医学
子宫内膜癌
临床终点
内科学
奥拉帕尼
无进展生存期
杜瓦卢马布
不利影响
癌症
肿瘤科
外科
临床试验
化疗
无容量
免疫疗法
生物化学
化学
聚合酶
聚ADP核糖聚合酶
基因
作者
Cathalijne C.B. Post,Anneke M. Westermann,Ingrid Boere,Petronella O. Witteveen,Petronella B. Ottevanger,Gabe S. Sonke,Roy Lalisang,Hein Putter,Elma Meershoek‐Klein Kranenbarg,Jeffrey P. B. M. Braak,Carien L. Creutzberg,Tjalling Bosse,Judith R. Kroep
标识
DOI:10.1016/j.ygyno.2022.02.025
摘要
BackgroundPatients with advanced endometrial cancer have a poor prognosis, and treatment options are limited. The investigator-initiated, multicenter, phase II DOMEC trial (NCT03951415) is the first trial to report data on efficacy and safety of combined treatment with PD-L1 and PARP inhibition for advanced endometrial cancer.Patients and methodsPatients with metastatic or recurrent endometrial cancer were enrolled. Patients received durvalumab 1500 mg intravenously q4w and olaparib 300 mg 2dd until disease progression, unacceptable toxicity, or patient withdrawal. Patients with at least 4 weeks of treatment were evaluable for analysis. The primary endpoint was progression-free survival at 6 months. Evidence for efficacy was defined as progression-free survival at 6 months in ≥50% of patients. Secondary endpoints included safety, objective response and overall survival.ResultsFrom July 2019, through November 2020, 55 patients were enrolled. At data cut-off (September 2021), 4 of the 50 evaluable patients were still on treatment. Seventeen patients (34%) were progression-free at 6 months. Objective response rate was 16% (95% CI, 8.3 to 28.5) with 1 complete and 7 partial responses. With a median follow-up of 17.6 months, median progression-free survival was 3.4 months (95% CI, 2.8 to 6.2) and median overall survival was 8.0 months (95% CI, 7.5 to 14.3). Grade 3 treatment-related adverse events occurred in 8 patients (16%), predominantly anemia. There were no grade 4 or 5 treatment-related adverse events.ConclusionThe combination of durvalumab and olaparib was well tolerated, but did not meet the prespecified 50% 6-month progression-free survival in this heterogeneous patient population with advanced endometrial cancer.
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