Background & objective: It has been confirmed that calcium folinate (CF), as a chemotherapy-biochemical modulator of 5-fluorouracil (5-FU), can improve the effect of antitumor of 5-FU. But the usage and dosage of this therapy should be further studied. The purpose of this article was to study the maximum tolerated dose (MTD) and the dose limiting toxicity (DLT) of human body to simultaneously intravenous infusion of 5-FU and CF.
Methods: The cases being up to the selecting standard were treated with DDP+CF/5-FU regimen. The dose of CF and DDP for every course was fixed. The first dose of 5-FU was 500 mg x (m(2) x d)(-1),then the doses were increased by degree of 50 mg x (m(2) x d)(-1), if no severe side effect was observed, up to maximum toxicity tolerated dose. There were 3-6 cases in each degree of dose.
Results: Thirty-two cases were treated and given total 64 courses of the administration in all. The overall remission rate was 84.4%. The MTD of 5-FU was 800 mg x (m(2) x d)(-1). Mucositis and diarrhea were found to be the DLT.
Conclusion: Simultaneous continuous infusion of 5-FU and CF can enhance the dosage of 5-FU, and has a better efficacy to advanced digestive tract, head and neck cancers. So the authors recommend that the dosage of 5-FU in phase II clinical trial is 700 mg x (m(2) x d)(-1). This dose can be used for 5 consecutive days and be repeated after 3 weeks.