A phase III trial showed that irinotecan (Camptosar®)/5-FU/LV (IFL) showed no improvement in overall survival and failure-free survival compared to 5-FU/LV in patients with stage III colon cancer. Furthermore, Camptosar®/5-FU/LV was associated with a greater degree of neutropenia, neutropenic fever, and death on treatment compared to 5-FU/LV. These results were presented in a late-breaking oral abstract at the 40th annual meeting of the American Society of Clinical Oncology held in New Orleans LA, June 4-8, 2004.

This trial involved 1264 patients who had Tx/N1-3/M0 disease. After a median follow-up of 2.6 years, which included 67% of expected deaths and 85% of total expected failures, IFL showed no improvement of 5FU/LV in either overall survival (p=0.88) or failure-free survival (p=0.84). The researchers concluded that weekly IFL should not be used in the management of stage III colon cancer.

Reference: Saltz LB, Niedzwiecki D, Hollis D, Goldverg RM, et al. Irinotecan plus fluorouracil/leucovorin (IFL) versus fluorouracil/leucovorin along (FL) in stage III colon cancer (Intergroup trial CALGB C89803). Proceedings from the 40th annual meeting of the American Society of Clinical Oncology, held in New Orleans LA, June 5-8, 2004; Abstract #3500.