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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

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    Authors
    Geyer, C. E., Jr.
    Garber, J. E.
    Gelber, R. D.
    Yothers, G.
    Taboada, M.
    Ross, L.
    Rastogi, P.
    Cui, K.
    Arahmani, A.
    Aktan, G.
    Armstrong, Anne C
    Arnedos, M.
    Balmaña, J.
    Bergh, J.
    Bliss, J.
    Delaloge, S.
    Domchek, S. M.
    Eisen, A.
    Elsafy, F.
    Fein, L. E.
    Fielding, A.
    Ford, J. M.
    Friedman, S.
    Gelmon, K. A.
    Gianni, L.
    Gnant, M.
    Hollingsworth, S. J.
    Im, S. A.
    Jager, A.
    Jóhannsson, Ó.
    Lakhani, S. R.
    Janni, W.
    Linderholm, B.
    Liu, T. W.
    Loman, N.
    Korde, L.
    Loibl, S.
    Lucas, P. C.
    Marmé, F.
    Martinez de Dueñas, E.
    McConnell, R.
    Phillips, K. A.
    Piccart, M.
    Rossi, G.
    Schmutzler, R.
    Senkus, E.
    Shao, Z.
    Sharma, P.
    Singer, C. F.
    Španić, T.
    Stickeler, E.
    Toi, M.
    Traina, T. A.
    Viale, G.
    Zoppoli, G.
    Park, Y. H.
    Yerushalmi, R.
    Yang, H.
    Pang, D.
    Jung, K. H.
    Mailliez, A.
    Fan, Z.
    Tennevet, I.
    Zhang, J.
    Nagy, T.
    Sonke, G. S.
    Sun, Q.
    Parton, M.
    Colleoni, M. A.
    Schmidt, M.
    Brufsky, A. M.
    Razaq, W.
    Kaufman, B.
    Cameron, D.
    Campbell, C.
    Tutt, A. N. J.
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    Affiliation
    NRG Oncology/NSABP Foundation, Pittsburgh, USA; Department of Medicine, UPMC Hillman Cancer Center, Pittsburgh, PA, USA
    Issue Date
    2022
    
    Metadata
    Show full item record
    Abstract
    Background: The randomized, double-blind OlympiA trial compared one 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 (HER2)-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: 1,836 patients were randomly assigned to olaparib or placebo following (neo)adjuvant chemotherapy (N)ACT, 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 median follow-up of 3.5 years, the second IA of OS demonstrated significant improvement in the olaparib-group relative to the placebo-group (HR, 0.68; 98.5% CI 0.47 to 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 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 myelogenous leukemia or myelodysplastic syndrome (AML/MDS). 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.
    Citation
    Geyer CE, Jr., Garber JE, Gelber RD, Yothers G, Taboada M, Ross L, et al. 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. Annals of oncology : official journal of the European Society for Medical Oncology. 2022 Oct 10. PubMed PMID: 36228963. Epub 2022/10/14. eng.
    Journal
    Annals of Oncology
    URI
    http://hdl.handle.net/10541/625717
    DOI
    10.1016/j.annonc.2022.09.159
    PubMed ID
    36228963
    Additional Links
    https://dx.doi.org/10.1016/j.annonc.2022.09.159
    Type
    Article
    Language
    en
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.annonc.2022.09.159
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