Multicenter, Randomized, Open-Label, Phase III Trial of
Decitabine Versus Patient Choice, With Physician Advice, of
Either Supportive Care or Low-Dose Cytarabine for the Treatment
of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

J 2012

Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

KANTARJIAN, Hagop M.; Xavier G. THOMAS; Anna DMOSZYNSKA; Agnieszka WIERZBOWSKA; Grzegorz MAZUR et. al.

Základní údaje

Originální název

Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia

Autoři

KANTARJIAN, Hagop M. (840 Spojené státy, garant); Xavier G. THOMAS (250 Francie); Anna DMOSZYNSKA (616 Polsko); Agnieszka WIERZBOWSKA (616 Polsko); Grzegorz MAZUR (616 Polsko); Jiří MAYER (203 Česká republika, domácí); Jyh-Pyng GAU (158 Tchaj-wan); Wen-Chien CHOU (158 Tchaj-wan); Rena BUCKSTEIN (124 Kanada); Jaroslav CERMAK (203 Česká republika); Ching-Yuan KUO (158 Tchaj-wan); Albert ORIOL (724 Španělsko); Farhad RAVANDI (840 Spojené státy); Stefan FADERL (840 Spojené státy); Jacques DELAUNAY (250 Francie); Daniel LYSÁK (203 Česká republika); Mark MINDEN (124 Kanada) a Christopher ARTHUR (36 Austrálie)

Vydání

Journal of Clinical Oncology, Alexandria, Amer Soc Clinical Oncology, 2012, 0732-183X

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

Odkazy

URL

Impakt faktor

Impact factor: 18.038

Kód RIV

RIV/00216224:14740/12:00060217

Organizační jednotka

Středoevropský technologický institut

DOI

http://dx.doi.org/10.1200/JCO.2011.38.9429

UT WoS

000306556900020

Klíčová slova anglicky

Acute Myeloid Leukemia; clinical trial; Decitabine

Štítky

ok, rivok

Příznaky

Mezinárodní význam

Změněno: 11. 4. 2013 13:37, Olga Křížová

Anotace

V originále

This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. Patients and Methods Patients (N=485) age around 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m2 per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m2 per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp). Adverse events (AEs) were recorded. Results The primary analysis with 396 deaths (81.6%) showed a nonsignificant increase in median OS with decitabine (7.7 months; 95% CI, 6.2 to 9.2) versus TC (5.0 months; 95% CI, 4.3 to 6.3; P=.108; hazard ratio [HR], 0.85; 95% CI, 0.69 to 1.04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0.82; 95% CI, 0.68 to 0.99; nominal P=.037). The CR rate plus CRp was 17.8% with decitabine versus 7.8% with TC (odds ratio, 2.5; 95% CI, 1.4 to 4.8; P=.001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). Conclusion In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis.

Přiložené soubory

Kantarjian_2012_J_Clin_Oncol_p2670.pdf

Požádat o autorskou verzi souboru

Citovat

KANTARJIAN, Hagop M.; Xavier G. THOMAS; Anna DMOSZYNSKA; Agnieszka WIERZBOWSKA; Grzegorz MAZUR; Jiří MAYER; Jyh-Pyng GAU; Wen-Chien CHOU; Rena BUCKSTEIN; Jaroslav CERMAK; Ching-Yuan KUO; Albert ORIOL; Farhad RAVANDI; Stefan FADERL; Jacques DELAUNAY; Daniel LYSÁK; Mark MINDEN a Christopher ARTHUR. Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia. Journal of Clinical Oncology. Alexandria: Amer Soc Clinical Oncology, 2012, roč. 30, č. 21, s. 2670-2677. ISSN 0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.2011.38.9429.

