Phase II Trial of Capecitabine/Irinotecan and Capecitabine/Oxaliplatin in Advanced Gastrointestinal Cancers

摘要: Combination protocols of 5-fluorouracil/leucovorin (5-FU/LV) plus irinotecan or oxaliplatin have demonstrated high activity in metastatic colorectal cancer. Capecitabine, an oral 5-FU prodrug, may replace infusional 5-FU/LV combination with oxaliplatin. We therefore initiated a phase II study capecitabine either to determine the efficacy and toxicity specific patients advanced gastrointestinal (GI) tumors. Capecitabine 1000 mg/m(2) taken orally twice day on days 1-14, 70 1 8, 100 8; repeated every 3 weeks outpatient setting. Patient tumor characteristics were as follows: median age, 68 years (range, 34-77 years); sex: 10 women, 33 men; types: 35 cancer; 8 other GI tumors including 5 gastric, 2 pancreatic, duodenal All 43 treated evaluable for (capecitabine/oxaliplatin, 24 patients; capecitabine/irinotecan, 19 patients), 39 22; 17). Grade 3/4 toxicities (National Cancer Institute Common Toxicity Criteria Version 2.0) limited diarrhea, 9 (capecitabine/irinotecan, n = 5; capecitabine/oxaliplatin, 4); hand-foot syndrome, patient (capecitabine/irinotecan); nausea, (capecitabine/oxaliplatin); vomiting, peripheral neuropathy, (capecitabine/oxaliplatin). No grade myelosuppression was noted protocol. Capecitabine/irinotecan capecitabine/oxaliplatin significant clinical cancer cancers first-line salvage therapy. Capecitabine/oxaliplatin capecitabine/irinotecan show excellent safety profile The main both arms manageable diarrhea. This trial served basis randomized multicenter comparing therapy