Safety
deaths, cardiac arrest, colon cancer, abscess, Dukes’ B3 and C disease, pulmonary embolus, Toxicity, sepsis, ileus
POSTOPERATIVE COMPLICATIONS, WOUND INFECTION, CARDIAC ARREST, COLON CANCER, ABSCESS, PULMONARY EMBOLUS, SEPSIS, ILEUS
There were no significant differences in postoperative complications (wound infection, abscess, prolonged ileus) within 30 days of surgery, between the patients who received perioperative 5-FU and those randomized to surgery alone without perioperative chemotherapy (Table Surgical complicationsEfficacy outcomes in ITT patientsThere were seven deaths during step 1, four attributed to treatment. Of the patients randomized to perioperative 5-FU, two died from sepsis at 2 and 7 days after completing chemotherapy, and a third patient suffered a fatal cardiac arrest on day 3 of infusional 5-FU. All were considered treatment related. Two other patients died from unrelated causes, one on the last day of chemotherapy, and the other 3 weeks after completing chemotherapy. Two deaths occurred in patients randomized to arm B, one from a pulmonary embolus in the immediate postoperative period classified as treatment related. The second patient incorrectly received perioperative 5-FU and died on the last day of the infusion from a treatment-unrelated cause.After the surgery and perioperative period, the 240 patients with B2 colon cancer received no further adjuvant therapy. Of the 233 patients with Dukes’ B3 and C disease who went on to standard adjuvant therapy, 170 received adjuvant 5-FU/levamisole and 62% completed 12 months of therapy. Sixty-three patients initiated 5-FU/leucovorin and 76% completed six cycles of therapy. Toxicity and patient withdrawal or refusal were the two major reasons for discontinuation of adjuvant chemotherapy. There were four treatment-related deaths, two in patients receiving 5-FU/leucovorin and two receiving 5-FU/levamisole.