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.
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.
Department of Medicine, Samsung Medical Center, Seoul, Korea.
Jong-Mu
JM
Sun
Ki Hyeong
KH
Lee
Sang-We
SW
Kim
Dae Ho
DH
Lee
Young Joo
YJ
Min
Hwan Jung
HJ
Yun
Hoon Kyo
HK
Kim
Hong Suk
HS
Song
Yeul Hong
YH
Kim
Bong-Seog
BS
Kim
In Gyu
IG
Hwang
Keehyun
K
Lee
Sook Jung
SJ
Jo
Jae Won
JW
Lee
Jin Seok
JS
Ahn
Keunchil
K
Park
Myung-Ju
MJ
Ahn
D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D000077156:Gefitinib; D005971:Glutamates / Q000627:therapeutic use*; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D000068437:Pemetrexed; D011379:Prognosis; D011446:Prospective Studies; D011799:Quinazolines / Q000627:therapeutic use*; D016879:Salvage Therapy; D015996:Survival Rate
D000970:Antineoplastic Agents; D005971:Glutamates; D009944:Organoplatinum Compounds; D011799:Quinazolines; D000068437:Pemetrexed; D006147:Guanine; D000077156:Gefitinib