The role of pre-operative adjuvant therapy in the management of borderline operability rectal cancer.

One hundred and forty-three patients with potentially operable primary rectal cancer (of stage T2, T3 and T4), were allocated to one of three regimens of therapy, i.e. surgery only (S), pre-operative radiotherapy followed by surgery (R), or pre-operative radiotherapy combined with daily intravenous fluorouracil during the first 4 days of irradiation followed by surgery (C). The adjuvant therapy was well tolerated. It had no adverse effects on surgical procedures or morbidity. There was improvement in the resectability rate C greater than R greater than S, and reduction in the incidence of Duke's C category in the surgical specimens C less than R less than S. Five-year follow-up analysis showed marked differences in the local control rates, and a reduced incidence of liver metastases in group C. There was no significant difference in survival overall between the three treatment groups, but when patients with T3 and T4 tumours were analysed separately there was a statistically significant improvement 5-year survival in group C (P less than 0.01) when compared to group S, while group R gave a marginally significant result when compared to group S (P=0.05).