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Publications

Journal Article Epublish

PubMed: 42927328 DOI: 10.1016/j.esmorw.2026.100793

Adjuvant olaparib for patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer: real-world data from a French early access program.

ESMO Real World Data Digit Oncol 14:100793

Authors: J-S Frenel, A Gonçalves, J Quintin, A Johnson, C Alexandru, N Olympios, O Rigal, C Bonnard, A Lahouegue, F Lazreg, D Suau, A Debbache, A de Nonneville

Affiliations

  • Medical Oncology Department, Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain, Nantes Université, Nantes, France.
  • Department of Medical Oncology, Aix-Marseille University, CNRS, INSERM, Institut Paoli-Calmettes, CRCM, Marseille, France.
  • Medical Oncology Department, Centre François Baclesse, Caen, France.
  • Medical Oncology Department, Centre Henri Becquerel, Rouen, France.
  • Department of Oncology, Oncology Medical Affairs, AstraZeneca SAS, Courbevoie, France.

Abstract

BACKGROUND

In the OlympiA trial, adjuvant olaparib improved survival in patients with germline BRCA1/BRCA2 mutations (gBRCAm) and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (eBC). This analysis presents real-world data from the French-funded early access program for adjuvant olaparib.

PATIENTS AND METHODS

Eligible adults had gBRCAm and high-risk, HER2-negative eBC, and had received neoadjuvant/adjuvant chemotherapy plus local treatment. Data on olaparib dosing, adverse events (AEs), and health-related quality of life (QoL) were collected during the 12-month treatment period.

RESULTS

Between March 2022 and September 2024, 320 treatment access requests were submitted, of which 308 were approved, with treatment for 217 of the 308 patients (70.5%) at a median follow-up of 10.1 months. Triple-negative tumors were reported in 182 of 308 patients (59.1%) and hormone receptor-positive/HER2-negative tumors in 126 (40.9%). Median age was 45 years (range, 24-82). Most treated patients (208 of 217; 95.9%) started olaparib at 300 mg twice daily. Treatment changes occurred in 139 of 217 patients (64.0%), including interruptions (73 of 217; 33.6%) and dose modifications (66 of 217; 30.4%). Treatment-related AEs occurred in 68 of 217 patients (31.3%), serious AEs in 19 of 217 (8.7%), and AE-related discontinuations in 22 of 217 (10.1%). Two non-olaparib-related deaths occurred and no myelodysplastic syndrome/acute myeloid leukemia was reported. QoL data were available for 85 patients at baseline, decreasing to 26 at month 12. Median global health status/QoL score remained stable throughout treatment. Disease recurrence occurred in 5 of 217 patients (2.3%).

CONCLUSIONS

These real-world findings support adjuvant olaparib as standard-of-care in patients with gBRCAm and high-risk, HER2-negative eBC, with no new safety signals.

MeSH

Quality Of Life, Breast Neoplasms, Neoplasms, Breast, Therapeutics