Short and long term effects of granulocyte colony-stimulating factor during induction therapy in acute myeloid leukemia patients younger than 65: Results of a randomized multicenter phase III trial

被引:14
作者
Beksac, Meral [1 ]
Ali, Ridvan [3 ]
Ozcelik, Tulay [3 ]
Ozcan, Muhit [1 ]
Ozcebe, Osman [2 ]
Bayik, Mahmut [4 ]
Paydas, Semra [5 ]
Buyukasik, Yahya [2 ]
Ilhan, Osman [1 ]
Ozkalemkas, Fahir [3 ]
Gurman, Gunhan [1 ]
Uysal, Akin [1 ]
Akan, Hamdi [1 ]
Soydan, Ender Akcaglayan [1 ]
Tunali, Ahmet [3 ]
机构
[1] Ankara Univ, Dept Hematol & Bone Marrow Transplantat, TR-06620 Ankara, Turkey
[2] Hacettepe Univ, Dept Hematol & Bone Marrow Transplantat, TR-06100 Ankara, Turkey
[3] Uludag Univ, Dept Hematol, Bursa, Turkey
[4] Univ Marmara, Dept Hematol, Istanbul, Turkey
[5] Cukurova Univ, Dept Hematol, Adana, Turkey
关键词
Granulocyte colony-stimulating factor; Acute myeloid leukemia; Induction; Survival; ACUTE MYELOGENOUS LEUKEMIA; PLACEBO-CONTROLLED TRIAL; SOUTHWEST-ONCOLOGY-GROUP; ELDERLY-PATIENTS; DOUBLE-BLIND; ADULT PATIENTS; GROWTH-FACTORS; G-CSF; FEBRILE NEUTROPENIA; PROGNOSTIC-FACTORS;
D O I
10.1016/j.leukres.2010.07.005
中图分类号
R73 [肿瘤学];
学科分类号
100214 [肿瘤学];
摘要
This prospective multicenter phase III clinical trial was designed to assess efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy (www.clinicaltrials.gov.NCT00820976). Patients' characteristics were similar in both arms. G-CSF improved severity and duration of leukopenia. Three-year OS were similar (25.6 +/- 5.1% vs. 31.8 +/- 5.6%) in both arms except for patients with myeloblastic features. Significant factors for better survival were the use of G-CSF (p = 0.049), female sex (p = 0.05) and single induction cycle (p < 0.001) in multivariate analysis. Female patients performed better than male patients. Better survival obtained among female AML patients needs to be validated within the context of cytogenetic analysis. (C) 2010 Elsevier Ltd. All rights reserved.
引用
收藏
页码:340 / 345
页数:6
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