Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY

Research output: Contribution to journalResearch articleContributedpeer-review

Contributors

  • The LUCY investigators - (Author)
  • Judith Balmaña - , Vall d'Hebron Institute of Oncology (VHIO) (Author)
  • Peter A. Fasching - , Friedrich-Alexander University Erlangen-Nürnberg (Author)
  • Fergus J. Couch - , Mayo Clinic Rochester, MN (Author)
  • Suzette Delaloge - , Institut Gustave Roussy (Author)
  • Intidhar Labidi-Galy - , Geneva University Hospitals (Author)
  • Joyce O’Shaughnessy - , Baylor University Medical Center at Dallas (Author)
  • Yeon Hee Park - , Samsung Medical Center (Author)
  • Andrea F. Eisen - , University of Toronto (Author)
  • Benoit You - , Hospices civils de Lyon, Universite Claude Bernard Lyon 1, Association for Research in Gynecological Cancers (ARCAGY) (Author)
  • Hughes Bourgeois - , Jean Bernard Center (Author)
  • Anthony Gonçalves - , Institut Paoli Calmettes, Centre de Recherche en Cancerologie de Marseille (Author)
  • Zoe Kemp - , Royal Marsden NHS Foundation Trust (Author)
  • Angela Swampillai - , Guy's and St Thomas' NHS Foundation Trust, King's College London (KCL) (Author)
  • Tomasz Jankowski - , Medical University of Lublin (Author)
  • Joo Hyuk Sohn - , Yonsei University (Author)
  • Elena Poddubskaya - , VitaMed (Author)
  • Guzel Mukhametshina - , Ministry of Health of the Republic of Tatarstan (Author)
  • Sercan Aksoy - , Hacettepe University (Author)
  • Constanta V. Timcheva - , Nadezhda Hospital (Author)
  • Tjoung Won Park-Simon - , Hannover Medical School (MHH) (Author)
  • Antonio Antón-Torres - , University of Zaragoza (Author)
  • Ellie John - , AstraZeneca (Author)
  • Katherine Baria - , AstraZeneca (Author)
  • Isabel Gibson - , AstraZeneca (Author)
  • Karen A. Gelmon - , University of British Columbia (Author)

Abstract

Purpose: The interim analysis of the phase IIIb LUCY trial demonstrated the clinical effectiveness of olaparib in patients with germline BRCA-mutated (gBRCAm), human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer (mBC), with median progression-free survival (PFS) of 8.11 months, which was similar to that in the olaparib arm of the phase III OlympiAD trial (7.03 months). This prespecified analysis provides final overall survival (OS) and safety data. Methods: The open-label, single-arm LUCY trial of olaparib (300 mg, twice daily) enrolled adults with gBRCAm or somatic BRCA-mutated (sBRCAm), HER2-negative mBC. Patients had previously received a taxane or anthracycline for neoadjuvant/adjuvant or metastatic disease and up to two lines of chemotherapy for mBC. Results: Of 563 patients screened, 256 (gBRCAm, n = 253; sBRCAm, n = 3) were enrolled. In the gBRCAm cohort, median investigator-assessed PFS (primary endpoint) was 8.18 months and median OS was 24.94 months. Olaparib was clinically effective in all prespecified subgroups: hormone receptor status, previous chemotherapy for mBC, previous platinum-based chemotherapy (including by line of therapy), and previous cyclin-dependent kinase 4/6 inhibitor use. The most frequent treatment-emergent adverse events (TEAEs) were nausea (55.3%) and anemia (39.2%). Few patients (6.3%) discontinued olaparib owing to a TEAE. No deaths associated with AEs occurred during the study treatment or 30-day follow-up. Conclusion: The LUCY patient population reflects a real-world population in line with the licensed indication of olaparib in mBC. These findings support the clinical effectiveness and safety of olaparib in patients with gBRCAm, HER2-negative mBC.

Details

Original languageEnglish
Pages (from-to)237-248
Number of pages12
JournalBreast Cancer Research and Treatment
Volume204(2024)
Issue number2
Publication statusPublished - Apr 2024
Peer-reviewedYes

External IDs

PubMed 38112922

Keywords

Sustainable Development Goals

Keywords

  • Breast cancer, Breast cancer 1 gene product, Breast cancer 2 gene product, Kaplan–Meier survival curves, Olaparib, Overall survival, Progression-free survival