Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01)†
An open-label, phase 3 trial
Article first published online: 6 JUN 2012
Copyright © 2012 American Cancer Society
Volume 118, Issue 24, pages 6234–6242, 15 December 2012
How to Cite
Sun, J.-M., Lee, K. H., Kim, S.-w., Lee, D. H., Min, Y. J., Yun, H. J., Kim, H. K., Song, H. S., Kim, Y. H., Kim, B.-S., Hwang, I. G., Lee, K., Jo, S. J., Lee, J. W., Ahn, J. S., Park, K., Ahn, M.-J. and for the Korean Cancer Study Group (KCSG) (2012), Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01). Cancer, 118: 6234–6242. doi: 10.1002/cncr.27630
The first 2 authors contributed equally to this work.
- Issue published online: 3 DEC 2012
- Article first published online: 6 JUN 2012
- Manuscript Accepted: 3 APR 2012
- Manuscript Revised: 30 MAR 2012
- Manuscript Received: 14 FEB 2012
- nonsmall cell lung cancer
Gefitinib was compared with pemetrexed as second-line therapy in a clinically selected population previously treated with platinum-based chemotherapy.
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.
Gefitinib showed superior efficacy to pemetrexed as second-line therapy in Korean never-smokers with pulmonary adenocarcinoma. Cancer 2012. © 2012 American Cancer Society.