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Interim Data on Irinotecan in Relapsed/Refractory NHL Shows Substantial Activity

Interim Data on Irinotecan in Relapsed/Refractory NHL Shows Substantial Activity

HOUSTON, Texas—Interim data from a trial of relatively high-dose
irinotecan (Camptosar) given every 3 weeks show that the regimen can be
tolerated and has substantial activity in relapsed aggressive or indolent
non-Hodgkin’s lymphomas (NHL). Andreas H. Sarris, MD, PhD, associate
internist in the Department of Lymphoma and Myeloma at the University of Texas
M. D. Anderson Cancer Center in Houston, Texas, discussed the ongoing study.
"Irinotecan weekly schedules have been associated with both early and
delayed diarrhea, which is often dose limiting. Recent studies have
demonstrated that 300 mg/m² IV every 21 days is active and tolerated in
patients with colon cancer," Dr. Sarris said.

The phase II study Dr. Sarris described enrolled patients with relapsed or
refractory aggressive NHL, relapsed indolent NHL, and relapsed or refractory
mantle cell NHL. Refractory disease was defined as showing no response to
initial treatment. Dr. Sarris said that refractory NHL has a particularly poor
prognosis and so was separated from relapsed NHL in this study. Patients could
have had no more than two prior regimens and no prior stem-cell or bone marrow
transplantation.

Baseline staging was done within 3 weeks of treatment. Irinotecan was given
at 300 mg/m² IV every 21 days, and patients had complete restaging every two
courses. Patients with complete or partial responses after two courses received
up to six courses of irinotecan.

Promising Results

Dr. Sarris reported data for 22 evaluable patients. This included 5 with
indolent lymphomas, 11 with aggressive relapsed lymphomas, 3 with aggressive
refractory lymphomas, and 3 with mantle cell lymphomas. Eleven of 20 patients
had elevated lactate dehydrogenase (LDH) levels at baseline. Five of 19 had b2-microglobulin greater than 3.0 mg/dL at baseline. "This was not a
good-prognosis population," Dr. Sarris said.

Irinotecan produced complete or partial responses in 43% of patients with
indolent lymphomas, 44% of patients with relapsed aggressive lymphomas, 20% of
patients with refractory aggressive lymphomas, but none of the patients with
mantle cell lymphomas.

"Median duration of response was 6 months, so these were not
short-lived responses but also were not a cure," Dr. Sarris said.

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