Abstract
LBA8 Background: Infused irinotecan regimens have improved survival in metastatic CRC. This international, multicenter, open-label, randomized, prospective trial of adjuvant chemotherapy with IF vs. F was designed to confirm these results in pts with stage III colon cancer. Pts were given IF (Arm A) or F (Arm B) in 4 cycles of 3 infusions every 2 weeks (de Gramont regimen) or 4 cycles of the AIO regimen. Irinotecan was given as 180 mg/m2 per dose in the de Gramont regimen, and as 80 mg/m2 in the AIO regimen. Methods: Inclusion criteria were WHO performance status <2, and stage III disease (UICC criteria). Exclusion criteria were prior treatment with chemotherapy, and rectal cancer. The primary endpoint is the comparison of 3-year disease-free survival in stage III pts who received IF vs. F in the de Gramont regimen, using the log-rank test. A total of 2014 Stage III pts were to be randomized in order to obtain the 452 events calculated to guarantee 90% power to detect an increase in 3 yr DFS from 70% to 77% in Arm A (hazard ratio 1.36). The DFS and RFS curves will also be estimated using Kaplan-Meier methodology. Cox models will be used to analyze the influence of selected variables. Secondary endpoints include relapse-free survival, overall survival, safety, and potential prognostic markers. Results: Between Jan 2000 and April 2002, 2124 pts from 28 countries were randomized and 2101 pts treated. Tumor blocks from 1500 pts were collected for translational research. The two arms were well balanced - median age 60 (19–76), 55% male, 99% WHO PS <2. Median follow-up was 31 months. Selected grade 3/4 toxicities (%) in Arms A/B respectively were: myelosuppresion (1 vs. 0.3%) diarrhea (12 vs. 6%), venous thrombosis (7 vs. 5%), infection (2 vs. 0.2%). Conclusions: The primary endpoint will be analyzed before March 25, 2005 and will be presented at the ASCO meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Pfizer, sanofi-aventis Pfizer, sanofi-aventis sanofi-aventis sanofi-aventis
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