Toxicity and safety of weekly high-dose 5-FU as 24-h infusion and folinic acid (AIO regimen) in adjuvant therapy of UICC stage III colon cancer. InTACT: A multicenter phase III trial

Abstract

3586 Background: The AIO regimen is common for palliative treatment of colorectal cancer. We report for the first time on the toxicity and safety of the AIO regimen in an adjuvant phase III trial for UICC stage III colon cancer (CC). Methods: A prospective phase III trial based on quality controlled surgery and pathology (QSCP) in UICC stage III CC (R0). Group A: QSCP vs. group B: QSCP+AIO regimen for 6 months. End of trial: 9/01 after interim analysis (Wein et al, Ann Oncol 2002). Trial monitoring: by IMEREM, Nuremberg. In group B chemotherapy was terminated in all 79 patients (pt.). The AIO regimen was administered in the form of a 500 mg / m2 application (appl.) of folinic acid (FA) as 1–2 h i.v., followed by 2000 mg/m2 5-FU as a 24-h i.v. (AIO regimen) via port-a-cath on d 1, 8, 15, 22, 29, 36, qd 57; 3 cycles (6 months). Median follow up: 45.3 months. Results: AIO regimen: n = 79 pt.; m/f: 62%/38%; age: 61 years (28–75). ECOG: 0/1: 71%/29%; Frequent concomitant diseases: arterial hypertension: n=27 (...