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논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 발행연도
- 2016.1
- 수록면
- 458 - 464 (7page)
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Purpose We recently reported on a randomized, open-label, phase 3 trial comparing pemetrexedcisplatin chemotherapy followed by gefitinib maintenance therapy (PC/G) with gefitinib monotherapy in patients with non-small cell lung cancer (NSCLC). Here, we report on a post hoc subgroup analysis of that study assessing the demographics and disposition of the Korean patient subgroup, and comparing the tolerability of PC/G and gefitinib monotherapy and the tumor response with respect to epidermal growth factor receptor (EGFR) status.
Materials and Methods Patients, who were ! 18 years, chemonaïve, Korean, light ex-smokers/never-smokers with advanced NSCLC, were randomly assigned (1:1) to PC/G or gefitinib monotherapy. Treatment- emergent adverse events (TEAEs) were graded, and tumor response was measured as change in lesion sum from baseline at best response. The study was registered with ClinicalTrials.
gov, NCT01017874.
Results Overall, 111 Korean patients were treated (PC/G, 51; gefitinib, 60). Between-arm characteristics were balanced and similar to those of the overall population. Treatment discontinuations due to adverse events were low (PC/G: 1, 2.0%; gefitinib: 7, 11.7%). Overall, 92 patients (82.9%) reported ! 1 TEAE (PC/G, 44; gefitinib, 48); few patients (PC/G, 16; gefitinib, 7) reported severe TEAEs; the most frequent was neutropenia (PC/G arm) and elevated alanine aminotransferase (gefitinib arm). The lesion sum was decreased by PC/G treatment in most patients, regardless of EGFRmutation status, while gefitinib monotherapy reduced the lesion sum in EGFR-positive patients but had no effect in EGFR-negative patients.
Conclusion Our results confirm that both PC/G and gefitinib were well tolerated in Korean patients, regardless of EGFR status; however, patients with EGFR wild-type NSCLC may not benefit from gefitinib monotherapy.
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참고문헌 (9)
참고문헌 신청
Ferlay J / GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11
정규원 / 2014 / Prediction of Cancer Incidence and Mortality in Korea, 2014 / Cancer Research and Treatment 46(2):123~130
D'Addario G / 2010 / Metastatic non-small-cell lung cancer : ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up / Ann Oncol 21(Suppl 5):116~119
Azzoli CG / 2009 / American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer / J Clin Oncol 27:6251~6266
Lindeman NI / 2013 / Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors : guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology / Arch Pathol Lab Med 137:828~860
정규원 / 2014 / Prediction of Cancer Incidence and Mortality in Korea, 2014 / Cancer Research and Treatment 46(2):123~130
D'Addario G / 2010 / Metastatic non-small-cell lung cancer : ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up / Ann Oncol 21(Suppl 5):116~119
Azzoli CG / 2009 / American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer / J Clin Oncol 27:6251~6266
Lindeman NI / 2013 / Molecular testing guideline for selection of lung cancer patients for EGFR and ALK tyrosine kinase inhibitors : guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology / Arch Pathol Lab Med 137:828~860
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