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Gefitinib versus pemetrexed as second‐line treatment in patients with nonsmall cell lung cancer previously treated with platinum‐based chemotherapy (KCSG‐LU08‐01)
Author(s) -
Sun JongMu,
Lee Ki Hyeong,
Kim Sangwe,
Lee Dae Ho,
Min Young Joo,
Yun Hwan Jung,
Kim Hoon Kyo,
Song Hong Suk,
Kim Yeul Hong,
Kim BongSeog,
Hwang In Gyu,
Lee Keehyun,
Jo Sook Jung,
Lee Jae Won,
Ahn Jin Seok,
Park Keunchil,
Ahn MyungJu
Publication year - 2012
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.27630
Subject(s) - pemetrexed , gefitinib , medicine , hazard ratio , lung cancer , oncology , regimen , chemotherapy , population , clinical endpoint , epidermal growth factor receptor , confidence interval , chemotherapy regimen , cancer , randomized controlled trial , cisplatin , environmental health
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/m 2 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.