Gemcitabine plus vinorelbine in advanced non-small cell lung cancer: a phase II study of three different doses
2000

Gemcitabine plus Vinorelbine in Advanced Non-Small Cell Lung Cancer

Sample size: 126 publication Evidence: moderate

Author Information

Author(s): Gridelli C, Frontini L, Perrone F, Gallo C, Gulisano M, Cigolari S, Castiglione F, Robbiati S F, Gasparini G, Ianniello G P, Farris A, Locatelli M C, Felletti R, Piazza E

Hypothesis

The study aims to evaluate the activity and toxicity of the gemcitabine plus vinorelbine combination and to identify the optimal dose.

Conclusion

The combination of gemcitabine and vinorelbine is feasible at different doses, sufficiently active, and well tolerated.

Supporting Evidence

  • Out of 126 patients, there was one complete and 32 partial responses, resulting in a response rate of 26%.
  • Response rates at different dose levels were 27.9%, 21.4%, and 29.3%.
  • The overall median survival for patients was 33 weeks.

Takeaway

This study tested a combination of two cancer drugs to see how well they work and how safe they are for patients with lung cancer.

Methodology

A phase II study with different dose levels of gemcitabine and vinorelbine administered to previously untreated patients with advanced non-small cell lung cancer.

Limitations

Dose-level IV was unfeasible due to severe toxicity, and patients with worse health status tended to drop out earlier.

Participant Demographics

Previously untreated patients aged < 70 years with stage IV or IIIb non-small cell lung cancer.

Statistical Information

Confidence Interval

95% CI 18–34%

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1054/bjoc.2000.1341

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