Randomized phase III trial in elderly patients comparing LV5FU2 with or without irinotecan for first-line treatment of metastatic colorectal cancer (FFCD 2001-02)
Four arms were randomly assigned to receive 5-FU (5-fluorouracil)-based CT. No significant difference was observed for the median PFS. Adding irinotecan to an infusional 5-fu-based CT did not significantly increase either PFS or OS. The ORR was superior in IRI (P = 0.0003): FU 21.1% versus IRI 41.7%.
