title: Long-term results of a prospective randomized trial evaluating G-CSF priming in intensive induction chemotherapy followed by autologous stem cell transplantation in elderly patients with acute myeloid leukemia.
abstract: Few studies have evaluated granulocyte colony-stimulating factor (G-CSF) priming in elderly patients with intensively treated acute myeloid leukemia (AML), and no data are available for genetically defined AML subgroups. We provide long-term results (median follow-up 7.6 years) of a randomized trial in which 183 patients (median age 67 years) received G-CSF prior to (G-CSF priming) or after two cycles of induction chemotherapy. CR rates with G-CSF priming and G-CSF post-chemotherapy were comparable (57 vs. 67 %, p = 0.153), with overall survival (OS) probabilities of 14 vs. 17 % at 10 years. Induction mortality was significantly higher with G-CSF priming (23 vs. 10 %, p = 0.015), primarily in normal karyotype (NK) AML. In this subgroup, a trend for better relapse-free survival (RFS) was observed with G-CSF priming (44 vs. 22 % at 10 years, p = 0.074) but did not translate into an OS benefit. G-CSF priming had no impact on AML with FLT3-ITD and NPM mutations and did not improve outcome in patients with adverse cytogenetics. In a landmark analysis, late consolidation with autologous stem cell transplantation or a second consolidation cycle significantly improved RFS compared with one consolidation cycle (21.0 vs. 12.8 months, p = 0.046). Future studies on G-CSF priming should be restricted to NK AML and used only in post-remission therapy.
authors: Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Frankfurt, Germany.
authors: Gesine
authors: G
authors: Bug
authors: Steffen
authors: S
authors: Koschmieder
authors: Juergen
authors: J
authors: Krauter
authors: Michael
authors: M
authors: Heuser
authors: Felicitas
authors: F
authors: Thol
authors: Stefanie
authors: S
authors: Wiebe
authors: Wolf-Karsten
authors: WK
authors: Hofmann
authors: Stefan A
authors: SA
authors: Klein
authors: Gerd
authors: G
authors: Wegener
authors: Gudrun
authors: G
authors: Göhring
authors: Wolfgang
authors: W
authors: Heit
authors: Dieter
authors: D
authors: Hoelzer
authors: Arnold
authors: A
authors: Ganser
authors: Oliver G
authors: OG
authors: Ottmann
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D064592:Autografts; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects*; D018380:Hematopoietic Stem Cell Transplantation; D006801:Humans; D060828:Induction Chemotherapy / Q000009:adverse effects*; D015470:Leukemia, Myeloid, Acute / Q000235:genetics / Q000401:mortality* / Q000473:pathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009154:Mutation; D011446:Prospective Studies; D015996:Survival Rate; D013997:Time Factors; D051941:fms-Like Tyrosine Kinase 3 / Q000235:genetics
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; C497970:FLT3 protein, human; D051941:fms-Like Tyrosine Kinase 3