医学
卡铂
贝伐单抗
肿瘤科
奥拉帕尼
卵巢癌
紫杉烷
内科学
化疗
紫杉醇
随机对照试验
多中心试验
泌尿科
癌症
乳腺癌
多中心研究
顺铂
生物化学
化学
聚合酶
聚ADP核糖聚合酶
基因
作者
Florian Heitz,Christian Marth,Stéphanie Henry,Maurizio de Martino,David Cibula,Lydia Gaba Garcia,Nicoletta Colombo,Barbara Schmalfeld,Nikolaus de Gregorio,Pauline Wimberger,Annette Hasenburg,Jalid Sehouli,Martina Gropp‐Meier,Philip C. Schouten,Eric Hahnen,Jan Hauke,Sandra Polleis,Philipp Harter
出处
期刊:International Journal of Gynecological Cancer
[BMJ]
日期:2023-11-07
卷期号:33 (12): 1966-1969
被引量:6
标识
DOI:10.1136/ijgc-2023-004944
摘要
Phase III trial data have shown a significant benefit by the addition of a maintenance treatment with niraparib, irrespective of BRCA or HRD status, in patients with advanced high-grade ovarian cancers; and, a significant benefit of the combination of olaparib and bevacizumab compared with bevacizumab monotherapy in HRD positive patients. However, it is unclear whether a PARP inhibitor monotherapy is sufficient, or if the addition of bevacizumab is needed.This trial will investigate if the treatment strategy of carboplatin/paclitaxel/bevacizumab/niraparib is superior to the treatment of carboplatin/paclitaxel/niraparib in an all-comer population.Adding bevacizumab to chemotherapy followed by niraparib maintenance improves progression-free survival in patients with newly diagnosed advanced ovarian cancer.AGO-OVAR 28/ENGOT-ov57 is an international, multicenter, randomized, prospective phase III trial within the the European Network for Gynecological Oncological Trial (ENGOT), led by the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) study group. All patients should have completed the first cycle of chemotherapy (carboplatin and paclitaxel) as part of the Study Run-In-Period. Prior to day 1 of cycle 2, patients with a valid central tumor BRCA (tBRCA) test result were randomized in a 1:1 ratio into either: Arm 1, to receive five additional cycles of carboplatin and paclitaxel q21d, followed by niraparib for up to 3 years; or Arm 2, to receive five additional cycles of carboplatin and paclitaxel plus bevacizumab q21d, followed by bevacizumab q21d (for up to 1 year), and niraparib for up to 3 years.The trial population is composed of adult patients with newly diagnosed, advanced high-grade epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer FIGO III/IV (except FIGO IIIA2 without nodal involvement). Patients who are scheduled for neoadjuvant chemotherapy and interval debulking surgery are also eligible for the trial.The primary endpoint is progression-free survival.The study plans to recruit 970 patients (485 patients in each arm).The Last-Patient-In is expected to be enrolled in September 2024, with presentation of the primary endpoint in 2028.NCT05009082; EudraCT Number: 2021-001271-16.
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