European trials with total mesorectal excision.

The outcome after surgery for rectal cancer differs markedly between patient series regarding local recurrence rates and survival. A high incidence of local recurrence is associated with conventional, nonstandardized procedures. To improve results of surgery, various additional treatments, such as radiotherapy, chemotherapy, and immunotherapy, have been tested. The Swedish Rectal Cancer Trial (SRCT) was the first trial to show that better local control achieved with preoperative radiotherapy resulted in improved survival. In recent years local control and survival have been further improved by the introduction of standardized total mesorectal excision (TME) surgery. A major problem of published studies on adjuvant therapy is that surgery was not standardized in these studies. Furthermore, quality control of the surgical technique by standardized pathological examination of the specimen is absent in most studies. In Europe, TME has become the preferred standard of operative management for rectal cancer. Adjuvant therapy studies should now be reexamined based on a platform of standardized, optimal surgery and pathology. We studied the European trials in which TME surgery is intentionally performed. Most of these trials are still in progress, with follow-up too short for definitive results, apart from interim analyses. However, the Dutch TME trial has already shown that performing a large, multicenter trial with quality control of both surgery and pathology is feasible.