@article{984980,
   author = {Kantarjian, Hagop M. and Thomas, Xavier G. and Dmoszynska, Anna and Wierzbowska, Agnieszka and Mazur, Grzegorz and Mayer, Jiří and Gau, JyhandPyng and Chou, WenandChien and Buckstein, Rena and Cermak, Jaroslav and Kuo, ChingandYuan and Oriol, Albert and Ravandi, Farhad and Faderl, Stefan and Delaunay, Jacques and Lysák, Daniel and Minden, Mark and Arthur, Christopher},
   article_location = {Alexandria},
   article_number = {21},
   doi = {http://dx.doi.org/10.1200/JCO.2011.38.9429},
   keywords = {Acute Myeloid Leukemia; clinical trial; Decitabine},
   language = {eng},
   issn = {0732-183X},
   journal = {Journal of Clinical Oncology},
   title = {Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia},
   url = {http://jco.ascopubs.org/content/30/21/2670},
   volume = {30},
   year = {2012}
}

TY  - JOUR
ID  - 984980
AU  - Kantarjian, Hagop M. - Thomas, Xavier G. - Dmoszynska, Anna - Wierzbowska, Agnieszka - Mazur, Grzegorz - Mayer, Jiří - Gau, Jyh-Pyng - Chou, Wen-Chien - Buckstein, Rena - Cermak, Jaroslav - Kuo, Ching-Yuan - Oriol, Albert - Ravandi, Farhad - Faderl, Stefan - Delaunay, Jacques - Lysák, Daniel - Minden, Mark - Arthur, Christopher
PY  - 2012
TI  - Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia
JF  - Journal of Clinical Oncology
VL  - 30
IS  - 21
SP  - 2670-2677
EP  - 2670-2677
PB  - Amer Soc Clinical Oncology
SN  - 0732183X
KW  - Acute Myeloid Leukemia
KW  - clinical trial
KW  - Decitabine
UR  - http://jco.ascopubs.org/content/30/21/2670
L2  - http://jco.ascopubs.org/content/30/21/2670
N2  - This multicenter, randomized, open-label, phase III trial compared the efficacy and safety of decitabine with treatment choice (TC) in older patients with newly diagnosed acute myeloid leukemia (AML) and poor- or intermediate-risk cytogenetics. Patients and Methods Patients (N=485) age around 65 years were randomly assigned 1:1 to receive decitabine 20 mg/m2 per day as a 1-hour intravenous infusion for five consecutive days every 4 weeks or TC (supportive care or cytarabine 20 mg/m2 per day as a subcutaneous injection for 10 consecutive days every 4 weeks). The primary end point was overall survival (OS); the secondary end point was the complete remission (CR) rate plus the CR rate without platelet recovery (CRp). Adverse events (AEs) were recorded. Results The primary analysis with 396 deaths (81.6%) showed a nonsignificant increase in median OS with decitabine (7.7 months; 95% CI, 6.2 to 9.2) versus TC (5.0 months; 95% CI, 4.3 to 6.3; P=.108; hazard ratio [HR], 0.85; 95% CI, 0.69 to 1.04). An unplanned analysis with 446 deaths (92%) indicated the same median OS (HR, 0.82; 95% CI, 0.68 to 0.99; nominal P=.037). The CR rate plus CRp was 17.8% with decitabine versus 7.8% with TC (odds ratio, 2.5; 95% CI, 1.4 to 4.8; P=.001). AEs were similar for decitabine and cytarabine, although patients received a median of four cycles of decitabine versus two cycles of TC. The most common drug-related AEs with decitabine were thrombocytopenia (27%) and neutropenia (24%). Conclusion In older patients with AML, decitabine improved response rates compared with standard therapies without major differences in safety. An unplanned survival analysis showed a benefit for decitabine, which was not observed at the time of the primary analysis.
ER  -

KANTARJIAN, Hagop M.; Xavier G. THOMAS; Anna DMOSZYNSKA; Agnieszka WIERZBOWSKA; Grzegorz MAZUR; Jiří MAYER; Jyh-Pyng GAU; Wen-Chien CHOU; Rena BUCKSTEIN; Jaroslav CERMAK; Ching-Yuan KUO; Albert ORIOL; Farhad RAVANDI; Stefan FADERL; Jacques DELAUNAY; Daniel LYSÁK; Mark MINDEN a Christopher ARTHUR. Multicenter, Randomized, Open-Label, Phase III Trial of Decitabine Versus Patient Choice, With Physician Advice, of Either Supportive Care or Low-Dose Cytarabine for the Treatment of Older Patients With Newly Diagnosed Acute Myeloid Leukemia. \textit{Journal of Clinical Oncology}. Alexandria: Amer Soc Clinical Oncology, 2012, roč.~30, č.~21, s.~2670-2677. ISSN~0732-183X. Dostupné z: https://dx.doi.org/10.1200/JCO.2011.38.9429.

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