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IVA (1)

CTCL, cutaneous T-cell lymphoma.

aLogistic regression favoring high dose for stage >IIB (P

Adapted from Foss FM.120

flulike symptoms. A vascular leak syndrome, associated with hypotension, edema, and hypoalbumine-mia, was also noted in approximately 25% of patients. Most side effects were transient and tended to occur early in treatment. Steroid premedication was not used in the pivotal trial to avoid ambiguity in interpreting efficacy; however, in a subsequent study with 15 CTCL patients, which allowed for the use of intravenous steroids, there was a higher response rate (60%) with denileukin diftitox with a substantial decrease in adverse effects.121 The improvement in patient's tolera-bility associated with concurrent steroid administration may have led to greater patient compliance and treatment completion, potentially resulting in better response rate; in the pivotal phase III trial, many patients discontinued therapy prior to completing four cycles due to toxicity and were deemed nonresponders. Therefore, steroid premedication may ultimately lead to greater patient compliance and higher response rates with this drug. Besides its efficacy in CTCL, denileukin diftitox also has activity in other T-cell lymphomas and deserves further study in these diseases.122123

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