Clinical outcome of neoadjuvant chemoradiation therapy with oxaliplatin and capecitabine or 5-fluorouracil for locally advanced rectal cancer.

BACKGROUND AND OBJECTIVES: This study evaluated the safety and efficiency of preoperative chemoradiation therapy (CRT) with the XELOX or FOLFOX regimen in locally advanced rectal cancer patients.
METHODS: One hundred forty-four patients (T3/T4 or N+) were enrolled between 2005 and 2011. The patients received preoperative concomitant CRT (XELOX or FOLFOX regimen). Patients were divided into four groups: pCR (pT0N0), downstaging, no-downstaging, and progression group. Clinical outcome with overall survival (OS) and disease-free survival (DFS) were compared for each group.
RESULTS: One hundred thirty-eight patients received radical resection after preoperative CRT. Twenty-seven patients (20%) achieved pCR. The response rate (pCR + downstaging) was 67%. The most common side effects were nausea (64%), diarrhea (49%), and leucopenia (49%). The overall estimated 5-year OS was 86% for all patients. The estimated 5-year OS was significantly better in the responders (pCR + downstaging) than the non-responders (no-downstaging + progression, 94% vs. 68%, P = 0.001). There was also statistical difference in 3-year DFS between the two groups (93% vs. 68%, P = 0.000).
CONCLUSIONS: pCR and downstaging after neoadjuvant CRT are associated with improved survival for locally advanced rectal cancer patients. Preoperative CRT with the XELOX or FOLFOX regimen is well tolerated and has mild adverse events.