University of South Alabama - Mitchell Cancer Institute, Mobile, AL, United States of America.
Arizona Oncology, Phoenix, AZ, United States of America.
Gynecol Oncol. 2021 Jun;161(3):676-680. doi: 10.1016/j.ygyno.2021.03.009. Epub 2021 Mar 11.
Recently, Vigil showed significant clinical benefit with improvement in relapse free (RFS) and overall survival (OS) in pre-planned subgroup analysis in stage III/IV newly diagnosed ovarian cancer patients with BRCA wild type (BRCA-wt) molecular profile. Here we analyze homologous recombination (HR) status of patients enrolled in the Phase 2b VITAL study and determine clinical benefit of Vigil in HR proficient (P) patients.
Patients were previously enrolled in a Phase 2b, double-blind, placebo-controlled trial. All were in complete response with Stage III/IV high grade serious, endometroid or clear cell ovarian cancer. HR status was determined using MyChoice®CDx score (<42 = HRP) (Myriad Genetics, Inc., UT). Post-hoc analyses were carried out using Kaplan Meier and restricted mean survival time (RMST) analysis to evaluate RFS and OS based on HR deficiency (D) status.
RFS was improved with Vigil (n = 25) in HRP patients compared to placebo (n = 20) (HR = 0.386; 90% CI 0.199-0.750; p = 0.007), results were verified by RMST (p = 0.017). Similarly, OS benefit was observed in Vigil group compared to placebo (HR = 0.342; 90% CI 0.141-0.832; p = 0.019). Results with OS were also verified with RMST (p = 0.008).
Vigil exhibited clinical benefit in HRP molecular profile patients.
最近，Vigil 在 III/IV 期新诊断的 BRCA 野生型（BRCA-wt）分子特征的卵巢癌患者的预设亚组分析中显示出显著的临床获益，改善了无复发生存（RFS）和总生存（OS）。在此，我们分析了 VITAL 研究 IIb 期入组患者的同源重组（HR）状态，并确定 Vigil 在 HR 有效的（P）患者中的临床获益。
患者先前入组了一项 IIb 期、双盲、安慰剂对照试验。所有患者均为 III/IV 期高级别浆液性、子宫内膜样或透明细胞卵巢癌，完全缓解。HR 状态使用 MyChoice®CDx 评分（<42=HRP）（Myriad Genetics，Inc.，UT）进行确定。采用 Kaplan-Meier 和限制平均生存时间（RMST）分析进行事后分析，根据 HR 缺陷（D）状态评估 RFS 和 OS。
与安慰剂组（n=20）相比，Vigil 组（n=25）的 HRP 患者 RFS 得到改善（HR=0.386；90%CI 0.199-0.750；p=0.007），结果经 RMST 验证（p=0.017）。同样，与安慰剂组相比，Vigil 组的 OS 也得到了改善（HR=0.342；90%CI 0.141-0.832；p=0.019）。OS 的结果也经 RMST 验证（p=0.008）。
Vigil 在 HRP 分子特征患者中表现出临床获益。
