ASCO LOS ANGELES--In a multicenter phase II study of mitogua-zone (MGBG) in relapsed or refractory AIDS-related non-Hodgkin's lymphoma (NHL), more than one quarter of patients responded to the drug, and all of the complete responders experienced an increase in their CD4 counts, Alexandra M. Levine, MD, reported at ASCO.
MGBG has previously shown efficacy in non-AIDS lymphoma, is relatively nonmyelosuppressive, and crosses the blood-brain barrier, a plus in AIDS lymphoma patients who often have CNS disease, said Dr. Levine, of the University of Southern California.
Eligible patients had to have failed at least one potentially curative lymphoma regimen; half had failed two to five prior regimens, and 35% had primary refractory disease. The median CD4 count prior to MGBG was 73, and 92% of patients at entry had counts less than 200. Ninety percent had high-grade lymphoma.
The agent was given at a dosage of 600 mg/m² IV over 30 minutes on days 1 and 8, then every 2 weeks. Patients received a median of three doses, and about 25% received more than seven doses.
Of 27 evaluable patients, three had a complete response and four a partial response, for a total response rate of 26%. Three patients had stable disease, and 17 progressed. The median duration of response was 4 months for the complete responders and 2.5 months for the partial responders. "One patient each is out 17+ months in maintained complete or partial response," Dr. Levine said.
Response was associated with improved quality of life (eg, weight gain, improved performance status). Of special interest, all three of the complete responders had an increase in CD4 counts, as did one of the partial responders.
Median survival from time of treatment with mitoguazone is 11 months among responders, 6.6 months for those with stable disease, and 2.3 months for those with progressive disease. Toxicity was mild, consisting primarily of a syndrome (facial flushing and circumoral paresthesias) that occurs during infusion.