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| Verfasst von: | Geyer, Charles Edward <Jr.> [VerfasserIn]  |
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| | Garber, J. E. [VerfasserIn] |
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| | Gelber, R. D. [VerfasserIn] |
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| | Yothers, G. [VerfasserIn] |
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| | Taboada, M. [VerfasserIn] |
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| | Ross, L. [VerfasserIn] |
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| | Rastogi, P. [VerfasserIn] |
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| | Cui, K. [VerfasserIn] |
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| | Arahmani, A. [VerfasserIn] |
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| | Aktan, G. [VerfasserIn] |
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| | Armstrong, A. C. [VerfasserIn] |
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| | Arnedos, M. [VerfasserIn] |
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| | Balmaña, J. [VerfasserIn] |
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| | Bergh, J. [VerfasserIn] |
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| | Bliss, J. [VerfasserIn] |
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| | Delaloge, S. [VerfasserIn] |
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| | Domchek, S. M. [VerfasserIn] |
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| | Eisen, A. [VerfasserIn] |
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| | Elsafy, F. [VerfasserIn] |
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| | Fein, L. E. [VerfasserIn] |
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| | Fielding, A. [VerfasserIn] |
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| | Ford, J. M. [VerfasserIn] |
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| | Friedman, S. [VerfasserIn] |
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| | Gelmon, K. A. [VerfasserIn] |
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| | Gianni, L. [VerfasserIn] |
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| | Gnant, M. [VerfasserIn] |
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| | Hollingsworth, S. J. [VerfasserIn] |
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| | Im, S.-A. [VerfasserIn] |
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| | Jager, A. [VerfasserIn] |
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| | Jóhannsson, Ó. Þ [VerfasserIn] |
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| | Lakhani, S. R. [VerfasserIn] |
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| | Janni, W. [VerfasserIn] |
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| | Linderholm, B. [VerfasserIn] |
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| | Liu, T.-W. [VerfasserIn] |
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| | Loman, N. [VerfasserIn] |
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| | Korde, L. [VerfasserIn] |
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| | Loibl, S. [VerfasserIn] |
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| | Lucas, P. C. [VerfasserIn] |
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| | Marmé, Frederik [VerfasserIn] |
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| | Martinez de Dueñas, E. [VerfasserIn] |
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| | McConnell, R. [VerfasserIn] |
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| | Phillips, K.-A. [VerfasserIn] |
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| | Piccart, M. [VerfasserIn] |
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| | Rossi, G. [VerfasserIn] |
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| | Schmutzler, R. [VerfasserIn] |
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| | Senkus, E. [VerfasserIn] |
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| | Shao, Z. [VerfasserIn] |
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| | Sharma, P. [VerfasserIn] |
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| | Singer, C. F. [VerfasserIn] |
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| | Španić, T. [VerfasserIn] |
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| | Stickeler, E. [VerfasserIn] |
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| | Toi, M. [VerfasserIn] |
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| | Traina, T. A. [VerfasserIn] |
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| | Viale, G. [VerfasserIn] |
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| | Zoppoli, G. [VerfasserIn] |
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| | Park, Y. H. [VerfasserIn] |
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| | Yerushalmi, R. [VerfasserIn] |
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| | Yang, H. [VerfasserIn] |
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| | Pang, D. [VerfasserIn] |
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| | Jung, K. H. [VerfasserIn] |
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| | Mailliez, A. [VerfasserIn] |
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| | Fan, Z. [VerfasserIn] |
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| | Tennevet, I. [VerfasserIn] |
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| | Zhang, J. [VerfasserIn] |
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| | Nagy, T. [VerfasserIn] |
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| | Sonke, G. S. [VerfasserIn] |
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| | Sun, Q. [VerfasserIn] |
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| | Parton, M. [VerfasserIn] |
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| | Colleoni, M. A. [VerfasserIn] |
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| | Schmidt, M. [VerfasserIn] |
