Real-World Data on Olaparib in Relapsed BRCA-mutated Ovarian Cancer: A Multicenter GINECO RETROLA Cohort Study

Anticancer Res. 2023 Feb;43(2):653-662. doi: 10.21873/anticanres.16202.

Abstract

Background/aim: Olaparib was approved in 2014 by the European Medicines Agency (EMA) as maintenance treatment for patients with breast cancer gene (BRCA)-mutated platinum-sensitive relapsed high-grade epithelial ovarian cancer (EOC) following the results of the Study 19. We present the results of a national real-world study on the effectiveness of olaparib in relapsed BRCA-mutated EOC patients.

Patients and methods: Patients with EOC, peritoneal, and/or fallopian-tube cancer treated with olaparib in a French Center between May 2014 and March 2017 were included. The primary end-point of the study was progression-free survival.

Results: Of the 128 patients analyzed, 89 were treated according to the EMA label. The median progression-free survival was 17.0 months. The most common treatment-related toxicity was fatigue. Treatment-related myelodysplastic syndrome (n=5) and a second cancer (n=1) were diagnosed.

Conclusion: In this real-life setting, olaparib confirmed its efficacy and safety profile, as previously shown in clinical trials.

Keywords: BRCA; BRCA mutation; Ovarian cancer; PARPi; olaparib; platinum; relapsed ovarian cancer; routine clinical practice.

Publication types

  • Multicenter Study

MeSH terms

  • Antineoplastic Agents* / therapeutic use
  • Carcinoma, Ovarian Epithelial / drug therapy
  • Carcinoma, Ovarian Epithelial / genetics
  • Cohort Studies
  • Female
  • Humans
  • Neoplasm Recurrence, Local / drug therapy
  • Neoplasm Recurrence, Local / genetics
  • Ovarian Neoplasms* / drug therapy
  • Ovarian Neoplasms* / genetics
  • Phthalazines / adverse effects

Substances

  • Antineoplastic Agents
  • olaparib
  • Phthalazines