Introduction: Randomized placebo-controlled phase III trials failed to show a survival benefit with the addition of gefitinib to platinum-based combination chemotherapy as first-line therapy in unselected patients with advanced non-small cell lung cancer (NSCLC). We conducted a retrospective analysis of the outcome in never smokers with advanced NSCLC who received gemcitabine-carboplatin-gefitinib (GCI) as first-line therapy and compared these patients with a historical control group who received gemcitabine-carboplatin (GC) alone in our center.
Methods: Never-smoker patients with chemonaive stage IIIB or IV NSCLC were treated with GCI. These patients were compared with a historical control group of never smokers who had been treated with GC alone as the first-line therapy.
Results: A total of 80 patients were reviewed: 51 patients were treated with GCI and 29 with GC. Most patients were women, and adenocarcinoma was the most common histologic subtype. The response rate for patients in the GCI group was 62.7% (95% confidence interval [CI] = 48.08-75.87), which was higher than that of the GC group, 27.6% (95% CI = 12.73-47.24). The GCI group showed a significant improvement in progression-free survival compared with the GC group (hazard ratio of 0.19, 95% CI = 0.105-0.351, p < 0.001). The median overall survival for the patients on GCI was 20.5 months compared 14.1 months (p = 0.05) for patients on GC.
Conclusion: The addition of gefitinib to first-line chemotherapy improved progression-free survival and overall survival when used as a first-line therapy in never smokers with advanced NSCLC in this retrospective study. A prospective randomized phase III study is needed to confirm this finding.