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 |
|---|---|
| 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 |
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Keywords
- Colorectal cancer
- Oxaliplatin
- Phase I/II
- S-1
- SOX
ASJC Scopus subject areas
- Cancer Research
- Oncology
Cite this
Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer. / Yamada, Y.; Tahara, M.; Miya, T.; Satoh, T.; Shirao, K.; Shimada, Y.; Ohtsu, A.; Sasaki, Y.; Tanigawara, Yusuke.
In: British Journal of Cancer, Vol. 98, No. 6, 25.03.2008, p. 1034-1038.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer
AU - Yamada, Y.
AU - Tahara, M.
AU - Miya, T.
AU - Satoh, T.
AU - Shirao, K.
AU - Shimada, Y.
AU - Ohtsu, A.
AU - Sasaki, Y.
AU - Tanigawara, Yusuke
PY - 2008/3/25
Y1 - 2008/3/25
N2 - 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.
AB - 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.
KW - Colorectal cancer
KW - Oxaliplatin
KW - Phase I/II
KW - S-1
KW - SOX
UR - http://www.scopus.com/inward/record.url?scp=40849136304&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=40849136304&partnerID=8YFLogxK
U2 - 10.1038/sj.bjc.6604271
DO - 10.1038/sj.bjc.6604271
M3 - Article
VL - 98
SP - 1034
EP - 1038
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 6
ER -