Phase II study and biomarker analysis of cetuximab combined with modified FOLFOX6 in advanced gastric cancer
2009

Cetuximab and FOLFOX6 for Advanced Gastric Cancer

Sample size: 38 publication Evidence: moderate

Author Information

Author(s): Han S-W, Oh D-Y, Im S-A, Park S R, Lee K-W, Song H S, Lee N-S, Lee K H, Choi I S, Lee M H, Kim M A, Kim W H, Bang Y-J, Kim T-Y

Primary Institution: Seoul National University Hospital

Hypothesis

EGFR and its ligands predict cetuximab efficacy in AGC.

Conclusion

Cetuximab combined with modified FOLFOX6 showed promising results in patients with EGFR expression and low serum ligand levels.

Supporting Evidence

  • Among 38 evaluable patients, confirmed response rate was 50.0%.
  • Median time-to-progression was 5.5 months.
  • Overall survival was 9.9 months.
  • Patients with EGFR expression and low ligand levels had a 100% response rate.

Takeaway

This study looked at a medicine called cetuximab combined with chemotherapy to help people with stomach cancer. It found that some patients did really well if they had certain markers in their body.

Methodology

This was a prospective multicentre phase II study where patients received cetuximab and modified FOLFOX6, and biomarkers were analyzed.

Limitations

The sample size was not large enough to test the differences between the statuses of various biomarkers.

Participant Demographics

{"total_patients":40,"male":30,"female":10,"median_age":55,"age_range":"33-74"}

Statistical Information

P-Value

p<0.001

Confidence Interval

95% CI 34.1–65.9

Statistical Significance

p<0.001

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604861

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