Results of a Spanish Lung Cancer Group Phase III Trial
James Metz, MD
University of Pennsylvania Cancer
Last Modified: May 12, 2001
Presenter: V. Alberola
Affiliation: Spanish Lung Cancer Group
The Spanish Lung Cancer Group has found in previous studies that a combination of Gemcytabine/Cisplatin is an effective regimen for the treatment of advanced lung cancer. This study was designed to evaluate this regimen against two other chemotherapy regimens, including a regimen without Cisplatin based therapy.
Materials and Methods:
- This study included patients with stage IIIb and IV NSCLC.
- Most patients were has ECOG performance status 0 or 1.
- Patients were randomized to receive CG (n=166) vs CGV (n=176) vs GV/IV (n=175)
- anemia and nausea/vomiting were significantly increased in the CGV regimen
- The median survival, 1 year survival, and time to progression were not significantly different between the arms
- The response rate, time to progression, and survival were the same for CG as the addition of a 3rd agent
- The hematologic toxicity was increased in the Cisplatin containing arms
- There was no survival differences between the regimens
- The addition of a third agent to a Cisplatin containing regimen was not shown to increase the benefits for patients
- The experimental arms in this study were not superior to the control are of CG
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