Dual Growth Factor (rhTPO + G-CSF) and Chemotherapy Combination Regimen for Elderly Patients with Acute Myeloid Leukemia: A Phase II Single-Arm Multicenter Study

Abstract Abstract 3626 Introduction: Although there have been remarkable improvements in treatment of acute myeloid leukemia (AML), the prognosis of AML in elderly patients remains poor, and the best induction chemotherapy for these patients remains yet unknown. To devise an effective induction regimen for elderly patients with AML, we conducted a phase II trial to evaluate the efficacy and safety of the modified fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) regimen in these patients. Patients and Methods: Elderly (60 years or older) AML patients who did not receive previous chemotherapy were enrolled. Patients received two consecutive cycles of m-FLAI chemotherapy as an induction. The m-FLAI regimen was comprised of fludarabine (25mg/m2, days 1–4), cytarabine (1000mg/m2, days 1–4), and attenuated-dose idarubicin (5mg/m2, days 1–3). The primary end point was complete remission (CR) rate. Results: A total of 108 patients (median age 68.4 years, M:F=64:44) were enrolled. CR was achieved in 62.9% of patients, and treatment-related mortality rate (TRM) was 25.8%. Median overall survival (OS) was 9.3 months, and median event-free survival (EFS) was 6.6 months. The mortality at 30 and 60 days was 18% and 24%, respectively. Performance status and comorbidity did not have prognostic value in these patients. Bone marrow expression of CD117 was related to long EFS and OS. Conclusion: In conclusion, m-FLAI is a safe and effective induction regimen for previously untreated AML in elderly patients. Bone marrow CD117 expression is an independent good prognostic factor in these patients. (ClinicalTrials.gov number, NCT01247493) Disclosures: No relevant conflicts of interest to declare.

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Phase II-Trial of Double-Consolidation Following Intensive Induction Treatment for Improvement of Survival in Elderly Patients with Acute Myeloid Leukemia

Leukemia & Lymphoma ◽

10.3109/10428199409073785 ◽

1994 ◽

Vol 12 (5-6) ◽

pp. 435-440 ◽

Cited By ~ 4

Author(s):

U. Jehn

Keyword(s):

Acute Myeloid Leukemia ◽

Elderly Patients ◽

Phase Ii ◽

Myeloid Leukemia ◽

Phase Ii Trial ◽

Induction Treatment ◽

Acute Myeloid

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A phase II trial of induction and consolidation therapy of acute myeloid leukemia with weekly oral idarubicin alone in poor risk elderly patients

Leukemia ◽

10.1038/sj.leu.2401522 ◽

1999 ◽

Vol 13 (10) ◽

pp. 1491-1496 ◽

Cited By ~ 13

Author(s):

R Bouabdallah ◽

F Lefrère ◽

C Rose ◽

P Chaïbi ◽

J-L Harousseau ◽

...

Keyword(s):

Acute Myeloid Leukemia ◽

Elderly Patients ◽

Phase Ii ◽

Myeloid Leukemia ◽

Phase Ii Trial ◽

Consolidation Therapy ◽

Poor Risk ◽

Acute Myeloid

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A Prospective, Multicenter Phase II Study Of Continuous Infusion Of FLAG For Patients Older Than 60 Years With Resistant Acute Myeloid Leukemia: A Comparison With Intensive Younger patients’ Trial

Blood ◽

10.1182/blood.v122.21.3968.3968 ◽

2013 ◽

Vol 122 (21) ◽

pp. 3968-3968

Author(s):

Hawk Kim ◽

Je-Hwan Lee ◽

Young-Don Joo ◽

Sung-Hwa Bae ◽

Jung-Hee Lee ◽

...

Keyword(s):

Overall Survival ◽

Acute Myeloid Leukemia ◽

Elderly Patients ◽

Treatment Failure ◽

Continuous Infusion ◽

Phase Ii ◽

Myeloid Leukemia ◽

Phase Ii Study ◽

Younger Patients ◽

Acute Myeloid

Abstract Relapsed/refractory acute myeloid leukemia (R/R AML) is hard to treat especially in elderly patients. We previously assessed continuous infusion (CI) of fludarabine and cytarabine plus idarubicin (CI-FLAG2) for patients under 65-years old with R/R AML. Also we started prospective phase II study of attenuated version of CI-FLAG2 for elderly patients (C-FLAG). R/R AML in elderly (¡Ã60 years old) patients were eligible. Induction chemotherapy consisted fludarabine and cytarabine (ARAC) as a 24-hr CI without idarubicin. Total 38 and 68 patients were enrolled in CI-FLAG1 and CI-FLAG2, respectively. There were no differences in terms of patients’ characteristics except for median age (p<0.001), HCT prior to salvage (p=0.002), WBC>20K/uL at salvage (p=0.004) and PB blast>40% at salvage, all which factors were unfavorable in C-FLAG. When comparing outcomes between CI-FLAG2 and C-FLAG, there were no difference in terms of CR rate (p=0.572) and objective response rate (ORR; p=0.899). Treatment failure patterns were also similar between C-FLAG and CI-FLAG2 (p=0.742). The most common treatment failure was resistant (66.7%) in C-FLAG. There were more frequent HCT in CI-FLAG2 (p<0.001) and consolidation chemotherapy in C-FALG (p=0.001). Poor predictors on ORR in C-FLAG were PB WBC>20K/uL at salvage (p=0.024) and PB blast >0% on early evaluation (p=0.013) by multivariate analysis. The overall survival of patients who achieve CR/CRp/CRi showed significantly prolonged survival compared with patients who did not in C-CLAG (p<0.001; Figure 1A). The median overall survivals were similar between CI-FLAG2 and C-FALG (p=0.427; Figure 1B).Figure 1Overall survivalFigure 1. Overall survival Attenuated salvage regimen C-FALG in elderly patients was as effective as more intensive younger patients’ regimen CI-FALG2 in terms of response and survival although elderly patients had more unfavorable clinical characteristics. Disclosures: No relevant conflicts of interest to declare.

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