First-line chemotherapy with fluorouracil and folinic acid for advanced colorectal cancer in elderly patients - A phase II study

Background: Colorectal cancer is one of the most common cancers in the elderly. Information on tolerability and efficacy of 5-Fluorouracil-based chemotherapy in such patients is limited. Primary aim of the study was to describe tolerability and activity of chemotherapy with the "de Gramont" schedule (FU bolus [400 mg/m(2)] + FU continuous infusion [600 mg/m2] + folinic acid [100 mg/m(2)] on days 1 and 2, every 2 weeks), in patients with advanced colorectal cancer aged 70 or older. Patients and methods: Patients aged 70 or more, with stage IV colorectal cancer, ECOG performance status not worse than 2. Results: Thirty-four patients were treated at two participating centers. Seven (20.6%, 95% exact CI = 8.7-37.9) had an objective response, complete in 3 and partial in 4 patients. Five cases of unacceptable toxicity were registered (2 cardiac, 1 each for liver, anemia and diarrhea). Fitting the statistical model to the observed data indicated that the treatment was sufficiently active and tolerated. Conclusions: The de Gramont scheme is active and tolerated in elderly patients with advanced colorectal cancer.