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

BRCA1, BRCA2

Germline BRCA1 or BRCA2 variants: sensitivity to PARP inhibitors, adjuvant olaparib for 12 months

This study reports real-world data from the French early access programme for adjuvant olaparib in patients carrying a germline BRCA1 or BRCA2 variant with high-risk HER2-negative early breast cancer, after neoadjuvant or adjuvant chemotherapy and local treatment. Between March 2022 and September 2024, 308 of 320 access requests were approved and 217 patients were treated (70.5%), with a median follow-up of 10.1 months; 59.1% of tumours were triple-negative and median age was 45 years. Nearly all treated patients (95.9%) started at 300 mg twice daily, and 64.0% had a treatment change: interruption (33.6%) or dose modification (30.4%). Treatment-related adverse events occurred in 31.3% of patients, serious adverse events in 8.7%, with 10.1% discontinuing for adverse events, no myelodysplastic syndrome or acute myeloid leukemia, and a stable global quality-of-life score. Recurrence occurred in 5 of 217 patients (2.3%), with no new safety signals.

Synthesis written by Geno'X. For the full original abstract, please refer to the source publication.

These data confirm the feasibility of adjuvant olaparib in French practice, with no new safety signals, but a median follow-up of 10.1 months says nothing about long-term efficacy. The drop in quality-of-life questionnaires, from 85 patients at baseline to 26 at 12 months, limits the scope of this result. For the geneticist, the message remains the urgency of germline testing at diagnosis, since eligibility for adjuvant treatment depends on it.

Analysis by Dr Thibaut Benquey