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404 Olaparib vs placebo as maintenance therapy after platinum based chemotherapy in advanced/metastatic endometrial cancer patients: the GINECO randomized phase IIb UTOLA trial
  1. Florence Joly1,
  2. Alexandra Leary2,
  3. Isabelle Ray-Coquard3,4,
  4. Bernard Asselain4,
  5. Manuel Rodrigues5,
  6. Laurence Gladieff6,
  7. Fernando Bazan7,
  8. Sophie Abadie-Lacourtoisie8,
  9. Coriolan Lebreton9,
  10. Leïla Bengrine Lefevre10,
  11. Karen Leroy11,
  12. Raphaël Leman1,
  13. Pierre Fournel12,
  14. Rémy Largillier13,
  15. Frédéric Selle14,
  16. Jean-Sebastien Frenel15,
  17. Yolanda Fernandez16,
  18. Cyril Foa17,
  19. Benoit You18 and
  20. Jérôme Alexandre19
  1. 1Centre François Baclesse, Caen, France
  2. 2Cancer Medicine department, Institut de Cancérologie Gustave Roussy, Villejuif, France
  3. 3Centre Léon Bérard, Lyon, France
  4. 4GINECO, Paris, France
  5. 5Department of Medical Oncology, INSERM U830, Institut Curie, Paris, France
  6. 6Institut Claudius Regaud - IUCT Oncopole, Toulouse, France
  7. 7Departement of Medical Oncology, CHRU Besançon-Hôpital Jean Minjoz, Besançon, France
  8. 8Department of Oncology, Institut de Cancérologie de l’Ouest, Site Paul Papin, Angers, France
  9. 9Institut Bergonié, Bordeaux, France
  10. 10Department of Oncology, Centre Georges François Leclerc, Dijon, France
  11. 11Department of genomic medicine for tumours and cancers, Hôpital Européen Georges Pompidou, Paris, France
  12. 12CHU de Saint-Etienne, Saint-Etienne, France
  13. 13Centre Azuréen de Cancérologie, Mougins, France
  14. 14Hospital Diaconesses-Croix St Simon, Paris, France
  15. 15Institut de Cancerologie de L'ouest, Nantes, France
  16. 16Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandoeuvre-Les-Nancy, France
  17. 17Department of Medical Oncology, Hôpital Saint-Joseph, Marseille, France
  18. 18Centre Hospitalier Lyon-Sud, Lyon, France
  19. 19Université de Paris Cité, Hôpital Cochin, Paris, France


Introduction/Background UTOLA assessed the efficacy of Parp-inhibitor for advanced/M+ EC pts without progression after 1st line platinum CT and to analyse efficacy in some molecular subgroups.

Methodology UTOLA is a 2/1 randomized, double-blind, placebo controlled, phase IIb trial, comparing olaparib maintenance (ola, 300 mg po BID) vs placebo (pl) until progression or intolerance with stratification on P53, MMR status, and the response to the previous CT. Primary endpoint was PFS in ITT. Main secondary endpoints were PFS according to P53 status, CT response, OS, safety. A pre-specified PFS analysis was performed according to NGS-HRD status (large genomic events).

Results 147 pts were randomized (98 to Ola, 49 to pl). 82% of the pts received at least 6 cycles of CT with 46 CR, 64 PR, 34 stable and 3 NED; tumor classification was 53% P53mut (n=75), 35% NSMP, 12% MMRd, and 1 tumor POLEmut. In total, 52% (73) were HRD positive, 79% in P53mut.

Median PFS in the ITT population was 5.6 mos (90%CI 3.8–7.4) and 4.0 (3.6–7.4) in ola and pl arms respectively (HR:0.94, p=0.29). Median PFS in P53mut were 5.6 mos (3.6–8.8) vs 3.6 ms (1.8–4.9) in ola and pl arms (HR:0.75, p=0.12) whereas 6.1 mos (3.6–11) vs 7.7 mos (2.9–14.5) (HR=1.13, p=0.3) in the P53WT.

In the HRD tumors (n=73), median PFS was 5.4 mos (90%CI 3.6–9.6) vs 3.6 mos (1.8–4.9) with pl (HR:0.59) regardless of P53 status. For the 46 pts with CR to previous CT, median PFS in ola arm reached 8.8 mos versus 3.8 mos. No difference for OS was observed.

Safety profile was similar as seen in other cancers (36% vs 10% of G3/4 toxicities).

Conclusion UTOLA suggests maintenance ola could prolong PFS in P53 +/- HRD-positive advanced/M+ EC. These data should be confirmed and warrants further PARP inhibitor studies in this population.

Disclosures COI cf. attached

This study was funded by AstraZeneca.

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