Phase II trial of adjuvant radiation and intraperitoneal 5-fluorouracil for locally advanced colon cancer: results with 10-year follow-up.

ABSTRACT

PURPOSE: To determine the toxicity, disease-free survival, and overall survival for patients with Modified Astler-Coller (MAC) B2-3 or C1-3 colon cancer receiving adjuvant radiation and sequential intraperitoneal 5-fluorouracil (5-FU). METHODS AND MATERIALS From August 1984 to June 1989, 45 patients were accrued to this Phase II trial and received a 21-week course of intraperitoneal 5-FU (20 mg/kg/d x 5) and external beam radiation. The radiation was delivered to the tumor bed and para-aortic lymph nodes in two split-courses of 22.5 Gy, alternating with the first two cycles of chemotherapy. All patients then received 4 additional cycles of intraperitoneal 5-FU. RESULTS: The therapy was well tolerated with 4 patients experiencing Grade 3 peritonitis. Four patients developed small bowel obstruction requiring surgery; in each instance, recurrent tumor was found at the time of laparotomy. The median and overall survivals at 10 years were 9.3 months and 53% respectively. Local failures were infrequent, occurring in only 11% of patients treated. CONCLUSIONS: Sequential intraperitoneal 5-FU and tumor-bed/para-aortic irradiation is tolerable in patients with resected colon cancer. Although the incidence of local and regional relapse appeared to be lower than anticipated, this did not appear to translate into improved survival.