e14049 Background: To evaluate the efficacy and safety of preoperative chemoradiation with Nimotuzumab(a humanized monoclonal antibody that targets and binds to the epidermal growth factor receptor)and capecitabine in the patients with locally advanced rectal cancer. Methods: Twelve patients with locally advanced, nonmetastatic, and mid- to lower rectal cancer were enrolled. Radiotherapy was delivered at a dose of 50 Gy/25 fractions. Concurrent therapy consisted of Nimotuzumab 400 mg/m2,1 week before radiotherapy, and then Nimotuzumab 400 mg/m2/week for 5 weeks, and capecitabine 1,650 mg/m2/day for 5 days a week (weekdays only) from the first day during radiotherapy. Three weeks after the end of chemoradiation, 1 cycle chemotherapy with oxaliplatin and capecitabine(XELOX) was performed. Oxaliplatin 130mg/m2, Day1 and capecitabine 1000 mg/m2, bid, from Day 1 to Day 14. Postoperative chemotherapy after surgery followed by preoperative CRT was in all patients, The same dosage of XELOX was started within 3 to 4 weeks after surgery, repeated every 3 weeks for 6 cycles. Total mesorectal excision was performed within 6 ~ 8 weeks. The pathologic response was evaluated as study endpoint, and an additional KRAS mutation analysis was performed. Results: In total, 9 patients completed their planned preoperative chemoradiation and underwent R0 resection. The pathologic complete response rate was 33.3% (3/9), and 3 patients (33.3%) showed near total regression of tumor. Grade 3 toxicities was diarrhea (2/12, 16.7 %), No grade 4 toxicity was observed. KRAS mutations were found in 2 of 12 patients (16.7%) who had available tissue for testing. Clinical outcomes were not significantly correlated with KRAS mutation status. Conclusions: Preoperative chemoradiation with Nimotuzumab and capecitabine was active and well tolerated. KRAS mutation status was not a predictive factor for pathologic response in this study.
KRAS Mutation Status Is Not a Predictor for Tumor Response and Survival in Rectal Cancer Patients Who Received Preoperative Radiotherapy With 5-Fluoropyrimidine Followed by Curative Surgery
