Phase II trial of modified FOLFOX6 and erlotinib in patients with metastatic or advanced adenocarcinoma of the oesophagus and gastro-oesophageal junction
2011

Study on FOLFOX6 and Erlotinib for Oesophageal Cancer

Sample size: 33 publication Evidence: moderate

Author Information

Author(s): Wainberg Z A, Lin L-S, DiCarlo B, Dao K M, Patel R, Park D J, Wang H-J, Elashoff R, Ryba N, Hecht J R

Primary Institution: Geffen School of Medicine at UCLA

Hypothesis

This study evaluates the efficacy and safety of mFOLFOX6 and erlotinib in patients with metastatic or advanced Eso/GEJ cancers.

Conclusion

The combination of mFOLFOX6 and erlotinib is active and has an acceptable toxicity profile in patients with Eso/GEJ adenocarcinoma.

Supporting Evidence

  • 33 patients were treated and evaluable, with an objective response rate of 51.5%.
  • Median progression-free survival was 5.5 months.
  • Median overall survival was 11.0 months.
  • Common grade 3-4 toxicities included diarrhoea (24%) and nausea/vomiting (11%).

Takeaway

Doctors tested a new treatment for a type of cancer in the food pipe and found it worked well and was safe for patients.

Methodology

Patients received modified FOLFOX6 and erlotinib, with treatment repeated every 14 days, and outcomes were measured based on response rates and survival.

Potential Biases

The small sample size and lack of a control group may introduce bias in the results.

Limitations

The study was a single-arm, non-comparative trial with a small sample size.

Participant Demographics

Most patients were men (87%) with a median age of 59; 95% had metastatic disease.

Statistical Information

Confidence Interval

95% CI, 34.5–68.6%

Digital Object Identifier (DOI)

10.1038/bjc.2011.280

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