Imatinib as the first-line treatment of patients with chronic
myeloid leukemia diagnosed in the chronic phase: can we compare
real life data to the results from clinical trials?

J 2011

Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials?

ŽÁČKOVÁ, Daniela; Hana KLAMOVÁ; Ladislav DUŠEK; Jan MUŽÍK; Kateřina MACHOVÁ POLÁKOVÁ et. al.

Basic information

Original name

Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials?

Authors

ŽÁČKOVÁ, Daniela (203 Czech Republic, guarantor, belonging to the institution); Hana KLAMOVÁ (203 Czech Republic); Ladislav DUŠEK (203 Czech Republic, belonging to the institution); Jan MUŽÍK (203 Czech Republic, belonging to the institution); Kateřina MACHOVÁ POLÁKOVÁ (203 Czech Republic); Jana MORAVCOVÁ (203 Czech Republic); Tomáš JURČEK (203 Czech Republic, belonging to the institution); Dana DVOŘÁKOVÁ (203 Czech Republic, belonging to the institution); Zdeněk RÁČIL (203 Czech Republic, belonging to the institution); Zdeněk POSPÍŠIL (203 Czech Republic, belonging to the institution); Alexandra OLTOVÁ (203 Czech Republic); Kyra MICHALOVÁ (203 Czech Republic); Jana BŘEZINOVÁ (203 Czech Republic); Filip RÁZGA (203 Czech Republic, belonging to the institution); Michael DOUBEK (203 Czech Republic, belonging to the institution); Petr CETKOVSKÝ (203 Czech Republic, belonging to the institution); Marek TRNĚNÝ (203 Czech Republic) and Jiří MAYER (203 Czech Republic, belonging to the institution)

Edition

American Journal of Hematology, 2011, 0361-8609

Other information

Language

English

Type of outcome

Article in a journal

Field of Study

30200 3.2 Clinical medicine

Country of publisher

United States of America

Confidentiality degree

is not subject to a state or trade secret

Impact factor

Impact factor: 4.671

RIV identification code

RIV/00216224:14110/11:00052253

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1002/ajh.21942

UT WoS

000287670600017

Keywords in English

Imatinib treatment; chronic phase; myeloid leukemia

Abstract

V originále

Imatinib (IM) dramatically improved the prognosis of chronic myeloid leukemia (CML), particularly with newly diagnosed patients in a chronic phase (CP) [1]. The most robust source of data about IM efficacy in this setting is the IRIS trial. However, every day clinical practice data are still scarce. We analyzed IM efficacy and safety in the first-line therapy of 152 consecutive adult CP-CML patients from a defined region. The estimated 4-year cumulative incidences of complete hematologic, complete cytogenetic, major, and complete molecular responses were 95.3%, 80.6%, 65.4%, and 39.2%, respectively. The 4-year probability of overall and progression-free survival (PFS) defined as with the IRIS [2] was 91.5% and 78.1%, respectively. We thus confirmed very good IM efficacy also in patients not participating in clinical trials. However, the estimated 4-year event-free survival (EFS), which also counted failure events according to valid recommendations [3] or IM discontinuation due to intolerance, was only 60.7%. The 4-year probability of an alternative treatment-free survival, our newly defined parameter, which better reflects the proportion of patients remaining on IM despite an event, was 67.6%. Therefore, more appropriate selection and unification of survival analyses end-points is desirable to describe and compare IM real efficacy.

Cite

ŽÁČKOVÁ, Daniela; Hana KLAMOVÁ; Ladislav DUŠEK; Jan MUŽÍK; Kateřina MACHOVÁ POLÁKOVÁ; Jana MORAVCOVÁ; Tomáš JURČEK; Dana DVOŘÁKOVÁ; Zdeněk RÁČIL; Zdeněk POSPÍŠIL; Alexandra OLTOVÁ; Kyra MICHALOVÁ; Jana BŘEZINOVÁ; Filip RÁZGA; Michael DOUBEK; Petr CETKOVSKÝ; Marek TRNĚNÝ and Jiří MAYER. Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials? American Journal of Hematology. 2011, vol. 86, No 3, p. 318-321. ISSN 0361-8609. Available from: https://dx.doi.org/10.1002/ajh.21942.

