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Blood, 15 July 2001, Vol. 98, No. 2, pp. 266-271
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Sudden death among patients with acute promyelocytic leukemia
treated with arsenic trioxide
Peter Westervelt,
Randy A. Brown,
Douglas R. Adkins,
Hanna Khoury,
Peter Curtin,
David Hurd,
Selina M. Luger,
Margaret K. Ma,
Timothy J. Ley, and
John F. DiPersio
From the Division of Bone Marrow Transplantation and
Stem Cell Biology, and the Division of Molecular Oncology, Washington
University School of Medicine, St Louis, MO; Division of
Hematology/Oncology, Oregon Health Sciences University,
Portland; Division of Hematology/Oncology, Comprehensive Cancer Center
of Wake Forest University, Winston-Salem, NC; and Division of
Hematology/Oncology, University of Pennsylvania School of Medicine,
Philadelphia.
Arsenic trioxide has been shown to be effective in treating acute
promyelocytic leukemia (APL), with minimal overall toxicity reported to
date. A phase I/II study was initiated in June 1998 using arsenic
trioxide for relapsed APL to determine the maximum tolerated or minimal
effective dose and to determine the efficacy of treatment at that dose.
Ten patients received 1 to 4 monthly cycles of treatment with 0.1 mg/kg
per day intravenous arsenic trioxide. Six of 7 patients
evaluable for response achieved cytogenetic or molecular complete
remission. However, 3 patients died suddenly during the first cycle of
treatment. Autopsies obtained on 2 of these failed to identify a cause
of sudden death, despite evidence of pulmonary hemorrhage in one. A
third patient, for whom an autopsy was not performed, became asystolic
and died while on continuous cardiac telemetry. These observations
suggest that arsenic trioxide may be significantly or even fatally
toxic at doses currently used and that caution is warranted in its use.
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