Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting : final analysis of LUCY
© 2023. The Author(s)..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:204 |
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| Enthalten in: |
Breast cancer research and treatment - 204(2024), 2 vom: 01. März, Seite 237-248 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Balmaña, Judith [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 19.03.2024 Date Revised 21.03.2024 published: Print-Electronic ClinicalTrials.gov: NCT03286842 Citation Status MEDLINE |
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| doi: |
10.1007/s10549-023-07165-x |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| 100 | 1 | |a Balmaña, Judith |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Clinical effectiveness and safety of olaparib in BRCA-mutated, HER2-negative metastatic breast cancer in a real-world setting |b final analysis of LUCY |
| 264 | 1 | |c 2024 | |
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| 500 | |a Date Completed 19.03.2024 | ||
| 500 | |a Date Revised 21.03.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a ClinicalTrials.gov: NCT03286842 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a CLINICAL TRIAL REGISTRATION: Clinical trials registration number: NCT03286842 | ||
| 650 | 4 | |a Clinical Trial, Phase III | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a Breast cancer 1 gene product | |
| 650 | 4 | |a Breast cancer 2 gene product | |
| 650 | 4 | |a Kaplan–Meier survival curves | |
| 650 | 4 | |a Olaparib | |
| 650 | 4 | |a Overall survival | |
| 650 | 4 | |a Progression-free survival | |
| 650 | 7 | |a olaparib |2 NLM | |
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| 650 | 7 | |a Phthalazines |2 NLM | |
| 650 | 7 | |a Piperazines |2 NLM | |
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| 700 | 1 | |a Couch, Fergus J |e verfasserin |4 aut | |
| 700 | 1 | |a Delaloge, Suzette |e verfasserin |4 aut | |
| 700 | 1 | |a Labidi-Galy, Intidhar |e verfasserin |4 aut | |
| 700 | 1 | |a O'Shaughnessy, Joyce |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Yeon Hee |e verfasserin |4 aut | |
| 700 | 1 | |a Eisen, Andrea F |e verfasserin |4 aut | |
| 700 | 1 | |a You, Benoit |e verfasserin |4 aut | |
| 700 | 1 | |a Bourgeois, Hughes |e verfasserin |4 aut | |
| 700 | 1 | |a Gonçalves, Anthony |e verfasserin |4 aut | |
| 700 | 1 | |a Kemp, Zoe |e verfasserin |4 aut | |
| 700 | 1 | |a Swampillai, Angela |e verfasserin |4 aut | |
| 700 | 1 | |a Jankowski, Tomasz |e verfasserin |4 aut | |
| 700 | 1 | |a Sohn, Joo Hyuk |e verfasserin |4 aut | |
| 700 | 1 | |a Poddubskaya, Elena |e verfasserin |4 aut | |
| 700 | 1 | |a Mukhametshina, Guzel |e verfasserin |4 aut | |
| 700 | 1 | |a Aksoy, Sercan |e verfasserin |4 aut | |
| 700 | 1 | |a Timcheva, Constanta V |e verfasserin |4 aut | |
| 700 | 1 | |a Park-Simon, Tjoung-Won |e verfasserin |4 aut | |
| 700 | 1 | |a Antón-Torres, Antonio |e verfasserin |4 aut | |
| 700 | 1 | |a John, Ellie |e verfasserin |4 aut | |
| 700 | 1 | |a Baria, Katherine |e verfasserin |4 aut | |
| 700 | 1 | |a Gibson, Isabel |e verfasserin |4 aut | |
| 700 | 1 | |a Gelmon, Karen A |e verfasserin |4 aut | |
| 700 | 0 | |a LUCY investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Koynova, Tatyana |e investigator |4 oth | |
| 700 | 1 | |a Popov, Vasil |e investigator |4 oth | |
