- 期刊
第一個針對BRCA突變卵巢癌的標靶治療：Olaparib
The First Targeted Therapy toward BRCA-mutated Ovarian Cancer: Olaparib
摘要
表皮卵巢癌是全世界女性第七名高的發生率。台灣女性癌症中的第九高。在2006至2013年間，雖然全球的重大研究中，沒有任何一個新藥在治療卵巢癌領域被核准。Olaparib在2014首度在美國食物藥品管理署被核准單一治療用於具有傷害性或懷疑的BRCA突變晚期且已經三或更多的化學治療；2017年再加上具有乳癌易感基因（breast cancer susceptibility gene,BRCA）突變的卵巢癌，對鉑類化療已經完全或部分反應後之維持療法。2018年6月5日olaparib在臺灣取得許可證。Olaparib是PARP酵素抑制劑的第一個上市藥品。PARP酵素在DNA受損反應路徑（DDR）特別是鹼基排除修護（BER）或單股斷片修護（SSBR）負責DNA受損修護的工作。臨床試驗（SOLO-2）中，證實在具有生殖細胞BRCA突變的卵巢癌、輸卵管癌、原發腹膜癌的病人，先前都接受過鉑化學治療，且最近一次對於鉑化學治療有萬全或部分反應者，Olaparib被證實可以延長無惡化存活期。主要副作用為血液學副作用，極少數（＜1%）病人在試驗中發生骨髓增生不良症候群與急性骨髓性白血病，所以接受本藥的病人，需要有全血球計數的基線值與定期檢測。
並列摘要
Epithelial ovarian cancer ranks top seven in female cancer incidence worldwide and top nine in Taiwan. From 2006 to 2013, there was not any antineoplastic agent approved for this disease. In 2014, US FDA approved the first targeted agent, Olaparib, for BRCA-mutated ovarian cancer after 3 or more prior chemotherapy. Then in 2017, Olaparib was approved for BRCA mutation maintenance after complete/partial response to platinum chemotherapy. Taiwan also gave her FDA approval to Olaparib in June, 2018. The mechanism of Olaparib is to inhibit poly(ADP-ribose) polymerase, which plays a vital role in the DNA damage repair. In the SOLO 2 trial, a phase III trial for ovarian, fallopian, and primary peritoneal cancer, patients with BRCA mutation maintenance therapy after complete/partial response to platinum chemotherapy responded to Olaparib with prolonged progression-free survival. The major adverse effects of Olaparib are mainly hematological. Very few (＜1%) patients in the clinical trial showed myelodysplastic syndrome or acute mylogenous leukemia after the start of therapy. Baseline and periodical complete blood counts need to be monitored.