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Blood, 1 February 2002, Vol. 99, No. 3, pp. 834-839
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Efficacy and safety of thalidomide in patients with acute
myeloid leukemia
Martin B. Steins,
Teresa Padró,
Ralf Bieker,
Sandra Ruiz,
Martin Kropff,
Joachim Kienast,
Torsten Kessler,
Thomas Buechner,
Wolfgang E. Berdel, and
Rolf M. Mesters
From the Department of Medicine/Hematology and
Oncology, University of Muenster, Germany.
Emerging data suggest an involvement of angiogenesis in the
pathophysiology of acute myeloid leukemia (AML). Thus, antiangiogenic therapy could constitute a novel strategy for the treatment of AML. To
test this hypothesis, a phase I/II dose-escalating trial was performed
to study the safety and efficacy of thalidomide, a putative inhibitor
of angiogenesis, in 20 patients with AML. Thirteen patients
were assessable for both toxicity and response, tolerating a maximum
dose of 200 to 400 mg daily for at least 1 month. Seven patients had to
be prematurely withdrawn from drug administration owing to progressive
disease and death (3 patients), personal decision (2 patients), or
inability to tolerate thalidomide (2 patients). Overall, adverse events
were fatigue, constipation, rash, and neuropathy (grade 1 to 2 in most
patients). In 4 patients, a partial response, defined as reduction of
at least 50% in the blast cell infiltration of the bone marrow
accompanied by increases in platelet counts and hemoglobin values, was
observed. One additional patient showed a hematologic improvement
without fulfilling the criteria of a partial response. The responses
lasted a median of 3 months (range, 1-8 months). In parallel,
microvessel densities significantly decreased in these 5 patients
during treatment with thalidomide (P < .05). This
decrease was accompanied by declining plasma levels of basic fibroblast
growth factor, one of the most potent angiogenic growth factors. In
conclusion, single-agent thalidomide has antiangiogenic and
antileukemic activity in AML, although a causal relationship between
both effects has still to be proven.
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