Phase II study of S-1 combined with oxaliplatin as therapy for patients with metastatic biliary tract cancer: influence of the CYP2A6 polymorphism on pharmacokinetics and clinical activity
2011

S-1 and Oxaliplatin for Metastatic Biliary Tract Cancer

Sample size: 49 publication Evidence: moderate

Author Information

Author(s): Kim K-p, Jang G, Hong Y S, Lim H-S, Bae K-s, Kim H-S, Lee S S, Shin J-G, Lee J-L, Ryu M-H, Chang H-M, Kang Y-K, Kim T W

Primary Institution: Asan Medical Center, University of Ulsan College of Medicine

Hypothesis

Does the CYP2A6 polymorphism influence the pharmacokinetics and clinical activity of S-1 combined with oxaliplatin in patients with metastatic biliary tract cancer?

Conclusion

The combination of S-1 and oxaliplatin is active and well tolerated in patients with metastatic biliary cancer, but the impact of CYP2A6 polymorphism on clinical efficacy or toxicity needs further evaluation.

Supporting Evidence

  • Overall response rate was 24.5%.
  • Median progression-free survival was 3.7 months.
  • Median overall survival was 8.7 months.
  • Neutropenia occurred in 14% of patients.
  • Diarrhoea occurred in 4% of patients.

Takeaway

Doctors tested a new medicine combination for patients with a serious type of cancer, and it worked pretty well without too many side effects.

Methodology

Patients with confirmed metastatic biliary cancer received oxaliplatin and S-1, with pharmacokinetic analysis and genotyping for CYP2A6 polymorphisms.

Limitations

The study did not meet its primary endpoint response rate of 35%, and the sample size was small.

Participant Demographics

Median age was 52 years, with 63% male and 94% having good performance status.

Statistical Information

P-Value

{"diarrhoea":0.074,"neutropenia":0.396,"clinical efficacy":{"response rate":0.583,"PFS":0.916}}

Confidence Interval

{"response_rate":"95% CI: 12.5–36.5%","PFS":"95% CI: 1.7–5.7 months","OS":"95% CI: 4.8–12.6 months","metabolic_ratio":"90% CI: 1.37–2.49"}

Digital Object Identifier (DOI)

10.1038/bjc.2011.17

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication