| Figure
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sReference
ssion=""1.0"" encoding=""UTF-8""?>
ss=""h4"">Background
XIAP (X-linked inhibitor of apopto
si
s protein) i
s an inhibitor of ca
spa
se
s 3 and 9 that i
s overexpre
ssed in acute myeloid leukemia (AML) and may contribute to chemore
si
stance. We report an open-label randomized pha
se II trial of reinduction chemotherapy with and without the XIAP anti
sen
se oligonucleotide in patient
s with AML who did not achieve remi
ssion with initial induction chemotherapy.
ss=""h4"">Methods
Twenty-seven patients with AML who were refractory to initial induction chemotherapy were randomized and treated with (650 mg) in combination with high-dose cytarabine and idarubicin. Thirteen patients were randomized and treated with high-dose cytarabine and idarubicin alone. The rates of response and toxicity were determined.
ss=""h4"">Results
Of the 27 patients assigned to in combination with high-dose cytarabine and idarubicin, 3 died during reinduction chemotherapy, 5 achieved complete remission (CR), and 6 achieved CR with incomplete platelet count recovery (CRp), for an overall response rate of 41 % . Of the 13 patients assigned to the control arm of the study, none died during reinduction, 6 achieved CR, and 3 achieved CRp, for an overall response rate of 69 % . The differences in response rates between patients in the and control arms were not statistically different (P = 0.18 by the ¦Ö<sup>2sup> test).
ss=""h4"">Conclusions
The addition of to reinduction chemotherapy was well tolerated but did not improve rates of remission. Therefore alternative therapeutic strategies should be explored in patients with AML refractory to induction chemotherapy.
