Resectability of liver metastases (LM) in patients with advanced colorectal cancer (ACRA) after treatment with the combination of oxaliplatin (OXA), irinotecan (IRI) and 5FU. Final results of a phase II study

3618 Background: OXA, IRI and 5FU have shown its efficacy in ACRC. The synergism of these three drugs has been shown in vitro and in vivo models. The purpose of this trial was to determine the response rate of the triple combination of OXA+IRI+5FU and to assess prospectively its impact on secondary resectability of previously non-resectable LM. Methods: 47 patients were included in the trial after signature of IRB-approved informed consent. All patients received OXA (85 mg/sqm) + IRI (150 mg/sqm) + 5FU (2250 mg/sqm in 48 h CI - TTD scheme) on D1 every 15 days, according to the recommended dose obtained from the phase I part of the trial (Anti-Cancer Drugs 2004, 15;469–471). Results: Male/female: 28/19, Median age 61.6 years (31–75), ECOG 0/1/2: 26/20/1. Efficacy and safety have been analyzed from a total of 489 cycles, being the median number of cycles per patient 11 (1–18). Grade 3–4 toxicities per patient were: neutropenia (40%), febrile neutropenia (4%), diarrhea (18%), nausea/vomiting (11%/15%), fatig...