Ahn, Jin-Hee; Kim, Tae-Won; Lee, Je-Hwan; Min, Young-Ju; Kim, Jeong-Gyun; Kim, Jin Cheon; Yu, Chang-Sik; Kim, Woo Kun; Kang, Yoon-Koo; Lee, Jung-Shin
American journal of clinical oncology
2003Feb ; 26 ( 1 ) :98-102.
PMID : 12576934
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Ahn, Jin-Hee -
Kim, Tae-Won -
Lee, Je-Hwan -
Min, Young-Ju -
Kim, Jeong-Gyun -
Kim, Jin Cheon -
Yu, Chang-Sik -
Kim, Woo Kun -
Kang, Yoon-Koo -
Lee, Jung-Shin -
ABSTRACT
This phase II study was designed to evaluate the efficacy and toxicities of oral doxifluridine plus leucovorin as a randomized trial with those of intravenous 5-fluorouracil (5-FU) plus leucovorin in previously untreated metastatic colorectal cancer (CRC). Patients with metastatic CRC were randomized in either group A (oral doxifluridine 1,000 mg/m /d plus leucovorin 30 mg/d on days 1 to 7 and 15 to 21 of each cycle), or group B (intravenous 5-FU 400 mg/m /d plus leucovorin 20 mg/m /d on days 1-5 of each cycle), with the cycles repeated every 4 weeks. Between July 1998 and May 2000, 77 patients were enrolled (38 in group A and 39 in group B). Response rates were 23.7% (95% CI, 11-42%) in group A, and 15.4% (95% CI, 0-25%) in group B on an intent-to-treat analysis. The median response durations of the two groups were similar with 5.6 months in group A and 5.5 months in group B. Progression-free survival and overall survival were 5.4 months and 14.9 months in group A; 4.7 months and 19.5 months in group B. Toxicities in both groups were generally mild and reversible. This study shows that a combination of oral doxifluridine plus leucovorin can be active and safe as a first-line treatment for patients with metastatic CRC.
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MESH
Adult, Aged, Antimetabolites, Antineoplastic/*therapeutic use, Colorectal Neoplasms/*drug therapy/pathology, Female, Floxuridine/*therapeutic use, Fluorouracil/*therapeutic use, Humans, Leucovorin/administration & dosage, Male, Middle Aged, Neoplasm Metastasis, Survival Analysis
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