title: Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia.
abstract: We previously reported the results of a double-blind, placebo-controlled study of Filgrastim in patients with de novo AML undergoing induction and consolidation chemotherapy. The study demonstrated that Filgrastim was effective and well tolerated and had no impact on complete remission or survival. We now report follow-up data on these patients, assessing long-term effects with emphasis on prognostic indicators. After a median follow-up of 7 years, 434 (83%) patients were dead, 73 (14%) were alive, and 14 (3%) were lost to follow-up. The proportions of deaths were similar in the Filgrastim (83%) and placebo (84%) groups. No differences in median time to death (1.04 years Filgrastim, 1.13 years placebo; P = 0.97) or median disease-free survival (0.86 years Filgrastim, 0.79 years placebo; P = 0.52) were evident. Proportional hazard modeling identified age, performance status, and French-American-British subtype as independent predictors for survival (P < 0.001, P = 0.005, and P = 0.036, respectively), whereas cytogenetic status was not (P = 0.118). Filgrastim had no effect on overall survival in any of these subgroup analyses as none of the treatment comparisons were statistically significant. These findings indicate that Filgrastim can be effectively used to support patients with AML undergoing induction and consolidation chemotherapy without worsening long-term disease outcome.
authors.affiliation: Department of Internal Medicine, University of Ulm, Ulm, Germany. Gerhard.Heil@klinikum-luedenscheid.de
authors.forename: G
authors.initials: G
authors.lastname: Heil
authors.forename: D
authors.initials: D
authors.lastname: Hoelzer
authors.forename: M A
authors.initials: MA
authors.lastname: Sanz
authors.forename: K
authors.initials: K
authors.lastname: Lechner
authors.forename: L
authors.initials: L
authors.lastname: Noens
authors.forename: J
authors.initials: J
authors.lastname: Szer
authors.forename: A
authors.initials: A
authors.lastname: Ganser
authors.forename: J
authors.initials: J
authors.lastname: Matcham
authors.forename: J
authors.initials: J
authors.lastname: Renwick
mesh_terms: D000208:Acute Disease; D000328:Adult; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D007951:Leukemia, Myeloid / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D011994:Recombinant Proteins; D016019:Survival Analysis
chemical_list: D000970:Antineoplastic Agents; D011994:Recombinant Proteins; D016179:Granulocyte Colony-Stimulating Factor; D000069585:Filgrastim