在2022年,三家大型製藥公司自願根據ARIEL4(Rubraca®; Clovis)、SOLO3(Lynparza®; AstraZeneca)和QUADRA(Zejula®; GSK)的更新結果,撤回了聚合酶(ADP核糖)聚合酶(PARP)抑制劑(PARP inhibitors) 使用於已重度治療過的卵巢癌患者。在獲得食品和藥物管理局的即時批准後,相關學術社團宣布了相關的建議:不應將PARP抑制劑單獨治療常規用於鉑金敏感性的復發性卵巢癌患者,也不應用於BRCA1/2野生型或鉑金抵抗性的復發性卵巢癌患者。儘管如此,需要仔細解讀除主要終點以外的研究結果,這些結果在確認性研究中的統計功效不足。然而,考慮到該設定中有關使用PARP抑制劑的證據正在演變,並且數據仍在不斷出現,在特定人群中,應個別選擇使用PARP抑制劑單獨治療。
In 2022, three large pharmaceutical companies voluntarily withdrew poly (ADP-ribose) polymerase (PARP) inhibitors for heavily pretreated ovarian cancer patients, based on the updated results from ARIEL4 (Rubraca®; Clovis), SOLO3 (Lynparza®; AstraZeneca), and QUADRA (Zejula®; GSK). Following the immediate sanction of the Food and Drug Administration, academic societies announced relevant recommendations: PARP inhibitor monotherapy should not be routinely offered to patients for the treatment of platinum-sensitive recurrent ovarian cancer or to patients with either BRCA1/2 wild-type or platinum-resistant recurrent ovarian cancer. Notwithstanding, a careful interpretation of study results other than the primary endpoints that did not have sufficient statistical power in the confirmatory study is needed. PARP inhibitor monotherapy in select populations should be individualized, considering that evidence on the use of PARP inhibitors in this setting is evolving and data are continuing to emerge.