Phase II study of S-1, a novel oral fluoropyrimidine derivative, in patients with metastatic colorectal carcinoma
2000

Study of S-1 for Metastatic Colorectal Cancer

Sample size: 63 publication Evidence: moderate

Author Information

Author(s): Ohtsu A, Baba H, Sakata Y, Mitachi Y, Horikoshi N, Sugimachi K, Taguchi T

Primary Institution: National Cancer Center Hospital East

Hypothesis

This study set out to evaluate the efficacy and toxicity of S-1 in patients with metastatic colorectal carcinoma.

Conclusion

S-1 shows similar responses to infusional 5-FU plus leucovorin with manageable toxicity.

Supporting Evidence

  • Thirty-five percent of eligible patients achieved partial remission.
  • The median survival time was 12 months.
  • Major adverse reactions included myelosuppressive and gastrointestinal toxicities.

Takeaway

Doctors tested a new medicine called S-1 on people with a type of cancer, and it worked pretty well without making them too sick.

Methodology

S-1 was given orally to patients for 28 days followed by a 14-day rest, with monitoring for efficacy and toxicity.

Limitations

The study had a small sample size and lacked a control group.

Participant Demographics

Patients with measurable metastatic colorectal carcinoma, none had prior chemotherapy except in adjuvant settings.

Statistical Information

Confidence Interval

95% CI: 25–48%

Digital Object Identifier (DOI)

10.1054/bjoc.2000.1236

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication