Outpatient consolidation treatment with clofarabine in a phase 2 study of older adult patients with previously untreated acute myelogenous leukemia

Abstract

This report describes outpatient (OP) administration of clofarabine in older patients (≥60 years) with untreated acute myelogenous leukemia (AML). Overall, 112 patients underwent clofarabine induction. Clofarabine was administered to 35 OPs for a total of 72 OP cycles, with 81% of these cycles representing consolidation treatment. Median length of hospital stay was 0–6 days and 5–25 days across OP and inpatient (IP) cycles, respectively. The most common adverse events (AEs) were nausea, vomiting, diarrhea, febrile neutropenia, edema, hypokalemia and pneumonia. The overall frequency of treatment-emergent grade ≥3 AEs and serious AEs was generally not different with IP or OP administration of clofarabine. No deaths were reported within 30 days following OP or IP consolidation cycles. In the appropriately selected older patient, OP administration of clofarabine consolidation appears feasible, is as well tolerated as IP administration and has potential to contribute to the quality of life in elderly patients with AML.

Key words::

• Clofarabine
• acute myelogenous leukemia
• outpatient administration

Acknowledgements

The development of this manuscript was supported by Genzyme Corporation. The authors would like to thank MedLogix Communications for editorial support and Angela Partisano (Genzyme Corporation) for help with coordinating the revisions of this manuscript. Additionally, the authors would like to thank all of the CLASSIC II investigators for their contributions to the study.

Potential conflict of interest:

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