| 700 | 1 | |a Timcheva, Constanta |e investigator |4 oth | |
| 700 | 1 | |a Tomova, Antoaneta |e investigator |4 oth | |
| 700 | 1 | |a Eisen, Andrea |e investigator |4 oth | |
| 700 | 1 | |a Gelmon, Karen |e investigator |4 oth | |
| 700 | 1 | |a Lemieux, Julie |e investigator |4 oth | |
| 700 | 1 | |a Augereau, Paule |e investigator |4 oth | |
| 700 | 1 | |a Bazan, Fernando |e investigator |4 oth | |
| 700 | 1 | |a Becuwe, Célia |e investigator |4 oth | |
| 700 | 1 | |a Bourgeois, Hugues |e investigator |4 oth | |
| 700 | 1 | |a Chakiba, Camille |e investigator |4 oth | |
| 700 | 1 | |a Chehimi, Mohamad |e investigator |4 oth | |
| 700 | 1 | |a Cheneau, Caroline |e investigator |4 oth | |
| 700 | 1 | |a Dalenc, Florence |e investigator |4 oth | |
| 700 | 1 | |a de Guillebon, Eléonore |e investigator |4 oth | |
| 700 | 1 | |a de La Motte Rouge, Thibault |e investigator |4 oth | |
| 700 | 1 | |a Frenel, Jean-Sébastien |e investigator |4 oth | |
| 700 | 1 | |a Gonçalves, Anthony |e investigator |4 oth | |
| 700 | 1 | |a Grenier, Julien |e investigator |4 oth | |
| 700 | 1 | |a Hardy-Bessard, Anne Claire |e investigator |4 oth | |
| 700 | 1 | |a Lamy, Regine |e investigator |4 oth | |
| 700 | 1 | |a Levy, Christelle |e investigator |4 oth | |
| 700 | 1 | |a Lortholary, Alain |e investigator |4 oth | |
| 700 | 1 | |a Mailliez, Audrey |e investigator |4 oth | |
| 700 | 1 | |a Medioni, Jacques |e investigator |4 oth | |
| 700 | 1 | |a Patsouris, Anne |e investigator |4 oth | |
| 700 | 1 | |a Spaeth, Dominique |e investigator |4 oth | |
| 700 | 1 | |a Teixeira, Luis |e investigator |4 oth | |
| 700 | 1 | |a Tennevet, Isabelle |e investigator |4 oth | |
| 700 | 1 | |a Venat-Bouvet, Laurence |e investigator |4 oth | |
| 700 | 1 | |a Villanueva, Cristian |e investigator |4 oth | |
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| 700 | 1 | |a Ettl, Johannes |e investigator |4 oth | |
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| 700 | 1 | |a Gerber, Bernd |e investigator |4 oth | |
| 700 | 1 | |a Hanusch, Claus Alexander |e investigator |4 oth | |
| 700 | 1 | |a Hoffmann, Oliver |e investigator |4 oth | |
| 700 | 1 | |a Park-Simon, Tjoung-Won |e investigator |4 oth | |
| 700 | 1 | |a Malter, Wolfram |e investigator |4 oth | |
| 700 | 1 | |a Reinisch, Mattea |e investigator |4 oth | |
| 700 | 1 | |a Tio, Joke |e investigator |4 oth | |
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| 700 | 1 | |a Cortesi, Enrico |e investigator |4 oth | |
| 700 | 1 | |a De Laurentiis, Michelino |e investigator |4 oth | |
| 700 | 1 | |a De Placido, Sabino |e investigator |4 oth | |
| 700 | 1 | |a Gianni, Luca |e investigator |4 oth | |
| 700 | 1 | |a Guarneri, Valentina |e investigator |4 oth | |
| 700 | 1 | |a Marchetti, Paulo |e investigator |4 oth | |
| 700 | 1 | |a Montemurro, Filippo |e investigator |4 oth | |
| 700 | 1 | |a Mosconi, Anna Maria |e investigator |4 oth | |
| 700 | 1 | |a Naso, Giuseppe |e investigator |4 oth | |
| 700 | 1 | |a Puglisi, Fabio |e investigator |4 oth | |
| 700 | 1 | |a Santoro, Armando |e investigator |4 oth | |
| 700 | 1 | |a Zamagni, Claudio |e investigator |4 oth | |
| 700 | 1 | |a Iwata, Hiroji |e investigator |4 oth | |
| 700 | 1 | |a Kim, Seung-Jin |e investigator |4 oth | |
| 700 | 1 | |a Nakamura, Seigo |e investigator |4 oth | |
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