Pediatrics international : official journal of the Japan Pediatric Society · 2017
Fludarabine, cytarabine, granulocyte colony-stimulating factor and idarubicin for relapsed childhood acute myeloid leukemia.
Клиническое исследование II фазыСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Nakayama Hideki, Tomizawa Daisuke, Tanaka Shiro, Iwamoto Shotaro, Shimada Akira, Saito Akiko M, Yamashita Yuka, Moritake Hiroshi, Terui Kiminori, Taga Takashi, Matsuo Hidemasa, Kosaka Yoshiyuki, Koh Katsuyoshi, Hosoi Hajime, Kurosawa Hidemitsu, Isoyama Keiichi, Horibe Keizo, Mizutani Shuki, Adachi Souichi
Аннотация
BACKGROUND: The combination of fludarabine (Flu), high-dose cytarabine (Ara-C) and granulocyte colony-stimulating factor (G-CSF; FLAG), with anthracyclines has become standard chemotherapy for refractory acute myeloid leukemia (AML) in European children and adults. To clarify the efficacy and the safety of FLAG-idarubicin (IDA) for children prospectively, we planned a multicenter phase II study (AML-R11) by the Japanese Pediatric Leukemia/Lymphoma Study Group.
METHODS: Patients with AML aged between 2 and 20 years old, who had the first bone marrow (BM) relapse or induction failure, were enrolled. The FLAG-IDA regimen consisted of Flu 30 mg/m2 for 5 days, Ara-C 2 g/m2 for 5 days, G-CSF (lenograstim) 5 μg/kg for 6 days and IDA 10 mg/m2 for 3 days. The primary endpoint was remission rate after therapy.
RESULTS: Due to drug supply issues, the trial was suspended after the inclusion of seven eligible patients. There were six cases of early relapse within 1 year of the first remission. All seven patients completed the therapy and no early death was observed. Hematological toxicity was common, and one patient developed grade 4 non-hematological toxicity of bacterial meningitis. Although only one patient with late relapse achieved complete remission, minimal residual disease was positive on both flow cytometry and Wilms' tumor 1 mRNA. Two patients were alive in remission following hematopoietic stem cell transplantation, whereas the other five patients died of either the disease or treatment-related causes.
CONCLUSION: FLAG-IDA might be tolerable for children with refractory AML although the efficacy should be further investigated.
METHODS: Patients with AML aged between 2 and 20 years old, who had the first bone marrow (BM) relapse or induction failure, were enrolled. The FLAG-IDA regimen consisted of Flu 30 mg/m2 for 5 days, Ara-C 2 g/m2 for 5 days, G-CSF (lenograstim) 5 μg/kg for 6 days and IDA 10 mg/m2 for 3 days. The primary endpoint was remission rate after therapy.
RESULTS: Due to drug supply issues, the trial was suspended after the inclusion of seven eligible patients. There were six cases of early relapse within 1 year of the first remission. All seven patients completed the therapy and no early death was observed. Hematological toxicity was common, and one patient developed grade 4 non-hematological toxicity of bacterial meningitis. Although only one patient with late relapse achieved complete remission, minimal residual disease was positive on both flow cytometry and Wilms' tumor 1 mRNA. Two patients were alive in remission following hematopoietic stem cell transplantation, whereas the other five patients died of either the disease or treatment-related causes.
CONCLUSION: FLAG-IDA might be tolerable for children with refractory AML although the efficacy should be further investigated.
Предметные рубрики MeSH
AdolescentAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsChildChild, PreschoolCytarabineDrug Administration ScheduleFemaleGranulocyte Colony-Stimulating FactorHumansIdarubicinLenograstimLeukemia, Myeloid, AcuteMaleRecombinant ProteinsRecurrenceTreatment OutcomeVidarabineYoung Adult