O'Cearbhaill, Roisin EPérez-Fidalgo, Jose-AlejandroMonk, Bradley JTusquets, IgnacioMcCormick, ColleenFuentes, JoseMoore, Richard GVulsteke, ChristofShahin, Mark SForget, FrédéricBradley, William HHietanen, SakariO'Malley, David MDørum, AnneSlomovitz, Brian MBaumann, KlausSelle, FrédéricCalvert, Paula MArtioli, GraziaLevy, TallyKumar, AalokMalinowska, Izabela ALi, YongGupta, DivyaGonzález-Martín, Antonio2023-05-032023-05-032022-05-09http://hdl.handle.net/10668/22548To evaluate the association between surgical timing and postoperative residual disease status on the efficacy of niraparib first-line maintenance therapy in patients with newly diagnosed advanced ovarian cancer at high risk of recurrence. Post hoc analysis of the phase 3 PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) study of niraparib in patients with newly diagnosed primary advanced ovarian, primary peritoneal, or fallopian tube cancer with a complete/partial response to first-line platinum-based chemotherapy. Progression-free survival (PFS) was assessed by surgical status (primary debulking surgery [PDS] vs neoadjuvant chemotherapy/interval debulking surgery [NACT/IDS]) and postoperative residual disease status (no visible residual disease [NVRD] vs visible residual disease [VRD]) in the intent-to-treat population. In PRIMA (N = 733), 236 (32.2%) patients underwent PDS, and 481 (65.6%) received NACT/IDS before enrollment. Median PFS (niraparib vs placebo) and hazard ratios (95% CI) for progression were similar in PDS (13.7 vs 8.2 months; HR, 0.67 [0.47-0.96]) and NACT/IDS (14.2 vs 8.2 months; HR, 0.57 [0.44-0.73]) subgroups. In patients who received NACT/IDS and had NVRD (n = 304), the hazard ratio (95% CI) for progression was 0.65 (0.46-0.91). In patients with VRD following PDS (n = 183) or NACT/IDS (n = 149), the hazard ratios (95% CI) for progression were 0.58 (0.39-0.86) and 0.41 (0.27-0.62), respectively. PFS was not evaluable for patients with PDS and NVRD because of sample size (n = 37). In this post hoc analysis, niraparib efficacy was similar across PDS and NACT/IDS subgroups. Patients who had NACT/IDS and VRD had the highest reduction in the risk of progression with niraparib maintenance.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/Maintenance therapyNiraparibOvarian cancerPARP inhibitorSurgeryCarcinoma, Ovarian EpithelialChemotherapy, AdjuvantCytoreduction Surgical ProceduresFemaleHumansIndazolesNeoadjuvant TherapyNeoplasm StagingNeoplasm, ResidualOvarian NeoplasmsPiperidinesresearch article35550709open access10.1016/j.ygyno.2022.04.0121095-6859PMC10025898http://www.gynecologiconcology-online.net/article/S0090825822002530/pdfhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC10025898/pdf