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Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia


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.

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The following hospitals and investigators participated in the International AML study group: Derriford Hospital, Plymouth, UK (A Prentice); Manchester Royal Infirmary, UK (JA Liu Yin); Royal London Hospital, UK (A Newland); Addenbrooke's Hospital, Cambridge, UK (R Marcus); Musgrove Park Hospital, Taunton, UK (S Johnson); Guys Hospital, London, UK (S Schey); John Radcliffe Hospital, Oxford, UK (T Littlewood and C Bunch); University of Frankfurt, Germany (D Hoelzer and A Ganser); University of Ulm, Germany (G Heil and H Heimpel); University of Freiburg, Germany (R Mertelsmann and A Lindemann); Johannes-Guttenberg University, Mainz, Germany (C Huber and K. Kolbe); Ospedali Riuniti, Bergamo, Italy (T Barbui); Ospedale Regionale, Bolzano, Italy (P Coser); Ospedale San Bortoli, Vicenza, Italy (R Battista and F Rodeghiero); Ospedale S Eugenio, Roma, Italy (G Papa and A Venditti); University Eppendorf, Hamburg, Germany (D Hossfeld); Stuyvenberg Ziekenhuis, Antwerpen, Belgium (P Zachée); Ospedale Nuovo San Gerardo, Monza, Italy (G Corneo and E Pogliani); Hospital La Fe, Valencia, Spain (M Sanz and G Martín); Hospital de la Princesa, Madrid, Spain (J Fernández-Rañada and J Tomás); University of Vienna, Austria (K Lechner and K Geissler); Belfast City Hospital, UK (TCM Morris); University of Gent, Belgium (L Noens); Centre Hospitalier Sart Tilman, Liège, Belgium (G Fillet); Instituto Portugues de Oncologia (A Parreira); University Hospital of Lund, Sweden (PG Nilsson); and the Australian Leukaemia Study Group: Peter McCallum Cancer Institute, Melbourne (J Bishop); Royal Adelaide Hospital (C Juttner and J Ho); Royal Prince Alfred Hospital, Sydney (D Joshua); Westmead Hospital, Sydney (K Bradstock); Alfred Hospital, Melbourne (J Szer); Royal Melbourne Hospital (J Szer).

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Correspondence to G Heil.

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Sponsored by Amgen Ltd, Cambridge, UK and F Hoffmann-La Roche Ltd, Basel, Switzerland.

Presented at the 44th annual meeting of the American Society of Hematology, Philadelphia, PA, USA; December 6–10, 2002.

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Heil, G., Hoelzer, D., Sanz, M. et al. Long-term survival data from a phase 3 study of Filgrastim as an adjunct to chemotherapy in adults with de novo acute myeloid leukemia. Leukemia 20, 404–409 (2006).

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  • hematologic malignancies
  • granulocyte colony-stimulating factor
  • neutropenia

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