Clinical study of 5-Fluorouracil and l-Leucovorin therapy for 56 patients with advanced recurrent colorectal carcinoma]

We have experienced 56 cases of advanced and recurrent colorectal carcinoma treated with 5-Fluorouracil (5-FU)/l-Leucovorin (LV) therapy from January 2000 to March 2005. The RPMI regimen was employed, but 5-FU was administered at the dose of 500 mg/body for the first cycle and 750 mg/body for subsequent cycles, thanks to its safety, economy, and simplicity. l-LV was administered at 375 mg/body for all cycles. An average of 3.6 cycles were given, and the average 5-FU dose was 427.7 mg/m(2). The probability of the toxicities (Grade 3 or 4) tended to be less frequent compared with that observed in multi-center cooperative studies in Japan, although the frequency of nausea and vomiting was similar. Responses were CR 0/56, PR 16/56, NC 23/56, and PD 17/56, and the overall response rate was 28.6%. The median progression-free survival time was 6.0 months, and the median overall survival time was 14.0 months, which was longer than that achieved in multi-center studies in Japan. These data suggest that new regimens such as FOLFOX 4 and infusional 5-FU/l-LV therapy can be administered at lower doses of anti-cancer drugs with less toxicity and possible longer survival time.