinib.

While these results are limited in our series: young patients and high risk patients begin their treatment on 2GTKI whereas older and with low-risk prognostication begin their treatment on Imatinib. Mean age for patients treated with Imatinib was almost 10 years older than that of patients treated with 2GTKI, with three times more patients over 70 years old being treated with Imatinib than with 2GTKI (27% vs 10.3%).

Session topic: 8. Chronic myeloid leukemia - Clinical

Abstract: PB1949

Type: Publication Only

Background
Normally, information regarding efficacy of treatments is obtained through clinical trials which are characterized by their strict inclusion and exclusion criteria.

In real life, results depend on the relationship between the physician and the patient and on the selection of first and subsequent lines of treatment for patients who show intolerance or resistance to TKI treatment.

Aims
TKI treatment description results among TKI patients with CML from the RALMC in real life: Overall survival rates (OS) as it relates with leukemia (LRS), progression and event free survival (PFS and EFS). Rates of discontinuation due to inefficacy and intolerance.

To compare effectiveness and security among imatinib and 2GTKI (nilotinib and dasatinib).

Methods
Retrospective descriptive analysis of patients from the RALMC with clinical and therapeutic follow-up since January 2002 to December 2016.

Analysis of survival rates through Kaplan-Meier method, distinguishing among OS: time span since diagnosis until death due to any cause; LRS: time span since diagnosis until dead due to a cause connected to CML; PFS: time span since diagnosis until progression to AP or BC or death and EFS: time span since diagnosis until death due to any cause, progression of illness or change of treatment on first line due to inefficacy or intolerance.

Results
505 patients, 279 males (55.2%), 104 (20.6%) of whom were over 70 years. 427 (84.6%) began on Imatinib, 46 (9.1%) on Nilotinib, and 32 (6.3%) on Dasatinib.

131 patients (30.7%) with imatinib in first-line changed treatment: 46 (10.8%) due to intolerance and 85 (19.9%) due to inefficacy. 11 patients with 2GTKI (14.1%) changed treatmente too: 6 (7.7%) due to intolerance and 5 (6.4%) due to inefficacy.

21 patients (4.2%) progressed to advanced phases: 14 (2.8%) to BC and 7 (1.4%) to AP.

63 patients (12.5%) died during the follow-up. 15 (23.8%) due to causes related to CML and 48 (76.2%) due to causes not directly related to CML.  49 patients over 70 (47.1%) died during the follow-up: 41 (83.7%) due to causes not related to CML.

Global series

OS

LRS

PFS

EFS

5 years

92.9%

98.3%

91.2%

69.7%

10 years

85.4%

97.2%

82.9%

57.6%

OS, PFS and EFS are higher among patients treated with 2GTKI vs Imatinib to 5 years (98.6% vs 81.6%; 97.2% vs 80.5%; 84.7% vs 59.8%, p=0.002) 

Conclusion
Patients from RALMC present high OS rates and death causes are not related directly with the illness, independently of time of diagnosis.

Patients treated on first line with 2GTKI present better OS, PFS and EFS rates than those treated with Imatinib.

While these results are limited in our series: young patients and high risk patients begin their treatment on 2GTKI whereas older and with low-risk prognostication begin their treatment on Imatinib. Mean age for patients treated with Imatinib was almost 10 years older than that of patients treated with 2GTKI, with three times more patients over 70 years old being treated with Imatinib than with 2GTKI (27% vs 10.3%).

Session topic: 8. Chronic myeloid leukemia - Clinical

By clicking “Accept Terms & all Cookies” or by continuing to browse, you agree to the storing of third-party cookies on your device to enhance your user experience and agree to the user terms and conditions of this learning management system (LMS).

Cookie Settings
Accept Terms & all Cookies