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 Blood, 15 May 2007, Vol. 109, No. 10, pp. 4158-4163.
Prepublished online as a Blood First Edition Paper on January 30, 2007; DOI 10.1182/blood-2006-07-035725.

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CLINICAL TRIALS AND OBSERVATIONS

A multicenter phase 2 study of the farnesyltransferase inhibitor tipifarnib in intermediate- to high-risk myelodysplastic syndrome

Pierre Fenaux1, Azra Raza2, Ghulam J. Mufti3, Carlo Aul4, Ulrich Germing5, Hagop Kantarjian6, Larry Cripe7, René Kerstens8, Peter De Porre8, and Razelle Kurzrock6

1 Hôpital Avicenne, Paris, France; 2 Rush Cancer Institute, Chicago, IL; 3 Kings College, London, United Kingdom; 4 St Johannes Hospital, Duisburg, Germany; 5 Heinrich Heine University, Düsseldorf, Germany; 6 University of Texas M. D. Anderson Cancer Center, Houston, TX; 7 Indiana University Cancer Center, Indianapolis, IN; 8 Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium

This multicenter phase 2 study evaluated the use of tipifarnib (R115777) in patients with poor-risk myelodysplastic syndrome (MDS; French-American-British classification). Patients (n = 82) received tipifarnib 300 mg orally twice daily for the first 21 days of each 28-day cycle. Twenty-six patients (32%) responded to tipifarnib: 12 (15%) complete responses (CRs) and 14 (17%) hematologic improvements; 37 patients (45%) had stable disease (modified International Working Group criteria, 2006). Among the 12 CRs, the median response duration was 11.5 months (range, 2.0-21.9 months), the median time to progression was 12.4 months (range, 3.9-23.8 months), and 7 were still alive at time of analysis (all > 3 years). Median overall survival was 11.7 months (95% CI, 9.4-15.0). Grade 3-4 neutropenia (18%) and thrombocytopenia (32%) were the most common treatment-related adverse events; severe nonhematologic adverse events were rarely reported. In this study, durable responses and acceptable side effects were observed. Tipifarnib is an active agent for the treatment of patients with intermediate- to high-risk MDS.


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