Aims and Background: To date adjuvant treatments of rectal cancer gene
rally include radiotherapy and more recently a combination of radiothe
rapy and chemotherapy. Trials have benn generally restricted to patien
ts with stage II and III rectal cancer. The purpose of the present stu
dy is to determine the efficacy of a preoperative combination of radia
tion therapy and chemotherapy in operable locally advanced rectal canc
er. Methods: From March 1990 to June 1994, 58 patients with histologic
ally documented adenocarcinoma of the rectum entered our protocol. 35
neoplasms were located in the lower third of the rectum and the remain
ing 23 in the middle third. At pre-treatment clinical staging 46 tumor
s were judged as stage III and 12 as stage II. Chemotherapy and radiot
herapy were started jointly on day one of the treatment. Mitomycin-C w
as given as a bolus intravenous at a dosage of 10 mg/m2, the first day
. 8-Fluorouracil was given in a dosage of 1000 mg./m(2)/day as a conti
nuous 24 h infusion for 4 days. Radiation therapy was given at a total
dosage of 37.8 Gy. Surgery was generally performed four to five weeks
following completion of the radiation therapy. Results: Patients comp
liance to the treatment was 96 percent. A reduction of tumor size > 50
percent was observed in 65 percent of patients. Tumor distance from a
nal canal increased in 75 percent of patients. Morbidity rate was 31 p
ercent; no postoperative mortality was reported. Histological examinat
ion of surgical specimens showed that in 54 percent of patients tumor
disappeared or was confined to the rectum; there was no evidence of tu
mor cells in 5 cases and stage I lesions were diagnosed in 19 cases (3
5 percent). Preliminary data on recurrences show a 5 percent local rec
urrence rate and a 7 percent distant metastases rate. Conclusions: It
may be concluded that preoperative radiochemotherapy is generally well
tolerated; surgery does not present additional technical difficulties
; the effect of stage reduction has been observed in a consistent numb
er of cases.