Reply: Irinotecan in patients with relapsed or cisplatin-refractory germ cell cancer: a phase II study of the German Testicular Cancer Study Group
2003

Irinotecan in Refractory Germ Cell Cancer

Sample size: 15 publication Evidence: low

Author Information

Author(s): Kollmannsberger C, Bokemeyer C

Primary Institution: University of Tuebingen

Hypothesis

Is irinotecan effective in patients with relapsed or cisplatin-refractory germ cell cancer?

Conclusion

Irinotecan has not shown clinically meaningful activity in patients with refractory germ cell cancer.

Supporting Evidence

  • None of the 15 patients responded to irinotecan.
  • The study design indicated a less than 5% probability of falsely rejecting an active drug.
  • Previous studies have shown that other agents have moderate activity in similar patients.

Takeaway

The study looked at a drug called irinotecan for patients with a tough type of cancer, but it didn't help any of the 15 patients who tried it.

Methodology

The study was a phase II trial involving 15 patients with refractory germ cell cancer.

Potential Biases

Potential bias due to the small number of patients and lack of control group.

Limitations

The study's small sample size limits the generalizability of the findings.

Participant Demographics

Patients were those with relapsed or cisplatin-refractory germ cell cancer.

Statistical Information

P-Value

<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6601177

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