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

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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

Keywords

  • gefitinib
  • nonsmall cell lung cancer
  • pemetrexed

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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    Sun, J. M., Lee, K. H., Kim, S. W., Lee, D. H., Min, Y. J., Yun, H. J., Kim, H. K., Song, H. S., Kim, Y. H., Kim, B. S., Hwang, I. G., Lee, K., Jo, S. J., Lee, J. W., Ahn, J. S., Park, K., & Ahn, M. J. (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, 118(24), 6234-6242. https://doi.org/10.1002/cncr.27630