P-0300 Preoperative Concomitant Chemoradiotherapy with Capecitabine in Locally Advanced Rectal Carcinoma: Results at 3 Years

ABSTRACT Introduction Rectal cancer is a real problem of public health in the world. It represents about 40% of colorectal cancer and its treatment has greatly improved these last ten years with the surgery of the mesorectum and the neo-adjuvant and adjuvant treatments. Sphincter preservation in low rectal cancers is usually difficult and their prognostics are worse due to anatomic and non-biologic factors and tumor is just near genital organs, trend to reach them and make so surgery difficult. The appearance of new surgical techniques, better knowledge of natural history of the disease and the impact of neo-adjuvant treatments of rectal cancer are needful to make a consensual approach of rectal cancer treatment which is in continuous evolution and providing a better quality of life of patients. Methods A prospective study has been achieved with the collaboration of the Medical Oncology Department of Oran University Hospital to evaluate concomitant chemo-radiotherapy with capecitabine in neo-adjuvant setting of locally advanced non metastatic rectal cancer (low and middle rectal cancer): Primary endpoint was Response Rate (RO) and secondary endpoints were: Sphincter preservation, Quality of life, time to recurrence and global survival. Results 46 patients were enrolled between 15 May 2007 and 30 June 2010 with locally advanced rectal cancer without metastasis (T3 – T4 /N+) and treated with Capecitabine (825mg/m2) and radiotherapy (45 Gy: 2Gy/day)in neo-adjuvant setting. Surgery was performed 4 to 8 weeks later in responding patients: 65% of patients were stage IIIB and 35% stage IIIC. Median age was 58 years. Time to diagnosis was 5.7 months. Time to treatment was 1.3 months. Three cycles of Capecitabine were given with concomitant radiotherapy (45 Gy: 2Gy/Day). Objective Response was observed in 63% of patients, Complete Pathological Response was achieved in 33% of cases and Sphincter preservation was possible in 20% of patients. Main adverse effects (NCI-CTC): Neutropenia G3: 2% and Diarrhea G3: 2%. The probability of survival after thirty six months follow-up is 42%. The median duration of the survival without relapse is 37.4+0.5 months. Conclusion Concomitant Chemo-radiotherapy with Capecitabine is an effective regimen with an acceptable safety profile for locally advanced rectal cancer leading to a high probability of tumor down staging and sphincter preservation.