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
- Authors
- Yoo, Kwai Han; Lee, Su Jin; Cho, Jinhyun; Lee, Ki Hyeong; Park, Keon Uk; Kim, Ki Hwan; Cho, Eun Kyung; Choi, Yoon Hee; Kim, Hye Ryun; Kim, Hoon-Gu; Ahn, Heui June; Lee, Ha Yeon; Yun, Hwan Jung; Kang, Jin-Hyoung; Jeong, Jaeheon; Choi, Moon Young; Jung, Sin-Ho; Sun, Jong-Mu; Lee, Se-Hoon; Ahn, Jin Seok; Park, Keunchil; Ahn, Myung-Ju
- Issue Date
- Apr-2019
- Publisher
- KOREAN CANCER ASSOCIATION
- Keywords
- Non-small cell lung carcinoma; Epidermal growth factor receptor; Mutation; Pemetrexed; Cisplatin; Quality of life
- Citation
- CANCER RESEARCH AND TREATMENT, v.51, no.2, pp.718 - 726
- Journal Title
- CANCER RESEARCH AND TREATMENT
- Volume
- 51
- Number
- 2
- Start Page
- 718
- End Page
- 726
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/1631
- DOI
- 10.4143/crt.2018.324
- ISSN
- 1598-2998
- Abstract
- 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 patients were randomized, and 91 patients were 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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