Article Text

Download PDFPDF

2022-RA-708-ESGO Real-world assessment of patients with ovarian cancer who received niraparib as second-line maintenance therapy in the United States: did first-line maintenance approval change the patient profile for second-line maintenance therapy?
Free
  1. Floor Backes1,
  2. Tirza Areli Calderón Boyle2,
  3. Jessica Perhanidis3,
  4. Jonathan Lim2,
  5. Linda Kalilani4,
  6. Jean A Hurteau3,
  7. Amanda Golembesky4 and
  8. Ritu Salani5
  1. 1The Ohio State University Comprehensive Cancer Center-The James Cancer Hospital and Solove Research Institute, Columbus, OH
  2. 2GSK, Upper Providence, PA
  3. 3GSK, Waltham, MA
  4. 4GSK, Durham, NC
  5. 5Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, Los Angeles, CA

Abstract

Introduction/Background Niraparib, a poly(ADP-ribose) polymerase inhibitor (PARPi), was first approved in the US on 27 Mar 2017 for maintenance treatment of recurrent epithelial ovarian cancer (EOC). To evaluate whether approval of niraparib first-line maintenance (1LM) affected the clinical profile of patients receiving niraparib second-line maintenance (2LM), this study described the characteristics of real-world patients with EOC who initiated 2LM with niraparib before and after niraparib 1LM approval, using a real-world database.

Methodology This retrospective cohort study from the nationwide electronic health record-derived de-identified Flatiron Health database and included patients who were diagnosed with EOC between 01Jan2011 and 30Nov2021, were ≥18 years old at diagnosis, and received 1L platinum-based therapy. The index date was defined as the initiation date of niraparib 2LM monotherapy, on or after 01Jan2017. Demographic and clinical characteristics were assessed from EOC diagnosis to index date. Patients were stratified by index date: before 29Apr2020 (niraparib 1LM preapproval cohort) and after 29Apr2020 (niraparib 1LM postapproval cohort).

Results 231 2LM niraparib monotherapy patients were included, with all receiving 2L platinum-based therapy. The median age was 68 years, and patients were primarily treated in a community setting (90.0%; table 1). The majority of patients had stage III/IV disease at diagnosis (78.4%) and had BRCA wild-type (BRCAwt, 74.0%). Homologous recombination deficiency status was unknown for most patients (92.2%). Median time from initial EOC diagnosis to 2L maintenance therapy was 803 days. Patient characteristics were broadly similar across the stratified cohorts, with a higher proportion of patients with BRCAwt in the niraparib 1LM postapproval cohort than in the preapproval cohort (85.3% vs 68.6%).

Abstract 2022-RA-708-ESGO Table 1

Demographic and clinical characteristic of 2LM Niraparib Patients

Conclusion This real-world analysis found that niraparib remained an important treatment option for 2LM in patients with recurrent EOC following niraparib 1LM approval, and that 1LM approval did not markedly change the profile of patients receiving niraparib maintenance therapy in a 2L setting.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.