Abstract
Two phase II studies of S-1 monotherapy have shown promising response rates (RR) of 35-40% with good tolerability in patients with untreated metastatic colorectal cancer. To investigate the usefulness of S-1 plus oxaliplatin (SOX) as an alternative to infusional 5-fluorouracil/leucovorin plus oxaliplatin, the recommended dose (RD) of SOX was determined, and its safety and preliminary efficacy were evaluated in a phase I/II study. Oxaliplatin was administered at a dose of 100 mg m-2 (level 1) or 130 mg m-2 (level 2) on day 1, and S-1 (80-120) was given twice daily for 2 weeks followed by a 1-week rest. This schedule was repeated every 3 weeks. Level 2 was determined to be the RD. For the 28 patients who received the RD, the median treatment course was 6.5 cycles (2-14), RR of 50% (1 CR and 13 PR: 95% CI 31-69%), with a median progression-free survival of 196 days. Survival rate (1 year) was 79%. Peripheral neuropathy was observed in all patients but with no functional disorders. Major grade 3 or 4 adverse reactions at the RD were neutropaenia (14%), thrombocytopaenia (28%), and diarrhoea (3%). SOX regimen is effective and easily manageable without central vein access.
Original language | English |
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Pages (from-to) | 1034-1038 |
Number of pages | 5 |
Journal | British Journal of Cancer |
Volume | 98 |
Issue number | 6 |
DOIs | |
Publication status | Published - 2008 Mar 25 |
Externally published | Yes |
Keywords
- Colorectal cancer
- Oxaliplatin
- Phase I/II
- S-1
- SOX
ASJC Scopus subject areas
- Oncology
- Cancer Research