EORTC Early Clinical Studies Group early phase II trial of S-1 in patients with advanced or metastatic colorectal cancer
2003

Study of S-1 for Colorectal Cancer

Sample size: 47 publication Evidence: moderate

Author Information

Author(s): Van den Brande J, Schöffski P, Schellens J H M, Roth A D, Duffaud F, Weigang-Köhler K, Reinke F, Wanders J, de Boer R F, Vermorken J B, Fumoleau P

Primary Institution: EORTC Early Clinical Studies Group

Hypothesis

Does S-1 provide an effective treatment for patients with advanced or metastatic colorectal cancer?

Conclusion

S-1 is active in patients with advanced colorectal cancer, but it is associated with a high incidence of severe diarrhea.

Supporting Evidence

  • S-1 showed a response rate of 24% in evaluable patients.
  • Diarrhea was a significant side effect, with 38% of patients experiencing grade 3-4 diarrhea at the higher dose.
  • The study included 47 patients treated across six centers.

Takeaway

This study tested a new medicine called S-1 for people with serious colon cancer, and while it helped some patients, many had bad stomach problems.

Methodology

This was a nonrandomised phase II study to determine the response rate of S-1 as first-line treatment for advanced colorectal cancer.

Potential Biases

Potential bias due to nonrandomised design and the subjective nature of response assessment.

Limitations

The study was nonrandomised and had a small sample size, which may limit the generalizability of the results.

Participant Demographics

Patients included were adults aged 18 and older with histologically or cytologically verified metastatic and/or locally advanced colorectal cancer.

Statistical Information

Confidence Interval

(2.3–34.4)

Digital Object Identifier (DOI)

10.1038/sj.bjc.6600781

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication