Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY
Copyright policy )Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting: final analysis of LUCY
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
- Aix-Marseille University France
- Hacettepe University Turkey
- Sunnybrook Health Science Centre Canada
- Wrocław Medical University Poland
- Samsung Medical Center Korea (Republic of)
Adult, Breast Neoplasms / drug therapy, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Breast cancer; Breast cancer 1 gene product; Breast cancer 2 gene product; Kaplan–Meier survival curves; Olaparib; Overall survival; Progression-free survival, Medicaments antineoplàstics - Ús terapèutic, Breast Neoplasms, Breast cancer 2 gene product, Breast cancer 1 gene product, Piperazines, Breast cancer, Olaparib, 616, Antineoplastic Combined Chemotherapy Protocols / adverse effects, Antineoplastic Combined Chemotherapy Protocols, Humans, Overall survival, Germ-Line Mutation, Other subheadings::Other subheadings::Other subheadings::/drug therapy, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, Progression-free survival, Clinical Trial, Female [MeSH] ; Olaparib ; Adult [MeSH] ; Breast cancer 2 gene product ; Humans [MeSH] ; Clinical Trial ; Breast Neoplasms/genetics [MeSH] ; Breast cancer ; Treatment Outcome [MeSH] ; Breast Neoplasms/drug therapy [MeSH] ; Overall survival ; Breast cancer 1 gene product ; Antineoplastic Combined Chemotherapy Protocols/adverse effects [MeSH] ; Piperazines [MeSH] ; Germ-Line Mutation [MeSH] ; Kaplan–Meier survival curves ; Progression-free survival ; Phthalazines/adverse effects [MeSH], Breast Neoplasms / genetics, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, Treatment Outcome, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos, Mama - Càncer - Tractament, Avaluació de resultats (Assistència sanitària), Phthalazines, Female, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama, Phthalazines / adverse effects, DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms, Kaplan–Meier survival curves, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
Adult, Breast Neoplasms / drug therapy, Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia, Breast cancer; Breast cancer 1 gene product; Breast cancer 2 gene product; Kaplan–Meier survival curves; Olaparib; Overall survival; Progression-free survival, Medicaments antineoplàstics - Ús terapèutic, Breast Neoplasms, Breast cancer 2 gene product, Breast cancer 1 gene product, Piperazines, Breast cancer, Olaparib, 616, Antineoplastic Combined Chemotherapy Protocols / adverse effects, Antineoplastic Combined Chemotherapy Protocols, Humans, Overall survival, Germ-Line Mutation, Other subheadings::Other subheadings::Other subheadings::/drug therapy, ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome, Progression-free survival, Clinical Trial, Female [MeSH] ; Olaparib ; Adult [MeSH] ; Breast cancer 2 gene product ; Humans [MeSH] ; Clinical Trial ; Breast Neoplasms/genetics [MeSH] ; Breast cancer ; Treatment Outcome [MeSH] ; Breast Neoplasms/drug therapy [MeSH] ; Overall survival ; Breast cancer 1 gene product ; Antineoplastic Combined Chemotherapy Protocols/adverse effects [MeSH] ; Piperazines [MeSH] ; Germ-Line Mutation [MeSH] ; Kaplan–Meier survival curves ; Progression-free survival ; Phthalazines/adverse effects [MeSH], Breast Neoplasms / genetics, TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento, Treatment Outcome, COMPUESTOS QUÍMICOS Y DROGAS::acciones y usos químicos::acciones farmacológicas::usos terapéuticos::antineoplásicos, Mama - Càncer - Tractament, Avaluació de resultats (Assistència sanitària), Phthalazines, Female, ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias de la mama, Phthalazines / adverse effects, DISEASES::Neoplasms::Neoplasms by Site::Breast Neoplasms, Kaplan–Meier survival curves, CHEMICALS AND DRUGS::Chemical Actions and Uses::Pharmacologic Actions::Therapeutic Uses::Antineoplastic Agents
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