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A prospective, multicenter phase II study of continuous infusion of FLAG for patients older than 60 yr with resistant acute myeloid leukemia: a comparison with intensive younger patients’ trial
Author(s) -
Kim Hawk,
Lee JeHwan,
Joo YoungDon,
Bae Sung Hwa,
Lee JungHee,
Kim DaeYoung,
Lee WonSik,
Ryoo HunMo,
Jo JaeCheol,
Choi Yunsuk,
Lee KyooHyung
Publication year - 2016
Publication title -
european journal of haematology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.904
H-Index - 84
eISSN - 1600-0609
pISSN - 0902-4441
DOI - 10.1111/ejh.12568
Subject(s) - idarubicin , flag (linear algebra) , medicine , cytarabine , regimen , myeloid leukemia , gastroenterology , fludarabine , refractory (planetary science) , multivariate analysis , intensive care unit , chemotherapy , surgery , physics , mathematics , astrobiology , pure mathematics , algebra over a field , cyclophosphamide
Relapsed or refractory acute myeloid leukemia (R/R AML ) in elderly (≥60 yr old) patients were eligible. Induction chemotherapy consisted fludarabine and cytarabine ( ARAC ) as a 24‐hr CI without idarubicin (C‐ FLAG ), which was compared with the results of C‐ FLAG with idarubicin ( CI ‐ FLAG 2) in younger patients’ trial. A total of 33 and 68 patients were enrolled in C‐ FLAG and CI ‐ FLAG 2, respectively. CR , CR p, and CR i were achieved in 10 (30.3%), 3 (9.1%), and 2 (6.1%), respectively. When comparing outcomes between C‐ FLAG and CI ‐ FLAG 2, there were no difference in terms of CR rate ( P = 0.572) and objective response rate ( ORR ; P = 0.899). Favorable predictors on ORR in C‐ FLAG were PB WBC ≤ 20K/ uL at salvage ( P = 0.024) and early evaluation peripheral BLAST = 0% ( P = 0.013) on multivariate analysis. The overall survival of patients who achieve CR / CR p/ CR i showed significantly prolonged survival compared with patients who did not in C‐ FLAG ( P < 0.001) and was a favorable predictor of longer survival by multivariate analysis ( P = 0.009). Median overall survival was 3.19 (95% CI , 2.05–4.33) months and similar with that of CI ‐ FLAG 2 ( P = 0.841). Attenuated salvage regimen C‐ FLGA in elderly patients was as effective as more intensive younger patients’ regimen CI ‐ FLAG 2 in terms of response and survival although elderly patients had more unfavorable clinical characteristics.