Evaluation of Response, Tolerability and Toxicity of New Chemotherapeutic Regimen in Advanced Gastric Cancer

Background: this study testing the effectiveness, toxicity and tolereability of new chemotherapeutic regimen (consist of irinotecan 5-fu and leucovorin) in locally advanced and metastatic gastric cancer.patients and methods: patients with locally advanced gastric cancer (at least stage 3) or metastatic gastric cancer that no treated previously with chemotherapeutic agents entered onto this study. treatment consist of 6-12 cycles (every 2 weeks) with irinotecan (cpt-11) 140mg/m2 iv, lecovorin 100mg/m2 iv, followed by 5-fu 400mg/m2 (in4hours) and then 5-fu 1200m2 (ci in 48h), all cycles given every 2 weeks and repeated at least for 6 cycles(6-12 cycles). results: ten (10) patients were enrolled and eligible patients received this protocol therapy. the over all response rate was 60% and 10% complete response, and 50% with partial response and 10% stable disease. median survival was 13 months and median event free survival was 8 months. the major toxicity was neutropenia (grade 4) in 3 cases (30%), that two cases died in neutropenic sepsis feature. grade 4 anemia was observed in one case that needs to transfusion therapy. other mild side effect and toxicity of this protocol therapy were: grade 1 neutropenia (10%), mild thrombocytopenia (10%),mild diarrhea (40%)mild nausea and vomiting (60%)and lethargia and mucositis were not seen. conclusion: this protocol consist of irinotecan iv bolus that followed with leucovorin and 5-fu in 4h and then 5-fu in 48h ci is very active in patients with locally advanced and metastatic gastric cancer. diarrhea and mucositis were less than other reports. future trials in large series need to documented effectiveness and tolereability and toxicity of this new protocol.