Single-agent gemcitabine in pretreated patients with non-small-cell lung cancer: results of an Argentinean multicentre phase II trial
1999

Gemcitabine for Advanced Lung Cancer

Sample size: 29 publication Evidence: moderate

Author Information

Author(s): Kooten M Van, Traine G, Cinat G, Cazap E, Comba A Zori, Vicente H, Sena S, Nievas O Rodriguez, Orlando M

Primary Institution: Alexander Fleming Institute

Hypothesis

The study aims to determine the objective tumour response rate and toxicity profile of single-agent gemcitabine in pretreated patients with non-small-cell lung cancer.

Conclusion

The study confirms that single-agent gemcitabine is active and safe for pretreated patients with advanced non-small-cell lung cancer.

Supporting Evidence

  • One patient achieved a complete response and five patients had a partial response, resulting in a total response rate of 20.6%.
  • Median response duration was 7 months.
  • Twelve (41%) patients reached stable disease after two cycles of therapy.
  • Median progression-free survival time was 3 months.
  • Median overall survival time was 5.5 months.
  • Toxicity was generally mild, with severe toxicities being rare.

Takeaway

This study tested a cancer drug called gemcitabine in patients who had already received treatment, and it showed that the drug can help some people feel better.

Methodology

Patients received 1000 mg/m² gemcitabine administered over 30 minutes on days 1, 8, and 15 of a 28-day cycle.

Limitations

The study had a small sample size and was limited to patients who had already been treated.

Participant Demographics

Patients with advanced NSCLC stage IIIB or IV who had received at least one prior chemotherapy regimen.

Statistical Information

Confidence Interval

95% CI 6–34

Digital Object Identifier (DOI)

10.1038/sj.bjc.6690774

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