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Blood, 15 June 2007, Vol. 109, No. 12, pp. 5151-5156.
Prepublished online as a Blood First Edition Paper on March 9, 2007; DOI 10.1182/blood-2006-09-046144.
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Submitted September 11, 2006
Accepted February 1, 2007
A phase 2 study of the oral farnesyltransferase inhibitor tipifarnib in patients with refractory or relapsed acute myeloid leukemia
Jean-Luc Harousseau*, Jeffrey E Lancet, Josy Reiffers, Bob Lowenberg, Xavier Thomas, Francoise Huguet, Pierre Fenaux, Steven Zhang, Wayne Rackoff, Peter De Porre, and Richard Stone
Service d'Hematologie, Hotel Dieu, Nantes, France
H. Lee Moffitt Cancer Center & Research Institute, University of South Florida, Tampa, FL, United States
Service des Maladies du Sang, Hopital du Haut Leveque, Pessac, France
Department of Hematology, Erasmus University Medical Center, Rotterdam, Netherlands
Service des Maladies du Sang, Hopital Edouard Herriot, Lyon, France
Service d'Hematologie, Chu Purpan, Toulouse Cedex, France
Hematologie, Avicenne Hopital, Paris, France
Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, United States
Adult Leukemia Program, Dana-Farber Cancer Institute, Boston, MA, United States
* Corresponding author; email: jean-luc.harousseau{at}univ-nantes.fr.
This phase 2 study evaluated the efficacy and safety of the oral farnesyltransferase inhibitor tipifarnib in adults with refractory or relapsed acute myeloid leukemia (AML). Patients (N = 252) received tipifarnib 600 mg BID for 21 days in 28-day cycles. Median age was 62 years; 99 patients (39%) were  65 years. Eleven of 252 patients (4%) achieved complete remission (CR) or complete remission with incomplete platelet recovery (CRp; 9 CR and 2 CRp). Nineteen patients (8%), including those who achieved CR/CRp, achieved a reduction in bone marrow blasts to <5% blasts. Bone marrow blasts were reduced >50% in an additional 8 patients (total = 27; 11%). Median survival was 369 days for patients who achieved CR/CRp. Myelosuppression was the most common adverse event. The most common nonhematologic toxicities were fever, nausea, and hypokalemia. Single-agent treatment with tipifarnib induced durable CR/CRp, which was associated with prolonged survival, in some patients with refractory or relapsed AML. The response rate observed in this heavily pretreated group of patients suggests the requirement to enhance the response rate either by combining tipifarnib with other active agents or determining factors that are predictive of response.
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