Report of two protocol planned interim analyses in a randomised multicentre phase III study comparing capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer receiving ECF
2005

Comparing Capecitabine and Fluorouracil in Advanced Oesophagogastric Cancer

Sample size: 204 publication Evidence: moderate

Author Information

Author(s): Sumpter K, Harper-Wynne C, Cunningham D, Rao S, Tebbutt N, Norman A R, Ward C, Iveson T, Nicolson M, Hickish T, Hill M, Oates J

Primary Institution: Royal Marsden NHS Trust

Hypothesis

What is the optimal dose of capecitabine in combination with oxaliplatin and fluorouracil for patients with advanced oesophagogastric cancer?

Conclusion

The optimal dose of capecitabine is 625 mg/m² b.i.d., which shows similar efficacy to fluorouracil with manageable toxicity.

Supporting Evidence

  • Grade 3/4 fluoropyrimidine-related toxicity was 5.1% for capecitabine 500 mg/m² b.i.d.
  • Grade 3/4 fluoropyrimidine-related toxicity was 14.7% for capecitabine 625 mg/m² b.i.d.
  • Combined complete and partial response rates were 31% for ECF, 39% for EOF, 35% for ECX, and 48% for EOX.

Takeaway

Doctors are trying to find the best dose of a medicine called capecitabine for patients with stomach cancer, and they found that a higher dose works well without causing too many side effects.

Methodology

The study used a two by two randomisation to compare capecitabine with fluorouracil and oxaliplatin with cisplatin in patients with advanced oesophagogastric cancer.

Limitations

The study is ongoing and the final analysis will provide more comprehensive survival data.

Participant Demographics

Patients with histologically verified locally advanced or metastatic adenocarcinoma, squamous cell or undifferentiated carcinoma of the oesophagus, oesophagogastric junction, or stomach.

Statistical Information

Confidence Interval

95% CI 18.7–46.3 for ECF, 95% CI 25.9–53.1 for EOF, 95% CI 21.4–50.3 for ECX, 95% CI 33.3–62.8 for EOX

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602572

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