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

Authors

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

Publication Date

7-1-2022

Journal

Gynecologic Oncology

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.

Keywords

Carcinoma, Ovarian Epithelial, Chemotherapy, Adjuvant, Cytoreduction Surgical Procedures, Female, Humans, Indazoles, Neoadjuvant Therapy, Neoplasm Staging, Neoplasm, Residual, Ovarian Neoplasms, Piperidines