Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01)
Sun J-M et al. – Gefitinib showed superior efficacy to pemetrexed as second-line therapy in Korean never-smokers with pulmonary adenocarcinoma.Methods
- A phase 3 trial of gefitinib (250 mg/day) versus pemetrexed (500 mg/m2 on day 1, every 3 weeks) was conducted in patients who had never smoked and who had advanced pulmonary adenocarcinoma treated with 1 previous platinum-based regimen.
- The primary endpoint was progression-free survival (PFS).
- A total of 135 patients were analyzed.
- The gefitinib group had significantly longer PFS compared with the pemetrexed group, with a median PFS time of 9.0 versus 3.0 months (P = .0006).
- The objective response rates were 58.8% and 22.4% for gefitinib and pemetrexed, respectively (P < .001).
- However, there was no statistically significant difference in overall survival between the 2 groups (22.2 vs 18.9 months; P = .37).
- The difference of PFS was increased in a subgroup analysis of 33 patients with activating epidermal growth factor receptor mutation (15.7 vs 2.9 months; hazard ratio, 0.3; 95% confidence interval, 0.13-0.72; P = .005), with numerical superiority of gefitinib in the 38 patients testing negative for epidermal growth factor receptor mutation (5.9 vs 2.7 months; P = .099).
- Both regimens were well tolerated.
- There were no significantly different changes in quality of life between the 2 groups, except that symptom scores for dyspnea and diarrhea favored the gefitinib and pemetrexed arms, respectively.