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| | Brufsky, A. M. [VerfasserIn] |
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| | Razaq, W. [VerfasserIn] |
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| | Kaufman, B. [VerfasserIn] |
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| | Cameron, D. [VerfasserIn] |
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| | Campbell, C. [VerfasserIn] |
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| | Tutt, A. N. J. [VerfasserIn] |
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| Titel: | Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer |
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| Titelzusatz: | original article |
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| Verf.angabe: | C.E. Geyer, Jr., J.E. Garber, R.D. Gelber, G. Yothers, M. Taboada, L. Ross, P. Rastogi, K. Cui, A. Arahmani, G. Aktan, A.C. Armstrong, M. Arnedos, J. Balmaña, J. Bergh, J. Bliss, S. Delaloge, S.M. Domchek, A. Eisen, F. Elsafy, L.E. Fein, A. Fielding, J.M. Ford, S. Friedman, K.A. Gelmon, L. Gianni, M. Gnant, S.J. Hollingsworth, S.-A. Im, A. Jager, Ó.Þ Jóhannsson, S.R. Lakhani, W. Janni, B. Linderholm, T.-W. Liu, N. Loman, L. Korde, S. Loibl, P.C. Lucas, F. Marmé, E. Martinez de Dueñas, R. McConnell, K.-A. Phillips, M. Piccart, G. Rossi, R. Schmutzler, E. Senkus, Z. Shao, P. Sharma, C.F. Singer, T. Španić, E. Stickeler, M. Toi, T.A. Traina, G. Viale, G. Zoppoli, Y.H. Park, R. Yerushalmi, H. Yang, D. Pang, K.H. Jung, A. Mailliez, Z. Fan, I. Tennevet, J. Zhang, T. Nagy, G.S. Sonke, Q. Sun, M. Parton, M.A. Colleoni, M. Schmidt, A.M. Brufsky, W. Razaq, B. Kaufman, D. Cameron, C. Campbell and A.N.J. Tutt, and the OlympiA Clinical Trial Steering Committee and Investigators |
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| E-Jahr: | 2022 |
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| Jahr: | 28 November 2022 |
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| Umfang: | 19 S. |
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| Fussnoten: | Gesehen am 05.06.2023 ; Online veröffentlicht: 10 October 2022, Artikelversion: 28 November 2022 |
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| Titel Quelle: | Enthalten in: Annals of oncology |
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| Ort Quelle: | Amsterdam [u.a.] : Elsevier, 1990 |
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| Jahr Quelle: | 2022 |
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| Band/Heft Quelle: | 33(2022), 12 vom: Dez., Seite 1250-1268 |
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| ISSN Quelle: | 1569-8041 |
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| Abstract: | Background - The randomized, double-blind OlympiA trial compared 1 year of the oral poly(adenosine diphosphate-ribose) polymerase inhibitor, olaparib, to matching placebo as adjuvant therapy for patients with pathogenic or likely pathogenic variants in germline BRCA1 or BRCA2 (gBRCA1/2pv) and high-risk, human epidermal growth factor receptor 2-negative, early breast cancer (EBC). The first pre-specified interim analysis (IA) previously demonstrated statistically significant improvement in invasive disease-free survival (IDFS) and distant disease-free survival (DDFS). The olaparib group had fewer deaths than the placebo group, but the difference did not reach statistical significance for overall survival (OS). We now report the pre-specified second IA of OS with updates of IDFS, DDFS, and safety. - Patients and methods - One thousand eight hundred and thirty-six patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy, surgery, and radiation therapy if indicated. Endocrine therapy was given concurrently with study medication for hormone receptor-positive cancers. Statistical significance for OS at this IA required P < 0.015. - Results - With a median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib group relative to the placebo group [hazard ratio 0.68; 98.5% confidence interval (CI) 0.47-0.97; P = 0.009]. Four-year OS was 89.8% in the olaparib group and 86.4% in the placebo group (Δ 3.4%, 95% CI −0.1% to 6.8%). Four-year IDFS for the olaparib group versus placebo group was 82.7% versus 75.4% (Δ 7.3%, 95% CI 3.0% to 11.5%) and 4-year DDFS was 86.5% versus 79.1% (Δ 7.4%, 95% CI 3.6% to 11.3%), respectively. Subset analyses for OS, IDFS, and DDFS demonstrated benefit across major subgroups. No new safety signals were identified including no new cases of acute myeloid leukemia or myelodysplastic syndrome. - Conclusion - With 3.5 years of median follow-up, OlympiA demonstrates statistically significant improvement in OS with adjuvant olaparib compared with placebo for gBRCA1/2pv-associated EBC and maintained improvements in the previously reported, statistically significant endpoints of IDFS and DDFS with no new safety signals. |
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| DOI: | doi:10.1016/j.annonc.2022.09.159 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: https://doi.org/10.1016/j.annonc.2022.09.159 |
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| | Volltext: https://www.sciencedirect.com/science/article/pii/S0923753422041655 |
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| | DOI: https://doi.org/10.1016/j.annonc.2022.09.159 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | adjuvant therapy |
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| | breast cancer |
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| | olaparib |
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| | PARP inhibition |
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| K10plus-PPN: | 1847425054 |
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| Verknüpfungen: | → Zeitschrift |
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Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer / Geyer, Charles Edward <Jr.> [VerfasserIn]; 28 November 2022 (Online-Ressource)
