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.

Základní údaje

Originální název

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?

Autoři

ŽÁČKOVÁ, Daniela (203 Česká republika, garant, domácí), Hana KLAMOVÁ (203 Česká republika), Ladislav DUŠEK (203 Česká republika, domácí), Jan MUŽÍK (203 Česká republika, domácí), Kateřina MACHOVÁ POLÁKOVÁ (203 Česká republika), Jana MORAVCOVÁ (203 Česká republika), Tomáš JURČEK (203 Česká republika, domácí), Dana DVOŘÁKOVÁ (203 Česká republika, domácí), Zdeněk RÁČIL (203 Česká republika, domácí), Zdeněk POSPÍŠIL (203 Česká republika, domácí), Alexandra OLTOVÁ (203 Česká republika), Kyra MICHALOVÁ (203 Česká republika), Jana BŘEZINOVÁ (203 Česká republika), Filip RÁZGA (203 Česká republika, domácí), Michael DOUBEK (203 Česká republika, domácí), Petr CETKOVSKÝ (203 Česká republika, domácí), Marek TRNĚNÝ (203 Česká republika) a Jiří MAYER (203 Česká republika, domácí)

Vydání

American Journal of Hematology, 2011, 0361-8609

Další údaje

Jazyk

angličtina

Typ výsledku

Článek v odborném periodiku

Obor

30200 3.2 Clinical medicine

Stát vydavatele

Spojené státy

Utajení

není předmětem státního či obchodního tajemství

Impakt faktor

Impact factor: 4.671

Kód RIV

RIV/00216224:14110/11:00052253

Organizační jednotka

Lékařská fakulta

DOI

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

UT WoS

000287670600017

Klíčová slova anglicky

Imatinib treatment; chronic phase; myeloid leukemia

Příznaky

Mezinárodní význam

Změněno: 12. 4. 2012 08:33, Mgr. Michal Petr

Anotace

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.

Citovat

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 a 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, roč. 86, č. 3, s. 318-321. ISSN 0361-8609. Dostupné z: 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 a 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, roč.~86, č.~3, s.~318-321. ISSN~0361-8609. Dostupné z: https://dx.doi.org/10.1002/ajh.21942.

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