RT Journal Article
T1 Efficacy of niraparib by time of surgery and postoperative residual disease status: A post hoc analysis of patients in the PRIMA/ENGOT-OV26/GOG-3012 study.
A1 O'Cearbhaill, Roisin E
A1 Pérez-Fidalgo, Jose-Alejandro
A1 Monk, Bradley J
A1 Tusquets, Ignacio
A1 McCormick, Colleen
A1 Fuentes, Jose
A1 Moore, Richard G
A1 Vulsteke, Christof
A1 Shahin, Mark S
A1 Forget, Frédéric
A1 Bradley, William H
A1 Hietanen, Sakari
A1 O'Malley, David M
A1 Dørum, Anne
A1 Slomovitz, Brian M
A1 Baumann, Klaus
A1 Selle, Frédéric
A1 Calvert, Paula M
A1 Artioli, Grazia
A1 Levy, Tally
A1 Kumar, Aalok
A1 Malinowska, Izabela A
A1 Li, Yong
A1 Gupta, Divya
A1 González-Martín, Antonio
K1 Maintenance therapy
K1 Niraparib
K1 Ovarian cancer
K1 PARP inhibitor
K1 Surgery
AB To 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.
YR 2022
FD 2022-05-09
LK http://hdl.handle.net/10668/22548
UL http://hdl.handle.net/10668/22548
LA en
DS RISalud
RD Apr 6, 2025