A phase II study to determine the ability of gefitinib to reverse fluoropyrimidine resistance in metastatic colorectal cancer (the INFORM study)
2008

Gefitinib and 5-FU for Colorectal Cancer

Sample size: 24 publication Evidence: low

Author Information

Author(s): Stebbing J, Harrison M, Glynne-Jones R, Bridgewater J, Propper D

Primary Institution: Imperial College, Imperial Healthcare, NHS Trust

Hypothesis

Can gefitinib reverse fluoropyrimidine resistance in metastatic colorectal cancer?

Conclusion

Gefitinib does not sensitize patients with fluoropyrimidine refractory metastatic colorectal cancer to 5-FU chemotherapy.

Supporting Evidence

  • There were no objective responses in the study.
  • The stable disease rate was 37.5%.
  • Median progression-free survival was 116 days.
  • Median overall survival was 226 days.
  • Quality of life remained unchanged compared to baseline.

Takeaway

This study tested a drug called gefitinib to see if it could help patients with a type of cancer that didn't respond to other treatments, but it didn't work.

Methodology

An open-label, non-comparative phase II study of gefitinib combined with 5-FU in 24 patients with metastatic colorectal cancer.

Limitations

The study had a small sample size and no objective responses were observed.

Participant Demographics

{"mean_age":64.3,"sex_distribution":{"male":14,"female":10},"race_distribution":{"caucasian":20,"black":3,"other":1}}

Statistical Information

Confidence Interval

95% CI: 18.80, 59.41

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604232

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