Evaluation of capecitabine and oxaliplatin administered prior to and then concomitant to radiotherapy in high risk locally advanced rectal cancer.

ABSTRACT

BACKGROUND AND OBJECTIVES: Systemic failure remains a predominant issue in locally advanced rectal cancer (LARC). A new strategy using capecitabine and oxaliplatin (XELOX regimen) administered prior to and then concomitant to radiotherapy for high risk LARC is developed in our practice. The aim of the present study was to evaluate the short-term efficacy and toxicities of this strategy. METHODS: Patients were treated with one cycle XELOX regimen (oxaliplatin 130 mg/m(2) on day 1 with capecitabine 1,000 mg/m(2) twice daily for 14 days every 3 weeks), followed by chemoradiation (50 Gy over 5 weeks) with modified XELOX regimen (oxaliplatin dose reduction to 100 mg/m(2)), and total mesorectal excision. Tumor response, toxicities, and surgical complications were recorded. RESULTS: Forty-two patients treated with the strategy were identified. All patients completed planned dose of induction chemotherapy and concurrent chemoradiotherapy. Grade 3 toxicities were thrombocytopenia (4.8%), diarrhea (7.1%), proctitis (4.8%), and radiation dermatitis (7.1%). Five patients (12.5%) developed postoperative complications. Pathologic complete response (pCR) and nearly pCR were achieved in 7 (15.0%) and 13 patients (35.0%). CONCLUSIONS: The preliminary results suggest that induction chemotherapy followed by chemoradiotherapy with capecitabine and oxaliplatin in LARC is well tolerated. The strategy achieves favorable short term outcome in terms of pCR and nearly pCR rate, which warrants further investigation.