IDA-FLAG (idarubicin, fludarabine, cytarabine, G-CSF), an effective remission-induction therapy for poor prognosis AML of childhood or autologous bone marrow transplantation: experiences of a phase II trial

Department of Paediatric Haematology/Oncology of University Bonn, Germany.
British Journal of Haematology (Impact Factor: 4.71). 09/1998; 102(3):647-55. DOI: 10.1046/j.1365-2141.1998.00836.x
Source: PubMed

ABSTRACT A phase II trial was designed to explore the potential feasibility and efficacy of a reinduction therapy consisting of fludarabine, cytarabine, idarubicin and granulocyte colony stimulating factor (G-CSF) for acute myelogenous leukaemia (AML) patients with poor prognosis.
Twenty-three patients aged 1.2–17.5 years with refractory (n = 3), relapsed (n = 19) or secondary (n = 1) AML were treated with the IDA-FLAG regimen, a combination therapy of idarubicin (days 2–4, 12 mg/m2/d), fludarabine (days 1–4, 30 mg/m2/d), cytarabine (days 1–4, 2000 mg/m2/d) and G-CSF (day 0 up to ANC > 1 × 109/l, 400 μg/m2/d). They received a total of 37 courses of IDA-FLAG and/or FLAG (IDA-FLAG without idarubicin). 17/23 patients achieved a complete remission (CR) with a median duration of 13.5 months (1–39 months), one patient showed a partial remission, and five were nonresponders while in CR, 11 patients underwent bone marrow or PBSC (peripheral blood stem cells) transplantation. Overall, nine patients remain in continuous complete remission with a median duration of 17.5 months (9.5–39 months). The toxicity of the IDA-FLAG courses was more severe than for the FLAG courses with marked neutropenia and thrombocytopenia (for IDA-FLAG: median 22.5 and 25 d respectively; for FLAG: median 10.5 and 14 d respectively). Pulmonary infections were the main nonhaematological toxicity. One patient died in CR from invasive aspergillosis.
The IDA-FLAG regimen produced a CR of >12 months in more than half of the patients and can be recommended as a therapeutic option prior to allogeneic or autologous bone marrow transplantation.

68 Reads
  • Source
    • "The patient did not finish the consolidation course due to prolonged neutropenia. Later, the patient relapsed and received chemotherapy with FLAG-IDA (idarubicin, fludarabine, cytarabine and G-CSF) (7). The patient exhibited prolonged febrile neutropenia for more than one month during the initial course of chemotherapy, but exhibited rapid relapse again, soon following neutropenia recovery. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Fusarium is a common soil mold. In severely immunocompromised patients, this fungus may cause disseminated disease and is often confused with Aspergillus, as the two pathogens have similar histopathological appearances. Disseminated Fusarium infection may cause significant morbidity and mortality in immunocompromised patients. The current case report presents a 20-year-old male with acute lymphoblastic leukemia who developed disseminated Fusarium infection during induction chemotherapy. Early diagnosis and treatment is extremely important since the mortality rate is extremely high in such patients. The clinician must consider that the clinical presentation of Fusarium infection resembles that of Aspergillus. There is no optimal treatment for patients with Fusarium infection; however, combination antifungal therapy may have benefit without significant toxicity.
    Oncology letters 02/2014; 7(2):334-336. DOI:10.3892/ol.2013.1738 · 1.55 Impact Factor
  • Source
    • "Following the treatment, 17 individuals entered the CR period. Then, 11 bone marrow transplantations were performed.[18] Likewise, Hashmi et al. treated 12 refractory or relapsed acute leukemia patients with FLAG-IDA regimen. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Oncologists today are greatly concerned about the treatment of relapsed/refractory acute leukemia. FLANG regimen, combination of novantron, cytarabine, fludarabine, and granulocyte-colony stimulating factor, has been used in treatment of refractory/relapsed acute leukemia since 1990s. The present study has evaluated mortality and response rate of this regimen. In this study, 25 patients with refractory/relapsed acute leukemia aged 15-55 years underwent FLANG regimen at Seyed-Al-Shohada Hospital, Isfahan, Iran during 2008-2009. One month later, bone marrow samples were taken to evaluate the responsiveness to treatment. Participants were followed for a year. The data was analyzed by student-t and chi-square tests, logistic, and Cox regression analysis, and Kaplan-Meier curves in SPSS(19). Out of the 25 patients, 8 patients (32%) had acute lymphoblastic leukemia (5 refractory and 3 relapsed cases) and 17 subjects had acute myeloid leukemia (7 refractory and 10 relapsed cases). According to the bone marrow biopsies taken one month after FLANG regimen, 10 patients (40%) had responded to treatment. Five patients of the 10 responders underwent successful bone marrow transplantation (BMT). On the other hand, 13 patients (52%), who had not entered the CR period, died during the follow-up. Logistic regression analysis did not reveal any significant associations between disease type and responsiveness to treatment. This study indicated higher rates of unresponsiveness to treatment while its mortality rate was comparable with other studies. Overall, according to limitations for BMT (as the only chance for cure) in Iran, it seems that FLANG therapy is an acceptable choice for these patients.
    08/2012; 1:54. DOI:10.4103/2277-9175.100166
  • Source
    • "The prognosis of such children is very poor: three of our patients with newly diagnosed JMML or MDS/AML were refractory to several different induction regimens; the remaining nine patients were either refractory to reinduction therapy or in second relapse after SCT. Further use of intensive CT is limited by its toxicity [28,29]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Gemtuzumab ozogamicin (GO) is a cytotoxic anti-CD33 monoclonal antibody that has given promising preliminary results in adult myeloid CD33+ AML. We conducted a retrospective multicenter study of 12 children treated with GO on a compassionate basis (median age 5.5 y). Three patients (2 MDS/AML, 1 JMML) were refractory to first-line treatment, 8 patients with de novo AML were in refractory first relapse, and one patient with de novo AML was in 2nd relapse after stem cell transplantation (SCT). CD33 expression exceeded 20% in all cases. GO was administered alone, at a unit dose of 3-9 mg/m2, once (3 patients), twice (3 patients), three (5 patients) or five times (1 patient). Mean follow-up was 128 days (8-585 d). There were three complete responses (25%) leading to further curative treatment (SCT). Treatment failed in the other nine patients, and only one patient was alive at the end of follow-up. NCI-CTC grade III/IV adverse events comprised hematological toxicity (n = 12), hypertransaminasemia (n = 2), allergy and hyperbilirubinemia (1 case each). There was only one major adverse event (grade IV allergy). No case of sinusoidal obstruction syndrome occurred. These results warrant a prospective trial of GO in a larger population of children with AML.
    BMC Cancer 02/2006; 6(1):172. DOI:10.1186/1471-2407-6-172 · 3.36 Impact Factor
Show more