Systemic adjuvant chemotherapy can improve overall survival and reduce the incidence of distant metastases for patients with advanced colon cancer.
Dr Bernard Nordlinger and colleagues investigated survival and recurrence for patients with stage II to III colorectal cancer.
The team considered whether regional chemotherapy combined with systemic chemotherapy was more effective than was systemic chemotherapy alone.
|5-year survival was 72% for patients assigned regional and systemic chemotherapy |
The investigators also compared systemic chemotherapy with fluorouracil and folinic acid with that of fluorouracil and levamisole.
The investigative team randomly assigned 753 patients during surgery, with stage II to III colorectal cancer.
Patients were randomized either to systemic chemotherapy alone, of which 379 received fluorouracil and folinic acid in Group 1, and 374 received fluorouracil and levamisole in Group 2.
The team also randomized 748 patients to postoperative regional chemotherapy with fluorouracil followed by systemic chemotherapy and with further randomization into Groups 3 and 4.
Group 3 consisted of 368 patients who received fluorouracil and folinic acid and 380 in Group 4 received fluorouracil and levamisole.
The investigators reported that tegional chemotherapy was given intraperitoneally to 415 or intraportally to 235 patients according to institution.
The primary endpoint was 5-year overall survival whilst secondary endpoints were 5-year disease-free survival and toxic effects.
The investigative team undertook analyses by intention to treat.
The investigators reported a median follow-up of 7 years.
The 5-year overall survival was 72% for patients assigned regional and systemic chemotherapy, compared with 72% for systemic chemotherapy alone.
The team also found that 5-year overall survival for all patients assigned fluorouracil and levamisole was 72%.
In addition, the 5-year overall survival for all those assigned fluorouracil and folinic acid was 72.3%.
The team noted that the hazard ratios for 5-year disease-free survival were 0.94 for regional versus non-regional treatment.
The investigators also noted that the hazard ratios for all fluorouracil and levamisole versus fluorouracil and folinic acid were 0.92.
The team found that Grade 3 to 4 toxic effects were low in all groups.
Dr Nordlinger's team concludes, “Fluorouracil-based regional chemotherapy adds no further benefit to that obtained with systemic chemotherapy alone in patients with advanced colorectal cancer.”