Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BRCA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial
© 2023. The Author(s)..
BACKGROUND: The efficacy and safety of olaparib compared with placebo in the subset of patients from Japan in the phase 3 OlympiA trial (NCT02032823) are reported here and contextualized with reference to the global OlympiA population.
METHODS: Patients with germline BRCA1 and/or BRCA2 pathogenic variants and HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy and completed local treatment were eligible. Patients were randomized 1:1 to receive olaparib or placebo for 1 year.
PRIMARY ENDPOINT: invasive disease-free survival (IDFS). Secondary endpoints: distant disease-free survival (DDFS), overall survival (OS), and safety. Data are reported from the first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) and the second, event driven, pre-specified interim analysis of OS (DCO July 12, 2021) in patients from Japan.
RESULTS: 140 patients were randomized in Japan (olaparib, n = 64; placebo, n = 76). At the first pre-specified interim analysis (median follow-up: 2.9 years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18-1.24) and 0.41 for DDFS (95% CI 0.11-1.16). At the second pre-specified interim analysis of OS, three deaths occurred in the olaparib group versus six deaths in the placebo group (HR, 0.62 [95% CI 0.13-2.36]). Findings were consistent with those for the global population. No new safety signals were observed.
CONCLUSIONS: While this analysis in a Japanese subset of patients was not powered to detect population-related treatment differences, efficacy and safety analysis results were consistent with the global OlympiA population, suggesting the findings from the global study are generalizable to clinical practice in Japan.
| Errataetall: |
CommentIn: Breast Cancer. 2023 Nov;30(6):1107. - PMID 37166624 |
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| Medienart: |
E-Artikel |
| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:30 |
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| Enthalten in: |
Breast cancer (Tokyo, Japan) - 30(2023), 4 vom: 02. Juli, Seite 596-605 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Yamauchi, Hideko [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 23.06.2023 Date Revised 22.12.2023 published: Print-Electronic CommentIn: Breast Cancer. 2023 Nov;30(6):1107. - PMID 37166624 Citation Status MEDLINE |
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| doi: |
10.1007/s12282-023-01451-8 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM355108186 |
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| 245 | 1 | 0 | |a Adjuvant olaparib in the subset of patients from Japan with BRCA1- or BRCA2-mutated high-risk early breast cancer from the phase 3 OlympiA trial |
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| 500 | |a Date Revised 22.12.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CommentIn: Breast Cancer. 2023 Nov;30(6):1107. - PMID 37166624 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023. The Author(s). | ||
| 520 | |a BACKGROUND: The efficacy and safety of olaparib compared with placebo in the subset of patients from Japan in the phase 3 OlympiA trial (NCT02032823) are reported here and contextualized with reference to the global OlympiA population | ||
| 520 | |a METHODS: Patients with germline BRCA1 and/or BRCA2 pathogenic variants and HER2-negative, high-risk early breast cancer who had received neoadjuvant or adjuvant chemotherapy and completed local treatment were eligible. Patients were randomized 1:1 to receive olaparib or placebo for 1 year | ||
| 520 | |a PRIMARY ENDPOINT: invasive disease-free survival (IDFS). Secondary endpoints: distant disease-free survival (DDFS), overall survival (OS), and safety. Data are reported from the first pre-specified interim analysis (data cut-off [DCO] March 27, 2020) and the second, event driven, pre-specified interim analysis of OS (DCO July 12, 2021) in patients from Japan | ||
| 520 | |a RESULTS: 140 patients were randomized in Japan (olaparib, n = 64; placebo, n = 76). At the first pre-specified interim analysis (median follow-up: 2.9 years), hazard ratios (HRs) for adjuvant olaparib compared with placebo were 0.5 for IDFS (95% confidence interval [CI] 0.18-1.24) and 0.41 for DDFS (95% CI 0.11-1.16). At the second pre-specified interim analysis of OS, three deaths occurred in the olaparib group versus six deaths in the placebo group (HR, 0.62 [95% CI 0.13-2.36]). Findings were consistent with those for the global population. No new safety signals were observed | ||
| 520 | |a CONCLUSIONS: While this analysis in a Japanese subset of patients was not powered to detect population-related treatment differences, efficacy and safety analysis results were consistent with the global OlympiA population, suggesting the findings from the global study are generalizable to clinical practice in Japan | ||
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