Adjuvant oral uracil and tegafur (UFT) improves survival after complete mesorectal excision (ME) for pathologic TNM stage III rectal cancer (RC): Results of the National Surgical Adjuvant Study (NSAS)-Colorectal Cancer (CC) 01 randomized trial

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Abstract
3524 Background: Optimal surgery and optimal adjuvant therapy for stage III RC have not been established yet. Although ME and preoperative radiotherapy are becoming standard practices for RC in the Western countries, ME for clinical stage I RC and ME with extended lateral pelvic lymph node dissection (ELPLND) for clinical stage II or III RCs have been standard practices in Japan. Methods: NSAS-CC01 is a randomized trial comparing postoperative adjuvant oral UFT (400 mg/m2/day for 5 days every 7 days for 1 year) after complete ME, versus complete ME alone in terms of relapse-free survival (RFS) and overall survival (OS). The patients who underwent ME or ME plus ELPLND with microscopic negative margins for pathologic stage III RC (PS 0–2, age 20–75 years, no other adjuvant therapy) were eligible for this trial. Extent of resection was determined by preoperative and intraoperative assessments of tumor location and stage according to the guidelines of the Japanese Society for Cancer of the Colon and Rectum. Extent of resection was documented, and pathologic examination was done according to the guidelines. Results: During 1996 to 2001, 276 (140 UFT, 136 surgery alone) patients were allocated from 28 institutions using a randomization center. Pretreatment characteristics were well balanced between the two groups; median age 58 years, male in 60%, the lower RC in 40%, pT3/T4 RC in 80%, ME with ELPLND in 38% of patients. 75% UFT patients completed more than 84% of scheduled doses. Grade 2 and Grade 3 events were observed in 65% and 17% of UFT patients, respectively. Due to them, 18 patients (13%) stopped UFT intake. Planned interim analysis in 2003 (median follow-up: 3 years) revealed significant prolongation of RFS (P=0.001) and OS (P=0.005) in the UFT group. Three-year RFS rate and OS rate were 78% and 91% in the UFT group, and 60% and 81% in surgery-alone group, respectively. Local recurrence rates were low in both groups (UFT 6%, surgery alone 10%). Conclusions: Adjuvant oral UFT improves survival after complete ME for pathologic stage III RC. No significant financial relationships to disclose.

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