Talazoparib versus chemotherapy in patients with germline BRCA1/2-mutated HER2-negative advanced breast cancer: final overall survival results from the EMBRACA trial
- Authors
- Litton, J.K.[Litton, J.K.]; Hurvitz, S.A.[Hurvitz, S.A.]; Mina, L.A.[Mina, L.A.]; Rugo, H.S.[Rugo, H.S.]; Lee, K.-H.[Lee, K.-H.]; Gonçalves, A.[Gonçalves, A.]; Diab, S.[Diab, S.]; Woodward, N.[Woodward, N.]; Goodwin, A.[Goodwin, A.]; Yerushalmi, R.[Yerushalmi, R.]; Roché, H.[Roché, H.]; Im, Y.-H.[Im, Y.-H.]; Eiermann, W.[Eiermann, W.]; Quek, R.G.W.[Quek, R.G.W.]; Usari, T.[Usari, T.]; Lanzalone, S.[Lanzalone, S.]; Czibere, A.[Czibere, A.]; Blum, J.L.[Blum, J.L.]; Martin, M.[Martin, M.]; Ettl, J.[Ettl, J.]
- Issue Date
- Nov-2020
- Publisher
- Elsevier Ltd
- Keywords
- breast cancer; germline BRCA mutation; overall survival; PARP inhibitor; talazoparib
- Citation
- Annals of Oncology, v.31, no.11, pp.1526 - 1535
- Indexed
- SCIE
SCOPUS
- Journal Title
- Annals of Oncology
- Volume
- 31
- Number
- 11
- Start Page
- 1526
- End Page
- 1535
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/25581
- DOI
- 10.1016/j.annonc.2020.08.2098
- ISSN
- 0923-7534
- Abstract
- Background: In EMBRACA, talazoparib prolonged progression-free survival versus chemotherapy (hazard ratio [HR] 0.542 [95% confidence interval (CI) 0.413-0.711]; P < 0.0001) and improved patient-reported outcomes (PRO) in germline BRCA1/2 (gBRCA1/2)-mutated advanced breast cancer (ABC). We report final overall survival (OS). Patients and methods: This randomized phase III trial enrolled patients with gBRCA1/2-mutated HER2-negative ABC. Patients received talazoparib or physician's choice of chemotherapy. OS was analyzed using stratified HR and log-rank test and prespecified rank-preserving structural failure time model to account for subsequent treatments. Results: A total of 431 patients were entered in a randomized study (287 talazoparib/144 chemotherapy) with 412 patients treated (286 talazoparib/126 chemotherapy). By 30 September 2019, 216 deaths (75.3%) occurred for talazoparib and 108 (75.0%) chemotherapy; median follow-up was 44.9 and 36.8 months, respectively. HR for OS with talazoparib versus chemotherapy was 0.848 (95% CI 0.670-1.073; P = 0.17); median (95% CI) 19.3 months (16.6-22.5 months) versus 19.5 months (17.4-22.4 months). Kaplan–Meier survival percentages (95% CI) for talazoparib versus chemotherapy: month 12, 71% (66% to 76%)/74% (66% to 81%); month 24, 42% (36% to 47%)/38% (30% to 47%); month 36, 27% (22% to 33%)/21% (14% to 29%). Most patients received subsequent treatments: for talazoparib and chemotherapy, 46.3%/41.7% received platinum and 4.5%/32.6% received a poly(ADP-ribose) polymerase (PARP) inhibitor, respectively. Adjusting for subsequent PARP and/or platinum use, HR for OS was 0.756 (95% bootstrap CI 0.503-1.029). Grade 3-4 adverse events occurred in 69.6% (talazoparib) and 64.3% (chemotherapy) patients, consistent with previous reports. Extended follow-up showed significant overall improvement and delay in time to definitive clinically meaningful deterioration in global health status/quality of life and breast symptoms favoring talazoparib versus chemotherapy (P < 0.01 for all), consistent with initial analyses. Conclusions: In gBRCA1/2-mutated HER2-negative ABC, talazoparib did not significantly improve OS over chemotherapy; subsequent treatments may have impacted analysis. Safety was consistent with previous observations. PRO continued to favor talazoparib. © 2020 The Authors
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