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
- Author:
Kwai Han YOO
1
;
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 AHN
;
Keunchil PARK
;
Myung Ju AHN
Author Information
- Publication Type:Multicenter Study
- Keywords: Non-small cell lung carcinoma; Epidermal growth factor receptor; Mutation; Pemetrexed; Cisplatin; Quality of life
- MeSH: 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
- From:Cancer Research and Treatment 2019;51(2):718-726
- CountryRepublic of Korea
- Language:English
- 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.
