非小細胞肺癌治療新標的─調查台灣地區間變性淋巴瘤激酶陽性率

Abstract

研究目的: 藉由分析台灣地區非小細胞肺癌(Non-Small Cell Lung Cancer)之間變性淋巴瘤激酶（anaplastic lymphoma kinase, ALK）免疫組織化學(immunohistochemistry，IHC)染色陽性率，將了解目前全台檢測ALK生物標記(biomarker)之現況，並可建立台灣本土ALK基因突變率之參考數據，以提供臨床醫師於治療非小細胞肺癌時檢測之參考! 方法: 本研究是回溯性分析全台55家醫院送檢ALK基因突變檢測之結果，對於ALK基因突變的檢測，皆採用符合TFDA之羅氏Ventana ALK (D5F3) 兔子單株抗體Detection Kit，使用免疫組織化學染色方法進行篩檢。 結果: 自2013/12/1至2014/11/30，全台55家醫院共送檢ALK基因突變檢測1816件，其中134件結果為陽性，ALK之IHC染色陽性率為7.37%. 結論: 台灣地區晚期非小細胞肺癌之ALK IHC 染色陽性率和其他國家(介於2-7%)是相當的(Planchard, 2013)，因此國內治療晚期非小細胞肺癌時，除了常規檢測表皮生長因子接受器（epidermal growth factor receptor, EGFR）外，也應考慮將 ALK檢測納入檢驗項目之一，以協助病患早日找到目標明確且效果顯著的標靶藥物治療。

Study Aims: Anaplastic lymphoma kinase (ALK) inhibitor, a new targeted agent, has become the standard treatment for non-small lung cancer (NSCLC) harboring ALK gene mutation. This study was designed to investigate the anaplastic lymphoma kinase (ALK) gene mutation rate of non-small lung cancer patients in Taiwan. This study could establish the prevalence rate of ALK mutation in Taiwan and help clinicians to evaluate the optimal timing of performing ALK mutational analysis in late stage NSCLC patients. Methods: We retrospectively collect the database from 55 hospitals in Taiwan. The ALK gene analysis was performed by immunohistochemical (IHC) staining method with rabbit monoclonal antibody-based Ventana ALK (D5F3) Detection Kit which has been approved by Taiwan Food and Drug Administration. Results: Total 1,816 samples were tested for ALK mutational analysis from Dec.1st, 2013 to Nov.30th, 2014 in 55 hospitals in Taiwan. One hundred and thirty-four samples are positive, and the IHC positive rate of ALK is 7.37%.(Planchard, 2013) Conclusions: The ALK positive rate by IHC method is comparable to those of international studies. Clinicians might consider to check ALK mutational analysis by IHC method in addition to standard checkup of epidermal growth factor receptor mutational analysis before treating late stage NSCLC patients.