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Cisplatin/Gemcytobine (CG) vs Cisplatin/Gemcytobine/Vinorelbine (CGV) vs Sequential Doublets of Gemcytobine/Vinorelbine Followed by Ifosfamide/Vinorelbine (GV/IV) in Advanced Non-Small Cell Lung Cancer (NSCLC): 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

Background:

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)

Results:

• 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

Authors' Conclusions

• 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

Clinical/Scientific Implications:

• 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