Capecitabine, an oral 5-fluorouracil (5-FU) prodrug, is increasingly replacing intravenous i.v. 5-FU/leucovorin in colorectal cancer treatment. THE AIM of this study was to evaluate efficacy and safety of the combination chemotherapy of irinotecan plus capecitabine (XELIRI), in patients with advanced colorectal adenocarcinoma.
Patients and methods: Forty patients received first-line chemotherapy with capecitabine (1.000 mg/m2 twice daily) on days 1-14 and irinotecan (240 mg/m2) on day 1 of a 21-day cycle. Baseline characteristics: 24 men, 16 women; median age 64.5 years. Most common metastatic sites were the liver (55%), lymph nodes (45%), lung (22.5%) and bones (17.5%).
Results: There were 12 partial responses (30%), 11 cases of stable disease (27.5%), and 17 cases of disease progression (42.5%). The median survival was 16 months (range, 6-26 months) and median progression-free survival was 7 months (range, 3-14 months). Frequently encountered therapy-related events were leukopenia and gastrointestinal side effects including diarrhea.
Conclusion: XELIRI is a well-tolerated regimen, with an activity comparable to, but more convenient than, irinotecan-5-FU i.v. combinations in patients with previously untreated advanced colorectal cancer.