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 AhnKeunchil Park, Myung Ju Ahn

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7 Scopus citations

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 first-line EGFR-TKI might not be improved by adding cisplatin.

Original languageEnglish
Pages (from-to)718-726
Number of pages9
JournalCancer Research and Treatment
Volume51
Issue number2
DOIs
StatePublished - 2019

Keywords

  • Cisplatin
  • Epidermal growth factor receptor
  • Mutation
  • Non-small cell lung carcinoma
  • Pemetrexed
  • Quality of life

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