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
Cancer
2012Dec ; 118 ( 24 ) :6234-42.
PMID : 22674612
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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/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. CI - Copyright (c) 2012 American Cancer Society.
Adenocarcinoma/*drug therapy/mortality/pathology; Adult; Aged; Antineoplastic Agents/*therapeutic use; Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology; Disease Progression; Female; Follow-Up Studies; Glutamates/*therapeutic use; Guanine/*analogs & derivatives/therapeutic use; Humans; Lung Neoplasms/*drug therapy/mortality/pathology; Male; Middle Aged; Neoplasm Staging; Organoplatinum Compounds/therapeutic use; Prognosis; Prospective Studies; Quinazolines/*therapeutic use; *Salvage Therapy; Survival Rate
MESH
Adenocarcinoma/*drug therapy/mortality/pathology, Adult, Aged, Antineoplastic Agents/*therapeutic use, Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/pathology, Disease Progression, Female, Follow-Up Studies, Glutamates/*therapeutic use, Guanine/*analogs & derivatives/therapeutic use, Humans, Lung Neoplasms/*drug therapy/mortality/pathology, Male, Middle Aged, Neoplasm Staging, Organoplatinum Compounds/therapeutic use, Pemetrexed, Prognosis, Prospective Studies, Quinazolines/*therapeutic use, *Salvage Therapy, Survival Rate
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