Bimonthly high dose leucovorin and 5-fluorouracil 48-hour continuous infusion in patients with advanced colorectal carcinoma

作者：Karine Beerblock, Yves Rinaldi, Thierry Andr�, Christophe Louvet, Éric Raymond, Christophe Tournigand, Élisabeth Carola, Roger Favre, Aimery de Gramont, MARCEL KRULIK, for the Groupe d'Etude et de Recherche sur les Cancers de l'Ovaire et Digestifs (GERCOD) · 发表于：Cancer · 年份：1997 · DOI：10.1002/(sici)1097-0142(19970315)79:6<1100::aid-cncr7>3.0.co;2-j · 被引用次数：31 · 研究领域：Colorectal Cancer Treatments and Studies、Colorectal Cancer Surgical Treatments、Genetic factors in colorectal cancer

BACKGROUND: It has been suggested that there is a relationship between 5-fluorouracil (5-FU) dose levels and response rates. A bimonthly 2-day regimen of leucovorin (LV) and 5-FU bolus plus infusion has been found to be superior to a monthly 5-FU bolus with low dose LV. Based on these reports, a first-line Phase II study was performed in 101 patients with advanced colorectal carcinoma who were given a bimonthly combination of high dose LV and a high dose 48-hour infusion of 5-FU. METHODS: The selected regimen included a 2-hour infusion of LV, 500 mg/m2, on each of 2 consecutive days and a 48-hour infusion of 5-FU, 1.5 to 2 g/m2/24 hours starting after Day 1 of LV treatment every 2 weeks until there was evidence of disease progression. Evaluation was performed every six cycles. This study reports the treatment of 101 patients with measurable disease. RESULTS: World Health Organization toxicity Grade 3-4 occurred in 15% of patients, nausea in 2%, diarrhea in 5.1%, mucositis in 4%, neutropenia in 4% (Grade 4: 2%), hand-foot syndrome in 2%, alopecia in 4%, and encephalopathy in 1%. The overall response rate was 33.7%. Five patients had a complete response (5%), and 29 had a partial response (28.7%). In 45 patients disease was stable (44.6%), and in 19 patients there was disease progression (18.8%). Three patients (3%) could not be evaluated. The median progression free survival was 8 months and median survival was 18 months. CONCLUSIONS: In the current study, bimonthly high dose ...