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 / Journal of the Korean Cancer Association, 대한암학회지
Cancer Research and Treatment
; : 718-726, 2019.
Article
ي En
| WPRIM
| ID: wpr-763124
المكتبة المسؤولة:
WPRO
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.
Key words
النص الكامل:
1
الفهرس:
WPRIM
الموضوع الرئيسي:
Arm
/
Quality of Life
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Tyrosine
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Protein-Tyrosine Kinases
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Follow-Up Studies
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Cisplatin
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Carcinoma, Non-Small-Cell Lung
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Disease-Free Survival
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Disease Progression
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Epidermal Growth Factor
نوع الدراسة:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
المحددات:
Humans
البلد/الأقليم حسب الموضوع:
Asia
اللغة:
En
مجلة:
Cancer Research and Treatment
السنة:
2019
نوع:
Article