Seium Y et al. (2005) Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I–II study. Ann Oncol 16: 762–766

Results of a phase I–II study from Switzerland have demonstrated the safety and efficacy of OCFL—a combination of oxaliplatin, irinotecan and 5-fluorouracil/leucovorin—in patients with metastatic colorectal cancer.

The study included 30 patients with metastatic colorectal cancer and a performance status of ≤1, none of whom had received previous palliative chemotherapy. Patients received a weekly 24 h infusion of 5-fluorouracil (2,300 mg/m2), intravenous leucovorin (30 mg) on days 1, 8, 15 and 22, and alternating doses of oxaliplatin (on days 1 and 15) and irinotecan (on days 8 and 22). The oxaliplatin and irinotecan doses were escalated, from 70 to 85 mg/m2 and 80 to 140 mg/m2, respectively, in cohorts of between three and six patients. The treatment cycle was repeated every 5 weeks and patients received a median of 5 cycles each.

Dose-limiting toxicity was observed at dose level 3; dose level 2 (oxaliplatin 70 mg/m2 and irinotecan 100 mg/m2) was therefore recommended for phase II. The regimen was well tolerated overall, with diarrhea and neutropenia the most common grade 3 and 4 toxicities (23% and 20% of patients, respectively).

Of 28 patients with measurable disease, two achieved a complete response to treatment and 20 showed a partial response. This corresponded to an overall response rate of 78%, which is “...amongst the highest response rates ever reported for metastatic colorectal cancer”. The authors conclude that the OCFL regimen is efficient, generally well tolerated, and suitable for tumor control prior to surgical resection of metastatic lesions.