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- Title
Prospective, Multicenter, Phase II Study on Reducing the Dosage of Idarubicin and FLAG for Patients Younger than 65 Years with Resistant Acute Myeloid Leukemia: A Comparison with a Higher Dosage Trial.
- Authors
Kim, Hawk; Lee, Je-Hwan; Joo, Young-Don; Bae, Sung Hwa; Lee, Jung-Hee; Kim, Dae-Young; Lee, Won-Sik; Ryoo, Hun-Mo; Jo, Jae-Cheol; Park, Jae-Hoo; Lee, Kyoo-Hyung
- Abstract
We previously assessed continuous infusion (CI) of fludarabine and cytarabine plus idarubicin (CI-FLAG1) for patients under 65 years of age with resistant acute myeloid leukemia. Induction chemotherapy consisted of idarubicin (IDA) plus fludarabine and cytarabine (ARAC) as a 24-hour CI. In response to induction, 31.6% of patients achieved complete remission (CR) and in 68.4% the treatment failed. We concluded that CI-FLAG1 carried a high risk of toxicity and reduced CI-FLAG doses were recommended. Therefore, we revised the protocol (CI-FLAG2) by reducing the dose of IDA and ARAC. In total, 38 and 68 patients were enrolled into CI-FLAG1 and CI-FLAG2, respectively. When comparing outcomes between CI-FLAG1 and CI-FLAG2, there were no differences in terms of the CR rate (p = 0.306) and the overall response rate (ORR; p = 0.206). The treatment failure patterns were different between CI-FLAG1 and CI-FLAG2. The median overall survival showed only a trend towards longer survival in CI-FLAG2 (p = 0.074). Among intermediate-risk patients, there were high response rates favoring CI-FLAG2 in terms of the CR rate (p = 0.108), the ORR (p = 0.031), and overall survival (p = 0.033). This represented a relatively improved response rate compared to our previous study. There was decreased aplasia with dose reductions at the expense of increased resistance. A reduced dose of CI-FLAG might be most beneficial for intermediate-risk groups. © 2014 S. Karger AG, Basel
- Subjects
ACUTE myeloid leukemia treatment; IDARUBICIN; AGE factors in disease; DRUG dosage; COMBINATION drug therapy; COMPARATIVE studies; THERAPEUTICS
- Publication
Acta Haematologica, 2014, Vol 132, Issue 1, p87
- ISSN
0001-5792
- Publication type
Article
- DOI
10.1159/000357093