Sequential (gemcitabine/vinorelbine) and concurrent (gemcitabine) radiochemotherapy with FDG-PET-based target volume definition in locally advanced non-small cell lung cancer: first results of a phase I/II study
2007

Gemcitabine and Vinorelbine with Radiotherapy for Lung Cancer

Sample size: 33 publication 10 minutes Evidence: moderate

Author Information

Author(s): Gagel Bernd, Piroth Marc, Pinkawa Michael, Reinartz Patrick, Krohn Thomas, Kaiser Hans J, Stanzel Sven, Breuer Christian, Asadpour Branka, Schmachtenberg Axel, Eble Michael J

Primary Institution: RWTH Aachen University

Hypothesis

What is the maximum tolerated dose of gemcitabine when combined with radiotherapy for treating locally advanced non-small cell lung cancer?

Conclusion

The study found that a regimen of gemcitabine at 500 mg/m2 every two weeks during thoracic radiotherapy is effective and tolerable for treating non-small cell lung cancer.

Supporting Evidence

  • The maximum tolerated dose of gemcitabine was determined to be 500 mg/m2.
  • The overall response rate after therapy was 64%.
  • Median overall survival was 19.9 months for all eligible patients.
  • Median disease-free survival was 8.7 months.

Takeaway

Doctors tested a new treatment for lung cancer using a medicine called gemcitabine along with radiation, and they found a safe dose that works well.

Methodology

The study involved 33 patients with non-small cell lung cancer who received gemcitabine and vinorelbine followed by concurrent radiotherapy, with dose escalation to determine the maximum tolerated dose.

Potential Biases

Potential bias due to the single-institution study design and the lack of a control group.

Limitations

The study had a small sample size and was limited to a specific patient population with unresectable lung cancer.

Participant Demographics

Patients were primarily older adults with a mean age of 58 years, including both males and females.

Statistical Information

P-Value

p<0.05

Confidence Interval

[10.1; 29.7]

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1471-2407-7-112

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