Aims: The usefulness of oxaliplatin(L-OHP)as adjuvant chemotherapy for Stage III colon cancer has been shown in clinical trials, such as the MOSAIC trial. The Leucovorin, fluorouracil, and oxaliplatin(FOLFOX)regimen has been recommended as adjuvant chemotherapy for colorectal cancer in Japan. In the MOSAIC trial, 74.7% of patients completed all planned treatment cycles. Neurological toxicity caused byL -OHP is one of the factors for discontinuing treatment. Therefore, we planned to administer FOLFOX4 as postoperative adjuvant chemotherapy and evaluated the safety and feasibility of this regimen.
Methods: From November 2009, 13 patients with Stage III colon cancer who had undergone complete resection of a primary tumor were enrolled. Patients received 4 cycles of FOLFOX4, followed by 4 cycles of the simplified fluorouracil and Leucovorin (LV5FU2)regimen and 4 additional cycles of FOLFOX4(12 cycles in total).
Results: Thirteen patients were treated with our FOLFOX4 regimen. In total, 11 patients(84.6%)completed all 12 planned treatment cycles. The median L-OHP dose per patient was 560mg/m / 2(compared with the per-protocol 12-cycle dose of 680 mg/m2). Grade 1 neurological toxicity during treatment was reported in 10 patients(76.9%). Neurological toxicity was reduced during the 4 cycles without L-OHP.
Conclusion: Our FOLFOX4 regimen showed reduced neurological toxicity compared to other trials and can be used safely.