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• W2246366563 abstract "6557 Background: Tipifarnib (Zarnestra [Z]) is a non-peptidomimetic farnesyl transferase inhibitor (FTI) with clinical activity in AML and MDS. In vitro studies have demonstrated synergy when combining tipifarnib with chemotherapeutic agents. Methods: We have conducted a study where pts (aged 15 to 60 years) with previously untreated AML or high-risk MDS (blasts >10%) were treated with Idarubicin 12 mg/m 2 /d on days 1–3, cytarabine 1.5 g/m 2 IV over 24 hours daily on days 1–4 and Z; the first cohort (7 pts) received Z 200mg orally twice daily (BID), and all others 300 mg BID for 21 days. Pts achieving CR received consolidation (5 courses) with Idarubicin 8 mg/m 2 /d on days 1–2, cytarabine 0.75 g/m 2 /d on days 1–3, and Z 300 mg BID for 14 days every 4–6 weeks. Maintenance was with Z 300 mg BID for 21 days every 4–6 wk for 6 months. Results: We have treated 33 pts; median age 51 yrs (17–59 yrs). Twenty two pts (67%) have achieved CR, 3 (9%) CRp, and 2 (6%) PR. There were no induction deaths. Response (CR/CRp) by cytogenetics was: 13/15 (86%) for diploid, 5/6 (83%) with −5/−7, 1/2 (50%) with t(8;21), and 6/10 (60%) with other abnormalities. Response by Flt3 was 19/22 (86%) for unmutated Flt3, 3/5 (60%) for mutated Flt3. CR by age (excluding t(8;21)) was 13/16 (81%) if ≤ 50yrs, 4/6 (67%) if >50yrs and diploid, and 5/8 (63%) if >50yrs and other cytogenetics. With a median follow-up of 45 weeks, 5 pts have relapsed after 13 to 39 weeks and 1 died (in CR) after 18 wks. The most common grade 3 adverse events include reversible diarrhea in 7 (21%) and hyperbilirubinemia in 6 (18%). Twenty (61%) and 8 (53%) pts have required dose reductions during induction and consolidation courses, respectively. Conclusions: Z combined with Idarubicin and cytarabine induces a high rate of CR in AML/high risk MDS, with increased incidence of diarrhea and hyperbilirubinemia. Role of Z in prolongation of CR duration requires further follow-up. [Table: see text]" @default.
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• W2246366563 date "2006-06-20" @default.
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• W2246366563 title "Tipifarnib in combination with idarubicin and cytarabine in patients with newly diagnosed acute myeloid leukemia (AML) or high risk myelodysplastic syndrome (MDS)" @default.
• W2246366563 doi "https://doi.org/10.1200/jco.2006.24.18_suppl.6557" @default.
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