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. Issue 10 (13th January 2015)

• Record Type: Journal Article
• Authors: Cortes, Jorge E.; Kantarjian, Hagop M.; Rea, Delphine; Wetzler, Meir; Lipton, Jeffrey H.; Akard, Luke; Khoury, H. Jean; Michallet, Mauricette; Guerci‐Bresler, Agnès; Chuah, Charles; Hellmann, Andrzej; Digumarti, Raghunadharao; Parikh, Purvish M.; Legros, Laurence; Warzocha, Krzysztof; Baccarani, Michele; Li, Elizabeth; Munteanu, Mihaela; Nicolini, Franck E.
• Is Part Of: Cancer. Volume 121:Issue 10(2015)
• Page Start: 1637
• Page End: 1644
• Publication Date: 2015-01-13
• Subjects: Cancer -- Periodicals; Cancer -- Cytopathology -- Periodicals; 616.99405
• DOI: 10.1002/cncr.29240
• Languages: English
• ISSNs: 0008-543X

Abstract

<abstract abstract-type="main"> <title> <x xml:space="preserve">Abstract</x> </title> <sec id="cncr29240-sec-0001" sec-type="section"> <title>BACKGROUND</title> <p>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.</p> </sec> <sec id="cncr29240-sec-0002" sec-type="section"> <title>METHODS</title> <p>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<sup>2</sup> 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.</p> </sec> <sec id="cncr29240-sec-0003" sec-type="section"> <title>RESULTS</title> <p>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.</p> </sec> <sec id="cncr29240-sec-0004" sec-type="section"> <title>CONCLUSIONS</title> <p>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. <bold><italic>Cancer</italic> 2015;121:1637–1644</bold>. © <italic>2015 American Cancer Society</italic>.</p> </sec> </abstract>