This regimen was provided on an outpatient basis with significant antitumor activity and without the need for indwelling catheters and seems to be feasible for patients of all ages, with acceptable toxicity.

13569 Background: The combination of 5-FU + LV with irinotecan as first line treatment of advanced colorectal cancer (ACRC) has shown higher response rate compared with 5-FU +LV with the same progression free survival. Capecitabine is more active than 5-FU.The aim of this study is to determine the side-effect profile, dose limiting toxicity and response rate to CapIri combination as first line treatment in ACRC, on an outpatient basis. Methods: Inclusion criteria: age >18–75 years, ECOG ≤ (0–3), measurable disease, no previous treatment for advanced disease, previous adjuvant chemo-therapy more than 6 months is allowed, signed informed consent and adequate hepatic, renal and hematological function. Exclusion criteria: Serious concurrent medical disorders, prior other malignancy, pregnancy or breast-feeding and patients with poor compliance. Capecitabine 1000mg/m2 twice daily was given for 14 days followed by 7 days rest and Irinotecan (100mg/m2) was given days 1 and 8. Treatment was repeated on day 2. Results: 28 patients (pts) were included. All patients were assessable for response and toxicity. Average age was 64 years, male/female ratio 20/8. Fourteen pts had liver metastases, 5 had lung and 9 had abdominal metastases. Median No of cycles was 4. Grade III and IV diarrhea was observed in 12 (44%) pts, vomiting in 9 (31%) pts, fatigue in 12 (44%) pts, grade IV leucopenia in 5 (17%) pts. Complete response was achieved in 3 (11%) pts, partial response in 15 (53%), stabilization of disease in 5 (18%) and tumor progression in 5 (18%) pts. Progression free survival is 8.4 months. Overall survival is not yet available. Conclusions: This regimen appears feasible with acceptable toxicity except for grade III diarrhea, on an outpatient treatment basis, with significant antitumor activity, without the requirement for indwelling catheters. It is also feasible for older patients. No significant financial relationships to disclose.

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