Combination chemotherapy based on cisplatin has been the standard treatment for non-small cell lung cancer. Doctors of the Spanish Lung Cancer Group tested two alternative chemotherapy regimens designed to improve response rates and decrease cisplatin-related toxicity.

The Phase III study of 410 patients with Stage IIIb or Stage IV non-small cell lung cancer was designed to test whether adding a third drug to a standard, two-drug cisplatin-based regimen would improve response rates. A regimen without cisplatin was also tested with the goal of decreasing toxicity.

Patients were randomized to one of three treatment groups: cisplatin/gemcitabine; cisplatin/gemcitabine/vinorelbine; or gemcitabine/vinorelbine for three cycles followed by ifosfamide/vinorelbine.

Analysis of the results showed no statistically significant difference in the overall response rates of 43.4% in the cisplatin/gemcitabine group, 38.6% in the cisplatin/vinorelbine group and 25.7% in the group given gemcitabine/vinorelbine followed by ifosfamide/vinorelbine. After 12 months of follow-up, median survival and time-to-progression also did not differ significantly among the treatment groups.

Toxicities including anemia and neutropenic fever occurred at higher rates among patients receiving the three-drug regimen. Neutropenia was significantly lower in those receiving the regimen without cisplatin.

Dr. Alberola concluded that adding a third drug to the standard cisplatin-based regimen for non-small cell lung cancer did not improve survival and caused increased rates of neutropenia. However, results for the regimen that excluded cisplatin, which showed decreased toxicity with comparable response, warrants further study of that particular chemotherapeutic combination.