OBJECTIVETo investigate the toxicity and safety of FOLFOX regimen concurrent with radiotherapy in neoadjuvant setting in patients with low rectal cancer.

METHODSFifty-six patients with stage T(3-4)N(0)M(0) and T(1-4)N(1-2)M(0) were eligible from Aug. 2004 to Jul. 2007. Upon entry the study, they received 4 cycles of chemotherapy with FOLFOX regimen. Radiotherapy was added from the second cycle of chemotherapy (CT). The total dose of radiotherapy (RT) was 46 Gy (2 Gy x 23). Total mesorectal excision (TME) was performed 4-8 weeks after RT.

RESULTSAmong them, 54 cases received 4 cycles of CT, 1 patient stopped CT after the second cycle of CT because of unrecovery from neutropenia. One patient stopped chemoradiotherapy(CRT) because of complicating with active pulmonary tuberculosis after 2 cycles of CT and 10 times of RT. Two occurred liver, lung and bone metastases after CT. Totally 220 cycles of CT were administrated. Fifty-two patients received operation after CRT, 50 with anal interior sphincter reservation, 19 with prophylactic ileac stoma. Anastomotic leakage occurred in 2 patients after operation, and rectal vaginal fistula in 2 patients 1 month after operation. According to the pathologic results, 7 patients achieved complete response, 41 partial response, 4 stable disease, and the objective response rate was 85.7%.

CONCLUSIONConcomitant treatment of FOLFOX regimen and RT in neoadjuvant setting of rectal cancer was safe and tolerable, and it suggests that protective ileostomy for anastomotic leakage following anus-preserving operation should be performed.