唾液腺導管癌為惡性唾液腺癌中常見的組織學型態，常有人類表皮生長因子受 體 (human epidermal growth factor receptor 2, HER2) 過度表現。依美國國家癌症 資訊網 (National Comprehensive Cancer Network) 治療準則，針對遠端轉移性唾液腺癌以參與臨床試驗為優先，在特定情況下可使用其他標靶藥物，如 HER2 陽性以 trastuzumab 或 ado-trastuzumab emtansine (T-DM1, Kadcyla® ) 治療。目前 T-DM1 用在 HER2 陽性轉移性唾液腺癌的大型研究皆為籃式 (basket) 試驗， 即同一標靶藥物針對相同基因突變或生物標記但不同組織學癌症所衍生出來的新型試驗設計，此類試驗有助於加速基因突變的罕見疾病治療發展。本文探討一 66 歲男性 HER2 陽性轉移性唾液腺癌第四期，使用 T-DM1 治療後的臨床結果，並以實證醫學方法評判當前最佳研究證據。迄今籃式試驗尚無合適的評讀工具，我們使用 ROBINS-I (risk of bias in non-randomized studies of interventions) 與 Park 等人文獻評讀，以 GRADE (the grading of recommendations assessment, development and evaluation) 整合證據，證據力非常低，還需更進一步的研究。

 

The most common histology in malignant salivary gland cancer is salivary gland duct cancer, often accompanied by overexpression of human epidermal growth factor receptor 2 (HER2). According to the National Comprehensive Cancer Network guidelines, trastuzumab or ado-trastuzumab emtansine (T-DM1, Kadcyla®) may be used in malignant salivary gland cancers with HER2 overexpression. Currently, all large-scale clinical trials on T-DM1 used in metastatic salivary gland tumors with HER2 overexpression are basket trials—a study designed to evaluate targeted therapy for multiple diseases sharing common molecular alterations. Such biomarkerguided study designs can help accelerate drug development for rare diseases with gene mutations. This study reports the clinical outcome of the third dose of T-DM1 administered to a 66-year-old male with metastatic salivary gland cancer with HER2 overexpression (stage IVA) who was evaluated for the current best evidence by the method of evidence-based medicine. There have been no suitable evaluating tools (such as basket or umbrella trials) for such trials that are biomarker guided. Therefore, we used ROBINS-I (risk of bias in non-randomized studies of interventions) and a study by Park et al. to evaluate the quality of the studies included herein. Additionally, we used the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) tool to classify the quality of evidence and formulate recommendations from previous evidence. However, the certainty of the evidence of the objective response rate is very low; further studies are required on the efficacy of T-DM1 used in metastatic salivary gland cancer with HER2 overexpression.

 

Summited for publication: 2021.7.5; Accepted for publication: 2022.6.6