Title: A randomized phase 3 study of tipifarnib compared with best supportive care, including hydroxyurea, in the treatment of newly diagnosed acute myeloid leukemia in patients 70 years or older
Authors: Harousseau, Jean-Luc ×
Martinelli, Giovanni
Jedrzejczak, Wieslaw W
Brandwein, Joseph M
Bordessoule, Dominique
Masszi, Tamas
Ossenkoppele, Gert J
Alexeeva, Julia A
Beutel, Gernot
Maertens, Johan
Vidriales, Maria-Belen
Dombret, Hervé
Thomas, Xavier
Burnett, Alan K
Robak, Tadeusz
Khuageva, Nuriet K
Golenkov, Anatoly K
Tothova, Elena
Mollgard, Lars
Park, Youn C
Bessems, Annick
De Porre, Peter
Howes, Angela J #
Issue Date: Aug-2009
Publisher: W.B. Saunders
Series Title: Blood vol:114 issue:6 pages:1166-1173
Abstract: This phase 3, multicenter, open-label study evaluated the efficacy and safety of tipifarnib compared with best supportive care (BSC), including hydroxyurea, as first-line therapy in elderly patients (>or=70 years) with newly diagnosed, de novo, or secondary acute myeloid leukemia. A total of 457 patients were enrolled with 24% 80 years of age or older. Tipifarnib 600 mg orally twice a day was administered for the first 21 consecutive days, in 28-day cycles. The primary endpoint was overall survival. The median survival was 107 days for the tipifarnib arm and 109 days for the BSC arm. The hazard ratio (tipifarnib vs BSC) for overall survival was 1.02 (P value by stratified log-rank test, .843). The complete response rate for tipifarnib in this study (8%) was lower than that observed previously, but with a similar median duration of 8 months. The most frequent grade 3 or 4 adverse events were cytopenias in both arms, slightly more infections (39% vs 33%), and febrile neutropenia (16% vs 10%) seen in the tipifarnib arm. The results of this randomized study showed that tipifarnib treatment did not result in an increased survival compared with BSC, including hydroxyurea. This trial was registered at as #NCT00093990.
ISSN: 0006-4971
Publication status: published
KU Leuven publication type: IT
Appears in Collections:Hematology Section (-)
× corresponding author
# (joint) last author

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