A phase I study using bortezomib with weekly idarubicin for treatment of elderly patients with acute myeloid leukemia

Dianna S. Howard, Jane Liesveld, Gordon L. Phillips, John Hayslip, Heidi Weiss, Craig T. Jordan, Monica L. Guzman

Research output: Contribution to journalArticlepeer-review

18 Scopus citations


We report the results of a phase I study with four dose levels of bortezomib in combination with idarubicin. Eligible patients were newly diagnosed with acute myeloid leukemia (AML) age ≥60 years, or any adult with relapsed AML. Bortezomib was given twice weekly at 0.8, 1.0, or 1.2mg/m2 with once weekly idarubicin 10mg/m2 for four weeks. Twenty patients were treated: 13 newly diagnosed (median age 68, range 61-83) and 7 relapsed (median age 58, range 40-77). Prior myelodysplastic syndrome (MDS) was documented in 10/13 (77%) newly diagnosed and 1/7 (14%) relapsed patients; the three newly diagnosed patients without prior MDS had dyspoietic morphology. Two dose-limiting toxicities occurred at the initial dose level (bortezomib 0.8mg/m2 and idarubicin 10mg/m2); idarubicin was reduced to 8mg/m2 without observing subsequent dose-limiting toxicities. The maximum tolerated dose in this study was bortezomib 1.2mg/m2 and idarubicin 8mg/m2. Common adverse events included: neutropenic fever, infections, constitutional symptoms, and gastrointestinal symptoms. No subjects experienced neurotoxicity. Most patients demonstrated hematologic response as evidenced by decreased circulating blasts. Four patients (20%) achieved complete remission. There was one treatment-related death. The combination of bortezomib and idarubicin in this mostly poor-risk, older AML group was well tolerated and did not result in high mortality. This trial was registered at www.clinicaltrials.gov as #NCT00382954.

Original languageEnglish
Pages (from-to)1502-1508
Number of pages7
JournalLeukemia Research
Issue number11
StatePublished - Nov 2013

Bibliographical note

Funding Information:
Funding : This study was supported by Millennium Pharmaceuticals and NIH/NCI grant R21 CA108162-01A1 , neither of which were involved in the study design, collection, analysis and interpretation of data; in the writing of the manuscript; or in the decision to submit the manuscript for publication.


  • Acute myeloid leukemia
  • Bortezomib
  • Elderly
  • Idarubicin

ASJC Scopus subject areas

  • Hematology
  • Oncology
  • Cancer Research


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