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A Randomized, Open-Label, Phase II Study Comparing Pemetrexed Plus Cisplatin Followed by Maintenance Pemetrexed versus Pemetrexed Alone in Patients with Epidermal Growth Factor Receptor (EGFR)-Mutant Non-small Cell Lung Cancer after Failure of First-Line EGFR Tyrosine Kinase Inhibitor: KCSG-LU12-13

 Kwai Han Yoo  ;  Su Jin Lee  ;  Jinhyun Cho  ;  Ki Hyeong Lee  ;  Keon Uk Park  ;  Ki Hwan Kim  ;  Eun Kyung Cho  ;  Yoon Hee Choi  ;  Hye Ryun Kim  ;  Hoon-Gu Kim  ;  Heui June Ahn  ;  Ha Yeon Lee  ;  Hwan Jung Yun  ;  Jin-Hyoung Kang  ;  Jaeheon Jeong  ;  Moon Young Choi  ;  Sin-Ho Jung  ;  Jong-Mu Sun  ;  Se-Hoon Lee  ;  Jin Seok Ahn  ;  Keunchil Park  ;  Myung-Ju Ahn 
 CANCER RESEARCH AND TREATMENT, Vol.51(2) : 718-726, 2019 
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Cisplatin ;  Epidermal growth factor receptor ; Mutation ;  Non-small cell lung carcinoma ;  Pemetrexed ; Quality of life
PURPOSE: The optimal cytotoxic regimens have not been established for patients with non-small cell lung cancer (NSCLC) who develop disease progression on first-line epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). MATERIALS AND METHODS: We conducted a multi-center randomized phase II trial to compare the clinical outcomes between pemetrexed plus cisplatin combination therapy followed by maintenance pemetrexed (PC) and pemetrexed monotherapy (P) after failure of first-line EGFR-TKI. The primary objective was progression-free survival (PFS), and secondary objectives included overall response rate (ORR), overall survival (OS), health-related quality of life (HRQOL), and safety and toxicity profiles. RESULTS: A total of 96 patientswere randomized, and 91 patientswere treated at 14 centers in Korea. The ORR was 34.8% (16/46) for the PC arm and 17.8% (8/45) for the P arm (p=0.066). With 23.4 months of follow-up, the median PFS was 5.4 months in the PC arm and 6.4 months in the P arm (p=0.114). The median OS was 17.9 months and 15.7 months in PC and P arms, respectively (p=0.787). Adverse events ≥ grade 3 were reported in 12 patients (26.1%) in the PC arm and nine patients (20.0%) in the P arm (p=0.491). The overall time trends of HRQOL were not significantly different between the two arms. CONCLUSION: The outcomes of pemetrexed therapy in NSCLC patients with disease progression after firstline EGFR-TKI might not be improved by adding cisplatin.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Hye Ryun(김혜련) ORCID logo https://orcid.org/0000-0002-1842-9070
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