ABSTRACT
Background and purpose:Advanced and metastatic colorectal cancer is the second leading cause of cancer death. In the past ,the standard treatment for patients with advanced CRC was fluorouracil(5-FU) biochemically modulated by leucovorin(LV), which demonstrated a response rate of about 23% .In 1990s, a number of new treatment options have been available. In particular, one new cytotoxic agent ,irinotecan (CPT-11), which is a specific inhibitor of topoisomerase I, have been proven to have efficacy in the tretment of CRC .Furthermore, several first-line phase Ⅲ trials show a significant improvement in result with the addition of CPT-11 to FU-LV combination therapy (FOLFIRI).We observed the survival situation, efficacy and safety of irinotecan plus 5-FU/LV after first-line chemotherapy failure for Chinese patients with advanced or/and metastatic colorectal cancer. Methods:Twenty-four patients with metastatic colorectal cancer whose disease had progressed after treatment with first-line oxaliplatin or other chemotherapeutics were included to receive biweekly FOLFIRI regimen (irinotecan 180mg/m~ 2 on day 1,with LV 200mg/m~ 2 adiministrated as a 2-hour infusion before 5-FU 400mg/m~ 2 administrated as an intravenous bolus injection and FU⒉4g/m~ 2 as 46-hour infusion immediately after 5-FU bolus ).All the patients were planned to receive at least 6 cycles of chemotherapy .They were assessed on the basis of WHO evaluation standard of objective therapeutic effect for solid tumor.Results:24 patients were assessable to observe the efficacy and safety. No case was CR.5 case were PR, response rate was 20% (5/24). 17 case were SD , rate was 70% (17/24). 2 case were PD, rate was 8%(2/24). Median time to progression (TTP) were 6.6 months (6 to 24 months ),median overall survival was 10.7 months. The majority of adverse reaction were nausea, vomiting, anorexia, diarrhea, leucopenia, alopecie. Most of them were Ⅰ/Ⅱ degree, only 6 cases reached III/IV degree. 3 cases had diarrhea with leucopenia and fever.Conclusions:The biweekly regimen of irinotcan in combination with 5-FU/LV results in significant and clinically meaningful improvement in survival and quality of life among patients with metastatic colorectal cancer. Toxicity is manageable.