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Randomized Controlled Trial
. 2012 Aug;158(4):519-22.
doi: 10.1111/j.1365-2141.2012.09165.x. Epub 2012 May 29.

The addition of the farnesyl transferase inhibitor, tipifarnib, to low dose cytarabine does not improve outcome for older patients with AML

Alan K Burnett  1 , Nigel H Russell, Dominic Culligan, Jamie Cavanagh, Jonathan Kell, Keith Wheatley, Andra Virchis, Robert K Hills, Donald Milligan; AML Working Group of the UK National Cancer Research Institute
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Randomized Controlled Trial

The addition of the farnesyl transferase inhibitor, tipifarnib, to low dose cytarabine does not improve outcome for older patients with AML

Alan K Burnett et al. Br J Haematol. 2012 Aug.

Abstract

The AML16 trial evaluated the combination of the farnesyltransferase inhibitor, tipifarnib, and low dose cytarabine (LDAC) in older acute myeloid leukaemia (AML) patients in a 'Pick a Winner' design. The aim was to double remission rates compared to LDAC, with initial evaluation after 100 patients. Failure to improve remission would result in discontinuation. A total of 65 patients, median age 74 years (range 62-86), were randomized. After reviewing the first 45 patients, the Data Monitoring Committee concluded that the overall aspirations would not be met and recommended closure. The addition of tipifarnib had no effect on response, toxicity or survival.

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