Organ preservation in rectal cancer.

Treatment of distal rectal cancer is aimed at sphincter preservation. Three trials were conducted to this purpose. They differed for T stage selection and therapy. Two of the trials are now completed, while patients are still recruited for the third trial. 21 T2 patients were selected for the first series and treated with local excision plus postoperative radiotherapy. External beam radiotherapy (ERT) was delivered at the dose of 45 Gy. Grade 3-4 (RTOG) acute toxicity was 5%; late toxicity was never observed. Sphincter function was rated as excellent or good in all patients. Sphincter preservation was achieved in 86% of cases. In the T3 FUMIR trial, 83 patients with extraperitoneal rectal cancer (T3) were treated with concomitant mitomycin C (10 mg/m2, day 1) plus 5FU (1000 mg/m2 days 1-4) plus ERT (38Gy). Grade 3-4 acute toxicity (RTOG) was 13%; late toxicity was never observed. Sphincter function was rated excellent or good in 96% of patients; sphincter preservation was achieved in 66% of patients with a lesion at less than 50 mm from the internal anal orifice. In the T3 PLAFUR trial, 19 patients with extraperitoneal rectal cancer (T3) were treated with concomitant cisplatin (60mg/m2, day 1 and 28) plus 5FU (1000 mg/m2 days 1-4 and 28-32) plus ERT (50.4 Gy). Grade 3-4 (RTOG) acute toxicity was 5%; late toxicity was never observed. Sphincter function was rated excellent or good in 93% of patients. Sphincter preservation was achieved in 73.7% of patients; in particular, in 55.6% of those with a lesion at less than 50 mm from the internal anal orifice. Combined modality therapies are showing the ability of sphincter preservation in patients with distal rectal cancer. Ongoing studies will identify the patients who are candidates for this therapeutic approach and the most suitable combined treatment.