Randomized controlled trial of postoperative radiotherapy and short-term time-scheduled 5-fluorouracil against surgery alone in the treatment of Dukes B and C rectal cancer

Abstract

Background The purpose of the present study was to investigate whether a 1-month regimen of postoperative radiotherapy combined with 5-fluorouracil could reduce the local recurrence rate and improve survival in patients with Dukes B and C rectal cancer. Methods One hundred and forty-four patients were randomized to surgery alone or surgery combined with postoperative radiotherapy (46 Gy) and bolus 5-fluorouracil 30 min before six of the radiotherapy fractions. One hundred and thirty-six patients were eligible. Results The adjuvant treatment was well tolerated. After an observation time of 4–8 years, patients in the adjuvant treatment group had a cumulative local recurrence rate of 12 per cent compared with 30 per cent in the group that had surgery only (P= 0·01). The 5-year recurrence-free and overall survival rate was 64 per cent in the adjuvant group compared with 46 per cent (P = 0·01) and 50 per cent (P = 0·05) respectively in the surgery group. The adjusted relative risk of recurrence and death for the adjuvant group was 0·48 (95 per cent confidence interval 0·28–0·82) and 0–56 (0·33–0·94) respectively. Conclusion The 1-month postoperative combination regimen improved treatment results in patients with Dukes B and C rectal cancer, in terms of local recurrence rate, recurrence-free survival and overall survival, without serious side-effects.