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

Balmaña J, Fasching P, Couch FJ, Delaloge S, Labidi-Galy I, O’Shaughnessy J, Park YH, Eisen AF, You B, Bourgeois H, Gonçalves A, Kemp Z, Swampillai A, Jankowski T, Sohn JH, Poddubskaya E, Mukhametshina G, Aksoy S, Timcheva CV, Park-Simon TW, Antón-Torres A, John E, Baria K, Gibson I, Gelmon KA (2023)

Publication Type: Journal article

Publication year: 2023

Journal

DOI: 10.1007/s10549-023-07165-x

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. Clinical trial registration: Clinical trials registration number: NCT03286842.

Authors with CRIS profile

Involved external institutions

Institut Gustave-Roussy France (FR) Geneva University Hospitals / Hôpitaux universitaires de Genève (HUG) Switzerland (CH) Baylor University Medical Center United States (USA) (US) Sungkyunkwan University (SKKU) Korea, Republic of (KR) Sunnybrook Health Sciences Centre Canada (CA) Centre Hospitalier Lyon Sud (CHLS) France (FR) Centre Jean Bernard: Institut Inter-régional de Cancérologie France (FR) Institute Paoli-Calmettes France (FR) Royal Marsden Hospital / The Royal Marsden NHS Foundation Trust United Kingdom (GB) Guy's and St Thomas' (NHS Foundation Trust) United Kingdom (GB) Medical University of Lublin / Uniwersytet Medyczny w Lublinie Poland (PL) Yonsei University Health System (YUHS) Korea, Republic of (KR) Ministry of Health of the Republic of Tatarstan / Министерство здравоохранения Республики Татарстан Russian Federation (RU) Hacettepe University Turkey (TR) Nadezhda Hospital Bulgaria (BG) Medizinische Hochschule Hannover (MHH) / Hannover Medical School Germany (DE) Hospital Universitario Miguel Servet Spain (ES) AstraZeneca UK Limited United Kingdom (GB) Mayo Clinic United States (USA) (US) University of British Columbia Canada (CA) Vall d'Hebron University Hospital / Hospital Universitari Vall d'Hebron Spain (ES)

How to cite

APA:

Balmaña, J., Fasching, P., Couch, F.J., Delaloge, S., Labidi-Galy, I., O’Shaughnessy, J.,... Gelmon, K.A. (2023). Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY. Breast Cancer Research and Treatment. https://dx.doi.org/10.1007/s10549-023-07165-x

MLA:

Balmaña, Judith, et al. "Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY." Breast Cancer Research and Treatment (2023).

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