Scientific publications
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
Roisin E O'Cearbhaill 1 , Jose-Alejandro Pérez-Fidalgo 2 , Bradley J Monk 3 , Ignacio Tusquets 4 , Colleen McCormick 5 , Jose Fuentes 6 , Richard G Moore 7 , Christof Vulsteke 8 , Mark S Shahin 9 , Frédéric Forget 10 , William H Bradley 11 , Sakari Hietanen 12 , David M O'Malley 13 , Anne Dørum 14 , Brian M Slomovitz 15 , Klaus Baumann 16 , Frédéric Selle 17 , Paula M Calvert 18 , Grazia Artioli 19 , Tally Levy 20 , Aalok Kumar 21 , Izabela A Malinowska 22 , Yong Li 22 , Divya Gupta 22 , Antonio González-Martín 23
Objective: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
CITATION Gynecol Oncol. 2022 Jul;166(1):36-43.
doi: 10.1016/j.ygyno.2022.04.012. Epub 2022 May 9.
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