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.

Content Provider	Europe PMC
Author	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
Copyright Year	2019
Abstract	PurposeThe 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 MethodsWe 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.ResultsA 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.ConclusionThe outcomes of pemetrexed therapy in NSCLC patients with disease progression after firstline EGFR-TKI might not be improved by adding cisplatin.
ISSN	15982998
Journal	Cancer Research and Treatment : Official Journal of Korean Cancer Association
Volume Number	51
PubMed Central reference number	PMC6473296
Issue Number	2
PubMed reference number	30177585
e-ISSN	20059256
DOI	10.4143/crt.2018.324
Language	English
Publisher	Korean Cancer Association
Publisher Date	2018-09-03
Access Restriction	Open
Rights License	This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Copyright © 2019 by the Korean Cancer Association
Subject Keyword	Non-small cell lung carcinoma Epidermal growth factor receptor Mutation Pemetrexed Cisplatin Quality of life
Content Type	Text
Resource Type	Article
Subject	Cancer Research Oncology