Irinotecan is active in chemonaive patients with metastatic gastric cancer: a phase II multicentric trial
2003

Irinotecan for Metastatic Gastric Cancer

Sample size: 40 publication 10 minutes Evidence: moderate

Author Information

Author(s): Köhne C-H, Catane R, Klein B, Ducreux M, Thuss-Patience P, Niederle N, Gips M, Preusser P, Knuth A, Clemens M, Bugat R, Figer I, Shani A, Fages B, Betta D Di, Jacques C, Wilke H J

Primary Institution: Robert Rossle Klinik, Charité University Hospital, Berlin, Germany

Hypothesis

Does irinotecan improve response rates in chemotherapy naive patients with metastatic gastric adenocarcinoma?

Conclusion

Irinotecan shows activity in treating metastatic gastric cancer, with a response rate of 20% and manageable side effects.

Supporting Evidence

  • Irinotecan showed a response rate of 20% in evaluable patients.
  • Two complete responses and five partial responses were observed.
  • The median survival time was 7.1 months.
  • Neutropenia was the most common severe side effect.
  • Patients experienced a median of 3 treatment cycles.

Takeaway

This study tested a medicine called irinotecan on patients with stomach cancer that hadn't been treated before, and it helped some of them feel better.

Methodology

Phase II trial with 40 patients receiving irinotecan every 3 weeks, assessing response rates and safety.

Potential Biases

Potential selection bias due to nonrandomized design.

Limitations

The study was nonrandomized and had a small sample size.

Participant Demographics

40 patients, 70% male, median age 58 years.

Statistical Information

P-Value

0.05

Confidence Interval

95% CI: 8.4-36.9%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601226

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