A multicenter phase II study of induction chemotherapy with FOLFOX-4 and cetuximab followed by radiation and cetuximab in locally advanced oesophageal cancer
2011

Multimodality therapy for oesophageal cancer

Sample size: 41 publication Evidence: moderate

Author Information

Author(s): De Vita F, Orditura M, Martinelli E, Vecchione L, Innocenti R, Sileni V C, Pinto C, Di Maio M, Farella A, Troiani T, Morgillo F, Napolitano V, Ancona E, Di Martino N, Ruol A, Galizia G, Del Genio A, Ciardiello F

Primary Institution: Second University of Naples

Hypothesis

Can the combination of FOLFOX-4 and cetuximab followed by radiation improve outcomes in patients with locally advanced oesophageal cancer?

Conclusion

The study shows that combining FOLFOX-4 and cetuximab followed by radiation is a feasible and effective preoperative treatment for locally advanced oesophageal cancer.

Supporting Evidence

  • 41 patients were enrolled in the study.
  • 27% of patients who underwent surgery achieved a complete pathological response.
  • The median overall survival time was 17.3 months.

Takeaway

Doctors tested a new treatment for a type of throat cancer and found that it helped some patients get better before surgery.

Methodology

This was a phase II, multicenter trial where patients received FOLFOX-4 and cetuximab followed by radiation and cetuximab.

Potential Biases

Potential biases may arise from the non-randomized design and the small number of patients.

Limitations

The study had a small sample size and the results may not be generalizable.

Participant Demographics

41 patients with locally advanced oesophageal cancer, median age 54, 30 males and 11 females.

Statistical Information

P-Value

0.0009

Confidence Interval

95% CI: 2.22–22.9

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1038/sj.bjc.6606093

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