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- W1584179619 abstract "BACKGROUND Omacetaxine, a protein synthesis inhibitor, is indicated in the United States for the treatment of patients with chronic‐phase (CP) or accelerated‐phase (AP) chronic myeloid leukemia (CML) with resistance and/or intolerance to 2 or more tyrosine kinase inhibitors. METHODS The final analysis, with 24 months of follow‐up, included additional efficacy and safety analyses to assess the benefit of long‐term omacetaxine administration (1.25 mg/m 2 twice daily for 14 days every 28 days followed by 7 days every 28 days) in CP‐CML and AP‐CML patients receiving >3 cycles. RESULTS Eighteen percent of CP‐CML patients achieved a major cytogenetic response (MCyR) with a median duration of 12.5 months (95% confidence interval [CI], 3.5 months to not reached [NR]); responses were maintained for ≥12 months in 3 of 14 responders, and the median overall survival (OS) was 40.3 months (95% CI, 23.8 months to NR). Among patients with AP‐CML, 14% achieved or maintained a major hematologic response for a median of 4.7 months (95% CI, 3.6 months to NR); MCyR was not achieved, and the median OS was 14.3 months (95% CI, 6.7‐18.7 months). In patients with CP‐CML and patients with AP‐CML who received >3 cycles of treatment (n = 50 and n = 14, respectively), the median OS was 49.3 months (95% CI, 23.8 months to NR) and 24.6 months (95% CI, 12‐37.2 months), respectively. Grade 3 or higher hematologic toxicities were the major side effects (79% and 73% for CP‐CML and AP‐CML, respectively), with discontinuation due to toxicity in 10% of CP patients and in 5% of AP patients. CONCLUSIONS These results suggest that the long‐term administration of omacetaxine is feasible with dose adjustments to manage toxicities and that omacetaxine provides a durable benefit for some patients. Cancer 2015;121:1637–1644 . © 2015 American Cancer Society ." @default.
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- W1584179619 date "2015-01-13" @default.
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- W1584179619 title "Final analysis of the efficacy and safety of omacetaxine mepesuccinate in patients with chronic- or accelerated-phase chronic myeloid leukemia: Results with 24 months of follow-up" @default.
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- W1584179619 doi "https://doi.org/10.1002/cncr.29240" @default.
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