Incidence and management of myelosuppression in patients with chronic- and accelerated-phase chronic myeloid leukemia treated with omacetaxine mepesuccinate

Abstract

Omacetaxine mepesuccinate (Synribo®) is an inhibitor of protein synthesis indicated for the treatment of patients with chronic- or accelerated-phase chronic myeloid leukemia (CML) with resistance and/or intolerance to two or more tyrosine kinase inhibitors. Myelosuppression is the most common and clinically significant toxicity experienced by patients treated with omacetaxine. Here, we further examine the patterns of hematologic toxicity observed in clinical trials and describe the approach to management as well as resolution of events. Omacetaxine-related myelosuppression typically occurs more frequently during induction cycles. In general, the myelosuppression observed with omacetaxine treatment is manageable and reversible, and long-term administration is feasible. Careful monitoring, dose delays and reduction in administration days, and appropriate supportive care are critical for successful management of hematologic toxicity. Concerns regarding myelosuppression, observed with many cancer treatments, should not prevent eligible patients from receiving omacetaxine, particularly CML patients with unsatisfactory responses to multiple lines of prior treatment.

Keywords:

• Hematologic toxicity
• neutropenia
• omacetaxine mepesuccinate
• supportive care
• thrombocytopenia

Acknowledgements

The authors thank the investigators in the Omacetaxine-202 and -203 Study Groups, the patients and their families, as well as the clinical study staff for their dedication and support. The original research was sponsored by ChemGenex Pharmaceuticals Limited, Menlo Park, CA (now a wholly owned subsidiary of Teva Branded Pharmaceutical Products R&D, Inc. Frazer, PA, USA). Financial support for medical writing assistance from Jin Tomshine, PhD, of Powered 4 Significance LLC was provided by Teva Branded Pharmaceutical Products R&D.

Potential conflict of interest

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