Refereed journal article or data article (A1)

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




List of Authors: O'Cearbhaill Roisin E., Pérez-Fidalgo Jose-Alejandro., Monk Bradley J., Tusquets Ignacio, McCormick Colleen, Fuentes Jose, Moore Richard G., Vulsteke Christof, Shahin Mark S., Forget Frédéric, Bradley William H., Hietanen Sakari, O'Malley David M., Dørum Anne, Slomovitz Brian M., Baumann Klaus, Selle Frédéric, Calvert Paula M., Artioli Gracia, Levy Tally., Kumar Aalok, Malinowska Izabela A., Li Yong, Gupta Divya, González-Martín Antonio

Publisher: Academic Press Inc.

Publication year: 2022

Journal: Gynecologic Oncology

Journal name in source: Gynecologic Oncology

Volume number: 166

Issue number: 1

DOI: http://dx.doi.org/10.1016/j.ygyno.2022.04.012

URL: https://doi.org/10.1016/j.ygyno.2022.04.012

Self-archived copy’s web address: https://research.utu.fi/converis/portal/detail/Publication/175559706


Abstract

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.


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Last updated on 2022-29-06 at 10:11