Irinotecan and high-dose fluorouracil/leucovorin for metastatic colorectalcancer

Two randomized phase III trials with irinotecan as second-line treatment of metastatic colorectal cancer have shown that irinotecan (CPT-11, Camptosar ) significantly improves survival when compared with best supportive care o r continuous infusion of fluorouracil (5-FU) after failure of 5-FU. The com bination of irinotecan and 5-FU/leucovorin produced a significantly higher response rate (40.8% vs 23.1%, P <.001), longer time to progression of dise ase (6.7 vs 4.4 months, P <.001), longer median survival (17.4 vs 14.1 mont hs, P =.03), and a greater chance of survival at 1 year (69% vs 59%, P =. 0 3) than 5-FU/leucovorin treatment alone, Such benefits have not previously been demonstrated in this setting. Although the use of irinotecan in combin ation with 5-FU/leucovorin increased the likelihood of neutropenia, the inc idence of febrile neutropenia and infection remained low. Other toxic effec ts were manageable, noncumulative, and reversible.