Adjuvant olaparib for patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer: real-world data from a French early access program.
5 affiliations
- 1Medical Oncology Department, Institut de Cancérologie de l'Ouest René Gauducheau, Saint-Herblain, Nantes Université, Nantes, France.
- 2Department of Medical Oncology, Aix-Marseille University, CNRS, INSERM, Institut Paoli-Calmettes, CRCM, Marseille, France.
- 3Medical Oncology Department, Centre François Baclesse, Caen, France.
- 4Medical Oncology Department, Centre Henri Becquerel, Rouen, France.
- 5Department 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.
Related
- Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2- -associated high-risk HER2-negative early breast cancer: Updated results from the OlympiA phase III trial
- BRCA2 reversion mutations as a resistance mechanism to olaparib in patients with BRCA2-mutated mCRPC: a case series
- Olaparib plus tremelimumab in women with recurrent ovarian cancer and a germline BRCA1 or BRCA2 mutation: a phase I/II study
- Postoperative ctDNA could potentially spare patients from unnecessary adjuvant therapy in HPV-negative head and neck squamous cell carcinoma: a meta-analysis
- Real-World Treatment Utilization and Patterns of Adjuvant Olaparib for Early-Stage Breast Cancer: Insights from the Komodo Research Database.
BibTeX
@article{frenel2026adjuvant,
title = {{Adjuvant olaparib for patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer: real-world data from a French early access program.}},
author = {J-S Frenel and A Gonçalves and J Quintin and A Johnson and C Alexandru and N Olympios and O Rigal and C Bonnard and A Lahouegue and F Lazreg and D Suau and A Debbache and A de Nonneville},
journal = {ESMO real world data and digital oncology},
year = {2026},
month = sep,
doi = {10.1016/j.esmorw.2026.100793},
url = {https://europepmc.org/article/MED/42927328},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Adjuvant olaparib for patients with germline BRCA-mutated, high-risk, HER2-negative early breast cancer: real-world data from a French early access program.
AU - J-S Frenel
AU - A Gonçalves
AU - J Quintin
AU - A Johnson
AU - C Alexandru
AU - N Olympios
AU - O Rigal
AU - C Bonnard
AU - A Lahouegue
AU - F Lazreg
AU - D Suau
AU - A Debbache
AU - A de Nonneville
PY - 2026
DA - 2026/09/22
JO - ESMO real world data and digital oncology
DO - 10.1016/j.esmorw.2026.100793
UR - https://europepmc.org/article/MED/42927328
AB - 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.
SN - 2949-8201
ER -