Sunitinib心毒性及肝毒性之文獻回顧及國內案例報告

Sunitinib-related Cardiotoxicity and Hepatotoxicity: Literature Review and Case Reports in Taiwan

Sunitinib 為一種口服抗癌藥物，其主要作用機轉是源自於它能抑制多種酪胺酸激酶（tyrosine kinase），此藥物在台灣於2007 年獲准上市（紓癌特膠囊[Sutent® Capsule]），衛生署通過適應症為：適用於imatinib mesylate 治療期間出現疾病惡化或對該藥出現不能忍受之腸胃道間質腫瘤以及治療晚期或轉移性腎細胞癌（病理上為亮細胞癌[clear cell carcinoma]）。由於Sunitinib 耐受性佳，病人於使用sunitinib 後發生第三級或第四級不良反應的發生率相對較低，故使得sunitinib 的臨床重要性日趨顯著，但值得注意的是，sunitinib 仍偶有心毒性（cardiotoxicity）及肝毒性（hepatotoxicity）之嚴重藥物不良反應的報導，必須小心地進行監控及預防。本篇文章整合臨床試驗（clinical trial）、觀察性研究（observational study）以及統合分析（meta-analysis）的研究結果並加上全國藥物不良反應通報中心所通報的國內案例，針對此一議題進行深入的討論。

Sunitinib is an oral multi－targeted receptor tyrosine kinase inhibitor approved for the treatment of metastatic renal carcinoma and gastrointestinal stromal tumor. Its efficacy in other tumor types, such as pancreatic neuroendocrine tumors is currently investigated. However, concerns about its cardiac safety have been raised. Previous clinical trials linked sunitinib with an increased risk of congestive heart failure. In addition, recent clinical trials and case reports revealed an increased risk of life-threatening hepatotoxicity associated with sunitinib. This article summarized existing studies and examined case reports of sunitinib-related cardiotoxicity and hepatotoxicity in Taiwan.