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. 2023 Jun;10(2):207-213.
doi: 10.1007/s40801-022-00349-9. Epub 2023 Jan 11.

Olaparib First-Line Maintenance Monotherapy in BRCA-Mutated Epithelial Ovarian Cancer: Descriptive Analysis of the First French Real-World Data Study

Charlotte Bellier  1 , Laurence Gladieff  2 , Fanny Le Du  3 , Dominique Berton  4 , Charlotte Bonnard  5 , Delphine Suau  6 , Anne-Céline Richard  6 , Ophélie Brenner  6 , Amir Lahouegue  6 , Gilles Freyer  7 , Anne Floquet  8 , Sophie Frank  9 , Maria Kfoury  10
Affiliations

Olaparib First-Line Maintenance Monotherapy in BRCA-Mutated Epithelial Ovarian Cancer: Descriptive Analysis of the First French Real-World Data Study

Charlotte Bellier et al. Drugs Real World Outcomes. 2023 Jun.

Abstract

Background: Olaparib, a poly(ADP-ribose) polymerase inhibitor, was approved by the European Commission in June 2019, following the results of the SOLO-1/GOG 3004 trial as maintenance monotherapy in adult patients with BRCA-mutated epithelial ovarian cancer.

Objective: This study aimed to provide a descriptive analysis of the first real-world data from patients with BRCA-mutated ovarian cancer who received olaparib as first-line maintenance monotherapy in the French cohort Temporary Authorisation for Use (Autorisation Temporaire d'Utilisation de cohorte, ATUc) programme from 11 March, 2019 to 16 January, 2020.

Methods: Eligible patients were aged 18 years and over with confirmed epithelial ovarian, primary peritoneal or Fallopian tube cancer and a deleterious or suspected deleterious germline or somatic BRCA 1/2 mutation. Patients were in complete or partial clinical response at the end of first-line platinum-based chemotherapy. Olaparib maintenance therapy was initiated within 8 weeks of the patients' last dose of chemotherapy. Real-world data were collected through treatment access request forms completed by physicians. Clinical and safety data were collected monthly until the end of the ATUc programme.

Results: A total of 107 centres in metropolitan France and the French Overseas Departments and Territories requested the inclusion for 238 patients, of whom 194 received maintenance olaparib. In total, 87.6% of the primary tumour locations were ovary, the most common histology was high-grade serous (93.0%) and the most common International Federation of Gynaecology and Obstetrics (Fédération Internationale de Gynécologie et d'Obstétrique) stage was IIIC (56.8%). BRCA testing was performed in routine practice, prior to inclusion into the ATUc programme. All patients had a BRCA mutation: 52.5% had a somatic mutation, 38.4% had a germinal mutation and 9.1% had germinal and somatic mutations. Twenty-four (12%) patients experienced serious adverse drug reactions at the last safety follow-up (17 February, 2020). The most common were anaemia (12 [6%] patients), neutropenia (3 [2%] patients) and thrombocytopenia (3 [2%] patients).

Conclusions: The rapid enrolment into the ATUc programme highlighted the strong unmet need for patients with ovarian cancer and a BRCA mutation in first-line maintenance treatment. Olaparib was well tolerated and no new safety signals were observed in this real-world patient population.

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Conflict of interest statement

CB, DB and CF declare no conflicts of interest. LG declares honoraria and consulting/advisory board work for AstraZeneca. FL declares honoraria for consulting or advisory board work for Daiichi Sankyo, Lilly, Seagen, Novartis, Pfizer, Roche and Sandoz and travel fees from Daiichi Sankyo, Lilly, Novartis, Pfizer and Pierre Fabre and serves as a speaker for Amgen, Lilly, Novartis and Pierre Fabre. GF declares honoraria and advisory board work for AstraZeneca, BMS, Clovis Oncology, GSK, Lilly, MSD, Novartis and Pfizer. AF declares honoraria and congress and presentation work for AstraZeneca, GSK and Clovis Oncology. MK declares honoraria as a speaker for AstraZeneca and consultancy work for GSK.

Figures

Fig. 1
Fig. 1
Geographical distribution of requesting physicians in metropolitan France
See this image and copyright information in PMC

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