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Use of arsenic trioxide (As2O3) in the treatment of acute promyelocytic
leukemia (APL): II. Clinical efficacy and pharmacokinetics in relapsed
patients
ZX Shen, GQ Chen, JH Ni, XS Li, SM Xiong, QY Qiu, J Zhu, W Tang, GL Sun, KQ Yang, Y Chen, L Zhou, ZW Fang, YT Wang, J Ma, P Zhang, TD Zhang, SJ Chen, Z Chen and ZY Wang
Shanghai Institute of Hematology, Department of Hematology, Rui-Jin
Hospital, P.R. China.
The therapeutic effect of arsenic trioxide (As2O3) in the treatment of
acute promyelocytic leukemia (APL) was evaluated among 15 APL patients at
relapse after all-trans retinoic acid (ATRA) induced and chemotherapy
maintained complete remission (CR). As2O3 was administered intravenously at
the dose of 10 mg/d. Clinical CR was achieved in nine of 10 (90%) patients
treated with As2O3 alone and in the remaining five patients treated by the
combination of As2O3 and low-dose chemotherapeutic drugs or ATRA. During
the treatment with As2O3, there was no bone marrow depression and only
limited side effects were encountered. Pharmacokinetic studies, which were
performed in eight patients, showed that after a peak level of 5.54
micromol/L to 7.30 micromol/L, plasma arsenic was rapidly eliminated, and
the continuous administration of As2O3 did not alter its pharmacokinetic
behaviors. In addition, increased amounts of arsenic appeared in the urine,
with a daily excretion accounting for approximately 1% to 8% of the total
daily dose administered. Arsenic contents in hair and nail were increased,
and the peak content of arsenic could reach 2.5 to 2.7 microg/g tissue at
CR. On the other hand, a decline of the arsenic content in hair and nail
was observed after withdrawal of the drug. We conclude that As2O3 treatment
is an effective and relatively safe drug in APL patients refractory to ATRA
and conventional chemotherapy.
Volume 89,
Issue 9,
pp. 3354-3360,
05/01/1997
Copyright © 1997 by The American Society of Hematology
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