Long-term results of preoperative 5-fluorouracil-oxaliplatin chemoradiation therapy in locally advanced rectal cancer.

ABSTRACT

AIM: To evaluate the activity, safety and long-term survival of patients after preoperative oxaliplatin and 5-fluorouracil chemoradiation therapy in locally advanced rectal cancer (LARC). PATIENTS AND METHODS: Patients with resectable, T3-4 and/or nodal involvement rectal adenocarcinoma were treated with oxaliplatin 60 mg/m(2) weekly and 5-fluorouracil 200 mg/m(2)/d infused continuously for five days, over a period of five weeks, and radiotherapy (45 Gy/25 fractions). The primary end-point was pathological complete response (ypCR). Safety, overall survival (OS) and relapse-free survival (RFS) were secondary end-points. RESULTS: Sixty-six patients were treated. Grade 1-2 diarrhea was the most common adverse event. The ypCR rate was 16.7% (95% confidence interval=7.7-25.7%). After a median follow-up of 73.5 months, 23 patients (34.8%) had experienced relapse. Five-year actuarial RFS and OS rates were 64% and 73%, respectively. Five-year actuarial RFS was 91.7% in the ypCR group versus 57.8% in non-ypCR cases. CONCLUSION: Long-term local control and survival after this very well-tolerated regimen appear encouraging.