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KMID : 0939920190510020718
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대한암학회지
2019 Volume.51 No. 2 p.718 ~ p.726
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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
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Yoo Kwai-Han
Lee Su-Jin
Cho Jin-Hyun
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 Jae-Heon
Choi Moon-Young
Jung Sin-Ho
Sun Jong-Mu
Lee Se-Hoon
Ahn Jin-Seok
Park Keun-Chil
Ahn Myung-Ju
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Abstract
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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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KEYWORD
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Non-small cell lung carcinoma, Epidermal growth factor receptor, Mutation, Pemetrexed, Cisplatin, Quality of life
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