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- Title
Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01).
- Authors
Sun, Jong-Mu; Lee, Ki Hyeong; Kim, Sang-we; Lee, Dae Ho; Min, Young Joo; Yun, Hwan Jung; Kim, Hoon Kyo; Song, Hong Suk; Kim, Yeul Hong; Kim, Bong-Seog; Hwang, In Gyu; Lee, Keehyun; Jo, Sook Jung; Lee, Jae Won; Ahn, Jin Seok; Park, Keunchil; Ahn, Myung-Ju
- Abstract
BACKGROUND: Gefitinib was compared with pemetrexed as second-line therapy in a clinically selected population previously treated with platinum-based chemotherapy. 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). RESULTS: 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. CONCLUSIONS: Gefitinib showed superior efficacy to pemetrexed as second-line therapy in Korean never-smokers with pulmonary adenocarcinoma. Cancer 2012. © 2012 American Cancer Society.
- Subjects
GEFITINIB; LUNG cancer treatment; PLATINUM compounds; CANCER chemotherapy; QUALITY of life measurement; EPIDERMAL growth factor receptor genetics; CONFIDENCE intervals; SUBGROUP analysis (Experimental design)
- Publication
Cancer (0008543X), 2012, Vol 118, Issue 24, p6234
- ISSN
0008-543X
- Publication type
Article
- DOI
10.1002/cncr.27630