@article{937303,
   author = {Žáčková, Daniela and Klamová, Hana and Dušek, Ladislav and Mužík, Jan and Machová Poláková, Kateřina and Moravcová, Jana and Jurček, Tomáš and Dvořáková, Dana and Ráčil, Zdeněk and Pospíšil, Zdeněk and Oltová, Alexandra and Michalová, Kyra and Březinová, Jana and Rázga, Filip and Doubek, Michael and Cetkovský, Petr and Trněný, Marek and Mayer, Jiří},
   article_number = {3},
   doi = {http://dx.doi.org/10.1002/ajh.21942},
   keywords = {Imatinib treatment; chronic phase; myeloid leukemia},
   language = {eng},
   issn = {0361-8609},
   journal = {American Journal of Hematology},
   title = {Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials?},
   volume = {86},
   year = {2011}
}

TY  - JOUR
ID  - 937303
AU  - Žáčková, Daniela - Klamová, Hana - Dušek, Ladislav - Mužík, Jan - Machová Poláková, Kateřina - Moravcová, Jana - Jurček, Tomáš - Dvořáková, Dana - Ráčil, Zdeněk - Pospíšil, Zdeněk - Oltová, Alexandra - Michalová, Kyra - Březinová, Jana - Rázga, Filip - Doubek, Michael - Cetkovský, Petr - Trněný, Marek - Mayer, Jiří
PY  - 2011
TI  - Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials?
JF  - American Journal of Hematology
VL  - 86
IS  - 3
SP  - 318-321
EP  - 318-321
SN  - 03618609
KW  - Imatinib treatment
KW  - chronic phase
KW  - myeloid leukemia
N2  - Imatinib (IM) dramatically improved the prognosis of chronic myeloid leukemia (CML), particularly with newly diagnosed patients in a chronic phase (CP) [1]. The most robust source of data about IM efficacy in this setting is the IRIS trial. However, every day clinical practice data are still scarce. We analyzed IM efficacy and safety in the first-line therapy of 152 consecutive adult CP-CML patients from a defined region. The estimated 4-year cumulative incidences of complete hematologic, complete cytogenetic, major, and complete molecular responses were 95.3%, 80.6%, 65.4%, and 39.2%, respectively. The 4-year probability of overall and progression-free survival (PFS) defined as with the IRIS [2] was 91.5% and 78.1%, respectively. We thus confirmed very good IM efficacy also in patients not participating in clinical trials. However, the estimated 4-year event-free survival (EFS), which also counted failure events according to valid recommendations [3] or IM discontinuation due to intolerance, was only 60.7%. The 4-year probability of an alternative treatment-free survival, our newly defined parameter, which better reflects the proportion of patients remaining on IM despite an event, was 67.6%. Therefore, more appropriate selection and unification of survival analyses end-points is desirable to describe and compare IM real efficacy.
ER  -

ŽÁČKOVÁ, Daniela; Hana KLAMOVÁ; Ladislav DUŠEK; Jan MUŽÍK; Kateřina MACHOVÁ POLÁKOVÁ; Jana MORAVCOVÁ; Tomáš JURČEK; Dana DVOŘÁKOVÁ; Zdeněk RÁČIL; Zdeněk POSPÍŠIL; Alexandra OLTOVÁ; Kyra MICHALOVÁ; Jana BŘEZINOVÁ; Filip RÁZGA; Michael DOUBEK; Petr CETKOVSKÝ; Marek TRNĚNÝ and Jiří MAYER. Imatinib as the first-line treatment of patients with chronic myeloid leukemia diagnosed in the chronic phase: can we compare real life data to the results from clinical trials? \textit{American Journal of Hematology}. 2011, vol.~86, No~3, p.~318-321. ISSN~0361-8609. Available from: https://dx.doi.org/10.1002/ajh.21942.

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