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Blood, 1 May 2002, Vol. 99, No. 9, pp. 3136-3143
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Tetra-arsenic tetra-sulfide for the treatment of acute
promyelocytic leukemia: a pilot report
Dao-Pei Lu,
Jing-Ying Qiu,
Bin Jiang,
Qin Wang,
Kai-Yan Liu,
Yan-Rong Liu, and
Shan-Shan Chen
From Peking University Institute of Hematology and
People's Hospital, Beijing, China.
In the past 6 years, we treated 129 patients who had acute
promyelocytic leukemia (APL) with a new arsenic agent, oral
tetra-arsenic tetra-sulfide (As4S4). Nineteen
of the patients had newly diagnosed APL, 7 had first relapse, and 103 had hematologic complete remission (HCR). HCR was achieved in all
patients with newly diagnosed APL and in all those with hematologic
relapse. Of 16 patients with newly diagnosed disease and available
cytogenetic and molecular analyses, 14 had cytogenetic and molecular
complete remission (CR). Cytogenetic and molecular CR was also obtained
in 5 of the 7 patients with hematologic relapse. In the HCR group, 35 of 44 patients positive for PML-RAR at baseline became negative. In the newly diagnosed group, estimated disease-free survival (DFS) rates
for 1 and 3 years were 86.1% and 76.6%, respectively, with a median
follow-up time of 13.5 months (range, 2-40 months). In the HCR group,
DFS rates for 1 and 6 years were 96.7% and 87.4%, respectively, with
a median follow-up of 23 months (range, 2-71 months). Treatment with
As4S4 was well tolerated, with only moderate side effects, including asymptomatic prolongation of corrected QT
interval, transient elevation in liver enzyme levels, rash, and mild
gastrointestinal discomfort; neither myelosuppression nor appreciable
long-term side effects occurred. Degeneration or apoptosis of APL
promyelocytes was observed during As4S4
therapy. Pharmacokinetic studies showed that the agent was absorbed
rapidly. Most urinary arsenic excretion occurred within the first 24 hours. Both blood and urinary arsenic levels declined after
discontinuation of As4S4. Our results show, for
the first time, that As4S4 treatment alone is
highly effective and safe in both remission induction and maintenance
therapy in patients with APL, regardless of disease stage.
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