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367 The use of real-world evidence from the edinburgh ovarian cancer database to explore a data gap in the prima trial
  1. Robert L Hollis1,
  2. Zsofia Kiss2,
  3. Nichola Roebuck2,
  4. Helen Starkie-Camejo2,
  5. Kiera Heffernan2 and
  6. Charlie Gourley1
  1. 1Nicola Murray Centre for Ovarian Cancer Research, Cancer Research UK Edinburgh Centre, MRC Institute of Genetics and Molecular Medicine, Edinburgh, UK
  2. 2GlaxoSmithKline Brentford, Middlesex, London, UK


Introduction/Background Niraparib is an oral, highly selective poly(ADP-ribose) polymerase inhibitor (PARPi). The PRIMA/ENGOT-OV26/GOG-3012 trial intention-to-treat population included stage III and IV ovarian cancer (OC) patients post-primary or interval debulking surgery (PDS/IDS) irrespective of residual disease (visible residual disease [VRD] or no VRD [NVRD]), except for stage III patients post-PDS with NVRD. A data gap therefore exists in the stage III post-PDS NVRD population. This study aims to use real-world evidence from the Edinburgh Ovarian Cancer Database to explore the difference in overall survival (OS) and progression-free survival (PFS) in: a) a ‘simulated-PRIMA cohort’ (stage III VRD after PDS, stage III and IDS, and stage IV OC), b) a ‘simulated-NVRD after PDS cohort’ (stage III NVRD after PDS) and c) a larger ‘simulated-broader cohort’ (both cohorts a and b plus the additional stage III non-evaluable debulking status cases).

Methodology A retrospective observational study was conducted to examine characteristics and long-term outcomes for patients diagnosed with advanced OC within the Edinburgh Cancer Centre between 1 January 2000 and 31 December 2015. Patients were followed until their last patient record or last data cut (January 2019) and were chosen to match the three defined populations. Main outcomes were OS and PFS, the latter defined as time from diagnosis to first progression as defined by radiology, tumour marker (CA125) or the treating physician where other investigations were not evaluable.

Results Baseline patient characteristics in the simulated-PRIMA (n=472), simulated-stage III NVRD after PDS (n=69) and simulated-broader (n=569) cohorts matched the PRIMA trial in most categories. PFS and OS for simulated cohorts are shown in the table 1. When compared with the simulated-PRIMA cohort, the simulated-stage III NVRD after PDS cohort had significantly longer PFS (hazard ratio [HR]=0.43, 95% CI 0.32–0.58, P<0.0001) and significantly longer OS (HR=0.43, 95% CI 0.32–0.60, P<0.0001). Furthermore, the simulated-broader cohort demonstrated a survival curve above the simulated-PRIMA curve. Within the 2010–2015 diagnosis (contemporary) stage III cohort (n=169), 57.4% had IDS and 42.6% had PDS, of whom 23.1% had PDS VRD, 17.2% had PDS NVRD, and 2.4% were PDS not evaluable for residual disease.

Abstract 367 Table 1

Conclusion The simulated-broader cohort showed longer duration of OS and PFS outcomes as the survival curves lie above the simulated-PRIMA cohort. This difference is driven by the better prognosis for patients with stage III NVRD after PDS population; this population accounted for approximately 17% of the contemporary patient cohort at this UK centre.

Disclosures This study was funded by GlaxoSmithKline.

Clinical Trial Registration: N/A

Dr. Hollis reports institutional grants and personal fees from GlaxoSmithKline.

Dr. Gourley reports personal fees from Roche, Clovis, Tesaro, Foundation One, Nucana, Aprea, Novartis, Chugai, and MSD; institutional grants from Clovis, Tesaro, Nucana, and Novartis.

Drs. Kiss, Roebuck, Heffernan and Starkie-Camejo are employees of GlaxoSmithKline.

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