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167 Safety and quality of life of first-line maintenance olaparib plus bevacizumab in older patients with advanced ovarian cancer in the PAOLA-1 trial
  1. C Montégut1,
  2. C Falandry2,
  3. S Cinieri3,
  4. L Montane4,
  5. F Rousseau1,
  6. F Joly5,
  7. J Frindte6,
  8. AM Mosconi7,
  9. E Guerra-Alia8,
  10. C Schauer9,
  11. H Fujiwara10,
  12. IB Vergote11,
  13. G Parma12,
  14. G Lindahl13,
  15. A Anota4,
  16. U Canzler14,
  17. F Marmé15,
  18. E Pujade-Lauraine16,
  19. I Ray-Coquard4,17 and
  20. R Sabatier1
  1. 1Institut Paoli-Calmette, and GINECO, Marseille, France
  2. 2CHU Lyon, and GINECO, Lyon, France
  3. 3U.O.C. Oncologia Medica – Ospedale Senatore Antonio Perrino, and MITO, Puglia, Italy
  4. 4Centre Léon Bérard, Lyon, France
  5. 5Centre François Baclesse, and GINECO, Caen, France
  6. 6Kliniken Essen-Mitte, Department of Gynecology and Gynecologic Oncology, and AGO, Essen, Germany
  7. 7S.C. di Oncologia Medica Ospedaliera S. Maria della Misericordia – AO di Perugia, and MITO, Perugia, Italy
  8. 8Hospital Ramon y Cajal, and GEICO, Madrid, Spain
  9. 9Hospital Barmherzige Brüder Graz, and AGO, Graz, Austria
  10. 10Jichi Medical University, and GOTIC, Tochigi, Japan
  11. 11University Hospital Leuven, Leuven Cancer Institute, and BGOG, Leuven, Belgium
  12. 12European Institute of Oncology IRCCS, and MANGO, Milan, Italy
  13. 13Linköping University Hospital, and NSGO, Linköping, Sweden
  14. 14Universitätsklinikum Carl Gustav Carus, Technische Universität Dresden, and AGO, Dresden, Germany
  15. 15Universitätsklinikum Heidelberg, and AGO, Heidelberg, Germany
  16. 16ARCAGY Research, and GINECO, Paris, France
  17. 17University Claude Bernard Lyon I, and GINECO, Lyon, France


Introduction/Background*The Phase III PAOLA-1/ENGOT-ov25 study (NCT02477644) demonstrated that the addition of olaparib to bevacizumab maintenance following standard platinum-based therapy plus bevacizumab improved progression-free survival (PFS) in patients with newly diagnosed advanced ovarian cancer (Ray-Coquard et al. NEJM 2019). We aimed to describe safety, quality of life (QoL), and efficacy with olaparib plus bevacizumab in patients ≥70 years old.

Methodology Safety (adverse events [AEs] graded according to CTCAE v5.0) and QoL (measured using EORTC QLQ-C30 global health status [GHS]) data were collected. We compared safety by age (older [≥70 years] and younger patients [<70 years]) in the olaparib arm. Geriatric features, including Geriatric Vulnerability Score (GVS; Falandry et al. Ann Oncol 2013) items, and QoL by treatment arm were assessed in older patients.

Result(s)*Of 806 patients enrolled, 142 (17.6%) were ≥70 years old; 104 of these were in the olaparib arm. There was no notable difference in baseline characteristics between olaparib and placebo arms (table 1). In evaluation of safety, moderately increased rates of grade ≥3 treatment-related AEs (TRAEs), dose reductions and interruptions, and treatment discontinuation due to TRAEs were reported in older than younger patients (table 2). Grade 3–4 any-cause anaemia (21.2% vs 16.5%) and neutropenia (9.7% vs 5.1%) were more frequent in older patients. The most common grade 3–4 non-haematological AE was hypertension (26.9% vs 16.7%). No acute myeloid leukaemia, myelodysplastic syndrome, or treatment-related death was reported among older patients. Interestingly, GHS during the first 2 years of maintenance was similar between arms. Median PFS was 21.1 months with olaparib vs 14.3 months with placebo. Analyses by GVS and homologous recombination deficiency subgroups are ongoing and will be presented.

Abstract 167 Table 1

Baseline geriatric characteristics in older patients (≥70 years)

Abstract 167 Table 2

Safety of olaparib plus bevacizumab in older (≥70 years) and younger (<70 years patients

Conclusion*Among older patients in PAOLA-1, olaparib plus bevacizumab maintenance had a manageable safety profile and had no adverse impact on GHS. Median PFS in older patients was similar to the overall population. Analyses stratified by GVS will provide further insight into the safety profile of maintenance olaparib plus bevacizumab in older patients.

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