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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

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

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

Shahin Mark S.
Gupta Divya
Bradley William H.
McCormick Colleen
Calvert Paula M.
Malinowska Izabela A.
O'Cearbhaill Roisin E.
Tusquets Ignacio
Dørum Anne
Li Yong
O'Malley David M.
Monk Bradley J.
Artioli Gracia
Moore Richard G.
Vulsteke Christof
Fuentes Jose
Levy Tally.
Forget Frédéric
Selle Frédéric
Kumar Aalok
Hietanen Sakari
Pérez-Fidalgo Jose-Alejandro.
González-Martín Antonio
Slomovitz Brian M.
Baumann Klaus
Katso/Avaa
1-s2.0-S0090825822002530-main.pdf (692.7Kb)
Lataukset: 

Academic Press Inc.
doi:10.1016/j.ygyno.2022.04.012
URI
https://doi.org/10.1016/j.ygyno.2022.04.012
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Julkaisun pysyvä osoite on:
https://urn.fi/URN:NBN:fi-fe2022081154620
Tiivistelmä

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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