• Gastrointestinal Cancer Disease Site Group. Use of irinotecan (camptosar, CPT-11) combined with 5-fluorouracil and leucovorin (5FU/LV) as first-line therapy for metastatic colorectal cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Feb [online update]. 20 p. (Practice guideline; no. 2-16b). [17 references]

• It is reasonable to offer the patient a choice between irinotecan/5-fluorouracil/leucovorin (irinotecan/5FU/LV) and 5FU/LV. Survival and response improvements with irinotecan/5FU/LV must be balanced against the increased toxicity (more hair loss, diarrhea and hospitalization with irinotecan versus more mucositis without irinotecan). Excess thrombotic events are also seen with irinotecan.
• For patients offered irinotecan therapy, careful monitoring of adverse effects and early intervention for diarrhea should be part of the treatment process.

None provided

October 2001 Guideline

Two phase III randomized trials of irinotecan combined with 5-fluorouracil and leucovorin (5FU/LV) compared with 5FU/LV alone as first-line therapy in patients with metastatic or advanced colorectal cancer, a combined analysis (in abstract form) of these two phase III trials using individual patient data, a U.S. Food and Drug Administration review of both phase III trials (available on the internet), and two phase II randomized trials (both abstracts) were reviewed.

February 2003 Update

Four phase III trials comparing irinotecan containing regimens with other treatments were obtained. The first study compared irinotecan/5FU/LV versus methotrexate/5FU/LV. The second compared irinotecan/5FU/LV versus Oxaliplatin/5FU/LV. The third and fourth studies compared irinotecan/5FU/LV to two different 5FU/LV regimens (AIO and MAYO).

• Gastrointestinal Cancer Disease Site Group. Use of irinotecan (camptosar, CPT-11) combined with 5-fluorouracil and leucovorin (5FU/LV) as first-line therapy for metastatic colorectal cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2003 Feb [online update]. 20 p. (Practice guideline; no. 2-16b). [17 references]

Not applicable: The guideline was not adapted from another source.

2001 Oct 23 (updated online 2003 Feb)

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

The Practice Guidelines Initiative (PGI) is the main project of the Program in Evidence-based Care (PEBC), a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

Cancer Care Ontario, Ontario Ministry of Health and Long-Term Care

Provincial Gastrointestinal Cancer Disease Site Group

Members of the Gastrointestinal Cancer Disease Site Group (DSG) disclosed potential conflict of interest information.

None available

This summary was completed by ECRI on July 19, 2002. The information was verified by the guideline developer on August 19, 2002. This summary was updated on August 6, 2003. The updated information was verified by the guideline developer on September 2, 2003.