Phase I/II study of oxaliplatin with oral S-1 as first-line therapy for patients with metastatic colorectal cancer

Y. Yamada, M. Tahara, T. Miya, T. Satoh, K. Shirao, Y. Shimada, A. Ohtsu, Y. Sasaki, Yusuke Tanigawara

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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 languageEnglish
Pages (from-to)1034-1038
Number of pages5
JournalBritish Journal of Cancer
Issue number6
Publication statusPublished - 2008 Mar 25



  • Colorectal cancer
  • Oxaliplatin
  • Phase I/II
  • S-1
  • SOX

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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