Intra-operative irradiation (IORT) for primary advanced and recurrent rectal cancer: a need for randomised studies

The aim of this study was to determine the impact of intra-operative irradi ation (IORT) combined with pre-operative external beam irradiation (EBRT) a nd surgical resection in patients with locally advanced primary or recurren t rectal cancer. 64 patients with locally advanced primary cancer and 104 w ith recurrence had EBRT (46-50 Gy) before surgery. 80 patients received IOR T (median dose 15 Gy energy 12 MeV). 80 patients had R0 resections, 47 R1 a nd 41 R2 resections. More R1 resections were performed in the IORT group, m ore R0 and R2 resections in the non-IORT group. Median follow-up was around 22 months. 146 patients were resected, 22 had exploratory laparotomy. The cumulative overall survival was similar for both the IORT and non-IORT grou ps. 5-year survival for primary cancers was 48% versus 28% for recurrences. No R2 resections survived 3.5 years. 5-year-survival for R0 resections was nearly 60% and around 30% for R1 resections. The survival curves of the pa tients given and not given IORT treatment was not statistically different w hen R0, R1 and R2 resections were analysed separately. IORT did not seem to influence the local recurrence rate when R0 and R1 resections were analyse d separately or in a multivariate analysis. The IORT and non-IORT groups we re not identical with regard to type of cancer and R-stage. Still the lack of an identifiable impact of IORT suggests that there is a need for randomi sed studies of the IORT effect. (C) 2000 Elsevier Science Ltd. All rights r eserved.