Preoperative chemoradiotherapy with 5-fluorouracil and oxaliplatin for locally advanced rectal cancer: long-term results of a phase II trial

The aim of this study was to report long-term results of patients with locally advanced rectal cancer treated by neoadjuvant chemoradiotherapy with fluorouracil, leucovorin, and oxaliplatin. From February 2002 to November 2006, a total of 58 patients with locally advanced rectal cancer were recruited. Secondary endpoints included the cumulative incidence of local and distant recurrences, disease-free survival, and overall survival. The median follow-up time was 138 months (109–151 months). The cumulative incidence of local recurrence at 10 years was 12.1 %. The cumulative incidence of distant recurrence at 10 years was 53.4 %. The overall survival in the intention-to-treat population was 39.5 % at 10 years. Disease-free survival in the intention-to-treat population was 41.8 % at 10 years. Univariate analysis revealed that pathologic complete response was associated with local recurrence, distant recurrence, disease-free survival, and overall survival ( p