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

• Published in: European journal of haematology Vol. 96; no. 2; pp. 188 - 197
• Main 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, Choi, Yunsuk, Lee, Kyoo-Hyung
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.02.2016
• Subjects: acute myeloid leukemia; Adolescent; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; continuous infusion; Cytarabine - therapeutic use; Drug Administration Schedule; elderly; Female; FLAG; Humans; Idarubicin - therapeutic use; Induction Chemotherapy - methods; Infusions, Intravenous - methods; Leukemia, Myeloid, Acute - drug therapy; Leukemia, Myeloid, Acute - mortality; Leukemia, Myeloid, Acute - pathology; Male; Middle Aged; Multivariate Analysis; relapsed/refractory; Remission Induction; Survival Analysis; Treatment Outcome; Vidarabine - analogs & derivatives; Vidarabine - therapeutic use; relapsed/refractory; acute myeloid leukemia; FLAG; elderly; continuous infusion
• ISSN: 0902-4441; 1600-0609; 1600-0609
• DOI: 10.1111/ejh.12568

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‐FLAG2) in younger patients’ trial. A total of 33 and 68 patients were enrolled in C‐FLAG and CI‐FLAG2, respectively. CR, CRp, and CRi were achieved in 10 (30.3%), 3 (9.1%), and 2 (6.1%), respectively. When comparing outcomes between C‐FLAG and CI‐FLAG2, 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/CRp/CRi 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‐FLAG2 (P = 0.841). Attenuated salvage regimen C‐FLGA in elderly patients was as effective as more intensive younger patients’ regimen CI‐FLAG2 in terms of response and survival although elderly patients had more unfavorable clinical characteristics.