A phase I and II study of 2-weekly irinotecan with capecitabine in advanced gastroesophageal adenocarcinoma
2006

Fortnightly irinotecan/capecitabine for gastroesophageal cancer

Sample size: 52 publication Evidence: moderate

Author Information

Author(s): Burge M E, Smith D, Topham C, Jackson D P, Anthoney D A, Halstead F, Seymour M T

Primary Institution: Cancer Research UK Clinical Centre, University of Leeds, Cookridge Hospital, Leeds, UK

Hypothesis

Is the combination of 2-weekly irinotecan and capecitabine effective for patients with advanced gastroesophageal adenocarcinoma?

Conclusion

The combination of irinotecan and capecitabine is active in advanced gastroesophageal adenocarcinoma but requires dose modifications to improve tolerability.

Supporting Evidence

  • 21 patients were entered in phase I, establishing the maximum tolerated dose at level 3.
  • 31 patients were treated in phase II, with a response rate of 32%.
  • The median overall survival for the phase II cohort was 10 months.

Takeaway

This study tested a new way to give two cancer drugs to help people with stomach and esophagus cancer, and it worked but made some people feel sick.

Methodology

The study included phase I and II components, with dose escalation in phase I to establish maximum tolerated doses and evaluation of efficacy in phase II.

Potential Biases

Potential selection bias due to the non-randomized design and the nature of patient recruitment.

Limitations

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

Participant Demographics

The median age was 61 years, with a majority being male and chemotherapy naïve.

Statistical Information

Confidence Interval

95% CI 16–52%

Digital Object Identifier (DOI)

10.1038/sj.bjc.6603084

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