title: 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.
abstract: 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.
authors.affiliation: Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Hawk
authors.initials: H
authors.lastname: Kim
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Je-Hwan
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Hematology/Oncology, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Korea.
authors.forename: Young-Don
authors.initials: YD
authors.lastname: Joo
authors.affiliation: Department of Hematology-Oncology, Daegu Catholic University Medical Center, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors.forename: Sung Hwa
authors.initials: SH
authors.lastname: Bae
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Jung-Hee
authors.initials: JH
authors.lastname: Lee
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Dae-Young
authors.initials: DY
authors.lastname: Kim
authors.affiliation: Department of Hematology/Oncology, Busan Paik Hospital, Inje University College of Medicine, Busan, Korea.
authors.forename: Won-Sik
authors.initials: WS
authors.lastname: Lee
authors.affiliation: Department of Hematology-Oncology, Daegu Catholic University Medical Center, Catholic University of Daegu School of Medicine, Daegu, Korea.
authors.forename: Hun-Mo
authors.initials: HM
authors.lastname: Ryoo
authors.affiliation: Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Jae-Cheol
authors.initials: JC
authors.lastname: Jo
authors.affiliation: Division of Hematology and Cellular Therapy, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Yunsuk
authors.initials: Y
authors.lastname: Choi
authors.affiliation: Department of Hematology, Asan Medical Center, University of Ulsan College of Medicine, Ulsan, Korea.
authors.forename: Kyoo-Hyung
authors.initials: KH
authors.lastname: Lee
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D003561:Cytarabine / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000627:therapeutic use*; D060828:Induction Chemotherapy / Q000379:methods; D007262:Infusions, Intravenous / Q000379:methods; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D012074:Remission Induction; D016019:Survival Analysis; D016896:Treatment Outcome; D014740:Vidarabine / Q000031:analogs & derivatives* / Q000627:therapeutic use
chemical_list: D003561:Cytarabine; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin
keywords: FLAG; acute myeloid leukemia; continuous infusion; elderly; relapsed/refractory