Department of Medical Oncology, HCL Cancer Institute & Lyon 1 University, GINECO, Lyon, France.
Department of Medical Oncology, University Hospital of Saint-Étienne, Saint-Étienne, GINECO, France.
Future Oncol. 2023 Aug;19(25):1715-1727. doi: 10.2217/fon-2023-0167. Epub 2023 Aug 31.
Following the results of the PRIMA and PAOLA-1 trials, the most effective maintenance strategy for International Federation of Gynecology and Obstetrics stage III patients is still debated, raising the question which of those two maintenance strategies is the most effective: PARP inhibitors alone or PARP inhibitors in combination with bevacizumab. The ongoing NIRVANA-1 study will try to answer this question by assessing the efficacy and safety of niraparib + bevacizumab in comparison with niraparib alone after adjuvant chemotherapy for completely resected stage III patients. Stratification factors include tumor status, International Federation of Gynecology and Obstetrics stage (IIIA vs IIIB/IIIC) and the use of hyperthermic intraperitoneal chemotherapy during surgery - within the OVHIPEC-2 trial. The primary end point will be progression-free survival rate at 24 months. Safety, median progression-free survival and overall survival will also be studied.
根据 PRIMA 和 PAOLA-1 试验的结果，国际妇产科联合会（FIGO）III 期患者最有效的维持治疗策略仍存在争议，这引发了一个问题，即这两种维持治疗策略中哪一种最有效：PARP 抑制剂单药治疗还是 PARP 抑制剂联合贝伐珠单抗治疗。正在进行的 NIRVANA-1 研究将通过评估尼拉帕利联合贝伐珠单抗与尼拉帕利单药治疗在完全切除的 III 期患者辅助化疗后的疗效和安全性来尝试回答这个问题。分层因素包括肿瘤状态、FIGO 分期（IIIA 与 IIIB/IIIC）以及手术中使用腹腔内热化疗 - 在 OVHIPEC-2 试验中。主要终点将是 24 个月时无进展生存率。还将研究安全性、中位无进展生存期和总生存期。
