ORLANDOIrinotecan, also known as CPT-11 (Camptosar), administered every 3
weeks to patients with fluorouracil (5-FU)-refractory colorectal cancer
produced response rates and toxicity profiles similar to irinotecan given
weekly in a phase III study. Charles S. Fuchs, MD, MPH, Dana-Farber Cancer
Institute, reported the results at the 38th Annual Meeting of the American
Society of Clinical Oncology (abstract 514).
"Our findings are consistent with other efficacy results of phase III
trials of single agent CPT-11 in 5-FU-refractory colorectal cancer," Dr.
Fuchs said. "In addition, these results continue to support the close
monitoring of patients treated with CPT-11."
Patients were randomized in a 1:2 ratio to weekly or every 3-week irinotecan.
The first group received a weekly schedule of 125 mg/m² for 4 consecutive weeks
followed by a 2-week rest. The second arm was given 350 mg/m² every 3 weeks.
Patients who were age 70 or older, had a performance status of 2, or had
received prior pelvic radiotherapy started irinotecan at 300 mg/m². About 55%
of the patients in the 3-week arm started at the lower dose.
Patients were managed with antiemetics and antidiarrheal medication as
needed and atropine for cholinergic symptoms during the infusion. Prophylactic
atropine was not permitted during the first treatment infusion.
Eligibility included patients with measurable metastatic colorectal cancer
that had progressed within 6 months of 5-FU-based chemotherapy for metastatic
disease or had relapsed within 12 months of adjuvant 5-FU therapy. Patients
also were required to have an ECOG performance status of 2 or less and adequate
laboratory parameters, including a serum bilirubin of no greater than 1.5 mg/dL.
Researchers excluded patients treated in the past with irinotecan.