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961 Impact of disease progression on health-related quality of life of advanced ovarian cancer (AOC) patients – pooled analysis from the PRIMA trial
  1. DM Chase1,
  2. M Romeo Marin2,
  3. F Backes3,
  4. S Han4,
  5. W Graybill5,
  6. B Lund6,
  7. B Pothuri7,
  8. G Mangili8,
  9. D O’malley9,
  10. D Berton10,
  11. L Willmott11,
  12. K Baumann12,
  13. R Coleman13,
  14. T Safra14,
  15. V Heinzelmann-Schwarz15,
  16. D Lorusso16,
  17. F Karl17,
  18. T Woodward18,
  19. BJ Monk1 and
  20. A Gonzalez-Martin19
  1. 1GOG and Arizona Oncology (US Oncology Network), University of Arizona, Creighton University, Phoenix, AZ, USA
  2. 2GEICO and Medical Oncology Department, Institut Català d’Oncologia, Badalona, Spain
  3. 3The Ohio State University Wexner Medical Center, GOG and the Department of Obstetrics and Gynecology, Columbus, OH, USA
  4. 4University Hospitals Leuven, BGOG and Department of Gynaecology and Obstetrics, Leuven, Belgium
  5. 5Medical University of South Carolina, Gynecologic Oncology Group (GOG) and Department of Gynecologic Oncology, Charleston, SC, USA
  6. 6NSGO and Aalborg University Hospital, Aalborg, Denmark
  7. 7Laura and Isaac Perlmutter Cancer Center, NYU Langone Health, GOG and Department of Obstetrics/Gynecology, New York, NY, USA
  8. 8MITO and IRCCS Ospedale San Raffaele, Milan, Italy
  9. 9Ohio State University COM – James CCC, GOG and Division of Gynecologic Oncology, Columbus, OH, USA
  10. 10GINECO and ICO, Nantes, France
  11. 11GOG-F and Arizona Oncology Associates, Phoenix, AZ, USA
  12. 12AGO and Klinikum der Stadt Ludwigshafen, Ludwigshafen Am Rhein, Germany
  13. 13US Oncology Research (GOG), The Woodlands, TX, USA
  14. 14ISGO and Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv, Israel
  15. 15SAKK and University Hospital Basel, Basel, Switzerland
  16. 16MITO and Fondazione Policlinico Universitario Agostino Gemelli, IRCCS, Rome, Italy
  17. 17GlaxoSmithKline, Berlin, Germany
  18. 18GlaxoSmithKline, Philadelphia, PA, USA
  19. 19Clínica Universidad de Navarra, GEICO and Medical Oncology Department, Madrid, Spain


Introduction/Background*Clinical trials consistently demonstrate the detrimental impact of progressive disease (PD) on patients’ health-related quality of life (HRQoL). Progression-free survival (PFS) is an established regulatory endpoint. However, PFS is often excluded as an efficacy endpoint on the basis that — PFS is not patient relevant — in early benefit assessment by select EU health technology agencies. The PRIMA/ENGOT-OV26/GOG-3012 (NCT02655016) Phase 3 trial showed niraparib significantly prolongs median PFS vs placebo in patients with AOC responsive to 1L platinum (Pt)-based chemotherapy, (CT), regardless of biomarker status. This post-hoc analysis of PRIMA is the first study to examine the relationship between HRQoL and PD in a broad frontline AOC maintenance treatment setting.

Methodology In PRIMA, patients with AOC responsive to 1L Pt CT were randomised 2:1 to once-daily, maintenance niraparib or placebo. Impact of PD on patient HRQoL, irrespective of treatment, was evaluated within the pooled ITT population by comparing HRQoL at the last on-treatment (pre-progression) visit with HRQoL at end of treatment (EOT), +4 weeks, +8w, +12w, and +24w. Assessments included FOSI, EORTC QLQ-C30, EQ-5D-VAS, and EORTC QLQ-OV28 abdominal/GI symptom scale. ANCOVA was applied with treatment as a fixed effect and HRQoL at last on-treatment visit as a continuous covariate. Mixed models for repeated measurements (MMRM) evaluated cumulative HRQoL changes.

Result(s)*Significant reductions in HRQoL from pre- to post-progression were observed across all measures. Compared with pre-progression, FOSI scores (Least-squares mean [95% CI]) were lower at EOT+4w (-2.2 [-2.8, -1.6]) and EOT+24w (-1.7 [-2.3, -1.1]); each p<0.0001. Similarly, at these timepoints EORTC-QLQ-C30 scores were lower by -10.2 (-12.4, -8.0) and -10.7 (13.2, -8.2) points, respectively, and EQ-5D-VAS by -8.2 (-10.4, -6.0) and -6.2 (-8.2, -4.2) points, respectively; each p<0.0001. EORTC QLQ-OV28 scores were significantly worse at EOT+4w (6.6 [4.3, 8.9]) and EOT+24w (5.0 [2.8, 7.2]); each p<0.0001. Similar changes were seen on MMRM analysis.

Conclusion*These findings demonstrate HRQoL is negatively impacted by PD in AOC. Preservation of HRQoL, an important therapy goal in the maintenance setting particularly for asymptomatic patients, can be achieved with PFS prolongation. PFS is of significant relevance and clinically important for AOC patients.

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