Original Guideline: April 1999
A search of MEDLINE, CANCERLIT, and the Cochrane Library was conducted for the period from January 1992 to January 1999 using the subject headings "camptothecin", "colonic neoplasms", "rectal neoplasms", and "colorectal neoplasms". Information was requested from Pharmacia & Upjohn, Inc., Canada, the manufacturer of irinotecan. Roussell Laboratories provided data from two randomized controlled trials (RCTs) relating to the adverse effects of irinotecan. Furthermore, personal reprint files, referenced articles, and proceedings of conferences, including the 1998 American Society of Clinical Oncology meeting, were reviewed. The Physician Data Query database was searched for relevant ongoing clinical trials.
July 2004 Update
The original literature search was updated using MEDLINE (through to June [week 2], 2004), EMBASE (through to week 25, 2004), CANCERLIT (through to October 2002), the Cochrane Library (through to Issue 2, 2004) databases. Abstracts published in the 1999 through 2004 proceedings of the annual meeting of the American Society of Clinical Oncology have been searched for evidence related to this practice guideline. The National Cancer Institute (NCI) clinical trials database was searched for relevant trial reports. The most recent literature search was performed on June 24, 2004.
Inclusion Criteria
Original Guideline: April 1999
Articles were selected for inclusion in this systematic review of the evidence is they met the following criteria:
- Articles or abstracts detailing phase II or III trials of irinotecan in patients with metastatic colorectal cancer and articles or abstracts discussing the adverse effects associated with the drug
- Only studies that reported results for the major outcomes of interest (objective response rates, duration of response or progression-free survival, adverse effects, symptom improvement, quality of life, and overall survival) were eligible for review.
July 2004 Update
Since the Practice Guidelines Coordinating Committee (PGCC) approval and subsequent publication of the original guideline, a companion Gastrointestinal Cancer Disease Site Group (DSG) practice guideline detailing the use of irinotecan combined with 5-fluorouracil/leucovorin (FU/LV) as first-line treatment has also been completed. Therefore, the updated literature search for this guideline was limited to peer-reviewed abstracts, fully published randomized controlled trials, and meta-analyses using irinotecan alone or in combination with other drugs as second-line treatment only.