Weekly oxaliplatin (OXA), 5-fluorouracil (FU) and leucovorin (LV) as first line treatment for advanced colorectal cancer (CRC) –A phase II study

Background: OXA has previously shown high efficacy in metastatic colorectal cancer when combined with 5FU/LV, mainly as a FOLFOX schedule. This phase II clinical study was designed to evaluate the efficacy and toxicity of a different OXA-5FU/LV schedule, as first line treatment of advanced colorectal cancer. Methods: Forty-five patients with advanced CRC (median age 69 years, range 50–80, 34 males, 11 females were included. Sites of metastases included liver 25 (55.6%), lymph nodes 14 (31.1%), pelvis 12 (26.7%), peritoneum 11 (24.4%), other 9 (20.0%). Eleven patients had received prior adjuvant chemotherapy, and two radiotherapy outside of the target lesions. The regimen consisted of 200 mg/m2 LV (2h i.v.), 450 mg/m2 5-FU (bolus), and 45 mg/m2 OXA (2h i.v.), weekly for 6 weeks as induction therapy and then weekly for 3 weeks with 1 week rest until progression or unacceptable toxicity. Results: All patients were evaluable for response and toxicity. Grade 3–4 toxicities were: neurotoxicity (4%), diarrhea (4%), leucopenia (2%), nausea/vomiting (2%) and allergy (2%). Dose reductions were necessary in 14 of 45 patients (31.1%) and treatment was early interrupted in 3 of 45 patients (2 progressive disease and 1 death due to acute myocardial infarction). Complete response was observed in 4/45 (8.9%), partial response in 11/45 (24.4%) for a response rate of 33.3%. At a median follow-up of 19 months, 29 patients had relapsed (64.5%). Median time to progression was 13.4 months [95% CI: 10.6–18.2], and median survival 20.4 months [95% CI: 17.2–28.2]. Conclusions: This schedule is highly effective as first line treatment for advanced CRC. It is a feasible, well-tolerated regimen, with low incidence of G3–4 toxicities. Further evaluation is warranted. No significant financial relationships to disclose