Biochemical modulation of fluorouracil with high dose methotrexate or folinic acid in advanced colorectal cancer patients. Gruppo Oncologico dell' Italia Meridionale (GOIM)
Colucci, G.; Maiello, E.; Leo, S.; Giuliani, F.; Pedicini, A.; Pezzella, G.; Valori, V.; Galetta, D.; Contillo, A.; Prete, F.
Anticancer Research 14(5b): 2157-2162
1994
ISSN/ISBN: 0250-7005 PMID: 7840516 Document Number: 423706
To compare the efficacy of two biochemical modulations of 5-Fluorouracil in advanced colorectal cancer, 104 patients were randomized to receive high dose methotrexate followed by 5-Fluorouracil and leucovorin rescue on day 1 (Arm A) or folinic acid and 5-Fluorouracil on day 1 to 5 (Arm B). Both treatments were repeated every 3 weeks. In the 92 evaluable patients, objective responses were observed in 34% in Arm A and 31% in Arm B, with a median duration of 7.5 and 8.5 months, respectively. Median overall survival was similar in both groups (12 versus 13 months, respectively). A statistically significant difference was found only between responders and non responders of group B (p = 0.004). Toxicity was mild. In conclusion, no difference in therapeutic activity was seen between the two treatments and additional biochemical modulation must be evaluated.