Gemcitabine and oxaliplatin in advanced biliary tract carcinoma: a phase II study
2008

GEMOX in advanced biliary tract carcinoma

Sample size: 70 publication Evidence: moderate

Author Information

Author(s): André T, Reyes-Vidal J M, Fartoux L, Ross P, Leslie M, Rosmorduc O, Clemens M R, Louvet C, Perez N, Mehmud F, Scheithauer W

Primary Institution: Hôpital Tenon, Université Paris 06

Hypothesis

The study evaluates the efficacy and safety of GEMOX as first-line therapy in patients with advanced biliary tract carcinomas.

Conclusion

GEMOX demonstrated activity in non-gallbladder carcinoma but poor activity in gallbladder carcinoma and is well tolerated in advanced biliary tract cancers.

Supporting Evidence

  • 10 confirmed partial responses were observed in the treated population.
  • Median overall survival was 8.8 months for the intent-to-treat population.
  • Grade 3/4 toxicities included thrombocytopenia and alanine aminotransferase elevation.

Takeaway

This study tested a combination of two drugs, gemcitabine and oxaliplatin, to see if they help people with a type of cancer called biliary tract carcinoma. It worked better for some patients than others.

Methodology

Patients with untreated locally advanced or metastatic biliary tract carcinoma received gemcitabine and oxaliplatin every two weeks.

Limitations

The study did not reach the target response rate and had a relatively small sample size.

Participant Demographics

{"gender_distribution":{"male":28,"female":42},"median_age":62,"metastatic_disease":51}

Statistical Information

Confidence Interval

{"overall_survival":"95% CI, 6.9–11.1%","progression_free_survival":"95% CI, 2.5–4.6%"}

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604628

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