Cancer Res Treat.  2019 Apr;51(2):718-726. 10.4143/crt.2018.324.

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

Affiliations
  • 1Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea. silkahn@skku.edu
  • 2Division of Hematology and Oncology, Department of Internal Medicine, Gachon University Gil Medical Center, Gachon University College of Medicine, Incheon, Korea.
  • 3Division of Hematology-Oncology, Department of Internal Medicine, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.
  • 4Division of Medical Oncology, Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.
  • 5Department of Hematology/Oncology, Keimyung Unversity Dongsan Hospital, Daegu, Korea.
  • 6Department of Internal Medicine, Seoul National University Boramae Medical Center, Seoul, Korea.
  • 7Division of Hematology and Oncology, Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences, Busan, Korea.
  • 8Division of Medical Oncology, Department of Internal Medicine, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
  • 9Division of Hematology-Oncology, Department of Internal Medicine, Gyeongsang Institute of Health Sciences, Gyeongsang National University College of Medicine and Gyeongsang National University Changwon Hospital, Changwon, Korea.
  • 10Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Korea.
  • 11Division of Hematology and Oncology, Department of Internal Medicine, National Medical Center, Seoul, Korea.
  • 12Division of Hematology/Oncology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, Korea.
  • 13Division of Medical Oncology, Department of Internal Medicine, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, Korea.
  • 14Division of Medical Oncology and Hematology, Department of Internal Medicine, Kyunghee University Hospital, Seoul, Korea.
  • 15Division of Hematology and Oncology, Department of Internal Medicine, Inje University Paik Hospital, Busan, Korea.
  • 16Department of Biostatistics and Bioinformatics, Duke University, Durham, NC, USA.

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 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.

Keyword

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

MeSH Terms

Arm
Carcinoma, Non-Small-Cell Lung
Cisplatin*
Disease Progression
Disease-Free Survival
Epidermal Growth Factor*
Follow-Up Studies
Humans
Korea
Lung Neoplasms*
Lung*
Pemetrexed*
Protein-Tyrosine Kinases*
Quality of Life
Receptor, Epidermal Growth Factor*
Tyrosine*
Cisplatin
Epidermal Growth Factor
Pemetrexed
Protein-Tyrosine Kinases
Receptor, Epidermal Growth Factor
Tyrosine
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