Optimisation of irinotecan dose in the treatment of patients with metastatic colorectal cancer after 5-FU failure: results from a multinational, randomised phase II study
2005

Optimizing Irinotecan Dose for Colorectal Cancer Treatment

Sample size: 164 publication 10 minutes Evidence: moderate

Author Information

Author(s): Van Cutsem E, Dirix L, Van Laethem J-L, Van Belle S, Borner M, Gonzalez Baron M, Roth A, Morant R, Joosens E, Gruia G, Sibaud D, Bleiberg H

Primary Institution: University Hospital Gasthuisberg

Hypothesis

Is a higher dose of irinotecan more effective than the standard dose for patients with metastatic colorectal cancer after 5-FU failure?

Conclusion

Individual dose optimization of irinotecan can improve treatment outcomes for patients with metastatic colorectal cancer.

Supporting Evidence

  • Overall response rates were 8% in Group A, 13% in Group B, and 9% in Group C.
  • Median duration of response was significantly longer in Groups A and B compared to Group C.
  • 34% of patients in Group B received a dose of 500 mg/m².

Takeaway

This study looked at how much irinotecan medicine to give to people with a certain type of cancer. Giving more medicine helped some people feel better.

Methodology

This was a prospective, randomised, multicentre, open-label, phase II study comparing different dosing strategies of irinotecan.

Potential Biases

Potential biases due to the open-label design and patient selection criteria.

Limitations

The study had a small sample size and may not be generalizable to all patients with colorectal cancer.

Participant Demographics

Patients had metastatic colorectal cancer, with a median age of 60 years, and a mix of genders.

Statistical Information

P-Value

0.030

Confidence Interval

95% CI 76.14–119.21

Statistical Significance

p=0.030

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602462

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