Neoadjuvant continuous infusion of weekly 5-fluorouracil and escalating doses of oxaliplatin plus concurrent radiation in locally advanced oesophageal squamous cell carcinoma: results of a phase I/II trial
2008

Neoadjuvant Chemotherapy and Radiation for Oesophageal Cancer

Sample size: 29 publication Evidence: moderate

Author Information

Author(s): Lorenzen S, Brücher B, Zimmermann F, Geinitz H, Riera J, Schuster T, Roethling N, Höfler H, Ott K, Peschel C, Siewert J R, Molls M, Lordick F

Primary Institution: Technical University of Munich

Hypothesis

The optimal dosage and efficacy of oxaliplatin and 5-fluorouracil combined with concurrent radiotherapy as neoadjuvant treatment for locally advanced oesophageal squamous cell carcinoma are unknown.

Conclusion

Weekly oxaliplatin and continuous infusional 5-fluorouracil with concurrent radiotherapy provide promising histological response rates and high rates of tumour-free resection in locally advanced oesophageal squamous cell carcinoma.

Supporting Evidence

  • Histopathological responses were observed in 10 of 16 patients (63%).
  • Overall, 16 of the 25 patients (64%) who underwent resection had a histopathological response.
  • Tumour-free resection (R0) was achieved in 80% of patients.

Takeaway

This study tested a new treatment for a type of throat cancer and found that it helped many patients have less cancer left after treatment and more successful surgeries.

Methodology

This was a multicentre, open-label, non-randomised phase I/II study assessing the maximum tolerated dose and histopathological response rate of the treatment.

Limitations

The study had a high postoperative mortality rate of 12% and a relatively low 2-year survival rate of 28%.

Participant Demographics

{"age_range":"19-67","median_age":60,"sex_distribution":{"male":25,"female":4}}

Statistical Information

P-Value

0.023

Confidence Interval

95% CI: 39–82%

Statistical Significance

p=0.023

Digital Object Identifier (DOI)

10.1038/sj.bjc.6604659

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