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. doi:10.1200/JCO.2011.38.9429.
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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
Originální 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
WWW 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
Změnil Změnila: Olga Křížová, učo 56639. Změněno: 11. 4. 2013 13:37.
Anotace
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.
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