Capecitabine/ irinotecan (CapIri) and capecitabine/oxaliplatin (CapOx) are active second-line protocols in patients with advanced colorectal cancer (ACRC) after failure of first-line combination therapy: Results of a randomized phase II study

3534 Background: Previously, we reported the interim results of a randomized phase II trial with CapIri vs CapOx as first-line therapy in ACRC (Grothey et al., ASCO 2003). The study protocol included a recommended cross-over as second-line therapy. Here we present the results of CapIri and CapOx as second-line treatment in patients with ACRC, pretreated with a capecitabine-based combination regimen. Methods: Treatment protocols consisted of capecitabine 1000 mg/m2 bid d1–14 plus irinotecan 100 mg/m2 iv d1,8 or oxaliplatin 70 mg/m2 iv d1,8; qd 22. A total of 161 patients (pts) were initially randomized in the phase II trial, of which 68 received CapOx or CapIri as 2nd-line therapy within the protocol (33 pts CapOx after CapIri, 35 pts CapIri after CapOx). Results: NCI-CTC grade 3/4 toxicities for 2nd-line therapies (CapIri vs CapOx): anemia 2.7% vs 6.0%, thrombocytopenia 8.1% vs 3.0%, diarrhea 10.8% vs 0%, nausea/vomiting 0% vs 3.0%, infection 2.7% vs 3.0%, bilirubin 8.6% vs 6.4%; HFS grade 2/3 13.5% vs 3....