Background: Palliative chemotherapy remains a challenge for oncologists. The combination of high dose folinic acid (HDFA) with 5-fluorouracil (5-FU) improves response rates, as do continuous infusions of 5-FU. These protocols have limiting toxicities such as diarrhea, stomatitis, and leukopenia. Another schedule of 5-FU and folinic acid has proven effective and is very well tolerated. The results of a similar regimen are reported.
Methods: Eighty-six eligible patients with evolutive advanced colorectal cancer were treated, after informed consent was obtained, with chemotherapy consisting of HDFA (200 mg/m2 in a 2-hour infusion, followed by 5-FU (400 mg/m2 IV bolus injection, then 600 mg/m2 in a 22-hour infusion) on days 1 and 2, every 15 days. Seven of 86 had received prior therapy for metastatic disease.
Results: Two complete and 31 partial responses were noted for an overall response rate of 38.3% (95% confidence interval, 0.25-0.45). Toxicity was low, as more than 60% of the patients had no or minor toxicity. Grade III or IV World Health Organization toxicities included stomatitis (7 patients), leukopenia (3 patients), diarrhea (2 patients), and cardiac toxicity (3 patients). The overall median survival was 10.3 months, and for those having a response, 17.1 months.
Conclusions: High dose folinic acid combined with 5-FU bolus and continuous infusion for 2 days every 2 weeks is an effective regimen. Its toxicity appears low. Moreover, this chemotherapy is feasible on an outpatient basis.