Randomised phase II evaluation of irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) vs 5-fluorouracil, leucovorin, and etoposide (ELF) in untreated metastatic gastric cancer
2005

Comparing Two Chemotherapy Regimens for Metastatic Gastric Cancer

Sample size: 114 publication 10 minutes Evidence: moderate

Author Information

Author(s): Moehler M, Eimermacher A, Siebler J, Höhler T, Wein A, Menges M, Flieger D, Junginger T, Geer T, Gracien E, Galle P R, Heike M

Primary Institution: Klinikum der Johannes-Gutenberg-Universität, Mainz, Dortmund, Germany

Hypothesis

Does irinotecan plus high-dose 5-fluorouracil and leucovorin (ILF) provide better efficacy than etoposide plus 5-fluorouracil and leucovorin (ELF) in untreated metastatic gastric cancer?

Conclusion

The study found that ILF provides a better response rate than ELF for treating metastatic gastric cancer.

Supporting Evidence

  • ILF showed a 30% objective clinical response rate compared to 17% for ELF after 14 weeks.
  • Overall response rates for ILF and ELF were 43% and 24%, respectively.
  • Median progression-free survival was longer for ILF at 4.5 months compared to 2.3 months for ELF.

Takeaway

Doctors tested two types of medicine to help people with stomach cancer. One type worked better than the other.

Methodology

This was an open-label, multicentre, phase II randomised trial comparing ILF and ELF in patients with untreated metastatic gastric cancer.

Potential Biases

Potential bias due to the open-label design and the specific patient population.

Limitations

The study had a relatively small sample size and was limited to patients from 17 centers in Germany.

Participant Demographics

Median age was 62 years, with a Karnofsky performance score of 90%.

Statistical Information

P-Value

0.0467

Confidence Interval

0.33–0.97

Statistical Significance

p=0.0467

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602649

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