Phase II trial of arsenic trioxide in relapsed and refractory acute myeloid leukemia, secondary leukemia and/or newly diagnosed patients at least 65 years old

Simrit Parmar, Lynn M. Rundhaugen, Larry Boehlke, Mary Beth Riley, Chadi Nabhan, Adekunle Raji, John L. Frater, Martin S. Tallman

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41 Scopus citations

Abstract

The prognosis for patients with relapsed/refractory AML, secondary leukemia and AML in older adults is extremely poor. An appealing alternative approach to intensive cytotoxic chemotherapy is to induce apoptosis with a novel agent. There is in vitro evidence that arsenic trioxide (ATO) has anti-proliferative and pro-apoptotic effects on myeloid leukemia cell lines. To evaluate efficacy and toxicities of ATO, we conducted a phase II trial including subjects with relapsed/refractory or secondary AML or age≥65 years with de novo disease. Eleven subjects were entered with a median age of 77 years (56-90) and a median total dose of ATO of 415.55 mg (91.5-793) with a daily dose of 0.25 mg/kg. Median survival following the first dose of ATO was 2.25 months (0.4-19). Myelosuppression was the major adverse effect, most likely due to disease progression rather than drug-related. All subjects had progressive disease. There was no direct treatment-related mortality. Based on this study, we do not recommend single agent ATO as a treatment option for AML.

Original languageEnglish
Pages (from-to)909-919
Number of pages11
JournalLeukemia Research
Volume28
Issue number9
DOIs
StatePublished - Sep 2004

Keywords

  • AML
  • Arsenic
  • Elderly
  • Secondary AML

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