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Phase II study of S-1 plus leucovorin in patients with metastatic colorectal cancer
Annals of Oncology, 10/19/09

Koizumi W et al. – S-1 combined with LV therapy demonstrated promising efficacy and acceptable safety in chemotherapy-naive patients with mCRC without the concurrent use of irinotecan, oxaliplatin, or molecular-targeted drugs.

Methods

S-1 was given orally twice daily for two consecutive weeks at a daily dose of 80–120 mg
Followed by 2-week rest period, within a 4-week cycle
LV given orally twice a day at daily dose of 50 mg, simultaneously with S-1

Results

Of 56 patients with previously untreated mCRC, 32 (57%) had partial responses
Median follow-up period 27.2 months
Median time to progression 6.7 months
Median survival time 24.3 months
No treatment-related death or grade 4 toxicity
Most common grade 3 toxic effects diarrhea (32%), anorexia (21%), stomatitis (20%), and neutropenia (14%)

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