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

Jong Mu Sun, Ki Hyeong Lee, Sang We Kim, Dae Ho Lee, Young Joo Min, Hwan Jung Yun, Hoon Kyo Kim, Hong Suk Song, Yeul Hong Kim, Bong Seog Kim, In Gyu Hwang, Keehyun Lee, Sook Jung Jo, Jae Won Lee, Jin Seok Ahn, Keunchil Park, Myung Ju Ahn

Research output: Contribution to journalArticle

74 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)6234-6242
Number of pages9
JournalCancer
Volume118
Issue number24
DOIs
Publication statusPublished - 2012 Dec 15

Fingerprint

Pemetrexed
Platinum
Non-Small Cell Lung Carcinoma
Drug Therapy
Disease-Free Survival
Epidermal Growth Factor Receptor
Therapeutics
Mutation
gefitinib
Dyspnea
Diarrhea
Quality of Life
Confidence Intervals

Keywords

  • gefitinib
  • nonsmall cell lung cancer
  • pemetrexed

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

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. / 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.

In: Cancer, Vol. 118, No. 24, 15.12.2012, p. 6234-6242.

Research output: Contribution to journalArticle

Sun, JM, Lee, KH, Kim, SW, Lee, DH, Min, YJ, Yun, HJ, Kim, HK, Song, HS, Kim, YH, Kim, BS, Hwang, IG, Lee, K, Jo, SJ, Lee, JW, Ahn, JS, Park, K & Ahn, MJ 2012, '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', Cancer, vol. 118, no. 24, pp. 6234-6242. https://doi.org/10.1002/cncr.27630
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. / 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. In: Cancer. 2012 ; Vol. 118, No. 24. pp. 6234-6242.
@article{95ab7b9cec854f67bbf94c1793d56f38,
title = "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",
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.",
keywords = "gefitinib, nonsmall cell lung cancer, pemetrexed",
author = "Sun, {Jong Mu} and Lee, {Ki Hyeong} and Kim, {Sang We} and Lee, {Dae Ho} and Min, {Young Joo} and Yun, {Hwan Jung} and Kim, {Hoon Kyo} and Song, {Hong Suk} and Kim, {Yeul Hong} and Kim, {Bong Seog} and Hwang, {In Gyu} and Keehyun Lee and Jo, {Sook Jung} and Lee, {Jae Won} and Ahn, {Jin Seok} and Keunchil Park and Ahn, {Myung Ju}",
year = "2012",
month = "12",
day = "15",
doi = "10.1002/cncr.27630",
language = "English",
volume = "118",
pages = "6234--6242",
journal = "Cancer",
issn = "0008-543X",
publisher = "John Wiley and Sons Inc.",
number = "24",

}

TY - JOUR

T1 - Gefitinib versus pemetrexed as second-line treatment in patients with nonsmall cell lung cancer previously treated with platinum-based chemotherapy (KCSG-LU08-01)

T2 - An open-label, phase 3 trial

AU - Sun, Jong Mu

AU - Lee, Ki Hyeong

AU - Kim, Sang We

AU - Lee, Dae Ho

AU - Min, Young Joo

AU - Yun, Hwan Jung

AU - Kim, Hoon Kyo

AU - Song, Hong Suk

AU - Kim, Yeul Hong

AU - Kim, Bong Seog

AU - Hwang, In Gyu

AU - Lee, Keehyun

AU - Jo, Sook Jung

AU - Lee, Jae Won

AU - Ahn, Jin Seok

AU - Park, Keunchil

AU - Ahn, Myung Ju

PY - 2012/12/15

Y1 - 2012/12/15

N2 - 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.

AB - 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.

KW - gefitinib

KW - nonsmall cell lung cancer

KW - pemetrexed

UR - http://www.scopus.com/inward/record.url?scp=84870688172&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84870688172&partnerID=8YFLogxK

U2 - 10.1002/cncr.27630

DO - 10.1002/cncr.27630

M3 - Article

VL - 118

SP - 6234

EP - 6242

JO - Cancer

JF - Cancer

SN - 0008-543X

IS - 24

ER -