Abstract

3742 Background: A previous phase I trial in patients (pts) with metastatic colorectal cancer (CRC) demonstrated that weekly CPT-11 and bolus 5FU/l-LV administered for 3 weeks every 28 days (modified Saltz regimen) showed a promising activity without severe toxicity. We conducted a multicenter phase II trial of this regimen in pts with metastatic CRC to evaluate the objective response rate (ORR), safety profile, time to progression (TTP), and overall survival (OS). Methods: 27 pts with metastatic CRC, measurable disease, ECOG PS less than 3, and adequate organ functions were enrolled. Prior chemotherapy was allowed. Pts received weekly doses of CPT-11 (100 mg/m2) and bolus 5FU (500 mg/m2) plus l-LV (20 mg/m2) for 3 weeks. Cycles were repeated every 28 days. Results: 25 pts (10 treated and 15 untreated pts) were evaluable for response and toxicity; M/F, 12/13, median age 63 years (45–73), ECOG PS 0–1, 96%. Metastatic sites were liver 48% (n=12), lung 40% (n=10), and lymph node 36% (n=9). To date, 213 cycles were administered (median 8.5, range 2–36). There were 10 PR (40%) and 13 SD (52%), and 2 PD, resulting in ORR of 40% (CI 95%: 20.8–59.2%) and disease control rate (PR+SD) of 92%. The response rates of the pts with or without previous treatments were 20% and 53.3%, respectively. Median TTP and OS have not been achieved yet, but were 6.9 months and 17.2 months, respectively for 16 early registered pts. Neutropenia was the only NCI-CTC grade 3/4 hematological toxicity, which occurred in 52% of pts. Non-hematological toxicity was mostly grade 1/2 with only one patient (4%) having a grade 3 diarrhea. No treatment related death has been encountered. Conclusions: This weekly CPT-11/5FU/l-LV administered for 3 weeks every 28 days has manageable toxicity profile and a substantial anti-tumor activity, specifically for chemotherapy-naive patients with metastatic CRC. No significant financial relationships to disclose.

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