Phase II study of gemcitabine and cisplatin in locally advanced/metastatic oesophageal cancer
2005

Gemcitabine and Cisplatin in Oesophageal Cancer

Sample size: 42 publication Evidence: moderate

Author Information

Author(s): Millar J, Scullin P, Morrison A, McClory B, Wall L, Cameron D, Philips H, Price A, Dunlop D, Eatock M

Primary Institution: Northern Ireland Cancer Clinical Trials Unit, Belfast City Hospital

Hypothesis

This study assesses the feasibility and activity of gemcitabine and cisplatin in patients with locally advanced/metastatic oesophageal cancer.

Conclusion

The combination of gemcitabine and cisplatin has manageable toxicity and significant activity in patients with locally advanced/metastatic oesophageal cancer.

Supporting Evidence

  • Overall response rate was 45%, with three complete responses and 16 partial responses.
  • Median survival was 11 months.
  • Grade 3–4 neutropenia occurred in 37% of cycles.

Takeaway

Doctors tested two medicines, gemcitabine and cisplatin, to see if they help people with a tough kind of cancer in the throat. They found that the medicines worked pretty well and didn't make people too sick.

Methodology

42 patients were treated with gemcitabine and cisplatin in a 21-day cycle, with interim safety analysis and response assessment.

Potential Biases

Potential bias due to the non-randomized design and the small number of patients.

Limitations

The study had a small sample size and was not randomized.

Participant Demographics

Median age was 60 years, with 34 males and 8 females.

Statistical Information

P-Value

0.036

Confidence Interval

95% CI 4.8–17.3 months

Statistical Significance

p=0.036

Digital Object Identifier (DOI)

10.1038/sj.bjc.6602842

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